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.

FDA Warns Curaleaf About Marketing of CBD Products

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning a large cannabis company to stop making unsubstantiated claims that its products can treat chronic pain, cancer, opioid withdrawal and other medical conditions.

An FDA warning letter was sent to Curaleaf, a Massachusetts-based company that sells cannabidiol (CBD) products online and in stores, and operates dispensaries in a dozen states. CVS Health responded to the FDA letter by pulling some Curaleaf products off its store shelves.

“Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” acting FDA Commissioner Ned Sharpless, MD, said in a statement. “Consumers should beware of purchasing or using any such products.”

Curaleaf, which claims to be the largest cannabis operator in the United States, makes an extensive line of CBD lotions, creams, oils and skin patches.

It recently began marketing a line of CBD products for pets to treat pain, spasms, anxiety and inflammation in animals.

The FDA’s warning letter to Curaleaf cited a number of unapproved marketing claims made by the company online and in social media, including:

• “CBD was effective in killing human breast cancer cells.”

• “CBD has been linked to the effective treatment of Alzheimer’s disease…”

• “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”

• “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”

• “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”

The FDA gave Curaleaf 15 working days to respond. Failure to correct the violations could result in legal action, including seizure of the company’s products.

“Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency's letter,” the company said in a statement.

“Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company's cultivation and manufacturing processes.”

CBD Products Loosely Regulated

Unlike prescription drugs approved by the FDA, the manufacturing process for CBD products is not subject to FDA review, and there has been no FDA evaluation of their effectiveness, proper dosage, how they could interact with drugs, or whether they have side effects.

Despite the lack of regulatory oversight, there has been explosive growth for CBD companies and their products are starting to appear in mainstream stores. In March, CVS Pharmacy and Walgreens started selling CBD lotions, tinctures, edibles and lozenges — including some made by Curaleaf.

“The only Curaleaf products we are selling are its CBD lotion and CBD transdermal patches,” CVS said in a statement. “Following the FDA’s warning letter to Curaleaf, we will be removing these items from our CBD offering.”  

The FDA sent similar warning letters to three cannabis operators in April. Until now, the enforcement actions have been sporadic and only targeted small companies.

“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, MD.

“We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related to other types of CBD products.”

The FDA held a public hearing on the issue in May, and opened a docket for public comments to obtain scientific data about the safety, manufacturing, quality, marketing, labeling and sale of CBD products. Nearly 4,500 comments were received. The agency plans to report on its progress this fall.

This week Curaleaf announced it will acquire GR Companies, a large cannabis retailer, in a cash and stock deal valued at $875 million. Curaleaf said the purchase solidifies it’s position as “the world's largest cannabis company by revenue and the largest in the U.S. across key operating metrics.”

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.

Common Meds Can Cause Cognition Problems in Seniors

By Judith Graham, Kaiser Health News

By all accounts the woman, in her late 60s, appeared to have severe dementia. She was largely incoherent. Her short-term memory was terrible. She couldn’t focus on questions that medical professionals asked her.

But Dr. Malaz Boustani, a professor of aging research at Indiana University School of Medicine, suspected something else might be going on. The patient was taking Benadryl for seasonal allergies, another antihistamine for itching, Seroquel (an antipsychotic medication) for mood fluctuations, as well as medications for urinary incontinence and gastrointestinal upset.

To various degrees, each of these drugs blocks an important chemical messenger in the brain, acetylcholine. Boustani thought the cumulative impact might be causing the woman’s cognitive difficulties.

He was right. Over six months, Boustani and a pharmacist took the patient off those medications and substituted alternative treatments. Miraculously, she appeared to recover completely. Her initial score on the Mini-Mental State Exam had been 11 of 30 — signifying severe dementia — and it shot up to 28, in the normal range.

An estimated 1 in 4 older adults take anticholinergic drugs — a wide-ranging class of medications used to treat allergies, insomnia, leaky bladders, diarrhea, dizziness, motion sickness, asthma, Parkinson’s disease, chronic obstructive pulmonary disease and various psychiatric disorders.

Older adults are highly susceptible to negative responses to these medications. Since 2012, anticholinergics have been featured prominently on the American Geriatrics Society Beers Criteria list of medications that are potentially inappropriate for seniors.

“The drugs that I’m most worried about in my clinic, when I need to think about what might be contributing to older patients’ memory loss or cognitive changes, are the anticholinergics,” said Dr. Rosemary Laird, a geriatrician and medical director of the Maturing Minds Clinic at AdventHealth in Winter Park, Fla.

Here’s what older adults should know about these drugs:

The Basics

Anticholinergic medications target acetylcholine, an important chemical messenger in the parasympathetic nervous system that dilates blood vessels and regulates muscle contractions, bodily secretions and heart rate, among other functions. In the brain, acetylcholine plays a key role in attention, concentration, and memory formation and consolidation.

