‘Radical Shift’ Predicted in Fibromyalgia Diagnosis and Treatment

By Pat Anson, PNN Editor

New research has uncovered a previously unknown connection between fibromyalgia and the early stages of diabetes, which could dramatically change the way the chronic pain condition is diagnosed and treated.

In a small study of 23 fibromyalgia patients and two control groups, researchers at The University of Texas Medical Branch at Galveston (UTMB) were able to separate patients with fibromyalgia (FM) from healthy individuals using a common blood test for insulin resistance, or pre-diabetes. They then treated the fibromyalgia patients with a medication targeting insulin resistance (IR), which dramatically reduced their pain levels.

“Although preliminary, these findings suggest a pathogenetic relationship between FM and IR,  which may lead to a radical paradigm shift in the management of this disorder,” researchers reported in the online journal PlosOne.

Fibromyalgia is a poorly understood disorder that causes widespread body pain, fatigue, insomnia, headaches and mood swings. The cause is unknown, the symptoms are difficult to treat and there is no universally accepted way to diagnose it.

"Earlier studies discovered that insulin resistance causes dysfunction within the brain's small blood vessels. Since this issue is also present in fibromyalgia, we investigated whether insulin resistance is the missing link in this disorder," said Miguel Pappolla, MD, a professor of neurology at UTMB.

Pappolla and his colleagues found that patients with fibromyalgia can be identified by their hemoglobin A1c levels, a protein in red blood cells that reflects blood sugar levels. A1c tests are widely used to diagnose type 2 diabetes and pre-diabetes, and are routinely used in diabetes management.

Researchers say pre-diabetics with slightly elevated A1c levels carry a higher risk of developing widespread body pain, a hallmark of fibromyalgia and other chronic pain conditions.

"Considering the extensive research on fibromyalgia, we were puzzled that prior studies had overlooked this simple connection," said Pappolla. "The main reason for this oversight is that about half of fibromyalgia patients have A1c values currently considered within the normal range.

“However, this is the first study to analyze these levels normalized for the person's age, as optimal A1c levels do vary throughout life. Adjustment for the patients' age was critical in highlighting the differences between patients and control subjects."

After identifying the fibromyalgia patients with elevated A1c levels, researchers treated them with metformin, an oral medication that manages insulin resistance by restoring normal blood sugar levels. The patients showed dramatic reductions in their pain levels, with half (8 of 16 patients) having a complete resolution of pain.

“Our data provides preliminary evidence suggesting that IR may be a pathological substratum in FM and sets the stage for future studies to confirm these initial observations. If confirmed, our findings may translate not only into a radical paradigm shift for the management of FM but may also save billions of dollars to healthcare systems around the world,” researchers reported.

Drug Diversion Widespread in Healthcare Facilities

By Pat Anson, PNN Editor

The Drug Enforcement Administration recently completed another National Prescription Drug Take Back Day, collecting over 468 tons of unused or expired medications. The idea is to get risky drugs – particularly opioids – out of medicine cabinets before they wind up on the streets.

“The current opioid crisis continues to take too many lives, and many people get their first pills to abuse from the home medicine cabinet,” said DEA New Jersey Special Agent in Charge Susan Gibson.

But the DEA’s Take Back program overlooks a growing problem in the healthcare industry: Opioid medications are increasingly being stolen before they even reach home medicine cabinets.

According to a new report by the healthcare analytics firm Protenus, over 47 million doses of medication were stolen in 2018 by doctors, nurses, pharmacists and other healthcare workers, an increase of 126% from the year before. Opioids were involved in 94% of the incidents, with oxycodone, hydrocodone and fentanyl the most common drugs stolen.

“For both doctors and nurses, the high stress of the profession, long shifts, fatigue, physical and emotional pain, along with easy access to controlled substances, contribute to why they might divert medications,” the report found.

“Drug diversion poses a great deal of harm to patients because it puts them at risk of being treated by care providers working under the influence of controlled substances as well as receiving the incorrect amount or type of medications.”

Among the incidents cited in the report are a Texas nurse stealing opioid medication from elderly patients and a Maryland pharmacist filling bogus opioid prescriptions in return for sexual favors. According to Protenus, the average amount of time it took to discover a case of healthcare drug diversion was 22 months, giving diverters plenty of time to continue their thefts and cover their tracks.

To combat in-house drug diversion, Protenus recommends that hospitals, pharmacies, nursing homes and other healthcare providers establish drug monitoring programs – similar to those used for patients – and educate their employees about detecting and preventing diversion.

“Drug diversion occurs in virtually every hospital and health system in America, but many are in denial that it is happening in their own organization,” said Russ Nix, Director of Drug Diversion Prevention at MedStar Health. “Very few resources exist today on how to identify and combat drug diversion, and what’s out there is siloed.”

Nix belongs to the advisory board of Healthcare Diversion Network, a new non-profit that has an online portal where healthcare employees can report drug thefts anonymously. The goal is to collect data and raise awareness about drug diversion in healthcare facilities. 

“I was really shocked when we put our initial database together at how many of those thefts were out of hospitals.”

— Tom Knight, Healthcare Diversion Network

“I think thefts out of home medicine cabinets happen, but I also know that thefts out of healthcare systems and hospitals happen,” said Tom Knight, Chairman of the Healthcare Diversion Network. “Many of those thefts are for self-use, where the person stealing is going to consume them themselves. But sadly, many of those thefts are where the person is planning to distribute them, typically for profit on the street illegally.

“I was really shocked when we put our initial database together at how many of those thefts were out of hospitals. There are numerous cases where people working in hospitals stole hundreds of thousands of doses that were sold on the street for years before they were eventually caught.”

Knight says about 10 percent of all healthcare workers are stealing opioids and other controlled substances. He told PNN there is no good data to indicate how much of the stolen medication sold on the street comes from medicine cabinets and how much comes from healthcare facilities or the drug distribution system.

“Pretty much anywhere they exist they’re being stolen. We’re trying to raise the visibility, particularly on the part of the healthcare facilities,” he said.

The Prescription Opioid Crisis Is Over

By Roger Chriss, PNN Columnist

In a very real sense, the prescription opioid crisis is over. But it didn’t end and we didn’t win. Instead, it has evolved into a broader drug overdose crisis. Opioids are still a factor, but so is almost every other class of drug, whether prescribed or sourced on the street.

The main players in the crisis now are illicit fentanyl, cocaine and methamphetamine. The vast majority of fatal overdoses include a mixture of these drugs, with alcohol and cannabis often present, and assigning any one as the sole cause of death is becoming tricky.

Connecticut Magazine recently reported on rising fentanyl overdoses in that state. According to the Office of the Chief Medical Examiner, fentanyl deaths in Connecticut spiked from 14 in 2012 to 760 in 2018. Fentanyl was involved in 75% of all overdoses last year, often in combination with other drugs

Meanwhile, overdoses involving the most widely prescribed opioid — oxycodone — fell to just 62 deaths, the lowest in years. Only about 6% of the overdoses in Connecticut were linked to oxycodone.

Similar trends can be seen nationwide, mostly east of the Mississippi. Opioids still play a major role in drug deaths, with the CDC reporting that about 68% of 70,200 drug overdose deaths in 2017 involving an opioid. But more than half of these deaths involved fentanyl and other synthetic opioids obtained on the black market.

According to the National Institute on Drug Abuse, overdoses involving prescription opioids or heroin have plateaued, while overdoses involving methamphetamine, cocaine and benzodiazepines have risen sharply.

In other words, deaths attributable to prescription opioids alone are in decline. Deaths attributable to fentanyl are spiking, and deaths involving most other drug class are rising rapidly. The CDC estimates that there are now more overdoses involving cocaine than prescription opioids or heroin.

Moreover, the crisis is evolving fast. At the American College of Medical Toxicology’s 2019 annual meeting, featured speaker Keith Humphreys, PhD, remarked that “Fentanyl was invented in the sixties. To get to 10,000 deaths took 50 years. To get to 20,000 took 12 months.”

In fact, provisional estimates from the CDC for 2018 suggest we have reached 30,000 fentanyl deaths. And state-level data show few signs of improvements for 2019.

Worryingly, methamphetamine use is resurgent. And cocaine is “making a deadly return.”  Illicit drugs are also being mixed together in novel ways, with “fentanyl speedballs” – a mixture of fentanyl with cocaine or meth – being one example.

Drug Strategies ‘Need to Evolve’

The over-emphasis on prescription opioids in the overdose crisis has led to an under-appreciation of these broader drug trends. Researchers are seeing a need for this to change.

“The rise in deaths involving cocaine and psychostimulants and the continuing evolution of the drug landscape indicate a need for a rapid, multifaceted, and broad approach that includes more timely and comprehensive surveillance efforts to inform tailored and effective prevention and response strategies,” CDC researchers reported last week. “Because some stimulant deaths are also increasing without opioid co-involvement, prevention and response strategies need to evolve accordingly.”   

It is now common to hear about the “biopsychosocial” model for treating chronic pain – understanding the complex interaction between human biology, psychology and social factors. This same model has a lot to offer substance use and drug policy.

Substance use and addiction involve a complex interplay of genetic and epigenetic factors combined with social and cultural determinants. Treatment must be more than just saying no or interdicting suppliers. At present, medication-assisted therapy for opioid use disorder remains hard to access. And other forms of addiction have no known pharmacological treatment.

Addressing the drug overdose crisis will require not only more and better treatment but also increased efforts at harm reduction, decriminalization of drug use, improvements in healthcare, and better public health surveillance and epidemiological monitoring. Further, the underlying social and cultural factors that make American culture so vulnerable to addiction must be addressed.

None of this is going to be easy. Current efforts are misdirected, making America feel helpless and look hapless. Novel and possibly disruptive options may prove useful, from treating addiction with psychedelics to reducing risks of drug use through safe injection sites and clean needle exchanges.

We are long past the prescription opioid phase of the crisis, and are now in what is variously being called a “stimulant phase” and a “poly-drug phase.” Recognition of the shape of the drug overdose crisis is an essential first step toward changing its grim trajectory.

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.

Is the DEA Overreaching Its Authority?

By Lynn Webster, MD, PNN Columnist 

The U.S. Department of Justice (DOJ) does not have the legal authority to determine which health care activities constitute a “legitimate medical purpose.” However, an increasing number of prescribers have been subjected to DOJ criminal investigations that operate under an expanded interpretation of federal law.

In 1970, Congress passed and President Nixon signed into law the Controlled Substances Act (CSA). In its broadest sense, the CSA regulates every aspect of controlled substances, from production to delivery, distribution, prescribing, possession and use. The CSA’s impact is far-reaching, touching many different sectors of our society, including healthcare, pharmaceuticals, law enforcement, politics, and state and federal judiciaries.

According to the CSA, a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” This statutory language is at the root of the issue. But who decides what is a legitimate medical purpose?

The Drug Enforcement Administration (DEA) is the branch of the DOJ that is tasked with enforcing the controlled substances laws and regulations of the United States.

In the context of trying to address the opioid crisis, the DEA has taken a proactive approach in determining which medical practices have a legitimate medical purpose and which do not. This hands-on approach is in direct contravention with the CSA. 

The DEA is effectively preempting state law as it relates to the regulation of controlled substances. In Gonzales v. Oregon, the U.S. Supreme Court ruled in 2006 that the authority to determine a legitimate medical purpose rests with state governments.

This means it is state lawmakers, not federal officials, who should regulate the practice of medicine. Medical boards are established by the authority of each state to protect the health, safety and welfare of patients through proper licensing and regulation of physicians and other practitioners.

If a doctor engages in an obviously nefarious activity, such as selling or trading prescriptions for sex or money, then that doctor is not in any way prescribing for a legitimate or legal medical purpose under the CSA. Remedies for this conduct would be within the authority of the DOJ, as well as state regulators.

The key phrases -- "legitimate medical purpose" and "in the usual course of a professional practice" -- are not defined in the CSA. This omission, unfortunately, has invited conjecture about the meaning of the phrases in recent years. The only way the phrase "legitimate medical purpose" would have any legal meaning would be if the concept of an "illegitimate medical purpose" were defined by the CSA -- and it is not.

Moreover, the words "legitimate" and "medical" are redundant. The practice of medicine is inherently legitimate, according to the CSA. The phrase "legitimate medical purpose" can be reduced to "medical purpose" without changing its meaning.

Any practice that is medical is legitimate and should be deemed consistent with the CSA regulation. The CSA, in other words, precludes the possibility that doctors who prescribe high doses of opioids have behaved criminally based only on the level of doses they prescribe.

Standard of Care

The DOJ is now using deviation from the “standard of care” to determine whether or not practitioners have a legitimate medical purpose to prescribe opioids. A standard of care is generally considered the customary or usual practice of the average physician.

In an attempt to address the opioid problem, the DOJ has hired medical experts who claim that any deviation from standard of care amounts to practicing without a legitimate medical purpose. In some instances, the government's experts have even used the CDC opioid guideline’s dose recommendation as a test of whether or not the prescribing of opioids has a legitimate medical purpose.

Using deviations from "standard of care" as criteria for compliance with the CSA is in direct conflict with the Supreme Court ruling in Gonzalez v Oregon, which found that the Attorney General “is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.”

Even substandard treatment by providers is not necessarily criminal behavior and should rarely involve prosecution by the DOJ. This is supported by a 1983 statement in a DEA newsletter that declares acts of prescribing or dispensing controlled substances lawful when they are done within the course of a provider’s professional practice. Even if a physician's behavior reflects the grossest form of medical misconduct or negligence, it is nevertheless legal.

The information provided in the newsletter isn't an opinion. It's the law.

Unquestionably, prescribers should be held to a high standard of care at all times. However, it is the responsibility of state medical boards to hold them to that standard. It is not the DOJ's role to determine the quality or boundaries of the practice of medicine.

 Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn 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.

Cancer Patient's Rite Aid Video Goes Viral

By Pat Anson, PNN Editor

April Doyle was frustrated and angry when she left a Rite Aid pharmacy Monday in her hometown of Visalia, California. A pharmacist there had once again refused to fill her prescription for opioid pain medication, so she got into her car and tearfully recorded a video that she uploaded to Twitter.

“I’m frustrated and that’s why I’m crying,” Doyle said, looking into her cell phone camera. “I’ve had a hard time getting my pain pills filled from them.”