Some medications have strong anticholinergic properties, others less so. Among prescription medicines with strong effects are antidepressants such as imipramine (brand name Trofanil), antihistamines such as hydroxyzine (Vistaril and Atarax), antipsychotics such as clozapine (Clozaril and FazaClo), antispasmodics such as dicyclomine (Bentyl) and drugs for urinary incontinence such as tolterodine (Detrol).

In addition to prescription medications, many common over-the-counter drugs have anticholinergic properties, including antihistamines such as Benadryl and Chlor-Trimeton and sleep aids such as Tylenol PM, Aleve PM and Nytol.

Common side effects include dizziness, confusion, drowsiness, disorientation, agitation, blurry vision, dry mouth, constipation, difficulty urinating and delirium, a sudden and acute change in consciousness.

Unfortunately, “physicians often attribute anticholinergic symptoms in elderly people to aging or age-related illness rather than the effects of drugs,” according to a research review by physicians at the Medical University of South Carolina and in Britain.

Seniors are more susceptible to adverse effects from these medications for several reasons: Their brains process acetylcholine less efficiently. The medications are more likely to cross the blood-brain barrier. And their bodies take longer to break down these drugs.

Long-Term Effects

In the late 1970s, researchers discovered that deficits in an enzyme that synthesizes acetylcholine were present in the brains of people with Alzheimer’s disease. “That put geriatricians and neurologists on alert, and the word went out: Don’t put older adults, especially those with cognitive dysfunction, on drugs with acetylcholine-blocking effects,” said Dr. Steven DeKosky, deputy director of the McKnight Brain Institute at the University of Florida.

Still, experts thought that the effects of anticholinergics were short-term and that if older patients stopped taking them, “that’s it — everything goes back to normal,” Boustani said.

Concerns mounted in the mid-2000s when researchers picked up signals that anticholinergic drugs could have a long-term effect, possibly leading to the death of brain neurons and the accumulation of plaques and tangles associated with neurodegeneration.

Since then several studies have noted an association between anticholinergics and a heightened risk of dementia. In late June, this risk was highlighted in a new report in JAMA Internal Medicine that examined more than 284,000 adults age 55 and older in Britain between 2004 and 2016.

The study found that more than half of these subjects had been prescribed at least one of 56 anticholinergic drugs. (Multiple prescriptions of these drugs were common as well.) People who took a daily dose of a strong anticholinergic for three years had a 49% increased risk of dementia. Effects were most pronounced for people who took anticholinergic antidepressants, antipsychotics, antiepileptic drugs and bladder control medications.

These findings don’t constitute proof that anticholinergic drugs cause dementia; they show only an association. But based on this study and earlier research, Boustani said, it now appears older adults who take strong anticholinergic medications for one to three years are vulnerable to long-term side effects.

Preventing Harm

Attention is now turning to how best to wean older adults off anticholinergics, and whether doing so might improve cognition or prevent dementia.

Researchers at Indiana University’s School of Medicine hope to answer these questions in two new studies, starting this fall, supported by $6.8 million in funding from the National Institute on Aging.

One will enroll 344 older adults who are taking anticholinergics and whose cognition is mildly impaired. A pharmacist will work with these patients and their physicians to take them off the medications, and patients’ cognition will be assessed every six months for two years.

The goal is to see whether patients’ brains “get better,” said Noll Campbell, a research scientist at Indiana University’s Regenstrief Institute and an assistant professor at Purdue University’s College of Pharmacy. If so, that would constitute evidence that anticholinergic drugs cause cognitive decline.

The second trial, involving 700 older adults, will examine whether an app that educates seniors about potential harms associated with anticholinergic medications and assigns a personalized risk score for dementia induces people to initiate conversations with physicians about getting off these drugs.

Moving patients off anticholinergic drugs requires “slow tapering down of medications” over three to six months, at a minimum, according to Nagham Ailabouni, a geriatric pharmacist at the University of Washington School of Pharmacy. In most cases, good treatment alternatives are available.

Advice for Older Adults

Seniors concerned about taking anticholinergic drugs “need to approach their primary care physician and talk about the risks versus the benefits of taking these medications,” said Shellina Scheiner, an assistant professor and clinical geriatric pharmacist at the University of Minnesota.

Don’t try stopping cold turkey or on your own. “People can become dependent on these drugs and experience withdrawal side effects such as agitation, dizziness, confusion and jitteriness,” Ailabouni said. “This can be managed, but you need to work with a medical provider.”

Also, “don’t make the assumption that if [a] drug is available over the counter that it’s automatically safe for your brain,” Boustani said. In general, he advises older adults to ask physicians about how all the medications they’re taking could affect their brain.

Finally, doctors should “not give anticholinergic medications to people with any type of dementia,” DeKosky said. “This will not only interfere with their memory but is likely to make them confused and interfere with their functioning.”

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.

Task Force: Canada's Chronic Pain Patients ‘Simply Deserve Better’

By Pat Anson, PNN Editor

In March, Health Canada created a new national task force to study how to prevent and treat chronic pain and remove barriers to pain treatment. Health Minister Ginette Petitpas Taylor called it “the first step in addressing the issue of chronic pain in this country.”