Doyle’s story is a familiar one to millions of pain sufferers, who often have trouble getting their opioid prescriptions filled at pharmacies across the country. But her story is a bit different. The 40-year old single mom has Stage 4 terminal breast cancer that has metastasized into her lungs, spine and hip.  Doyle’s oncologist wrote a prescription for Norco — an opioid medication — to relieve some of her pain.  

“And when you have metastatic cancer in your bones, you need it.  Because sometimes the pain is so much you can’t even function. And I just want to function. I want to be able to go to work and I want to be able to sleep. And I want to be able to do things with my child.  I just want it not to hurt all the time,” Doyle said.

Within days, Doyle’s 6-minute video would go viral on Twitter and Facebook, where it’s been viewed over 200,000 times.  She’d also get apologies from a Rite Aid vice-president, the store manager and the pharmacist who refused to fill her prescription.

Doyle was no stranger at that Rite Aid store. It’s right around the corner from her house and she’s been shopping there for 20 years. It’s where she’s been getting her prescriptions filled for chemotherapy, anti-depressants and anti-nausea drugs — all written by her oncologist. But Rite Aid always seemed to have trouble filling that prescription for Norco. 

“I have to take 20 pills a day just to stay alive,” Doyle explains in the video. “Every time I take my pain pill prescription there, they give me the runaround. They don’t have enough in stock or they need me to come back tomorrow because they can’t fill it today. Or something stupid. It’s always something and it’s always some stupid excuse.”

Federal and state prescribing guidelines – and those of insurers – specifically exempt cancer pain from restrictions on opioid medication.  But some cancer patients still get turned away at pharmacies. According to Doyle, the Rite Aid pharmacist told her he was worried about being fined or even losing his job if he filled her opioid prescription.   

Some of that caution is understandable. Rite Aid and other major pharmacy chains were recently added as defendants in opioid lawsuits filed by the firm of Simmons Hanly Conroy. In the current climate of opioid hysteria and litigation, every step of the drug supply chain, from manufacturers to wholesalers to retailers is under scrutiny. Billions of dollars are at stake. Caught in the middle are pharmacists and patients like April Doyle.

“It’s not right. I’m not a criminal. I’m not a drug addict. I don’t even take them as often as my doctor says to take them. It’s not fair,” she said.

Astonished at Reaction

Doyle has been shocked at the response her video has gotten from the pain community. And surprised at how common her story is. Hundred of people left comments on Doyle’s Facebook page after watching her video.

“Stop giving your money to Rite Aid! You deserve dignity and great customer service,” one supporter wrote. “This whole opioid epidemic is making it impossible for those who medically need the meds. We all have our own story to share. This has to stop!”

“It’s hard to be sick and have people who don’t understand what you’re going through judge you,” said another supporter. “I hope you can find a pharmacy that will treat you with dignity and the compassion you deserve.”

“I know this oh too well trying to get my mom’s scripts filled when she was battling cancer running from store to store feeling and looking like a junkie. It was the most horrible part of it all!”  said another.

 “It’s astonishing the reaction it has gotten. I had no idea this was so common. It’s actually kind of sad how common it is,” Doyle told PNN. “It really struck a nerve with what’s apparently a big problem. I’m just dumbfounded by it.”

A Rite Aid spokesman said he could not comment on Doyle’s case.

“At Rite Aid, we are committed to providing high-quality care to all of our customers and patients. Rite Aid is not able to provide additional detail due to patient privacy,” Chris Savarese, Rite Aid Director of Public Relations said in an email.

Although the company has apologized to Doyle, she does not intend to go back to her neighborhood Rite Aid.

“I have decided to find a locally owned mom and pop pharmacy that really wants the business,” she said.

Shades of Grey

By Mia Maysack, PNN Columnist

A blonde walks into the mall, minding her own business, and sits down at a table in the food court.

A random dude calls out, "Don't you know it's rude to keep sunglasses on in here?"

That line felt like a punch to me.

"Well good sir, what can I say? My migraine lacks proper manners."

Yes, I wear sunglasses indoors because I'm cool like that. But it's also because after living with persistent and debilitating head pain for almost two decades, I need to wear sunglasses as a shield against the brutal assault of fluorescent lighting.

And sunglasses are one of the few ways I can make my seemingly non-existent illness visible to the rest of the world.  

There are specially designated migraine glasses that provide relief by strategically dimming light. Brightness levels on cell phones and other devices can also be turned down by a special app that filters blue light.   

Despite these helpful tools, walking under the bulbs in any public place feels as though light is raining down on me and, like a sponge, absorbing all of my energy.

That is why a trip to the grocery store could go well, but afterwards I'm out for the count and barely able to make it up the stairs.

Within the last couple years, my mobility has continued to be compromised -- especially when it comes to either sitting (driving) or shifting positions (sitting to standing). At a conference recently, after noticing my navigation or lack thereof, a dear colleague suggested what I had been silently dreading: the possibility of using a cane. There's nothing wrong with canes, I'm grateful for all medical devices, but suffice to say they aren’t exactly what I had pictured at the ripe old age of 29.  

I've become accustomed to losing a lot as a result of chronic pain and illness, but confronting a limited physical future is my newest anguish.

The combination of chronic cluster headaches, daily intractable migraines and now fibromyalgia not only heighten the pain scale number, it hinders even the simplest of daily tasks. It impacts the few things I am still able to do that bring me joy, such as participate in creative body movement through yoga or dance.

I smirk thinking back to the days I could go out and dance for hours on end. There's a certain spark that comes alive in me when bass throbs its way through a loudspeaker. I'm quite aware that is contradictory to head pain, yet somehow, I cannot live without it. My soul begins to vibrate in the most calming way as I am enticed by the rhythm and it takes over.

Fast forward to today and I'm fortunate to get a couple minutes of dancing in before symptoms worsen. I cannot go as hard or as long as I used to, but it has caused an evolution in my movement, leading me to a whole-body present moment acceptance.  

Last week at an appointment, I mentioned that a cane will likely be needed daily in the near future. Initially the provider skipped over the remark entirely, but when I brought the conversation back around to ensure we were on the same page, she reacted with “Oh yes, your question about a cane.” 

I don’t recall needing an answer so much as an acknowledgement, as I do not feel the need to ask for permission to do what’s going to be best for myself. 

It’s never too far from my mind that I walked away from bacterial meningitis. If it is now catching up to me, there’s never an ideal time for that to happen and I am fortunate to have had moments with an abundance of blessings. No matter how dark life can get, it’s imperative we make the absolute most of every breath and make a conscious commitment for the sake of ourselves to never give up. 

Whether we live inflicted with physical ailments or not, none of us know what the future holds, nor when our number may be up. All it takes is a slight change in circumstance to alter our lives forever, so we must take time to appreciate and find ways to enjoy the gifts we have. 

The blonde kept the shades on and walked out with her cane like the bad ass that she is!      

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook support group, and Peace & Love Enterprises, a wellness coaching practice focused on holistic health.

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.

Out-of-Pocket Costs for Neurology Drugs Rise Sharply

By Pat Anson, PNN Editor

Out-of-pockets costs for medications to treat multiple sclerosis, peripheral neuropathy and other neurologic conditions rose sharply over 12 years, according to a new study that found the average monthly cost to patients for MS drugs rose nearly 2,000 percent.

One in six people lives with a neurologic disease or disorder, according to the American Academy of Neurology. The annual cost of treating neurologic disorders in the United States is more than $500 billion.

“With many new, high-priced neurologic drugs coming to market and a recent rise in use of high-deductible insurance plans, which shift costs to patients, it is likely out-of-pocket costs will continue to increase,” said lead author Brian Callaghan, MD, of the University of Michigan in Ann Arbor.

The study was published online in the journal Neurology.

Callaghan and his colleagues examined out-of-pocket costs for over 912,000 people with MS, neuropathy, epilepsy, dementia or Parkinson’s disease who were privately insured from 2004 to 2016.

Researchers found that out-of-pocket costs for MS drugs showed the steepest monthly increase. Patients paid an average of $309 a month in 2016, compared to just $15 in 2004. Costs for MS patients in high-deductible health plans were even higher, averaging $661 per month or nearly $8,000 a year.

Co-pays and deductibles for brand name medications for neuropathy, dementia and Parkinson’s disease also rose considerably.

“Everyone deserves affordable access to the medications that will be most beneficial, but if the drugs are too expensive, people may simply not take them, possibly leading to medical complications and higher costs later,” said Ralph Sacco, MD, President of the American Academy of Neurology.

Researchers said neurologists and other physicians usually do not know the cost of drugs they prescribe, so they don’t discuss alternative medications based on a patient’s disease, insurance plan, pharmacy and deductible.

“Out-of-pocket costs have risen to the point where neurologists should be able to consider the potential financial burden for the patient when prescribing medication, but they do not have this information available to them,” Callaghan said. “Neurologists need access to precise cost information for these drugs in the clinic so when they meet with patients to make treatment decisions, they can help minimize the financial burden.”

Even when a generic version of a drug becomes available, it can take years for out-of-pocket costs to drop substantially. It took five years for out-of-pocket costs for gabapentin, for example, to drop to those of other tricyclic anti-depressants after gabapentin went generic in 2004.

A 2015 study found an “alarming” increase in costs for MS drugs and suggested the price increases were coordinated by drug companies.

Why I’m Fed Up with the Healthcare System

By Nyesha Brooks, Guest Columnist

I'm so fed up with the healthcare system. I was diagnosed a year ago with a chronic invisible illness known as fibromyalgia. I also have depression and anxiety. I was relieved to finally have a name for what I was going through.

My journey with this illness has been pure hell. I live with chronic pain every day of my life. I had to resign from my employment of 8 years because I could not bear the pain any longer.

Suicide is a BIG concern when people have fibromyalgia. I had to reach out to the crisis hotline due to feeling like nobody understood. The pain is so unbearable, constant fatigue, numbness in your body parts, and crippling back pain at times. You also get brain fog that can cause memory loss and mood swings. It’s all isolating.

While there is no cure for fibromyalgia, doctors say it’s not fatal. But if you live your life in pain every day, it will cause all kinds of health problems that can lead to death.

My issue with the doctors today is they don't listen anymore and they stereotype everyone as opioid abusers. I’ve never done drugs or abused medications in my life. Even when I'm in severe pain, I still take only what is prescribed for me. It's almost like they want you to go home and suffer.

The problem with fibromyalgia is there's no detection or extensive research on it. There’s not a lot of information out there. To the naked eye I look fine and healthy. However, that’s not my reality. I have nerve damage. When I'm home I wear something very comfortable and I'm in bed most of my day. We are very sensitive to loud sounds and light. I listen to a lot of relaxing sounds on Youtube such as the rain falling.

NYESHA BROOKS

I have big help from my family that assist me throughout the day because I have limitations. I take all kinds of medications that I keep in a bag. The medication doesn't work at all. It just makes you very drowsy and increases the pain that you’re already in. Due to the opioid epidemic, we're restricted from getting the right medications.

I’ve been to the ER so many times because I get flare ups that can last all day or weeks. I'm on high blood pressure medicine due to being in severe pain. I'm telling you I don’t wish this on my worst enemy.

I have been fighting for my social security disability for a year now. I was rejected the first time and now I’m waiting on my appeal decision. It’s very upsetting because I'm a mother and I just want to take care my children.

Plan B is not even an option for me because I can't handle a day-to-day job. One task burns me out or takes me hours to do. My therapist says because I'm always stressing, I'm not going to be here to see my benefits. Today my doctor looked at me and suggested because of my age I should go back to the work world. I'm fed up. My doctor bases my reality on his research. How is research more accurate than my truth?

I met so many fibro warriors from a support group on Instagram and we all have similar stories with the healthcare system. I need help getting this awareness out because fibromyalgia matters and is real. The doctors need to take our illnesses seriously and listen. One rejection can cost a person their life. We need love, support and understanding.

Nyesha Brooks lives in South Philadelphia.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

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

CreakyJoints Under Scrutiny for Ties to Drug Makers

By Pat Anson, PNN Editor

Patient advocacy groups are coming under scrutiny again for their financial ties to drug companies. The latest is the Global Healthy Living Foundation (GHLF), a non-profit charity that created CreakyJoints, a website and social media platform that raises awareness about arthritis and other chronic illnesses. 

According to Bloomberg News reporter Ben Elgin, the foundation and CreakyJoints have long had a cozy relationship with Pfizer, Amgen, Johnson & Johnson and other corporate donors. Pfizer has donated nearly $1 million to the foundation over the past decade and one of its vice-presidents even serves on GHLF’s board of directors.

In a speech to drug makers in 2010, GHLF president Seth Ginsberg reportedly sought their donations -- while at the same time promising the companies “higher profits” and “sales rep participation in our programs.”

Ginsberg, who was diagnosed with spondyloarthritis as a teenager, co-founded GHLF in 1999 with marketing executive Louis Tharp.

In addition to CreakyJoints, GHLF has two other “grassroots” programs, Fail First Hurts and the 50-State Network, which advocate for healthcare policies that often align with the interests of its donors.  

According to GHLF’s 2017 tax return, the foundation had over $5 million in annual revenue. Ginsberg was paid a salary of $384,000, while Tharp received $220,000 as Executive Director.  Nearly $300,000 was also paid to a for-profit marketing company established by the two men, although it’s unclear what the payment was for.

Bloomberg reported that GHLF’s tax returns “reflect errors and unexplained entries that have obscured the amounts of money flowing to its cofounders.”

“Are they operating in a way that is extremely transparent? It’s safe to say they’re not,” Brian Mittendorf, a professor of accounting at Ohio State University told Bloomberg. “From looking at their disclosures, you have no idea how closely they’re related to some of the entities it pays.”

At least one GHLF board member and several patient volunteers reportedly left the organization because they were troubled by its relationships with donors.

GHLF did not grant an interview to Bloomberg, but replied to questions in writing.

“The only time we engage in advocacy is when it helps patients. If it doesn’t help patients, we don’t do it,” the foundation said in a statement. “Our mission is to engage in patient-centered research, provide advocacy for access-to-care, and to support people living with chronic disease by providing a supportive environment and accessible education.”