One in five Canadians lives with chronic pain and -- like their counterparts in the United States -- many have trouble just finding a doctor willing to treat them. Some patient advocates were skeptical of Health Canada’s task force and its plan to release an initial report this summer, followed by two more reports in 2020 and 2021. It sounded like bureaucratic foot dragging.

“We are happy they are actually acknowledging chronic pain is an issue. However, the time frame is wrong and a little bit too late,” said Barry Ulmer of the Chronic Pain Association of Canada (CPAC).

Four months later, that initial report from the task force has now been released. It calls pain a “significant public health issue” in Canada and admits the nation’s healthcare system often fails to treat pain patients. Efforts to rein in opioid prescribing — such as Canada’s opioid guideline — have made a bad situation worse.

“Some Canadians have been unable to access opioid medications when needed for pain and function. Others have faced undue barriers to obtaining or filling their opioid prescriptions, and some have had their opioid dose abruptly lowered or discontinued. This has resulted in unnecessary pain and suffering, and has led some Canadians to obtain illegal drugs to treat their pain,” the task force found.

“People living with pain have limited access to the services they require and often face stigma and undue suffering as a result of their condition. This stigma often intersects with other forms of discrimination related to poverty, housing and employment instability, mental illness, race and ethnicity, and other factors further complicating the challenge of living with pain. Canadians living with pain and their loved ones simply deserve better.”

Patients Not Believed

In its short history, the task force completed an ambitious review of pain care in Canada; holding public workshops, meeting with federal and local governments, and consulting with healthcare providers and researchers. Importantly, the panel also reached out to the pain community and invited 12 Canadians living with chronic pain to share their experiences. Many said they had poor access to pain care or were not believed by healthcare providers.

“I was bounced between various outpatient clinics and utilizing the ER multiple times a month and making no progress,” one patent said. “I was consistently questioned whether or not I was making up the pain for attention, or if the pain was due to a mental health condition.” 

“While I am fortunate to be seen periodically by a pain specialist, I do not have access to a multidisciplinary pain clinic where key services, such as physiotherapy and psychology are provided. Many patients in my community have even less (or no) access to a pain specialist and are unduly suffering as a result. They do not know where to turn,” another patient said.

“I found the transition from the pediatric pain clinic to the adult pain clinic very difficult. At the pediatric pain clinic they have a multi-disciplinary team, which include a psychologist, a physiotherapist, a nurse, and a pain specialist. At the adult pain clinic they only have a physician who is amazing but is overstretched, sometimes I can only get an appointment every 6 months,” another patient told the task force. 

Pain Education Lacking

Improving pain education in Canada’s medical schools was one of the first goals identified by the task force. In a review of 10 Canadian universities, the panel found that 68% of the medical programs were not providing any designated hours for pain education.  Incredibly, veterinary students receive 2 to 5 times more pain education than that of health science students.

The panel also found that pain care in Canada is largely dependent on where people live and what type of insurance they have; that pain patients need better access to psychological support, physical therapies and other healthcare services; and that more research and better evidence is needed to help providers make informed decisions on pain care.

“This report makes Health Canada aware of what Canadians with pain have known for too long: that pain care is largely not accessible, many health care providers lack the knowledge and skills to manage pain and breakthroughs in research are hampered by lack of funding,” said Maria Hudspith, co-chair of the task force and Executive Director of Pain BC, a patient advocacy group in British Columbia.

“We hope this report lays the foundation for a national pain strategy that will improve the lives of Canadians who live with pain.”

Not everyone is happy with the direction the task force is taking. CPAC called it a “knee jerk” reaction to the pain crisis that continues to spread stigma about pain patients and their use of opioid medication.

“You see it again in this report,” CPAC’s Ulmer said in a statement. “Pain patients are supposedly often mentally ill—somehow, the need for relief has been recast as mental illness, though it seems pretty sane to me. And patients are repeatedly said to be at high risk of addiction.”

Last month, a federal task force in the U.S. released a final report on recommended best practices for pain management. It found nearly identical problems as the panel in Canada — and called for a balanced approach to pain treatment that focuses on individualized patient care, not rigid prescribing guidelines that have triggered a pain crisis for millions of Americans.

Finding Safe Shores From Suicidal Thoughts

By Mia Maysack, PNN columnist

When you have lost or almost lost loved ones to suicide, it changes you.  

My first experience with this happened at a young age and I took it very personally, even though it was an intimate, personal decision that didn't involve me. I guess that is one of the things that hurt most about it.  

Time passed, life was experienced and as my health conditions worsened, I found myself on the stone-cold ground of rock bottom -- which granted me a bittersweet comprehension of the temptations to end never-ending pain.

Years later, someone I cared for took her own life, after secretly enduring the late stages of terminal cancer. I’d witnessed that kind of suffering before during my days working in hospice care. This further reshaped my mind around the concept.

Of course, none of us want to lose anyone, especially in a way such as this, but the question does remain.  Which could be considered more “selfish” -- someone eliminating their life or someone else not wanting them to?