In a related story, Bloomberg reported that several other recently formed non-profits – such as the U.S. Rural Health Network --  appear to be little more than front organizations for the pharmaceutical industry.

“There are a number of groups created by pharma companies that look and act like patient organizations, but they’re 100 percent funded by industry,” said Marc Boutin, chief executive officer of the National Health Council. “They sound and look like patient organizations, but they take positions that industry wants.”

Drug Companies Fined for Co-Pay Programs

Last week two drug companies agreed to pay $125 million in fines to settle allegations that they used charitable foundations as front organizations to bilk Medicare.

Amgen and Japanese drug maker Astellas Pharma paid the foundations to establish co-pay prescription drug programs for Medicare patients. Federal prosecutors say the programs were primarily designed not to help patients, but to illegally pay their co-pays for Astellas and Amgen products.

Federal anti-kickback laws prohibit pharmaceutical companies from making any kind of payment to induce Medicare patients to purchase their drugs. The prohibition includes co-pays.

“The companies’ payments to the foundations were not ‘donations,’ but rather were kickbacks that undermined the structure of the Medicare program and illegally subsidized the high costs of the companies’ drugs at the expense of American taxpayers,” U.S. Attorney Andrew Lelling said in a statement.

“When pharmaceutical companies use foundations to create funds that are used improperly to subsidize the co-pays of only their own drugs, it violates the law and undercuts a key safeguard against rising drug costs,” said U.S. Assistant Attorney General Jody Hunt.

Last year, Pfizer paid nearly $24 million to settle allegations that it also used a co-pay program to pay Medicare for the company’s prescription drugs.

U.S. Pain Foundation Co-Pay

The U.S. Pain Foundation is under investigation by the U.S. Senate Finance Committee for a similar co-pay program established with Insys Therapeutics, a controversial Arizona drug company. Insys makes Subsys, an expensive and potent fentanyl spray blamed for hundreds of overdose deaths.

U.S. Pain received $2.5 million from Insys to launch the “Gain Against Pain” program, which ostensibly helped Medicare patients pay for drugs prescribed for breakthrough cancer pain. Critics say the program was primarily used to increase prescriptions for Subsys, which can cost $24,000 for just a four-day supply.

Former U.S. Pain CEO Paul Gileno initially defended the co-pay program, saying the money from Insys “does not influence our values,” but later resigned over allegations that he misappropriated $2 million from his own charity.

The Gain Against Pain program was subsequently shutdown in August 2018 and U.S. Pain said it would no longer accept funding from Insys.

Sen. Ron Wyden (D-OR), the ranking member of the Senate Finance Committee, sent a lengthy letter last December to U.S. Pain interim CEO Nicole Hemmenway asking a series of questions about the Insys co-pay program. According to the senator’s office, Wyden has still not gotten a full response.  

“The U.S. Pain Foundation has yet to provide a substantial amount of the information that Senator Wyden requested in his letter. Staff is in communication with the organization in order to get to the bottom of the organization’s financial relationship with pharmaceutical manufacturers, including Insys, and its compliance with applicable federal laws,” a Wyden spokesperson said in a statement to PNN.

A federal jury in Boston is currently in its third week of deliberations in a criminal case against Insys founder John Kapoor and four former executives of the company, who are accused of bribing doctors to boost sales of Subsys. 

U.S. Pain also remains under investigation by the Connecticut Attorney General’s office for financial irregularities that led to Gileno’s resignation.

A Pain Platform: What Patients Should Look for in 2020 Candidates

By Crystal Lindell, PNN Columnist

I met my boyfriend, who also is a chronic pain patient, at a local county Democrat meeting a little over a year ago. We’re both crazy liberals, but he always says he knew it was love when I turned to him during the meeting and said, “If Donald Trump made hydrocodone over-the-counter, I’d vote for him in 2020.”

I have a political science bachelor’s degree and spent hours in my college classes lamenting about the surge of single-issue voters. Why would anyone vote for a presidential candidate just because they were pro-choice?

But now that I’m sick and depend on pain pills to function, I have to tell you, I kind of get it. If there were a candidate who supported my right to pain medication, I’d go work for their campaign.

Unfortunately though, there aren’t any candidates who really seem to represent the things pain patients need — not yet anyway. Both major parties have pushed for limits on opioid medication, regardless of whether your doctor thinks you need it. And both have ignored the pleas of pain patients for access to alternative treatments.

Here’s a list of 13 things that pain patients should be looking for in 2020 presidential candidates — a “Pain Platform” if you will. I’m not sure any candidate will truly live up to this ideal, but we won’t know until we ask.

1. Eliminate regulations for prescription opioids

This is the big one, obviously. And the most important. In a misguided attempt to respond to the opioid epidemic, there has been a surge in the number of regulations for opioid prescriptions that includes everything from limiting the amount a patient can get to arresting doctors who prescribe too much. That needs to stop.

2. Require insurers to fully cover alternative pain treatments

This one is also obvious. If they truly believe that opioids shouldn’t be the only pain treatment, then they need to support other treatments financially. And specifically the $0 co-pay is so important.

Insurance companies may think that a $30 co-pay for a physical therapy session isn’t that much, but if you need three sessions a week for three months suddenly you’re looking at more than $1,000. That’s too much. Especially for pain patients, who tend to have less income than the general population.

3. Provide research grants for new pain treatments

Even patients who use opioids know they aren’t a cure-all. But unfortunately, there aren’t many good alternatives for treating pain. That needs to change and requires research into new therapies that could help. If the government really wants people to use fewer opioids, they need to research alternatives that actually work.

4. Legalize recreational marijuana at the federal level

Personally, marijuana doesn’t help me much with pain. But for some people it’s exactly what they need, which is why it needs to be legalized. And yes, I think it needs to be legalized recreationally, because patients shouldn’t have to go a doctor and get a prescription to treat their pain.

5. Make kratom legal in all 50 states

I personally have found kratom to be extremely helpful for treating my chronic pain. In Illinois, I can get it over-the-counter, so I don’t have to drive over an hour each way to see a doctor every time I need a refill. Unfortunately, several states have made kratom illegal and some are considering it. That needs to change.

6. Forgive all medical debt

I have great insurance through a great job and I still have literally thousands of dollars in medical debt — all from co-pays. I can’t catch up because anytime I make any progress on it, I have another flare and rack up more bills. We live in the richest country in the world. Healthcare shouldn’t be what kills your credit.

7. Launch Medicare for all

I shouldn’t have to be over a certain age or legally disabled to get good health insurance. Everyone should have access to that. It’s not hard.

8. Make it easier to get disability while still working

The problem with disability is that you have to be out of work for a long period of time before you get your benefits. That’s impossible for anyone who’s responsible for their own bills. Yes, they give you back pay if you eventually qualify for disability, but landlords aren’t typically the type of people who will let you back pay them. You should be able to apply for disability while you’re still working so that you have steady income throughout.

9. Make disability pay a living wage

You’re barely allowed to make any income if you collect disability. But disability alone isn’t enough to live on in most places. People who depend on it shouldn’t also be relegated to poverty.

10. Allow people on disability to get married without penalty

This is a big one. As it stands right now, if you’re currently getting disability and Medicare you can lose those benefits if you get married because they count your spouse's income toward your income. Losing both kills your independence and can drastically increase your medical bills.

We should be encouraging love for people who are already dealing with so much, not discouraging it.

11. Require all government services for seniors to be provided to the disabled

This one is mind-blowing to me and I’m shocked that it’s not already the case. If you’re too sick to work, you are effectively retired no matter what your age. And you should have access to the same services seniors receive, such as transportation and other assistance. Some people lose their health early and basing benefits solely on age unfairly punishes those people.

12. Fund a public awareness program for invisible disabilities

I cannot read one more Facebook story about some poor person being screamed at for using a handicap spot because they “don’t look sick.” Lots of sick people look perfectly healthy. I look perfectly healthy, but I’m really sick. You can’t judge someone’s health by how they look. A public awareness campaign about invisible illness would go a long way toward making the lives of disabled people better.

13. Provide more medication-based addiction treatment centers

I know, I know. Patients aren’t addicts. But guess what, a lot of people who get addicted to opioids start with medications for legitimate pain. We shouldn’t abandon them. Providing more medication-based treatment centers is the first step toward helping them. There is a real need for those treatment centers in rural areas, which have been the hardest hit by the opioid crisis. The more addicts we help, the less we’ll have to deal with politicians blaming pain patients for the opioid crisis. 

What else would you add to the Pain Platform? What’s your wish list for 2020 candidates? Maybe if we all share our ideas, they’ll finally start listening to us. 

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. 

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

Is Fentanyl a Weapon of Mass Destruction?

By Lynn Webster, MD, PNN Columnist

Usually we think of bombs, missiles, rockets and dangerous chemicals as weapons of mass destruction (WMD). However, the military website Task & Purpose recently reported that James McDonnell, who heads the Department of Homeland Security’s WMD division, wants to classify fentanyl as a WMD.

McDonnell proposed this in a February memo to then-DHS Secretary Kirstjen Nielsen. The drug’s “high toxicity and increasing availability” make it “attractive to threat actors seeking nonconventional materials for a chemical weapons attack,” according to the memo.

There isn’t much evidence for classifying fentanyl as a WMD, but McDonnell’s suggestion could still find support for reasons that have more to do with politics than science.

According to federal law, weapons that can kill or severely injure "through the release, dissemination, or impact of toxic or poisonous chemicals, or their precursors" fall into the category of weapons of mass destruction.

McDonnell thinks fentanyl fits the definition. It is not clear that he is correct. And he neglected to mention that fentanyl has a legitimate medical use, too.

History of Fentanyl

Fentanyl is a powerful synthetic opioid typically prescribed to patients in acute pain or during surgeries. According to data from the National Center for Health Statistics, 48 million surgical inpatient procedures were performed in the United States in 2009. Most of those procedures involved administering fentanyl intravenously as an analgesic. 

Fentanyl was developed in 1960 by Belgian chemist Dr. Paul Janssen. The patent for fentanyl was obtained under his company name, Janssen Pharmaceutica. Fentanyl was first approved by the Food and Drug Administration in 1968 and introduced into the marketplace as an analog for Demerol, with plans that it would be used only for palliative care.

In 1978, I coauthored with my professor mentor, Dr. T.H. Stanley, a manuscript titled “Anesthetic Requirements and Cardiovascular Effects of Fentanyl” that described the use of high dose fentanyl for cardiac anesthesia.

The anesthetic technique we described allowed patients to undergo coronary artery bypass and valve replacement surgery more safely and with greater success because of fentanyl's unique pharmacologic properties. The technique was considered a seminal event in anesthesia for cardiac surgery.

Since the publication of that paper, millions of people have successfully undergone heart operations. The advance of using fentanyl in anesthesia may have helped some of those patients survive their heart operations.

It wasn’t until the late 1980s that testing was done for delivering fentanyl through a transdermal patch for the treatment of cancer-related pain and noncancer chronic pain. Later, oral transmucosal delivery of fentanyl was made available for cancer breakthrough pain. Each of these new uses of fentanyl exposed millions of Americans to the drug without evidence of an inordinate degree of harm if it was used as directed.

In contrast, nonpharmaceutical fentanyl has caused enormous harm. But as illicit use of the drug proliferates, so do myths about its dangers. McDonnell’s memo fits into an overarching narrative that bestows almost magical properties on fentanyl.

What's Behind the Fentanyl Panic?

The opioid crisis is real and the use of illicit fentanyl is often lethal. But mischaracterizing the effects of fentanyl may be only a political maneuver. 

In New York Magazine, Sarah Jones wrote about a 2017 Bloomberg News story that claimed fentanyl “is so potent that even a small amount — the equivalent of a few grains of salt — can be lethal.” 

“This isn’t really true,” wrote Jones. “You can’t get high or become ill simply by touching fentanyl, but police departments often claim otherwise. They report dramatic, but varied, symptoms that don’t mesh with established scientific evidence about fentanyl and the way it’s absorbed by the human body.” 

As Jones points out, Homeland Security’s WMD division has experienced a decline in funding because of the Trump administration’s focus on immigration and building a wall at the border. One way to reclaim some of that money for the WMD division is to build a case against fentanyl. 

Other drugs, such as ricin, pose greater risks and are probably more lethal than fentanyl as WMD’s. However, the word "fentanyl" packs a far larger emotional punch than ricin does because of the public's familiarity with it.  

WMDs are meant to kill the maximum number of people is the shortest amount of time. On the other hand, fentanyl -- even when it is laced with heroin -- is not intended to kill people. Drug cartels want to make money. Their goal isn't to murder their customers

Protecting Access to Legitimate Fentanyl 

The opioid crisis is now largely driven by nonpharmaceutical fentanyl and fentanyl analogs, not prescription fentanyl. Solving the opioid problem will require greater efforts to reduce the illegal production and distribution of illicit fentanyl. 

Could fentanyl be weaponized and used to attack citizens? Maybe, but not easily.  

The Pentagon realized the harm that an opioid attack could cause when the Russian military used aerosolized carfentanil -- a highly potent fentanyl analog --  against terrorists who had taken over a theater in Moscow in 2002. The drug killed dozens of innocent hostages and their captors, and it put the U.S. on notice that opioids could be weaponized.  

Before we classify fentanyl as a WMD, we need to know what that would mean for its legitimate use during surgery, or for cancer and chronic pain patients. Access to the medication for the treatment of pain must be part of the calculus in assessing if a relatively safe and effective drug should be classified as a WMD. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn 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.

What Next for CDC Opioid Guideline?

By Pat Anson, PNN Editor

The pain community is reacting with a fair amount of skepticism to efforts by the CDC to address the widespread misuse of its 2016 opioid prescribing guideline.

A CDC commentary published Wednesday in The New England Journal of Medicine warns against the “misapplication” of the guideline, which has resulted in hard dosing limits, forced tapering and the medical abandonment of thousands of chronic pain patients.

Although the guideline strongly recommends that daily doses of opioids not exceed 90 MME (morphine milligram equivalent), the guideline’s three co-authors say their advice was misinterpreted and that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages.”

A CDC media statement this week also claimed “the guideline does not support abrupt tapering or sudden discontinuation of opioids.” 