“I want to leave this earth because I feel as though I just can't do it anymore. It truly has nothing to do with anyone else. I am solely human and have reached my absolute breaking point.  Ultimately, I make my own decisions -- though it’s impossible to comprehend the ripple effect my actions will have on others.”

“I don't want you to leave this earth because I care so much about you. I know you feel as though you cannot do this anymore, but I am here for you and have a difficult time understanding why that isn't enough. I would do anything to ease your suffering. There are others who care and need you, so stick around for their sake.”   

The dialogue may as well be night and day, two entirely different realities.  Both lack consideration for the other on either end of the spectrum.  

Some pain sufferers may not have even one support person in their lives who they can turn to when the going gets tough, yet many seem to think the best way to deal with suicide is by not talking about it. They fear that by discussing it and making it real, somehow that will trigger chaos and we'll begin dropping like flies once the seed has been planted. 

The intent of this article is the exact opposite.

Recently I took part in a class where this topic was discussed in a small group session. To my left was a person who had been in pain their entire life. They were over it, pun fully intended, literally in the process of orchestrating a move to someplace where assisted suicide is legal. 

To my right was someone also in pain, who was squeamish about the subject and could not begin to relate to it.

Then there was me, a splash of irony right there in the middle.

Not too long ago, I took a mental health day at a local beach along Lake Michigan. When I am able to swim, my skills are strong. But as I approached my targeted distance, weather conditions shifted and I was both pulled under and pushed back. It was as though I'd been swept into a riptide and under current at the same time.  

At this point, I was exhausted and in low temperature water far longer than anticipated. Swirling thoughts crashed into my mind, much like the waves that had begun to cover my face. If I'm not able to move into shore I will die.

I've made it through worse, and there's no way this is how it's going to end-- not without a fight. So I powered through the water at full force until I felt as I could no longer – which is when the tip of my toes could finally touch the sand bar.  With a touch of hypothermia and major shock to the system, I made it.     

This is everyday life with chronic pain and illness. The emotions can submerge and escort us to the very edge of sanity, a tsunami that can swallow us whole and leave us fighting for every breath. Sometimes these ailments are much like anchors on our feet, shackling us to inevitable trenches of darkness and gloom.    

Many who can relate to these experiences are traumatized by judgmental stigma, so it's important that we acknowledge it is not only understandable but also normal to feel defeated. 

Observing these feelings as opposed to just absorbing them is a way of co-existence. The relationship with oneself is critical. At some of our lowest points, it is within us to choose the direction of our sails and head to safer shores.   

When navigating the treachery of these waters, our pursuit of quality of life against all odds presents itself as proof that we can make it through this and that we're in it together. We just gotta Keep Our Heads Up!  

If you or someone you know is contemplating suicide, PLEASE REACH OUT 

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

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.

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.”

The Future of CBD

By Roger Chriss, PNN Columnist

Is CBD a medical miracle or just another over-hyped health fad? The cannabinoid known as cannabidiol (CBD) is appearing in hundreds of foods, drinks and health products – even though we know little about its potential harms and benefits. Recent research runs the gamut, suggesting that CBD can fight superbug infections or cause liver damage.

A review of 35 clinical studies found CBD effective in treating anxiety and epilepsy, but there was no evidence it works for diabetes, Crohn's disease, ocular hypertension, fatty liver disease or chronic pain.

But there may be some untapped possibilities. Ingenious bench science and clinical research is improving our understanding of how CBD acts in the body, which is leading to new drugs with impressive potential for treating serious illnesses.

How Does CBD Work?

In simple terms, no one knows. CBD doesn’t seem to act directly on the cannabinoid receptors CB1 and CB2, although it does have some activity in serotonin 5HT1A, GRP55, and TRPV1 receptors that regulate anxiety, inflammation and pain sensation.  

Although none of these receptors is directly involved in seizures, CBD is being used successfully to treat epilepsy and other seizure disorders. CBD in the highly-purified form Epidiolex is FDA-approved as “add-on therapy” for Dravet syndrome and Lennox-Gastaut syndrome, two rare childhood seizure disorders.

New pharmacological research suggests that CBD may reduce seizure frequency through a “drug-drug interaction” rather than as an anti-seizure medication in and of itself.

In other words, whatever CBD is doing probably involves a host of small nudges often described as endocannabinoid activity. This makes for a complex set of interactions and contraindications, many still not well understood.  

New Drugs Derived from CBD

CBD acts on too many receptors in too many ways to make for predictable clinical effects. And at high doses CBD is potentially toxic to both the liver and nerves over the long term. But understanding this activity is helping guide research.

A potent CBD-derived compound called KLS-13019 has a more targeted effect on receptors and is being studied as a treatment for some neurological conditions.

Even more promising is EHP-101, an oral formulation of a synthetic CBD molecule that helped repair myelin around damaged nerve fibers in mice. This is an exciting if preliminary finding that may have potential for treating multiple sclerosis (MS). Emerald Health Therapeutics is planning to launch a Phase II clinical trial of EHP-101 in MS patients by the end of the year.

“Restoring the myelin sheath around nerves, or remyelination, would be considered a ‘Holy Grail’ outcome in the treatment of MS,” Jim DeMesa, MD, CEO of Emerald Health Pharmaceuticals, said in a statement. “These preclinical data provide the first evidence of remyelination with our lead clinical-stage drug product candidate and provide promising evidence for the possibility to treat, and potentially reverse, several forms of MS in the future.”

CBD itself may have uses as a wellness product for otherwise healthy people. It is certainly an appealing indulgence. But CBD-derived products that avoid the complications of CBD while taking advantage of specific activity learned from studying CBD are showing great promise.

New drugs replace old drugs all the time. Aspirin was outclassed by ibuprofen and naproxen, barbiturates by benzodiazepines, and MAO inhibitors by TCAs and more recently SSRIs. CBD may fade as a pharmaceutical, but its descendants could be the wonder drugs that CBD is often touted as.

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.

A Survival Guide for Opioid Withdrawal

By Crystal Lindell, PNN Columnist

Maybe your doctor cut off from your medications. Maybe you had a pain flare and ran out of pills a week before your next scheduled refill. Maybe you just don’t want to deal with opioids anymore because they’re harder to get than Beyonce tickets.

Whatever your reason for going off opioids, it’s likely you’ll have to deal with physical withdrawal — especially if you’ve been taking them for a while. But there are ways to minimize the symptoms.

I also would be remiss if I didn’t mention that my boyfriend, Chris — who also has chronic pain and gone through opioid withdrawal more than once — helped me compile and write this list.

So from two people who’ve gone through it more than a few times, here is our opioid withdrawal survival guide:

1. Talk to a doctor first

If you have access to a doctor, and you feel comfortable doing so, talk to her about it. I’m not a doctor, I’m just a patient, so please keep that in mind with everything else I say.

2. Be aware of what the symptoms are

Know thy enemy, as they say. There are a lot of symptoms caused by opioid withdrawal that you may not be expecting — especially if your only reference point is pop culture. I like to say that opioids sort of shut down your systems, and withdrawal turns everything back on at full volume.

You’ll probably experience some or all the following, and they’ll likely start kicking in within about 24-48 hours.

• Diarrhea

• Nausea and vomiting

• Sneezing and runny nose

• Anxiety and panic attacks

• Fatigue (Your natural instinct may be to reach for caffeine or other stimulants, but be careful. They likely will just make your anxiety worse and it won’t touch your fatigue)

• Insomnia

• Sweating

• Yawning and watery eyes

• Restless legs (Your legs move on their own while you’re sitting or lying down. I know, I thought it was fake too, but it is very real and difficult to deal with).

• Muscle aches

• Goosebumps

• Dilated pupils

• Hyper-libido and increased sex drive (Remember, opioids turned off everything and withdrawal turns it back on)

• Increased fertility (Being on opioids can make it difficult to get pregnant and withdrawal will have the opposite effect. If you want to avoid pregnancy, make sure to use birth control)

• Thrill-seeking behavior and mood swings (As the ups of your day give way to the lows, you may find yourself seeking out risky behavior as a way to improve your mood and receive the adrenaline that you so desperately crave).

3. Suicidal thoughts

I wanted to pull this one out separately from the other symptoms because it’s potentially so dangerous.

There are a lot of news reports about opioid users who kill themselves after they get clean. Reporters often frame it as though the person got off opioids, took a look around and decided that what’s left of their life just wasn’t worth living. That’s not usually the case though. Withdrawal itself will make you suicidal.

The good news? Knowing it’s being caused by withdrawal and not by crappy life circumstances may make it easier to push through it.

The best way to combat this symptom is to know it might happen and have a plan in place to deal with it if does. I once went seven days without any opioids when I had a full-on, hours long anxiety attack and planned to kill myself. I eventually gave in and took just one small hydrocodone, and within an hour my mind and spirit had calmed.

Which brings me to my next piece of advice.

4. Taper, Taper, Taper

Popular culture has perpetuated the idea that quitting opioids is all about will power. That’s a bunch of B.S.

Most relapses occur because people don’t properly taper their dose. Regardless of why you take opioids, your body has likely gotten accustomed to having them, just like it would have gotten used to a heart medication.

The best and safest way to successfully get unaccustomed to opioids is to taper off them as slowly as possible.

What does that look like? Well, if you take five pills a day, go to four for a couple weeks (yes, weeks), then three, then two, then one, and then even half. I personally noticed a lot of symptoms even going from one pill a day to zero — so if you can split a pill in half, do that.

If you are using drugs illegally, tapering might look a little different. One thing you can do to taper is switch to a weaker drug. Another important step would be changing how you take it. So if you’re snorting it, switch to taking it orally as part of the tapering process. If you’re injecting, try taking it in any other fashion that will allow you to bridge the gap.