That was surprising news to Rob Hale, a Missouri man with late-stage Ankylosing Spondylitis, a degenerative and incurable form of arthritis.  Like many other pain patients, Hale’s relatively high dose of opioid medication was significantly reduced soon after the guideline’s release.  As a result, he is now bedridden.

“This is amazing news, if they really intend to follow through with it,” said Hale in an email. “God, I hope this is the beginning of a turnaround in prescribing policies.  I just feel for the hundreds of us who gave up and took their lives or died as a result of the last 3 years of cruelty.”

Saving Face

Why the CDC is acting now is unclear. Reports of patient harm began circulating soon after the guideline’s release in March 2016, and have only accelerated as insurers, pharmacies, states and practitioners adopted the guideline as mandatory policy. In a recent PNN survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide.

“I regard this CDC statement to be an effort to save face and maintain political dominance on an issue into which CDC improperly inserted itself under the influence of Andrew Kolodny and PROP,” said patient advocate Richard “Red” Lawhern, referring to the founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing.

“The statement fails to engage with the underlying issues which render the Guidelines fatally flawed.  It fails to acknowledge the essential repudiation of the entire guideline concept by the American Medical Association, plus multiple prominent medical professionals.” 

“The CDC guidelines have been as harmful as predicted, and the silence over 3 years has been criminal. The ‘Who me?’ response is just as evil as the ignorant abuse of power that led to the crisis in the first place,” said Mark Ibsen, MD, a Montana physician whose license was suspended by the state medical board for “overprescribing” opioids. A judge overturned the board’s ruling.  

“Those who give a weak ‘mea culpa’ for misinterpretation of the guidelines are, in short, lying. The deaths of thousands of abandoned pain patients, including 6 of mine who lost access (to opioids), are on their hands,” Ibsen said. 

PNN asked a CDC spokesperson if the agency had received new information about patients being harmed by the guideline and received a vague response.  

“We have heard concerns from partners and stakeholders about policies and practices that are inconsistent with the 2016 Guideline and sometimes go beyond its recommendations. The misapplication of the Guideline can risk patient health and safety,” Courtney Lenard said in an email. “CDC authored this commentary to outline examples of misapplication of the Guideline, and highlight advice from the Guideline that is sometimes overlooked but is critical to safe and effective implementation of the recommendations.” 

The response was also vague when we asked if CDC would be directly contacting insurers, pharmacies and states to warn them about misapplying the guideline.

“CDC has engaged payers, quality improvement organizations, state health departments, and federal partners to encourage implementation of recommendations consistent with the intent of the Guideline,” said Lenard, citing a mobile app and a pocket guide to opioid tapering as examples of CDC outreach.

The agency also sent out a Tweet.

Lenard gave no indication that a revision of the guideline was imminent. She said the CDC was working with the Association of Healthcare Research and Quality (AHRQ) to evaluate “new scientific evidence” about the benefits and harms of opioids.  

“Results of these reviews will help CDC decide whether evidence gaps have been addressed and whether the Guideline should be updated or expanded for chronic or acute pain prescribing,” Lenard wrote. 

.@CDCgov #OpioidGuideline does not support abrupt tapering or sudden discontinuation of #opioids. Learn more in our recent @NEJM commentary: https://t.co/vK0ESNyGTU pic.twitter.com/TXZ2jDdMJB

— CDC Injury Center (@CDCInjury) April 24, 2019

Undoing the Damage

The American Medical Association – which took a stand against the “inappropriate use” of the guideline last year -- released a statement saying the CDC needed to work more closely with insurers.

“The guidelines have been misapplied so widely that it will be a challenge to undo the damage. The AMA is urging a detailed regulatory review of formulary and benefit design by payers and PBMs (pharmacy benefit managers),” said AMA President-elect Patrice Harris, MD.

“The CDC’s clarification underscores that patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than the guidelines or thresholds put forward by federal agencies, state governments, health insurance companies, pharmacy chains, pharmacy benefit managers and other advisory or regulatory bodies.”

Dr. Ibsen said the Drug Enforcement Administration was “the other elephant in the room” because it has weaponized the CDC guideline to demonize and prosecute doctors for prescribing high opioid doses. 

“Arresting and punishing doctors who treat the sickest pain patients. Civil asset forfeiture as used in dealing with criminal drug dealers. Equate physicians with a license to practice as equal to or below said criminal drug dealers,” said Ibsen, listing some of the tactics used by prosecutors.

“Charge physicians with one felony for every Rx they write, making absurdly dramatic charging documents and headlines against doctors who are left with no income or assets to defend themselves in a contaminated jury pool. Charge doctors with murder for prescribing medications to patients who fail to follow the directions.”

It’s not just the DEA. The National Association of Attorneys General recently declared that the dose and duration of opioid prescriptions should not be decided by doctors and that the CDC guideline should essentially be treated as law.

“As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment,” warns a letter signed by 39 state and territory attorney generals. “As Attorneys General of states with high rates of prescription drug abuse among our youth, policy makers and prescribers must be encouraged to continue to pursue laws and practices that reduce the high volume of opioids in our communities.”

“The standard of care is now determined by prosecutors and juries,” says Ibsen.

Pain Clinics Ordered Unnecessary Urine Drug Tests

By Fred Schulte, Kaiser Health News

A Tennessee-based chain of pain clinics that abruptly shut down last summer faces five whistleblower lawsuits accusing it of defrauding Medicare and other health insurers by billing for hundreds of unnecessary urine drug tests and other dubious health services, newly unsealed court records show.

The federal suits target Tennessee-based Comprehensive Pain Specialists, also known as Anesthesia Services Associates, PLLC, and several of its physician owners. At its peak, CPS ran 60 pain clinics in 12 states, according to the suits, as well as a lucrative urine-testing lab in Brentwood, Tenn. CPS closed with no warning in July, leaving patients in several states distressed and scrambling to find a new source of narcotic pain medicines.

In federal court filings unsealed in Nashville this week, federal prosecutors said they would take over the urine-testing allegations and sue several CPS owners, including co-founding anesthesiologists Peter Kroll and Steven Dickerson. Dickerson is a Republican state senator representing Nashville.

Kroll could not be reached for comment Wednesday. Dickerson did not respond to an email or a phone message left at his legislative office.

It is not clear whether the whistleblowers, who include former CPS doctors and other employees, would pursue several allegations against the company that the federal government declined to join in. CPS, in an unrelated court filing in December, said the company had terminated all of its employees and that debts “greatly exceed its assets.”

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, and a criminal investigation that ensnared its former chief executive, John Davis. Davis, 41, was convicted this month in federal court in Nashville on health care fraud charges. He is to be sentenced later this year.

CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized its Medicare billings for urine drug tests. Medicare paid the company at least $11 million for urine screenings and related tests in 2014, when five of CPS’ medical professionals stood among the nation’s top such Medicare billers. One 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.

Kroll, who also served as CPS’ medical director, said at the time that the tests were justified for patient safety and to reduce chances the pills might be sold on the black market. Kroll billed Medicare $1.8 million for urine tests in 2015, the KHN analysis of Medicare billing records found.

Kroll in an interview with KHN at the time said that he and fellow anesthesiologist Dickerson came up with the idea for the pain clinics over a cup of coffee at a Nashville Starbucks in 2005.