5. Consider using kratom

Of course, tapering only works if you still have access to pills or drugs. If you don’t — there’s still help available. Kratom is your new best friend. It will drastically reduce your withdrawal symptoms.

Personally, I think kratom is also a good long-term solution for chronic pain and is a lot milder than pharmaceutical-grade opioids. Assuming it’s legal in your state, kratom is much easier to get than opioids and does not require a prescription. You can get kratom online, at most smoke shops, and even some gas stations.

For the record, the FDA has not approved kratom for any medical condition — including addiction treatment. And some researchers say kratom is a public health threat because it is unregulated.

6. Consider using marijuana

If you can’t get kratom for whatever reason, marijuana will also help you taper down. Edibles in particular will help with insomnia, anxiety, muscle aches, and restless legs.

But beware, if you haven’t taken edibles before, even a very small dose may knock you out for a few hours.

7. OTC medications

There are some over-the-counter medications that will help reduce symptoms:

• Imodium (to help with diarrhea and nausea)

• Benadryl (to help with the sneezing and insomnia)

• Tylenol (to help with aches and pains)

• B1, B12, multivitamins and potassium (to help replenish what your body loses from the sweating and diarrhea, which is a huge step toward feeling better)

8. Avoid alcohol

You may be tempted to reach for a glass of wine or a shot of vodka to ease your symptoms — but trust me, they will just come roaring back even stronger after it quickly wears off. Try all other options before you resort to a stiff drink.

9. Consider Suboxone and methadone

Depending on what you were taking and for how long, you may not be able to get through withdrawal without medication assistance treatment.

Suboxone (buprenorphine) and methadone are two opioid medications that can help you through withdrawal, and they are medically proven to be effective. You’ll have to get both from a doctor, and they may not be covered by insurance. But they may also be your best shot at getting off opioids long-term.

10. Don’t go back to your old dose

You start off strong. You tell yourself you’ll never take even one more hydrocodone again. But seven days later, the hell of withdrawal has finally beaten you down enough that you decide it’s just not worth it.

It’s okay. It happens. It doesn’t mean you’re a bad person.

BUT DO NOT TAKE YOUR OLD DOSE!

I can’t be clear enough about this. In just one short week, your body’s tolerance levels have already shifted. And your old dose is going to hit you like a freight train. It may even be strong enough to kill you.

Sadly, this is how a lot of opioid users die. They assume their bodies can handle the same fentanyl patch they were using just a short seven days ago, and it’s suddenly way too strong. This can also happen when someone goes through a formal rehab program, gets out and goes right back to their old dose. It’s enough to stop their breathing.

You may have heard of this phenomenon when it comes to celebrity deaths, like Cory Monteith from Glee. As it explains on Monteith’s Wikipedia page: “After a period of cessation from opioid drug use, a previously tolerated drug concentration level may become toxic and fatal.”

In other words, he was just clean enough for the opioids to kill him.

Even if you’re used to a small dose, like 60mg of hydrocodone a day, once you’ve gone through a couple days of withdrawal, those 60mg are going to hit you incredibly hard.

11. Have Narcan on hand

Along those same lines, I highly recommend you have Narcan (naloxone) on hand just in case, as it can reverse the symptoms of an overdose and potentially save your life. In many states you can even it get it over-the-counter, without a prescription.

Narcan is one of those things you think you’ll never need until you need it. I keep a dose in my house because I regularly take prescription opioids and I want to be as safe as possible. Even if you don’t personally need it, you never know if a child or someone else might find your medications. And you’ll want to have it on hand if that happens.

12. Remember it’s a marathon

In the movies, withdrawal is like three days and then you’re healed. Even though most of the physical symptoms will be gone in about a week, you can still have withdrawal symptoms for up to two years.

It’s called Post-Acute Withdrawal Syndrome (PAWS) and it can include things like panic attacks, insomnia, restless legs, anxiety, risk taking behavior and suicidal thoughts.

13. Get help from family and friends

It’s so important to have a least a couple friends or family members around to help you through it. My best friend and my boyfriend are my go-to because I know they won’t judge me and they’ll be supportive.

If you have the option to be around another person as much as possible, definitely do that. They can help take your mind off the physical symptoms and help you cope with the long-term psychological ones you may experience. Anxiety is a lot easier to deal with when you’re hanging out with your best friend.

14. Find a therapist you trust

If you were getting opioids with a legitimate prescription from a legitimate doctor, you may not think you need long-term addiction treatment. But you still have a medical condition that warranted a long-term opioid prescription. That means you probably would benefit from having a therapist to talk to about how you’re coping with all of that.

Your doctor may be able to refer you to someone, and Psychology Today also has a decent directory. These days, you can even do it all online, with sites like Better Help, which offers access to counselors via phone and text.

I also personally found a low-dose SSRI helpful for dealing with the long-term anxiety and panic attacks, so you may want to talk to your doctor about an antidepressant or anti-anxiety medication.

15. Don’t be too hard on yourself

You’re doing better than you think you’re doing, I promise.

And we’re all rooting for you. You’ve got this.

Crystal Lindell is a journalist who lives in Illinois. She eats too much Taco Bell, drinks too much espresso, and spends too much time looking for the perfect pink lipstick. Crystal has hypermobile Ehlers-Danlos syndrome. 

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

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.

Medicare to Cover Acupuncture in Pilot Program

By Pat Anson, PNN Editor

A week after a federal report documented a significant decline in opioid prescriptions among Medicare beneficiaries, the Centers for Medicare & Medicaid Services (CMS) has taken a tentative step to cover acupuncture as an alternative treatment for chronic low back pain.

Under a CMS proposal, patients enrolled in clinical trials of acupuncture sponsored by the National Institutes of Health (NIH) or in studies approved by CMS would be covered under Medicare’s Part D program. CMS has been collaborating with the NIH in studying acupuncture as a treatment of chronic low back pain in adults 65 years of age and older.

In a statement, CMS acknowledged that while “questions remain” about acupuncture’s effectiveness, interest in the therapy had grown in recent years as a non-drug alternative to opioids.  

Acupuncture is an ancient Chinese form of treatment that involves the insertion of fine needles into various points on the body to alleviate pain and other symptoms.

“Chronic low back pain impacts many Medicare patients and is a leading reason for opioid prescribing,” said CMS Principal Deputy Administrator of Operations and Policy Kimberly Brandt. “Today’s proposed decision would provide Medicare patients who suffer from chronic low back pain with access to a nonpharmacologic treatment option and could help reduce reliance on prescription opioids.”

Currently, acupuncture is not covered by Medicare. CMS is inviting public comment on the proposal to gather evidence and help determine if acupuncture is appropriate for low back pain. Comments will be accepted through August 14.

“Defeating our country’s epidemic of opioid addiction requires identifying all possible ways to treat the very real problem of chronic pain, and this proposal would provide patients with new options while expanding our scientific understanding of alternative approaches to pain.” said Health and Human Services Secretary Alex Azar.

Spending on Opioids Peaked in 2015

Medicare Part D spending on opioid prescriptions has been falling for years. It peaked in 2015 at $4.2 billion and now stands at its lowest level since 2012, according to a report released last week by the HHS Office of Inspector General.

The decline in opioid prescriptions appears to be accelerating. Last year, 13.4 million Medicare beneficiaries received an opioid prescription, down from 14.1 million in 2017.

SOURCE: HHS OFFICE OF INSPECTOR GENERAL

The Inspector General identified over 350,000 Medicare patients as receiving high amounts of opioids, with an average daily dose great than 120 MME (morphine milligram equivalent) for at least three months. The CDC opioid guideline recommends that daily doses not exceed 90 MME.  

The report highlighted the case of an unnamed Pennsylvania woman who received 10,728 oxycodone tablets and 570 fentanyl patches in 2018. Her average daily dose was 2,900 MME. She received all of her opioid prescriptions from a single physician.

The report said there were 198 prescribers who “warrant further scrutiny” because they ordered high doses of opioids for multiple patients.

“Although these opioids may be necessary for some patients, prescribing to an unusually high number of beneficiaries at serious risk raises concerns. It may indicate that beneficiaries are receiving poorly coordinated care and could be in danger of overdose or dependence,” the report found.  “Prescribing to an unusually high number of beneficiaries at serious risk could also indicate that the prescriber is ordering medically unnecessary drugs, which could be diverted for resale or recreational use.”

Under a new federal law, CMS is required to identify and warn “outlier prescribers of opioids” on an annual basis about their prescribing patterns. Medicare insurers could also require high-risk patients to use selected pharmacies or prescribers for their opioid prescriptions.

When I Call Myself Disabled

By Barby Ingle, PNN Columnist

Recently an interesting hashtag started trending on Twitter: #WhenICallMyselfDisabled.

Cassie, a friend who also has chronic pain, sent me a message to make sure that I had seen it. I am so glad she did because it sparked something in me that I didn’t even know I had an opinion about.

There are so many people in the chronic pain community and we all have different disabilities, diseases, genetics, treatments, healthcare, etc. Even people with the same diseases and conditions can have different levels of disability.

There are many legal and governmental definitions of disability. For example, to qualify for Social Security disability, a person must have a physical or mental impairment that has lasted or is expected to last at least 12 months and which prevents them from doing a "substantial” amount of work.  

The American with Disabilities Act broadly defines disability as a physical or mental condition that substantially limits one or more major life activity.

Often healthy people have a tough time understanding what we live with or the challenges we face on a daily basis. That’s where #WhenICallMyselfDisabled comes in. It can help us explain our own personal definitions of disability and how being disabled impacts our lives.  

The first time I pulled up the hashtag on Twittter, I didn’t plan on sharing it. I was just reading through various tweets when my personal lightbulb went off. When did I start considering myself disabled? How do I define it?

Here’s how I responded on Twitter:

#WhenICallMyselfDisabled its because I do not know when I will be able 2 physically attend an event or have to leave early due to lights, noise, fatigue, having a seizure, a pain flare that no 1 can see but levels me, having an asthma attack from walking or smoke... I could go on pic.twitter.com/aEzxgKJZKH

— Barby Ingle 📣 (@BarbyIngle) July 5, 2019

Here's how some people responded to my Tweet:

 It's a life of pure hell isn't it? This is called living???😟😟😥

Oh, I can so relate hun. 💟

Me three. I’m tired & in constant pain. Don’t make me wait in lines, stand at counters, walk stairs, etc. It’s not cuz I’m lazy I gd walked 4,000 miles once! But of course, everyone assumes it’s cuz I’m unmotivated & they hope that pushing my limits is tough love lesson I need.  

I later went to Facebook and shared a longer version of my Twitter message:

#WhenICallMyselfDisabled it’s because I do not know when I will be able to physically attend an event or have to leave early due to lights, noise, fatigue, having a seizure, a pain flare that no 1 can see but levels me, migraine, having an asthma attack from walking or smoke... I could go on, when was the last time I slept, when is the last time I vomited from the pain, is my hand working or is the dystonia attacking today. I could go on and on!

I call myself disabled because I can’t sing, dance and cheer the way I used to. I could go on and on... Despite being disabled, I do my best to be my best and be the best me I can be. Being disabled just means it takes me longer, I have to find another way to accomplish things in life, I still have value and worth.

I didn’t know if my Facebook message would resonate or not.  I just had a feeling how powerful this hashtag could be in helping others understand we may look normal and fully functioning, but don’t take our looks for granted. Here are a few tweets I saw after my post on Facebook.

#WhenICallMyselfDisabled I am acknowledging that my body is different but normal.

#WhenICallMyselfDisabled I feel like I finally really understand my body and mind and can accept them as they are. I have so much more confidence moving through the world, and acceptance (from myself) that the accommodations I need aren't laziness or selfishness.  

My Facebook message received more than 80 likes, comments and shares, so I know it resonated with my pain friends and “non-disabled” friends. It was an outpouring of support and helped lift stigmas that society often puts on people who need some extra help, assistance or time.  

Knowing that no matter what disability I have that I still have value and worth makes me feel so much better. I’m glad the hashtag trended. It could have been a pity hashtag, but I found it to be socially educational and meaningful. I am glad so many others joined in before and after me. A message like this can go a long way to change how we are viewed.  

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.  

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.

Stem Cell Fearmongering

By A. Rahman Ford, PNN Columnist

In a recent Canadian Medical Association Journal case report, Canadian researchers report the case of a 38-year-old man who suffered an adverse event from a very specific form of stem cell therapy – an olfactory mucosa graft.

Rather than simply present the medical particulars of the case itself, the authors proceed to make a broad indictment of stem cell therapy (SCT) as a whole. This politicization is unnecessary, irresponsible and patently unscientific.

Furthermore, it undermines the objectivity of the research itself and regrettably continues the trend of SCT fearmongering prevalent in certain mainstream publications like STAT and the Los Angeles Times, which immediately ran with the story, pushing a fear-based narrative.

In the procedure in question, nasal cells were transplanted into a spinal cord lesion that resulted from a spinal fraction that occurred when the patient was 20 years old, leaving him partially paralyzed .

He had the olfactory mucosa graft in Portugal at age 26 to potentially treat his pain and paralysis. The treatment was unsuccessful.

A dozen years later, the patient experienced deteriorating neurological function and doctors discovered a large mass on his spine “with mucinious material and tissue consistent with ectopic olfactory mucosa.”

This discovery confirmed the doctors’ preoperative diagnosis that the spinal mass was related to the stem cell procedure the patient had undergone years prior.

If the authors had stopped there, this could be considered an important contribution to the stem cell literature. Cases of adverse events from any medical procedure should be reported and taken seriously.

Unfortunately, the authors proceed much further to extrapolate wildly from their one very unique case of a very specific and experimental form of SCT. Rather than present the data and their scientific analysis, they stray into the political, diminishing the overall value of their work. Sadly, the paper reads more like an op-ed rather than objective peer-reviewed research.

The paper’s most glaring and egregious problem is that it lumps all forms of SCT together with no mention of the different types of cells, different tissues those cells come from, different methods of administration of those cells, and the differences in the clinics offering those therapies. These distinctions are critical and the authors’ failure to discuss them is troubling to say the least.  

Instead, the authors condemn the stem cell “industry” in toto, lumping cosmetic and medical procedures together, with no justification as to why the two are technically comparable, and lamenting the phantom maelstrom of SCT adverse advents that curiously has yet to materialize.

The authors then make a rather supreme leap in logic with the unsubstantiated claim that, “although some of the reported adverse events might relate to surgical technique alone, others are likely the direct result of the yet unproven treatments using stem cells.”

They provide absolutely no evidentiary basis for such a sweeping claim. If a claim cannot be supported by evidence then it should not be made. Otherwise, anyone who reads the claim might be left to make reasonable inferences about professionalism, undisclosed subjectivities and possible hidden agendas.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

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

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.