One of the whistleblower suits alleging unnecessary urine tests was first filed under seal in 2016 by Suzanne Alt, a doctor who worked in the company’s pain clinics in Troy, Mo., and Keokuk, Iowa, from May 2014 to March 2015. She alleged CPS doctors were “strongly encouraged to order full-panel urine drug screens on each patient, every time, despite the patient’s history, compliance and risk.”

She also said that the company’s electronic medical records “made it extremely difficult to order anything less than the full panel.” Alt said she was told the Tennessee lab did about 600 of these screens daily. Another whistleblower 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 suit.

“They were making a killing,” said Birmingham, Ala., attorney Don McKenna, who represents Alt in the case.

Another of the whistleblowers, former CPS anesthesiologist Cynthia Niendorff, alleged that the company billed Medicare about $754 for each additional urine test, even though earlier results had come back negative. She said CPS grossed approximately $6 million per month from the urine-testing lab and said about 20% of this amount was suspect, according to the suit.

Mary Butner, a former insurance specialist for CPS in Gallatin, Tenn., alleged that CPS charged some patients $1,500 for a drug test to measure blood levels of medication and $400 for a drug test designed to detect illegal drugs — charges that the suit called “grossly inflated and disproportional to the actual costs.” She also alleged that CPS would fill prescriptions for patients whose drug tests detected the presence of illegal drugs, or showed that they were not taking their medication as directed.

Butner also accused medical director Kroll of approving prescriptions for back braces when it was “clearly medically unnecessary,” including some people who had injuries to a knee or elbow.

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.

CDC: Opioid Guideline Should Not Be Used to Taper Patients

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has taken its first concrete step to address the widespread misuse and misapplication of its opioid prescribing guideline.

In a commentary published in The New England Journal of Medicine, the guideline’s authors say the agency does not support abrupt tapering or discontinuation of opioid medication, and that the guideline’s recommendation that daily doses be limited to no more than 90 MME (morphine milligram equivalent) should only be applied to patients who are starting opioid therapy.

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” wrote Deborah Dowell, MD, Tamara Haegerich, PhD, and Roger Chou, MD. “A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

The co-authors also noted that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages,” nor does it seek to deny opioids to patients with cancer, sickle cell disease or recovering from surgical procedures.

The CDC’s clarification was cheered by patient advocates, who have been calling on the agency to address the suicides, patient abandonment and other unintended consequences of the guideline for over three years.

“The statement from the CDC is a long-awaited, robust clarification that has come at a critical time. They clearly defined that its Guideline cannot and should not be invoked to justify the forced reduction or denial of opioid pain medication to patients who use opioids to manage their long-term pain,” said Andrea Anderson, a patient advocate with the Alliance for the Treatment of Intractable Pain (ATIP).

The CDC’s controversial guideline was released in March 2016 as a voluntary set of recommendations meant to discourage primary care physicians from prescribing opioids for chronic non-cancer pain. But the guideline was quickly adopted by states, insurers, pharmacies, practitioners and even law enforcement agencies, who saw it as a mandatory policy that all physicians should follow to reduce rates of opioid addiction and overdose.

Reports soon began surfacing of patients being forcibly tapered off opioids or being abandoned by doctors who no longer wanted to treat them. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.”

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated. Many are hoarding opioids because they fear losing access to the drugs and some are turning to other substances – both legal and illegal – for pain relief.

‘Unintended Harms’

Not until this month did CDC acknowledge that its guideline was causing patient harm.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms,” CDC Director Dr. Robert Redfield wrote in an April 10 letter to a group of healthcare professionals. who had asked the agency to make a “bold clarification” of the guideline.

Redfield’s letter was sent the day after the Food and Drug Administration warned doctors not to abruptly taper or discontinue opioids. The FDA said it had received reports of “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.    

“The clarification is an essential beginning because it is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia,” said Kate Nicholoson, a civil rights attorney and pain patient.  

“It is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia.”

— Kate Nicholson, Civil Rights Attorney

“Given the harms suffered by pain patients, a muscular, public-facing clarification from the CDC was needed. We hope that this action and the warning the FDA issued last week against abrupt tapering of pain patients will mark a beginning in protecting the rights of patients who use opioid medication appropriately to manage pain.” 

But other patient advocates wonder why it took so long for the CDC to act.

“It's gratifying to see CDC admit that its guideline is being misinterpreted and misapplied, as many of us have been warning for some time,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management. “It's a bit puzzling to me why it has taken them three years to do so, when many of us, myself included, told them within days of the guideline's issuance that these things were going to happen.

“Unfortunately, we've spent the past three years watching three dozen states violate CDC's stated intent that the guideline not be legislated, not to mention the untold numbers of insurance companies, health care systems, private practices, and pharmacy chains that have created a whole population of opioid refugees by misusing the guideline. Serious harms, including patient deaths, have resulted, and there is virtually no evidence that the intended effect of reducing prescription opioid overdose deaths has occurred, while overall opioid overdose deaths continue to climb rapidly.”

The New England Journal of Medicine is a respected publication with a wide reach among healthcare professionals, but it is not clear what CDC will do to caution states, insurers, pharmacies and law enforcement agencies about their misuse of the guideline.

“Unless Congress and the Executive Branch tell the DEA (and by association, state drug enforcement authorities and prosecutors) to stand down from persecuting doctors, I don't see any useful impact for this statement at all,” Richard “Red” Lawhern, PhD, of ATIP wrote in an email. “Doctors will continue to leave pain management and to desert their patients until they can be assured they will not be sanctioned, so long as they act in good faith to treat pain and manage their patients.” 

In recent months, federal prosecutors in Wisconsin and several other states sent letters to hundreds of physicians warning them that their opioid prescribing practices exceed those recommended by the CDC. The doctors were identified through data-mining of prescription drug monitoring programs (PDMPs), which have been weaponized to target physicians. 

“Practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain,” a DOJ spokesperson told PNN.  

Just last week, a DEA task force charged dozens of doctors and other healthcare providers with illegal opioid prescribing. Prosecutors say more criminal cases are in the pipeline. 

"We have hyper-accurate data at the DEA and other agencies in the federal government where we are able to (use) that data and we can sort of pinpoint where these pills are being over-prescribed just by the population center in which they're being prescribed," said Jay Town, a federal prosecutor in Alabama.  "There are more doctors out there, there are more people working in clinics, and physicians’ offices, or pharmacies, or in compounding pharmacies, that we still have ongoing investigations or beginning investigations.” 

‘Achieve Widespread Adoption’ 

The CDC may have finally acknowledged the “unintended harms” caused by the guideline, but the data-mining and wholesale adoption of its recommendations are exactly what the agency outlined in a 2015 CDC memo obtained by PNN:   

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings. CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.  

Activities such as development of clinical decision support in electronic health records to assist providers’ treatment decisions at the point of care, identification of mechanisms that insurers and pharmacy benefit plan managers can use to promote safer prescribing within plans, and development of clinical quality improvement measures and initiatives to improve prescribing and patient care.”

Can the CDC undo all the harm its “user-friendly materials” have caused over the last three years? Will states be advised to rollback their laws and regulations? Will insurers and pharmacies be told to stop limiting the dose of opioid prescriptions? And what about the patients who committed suicide? The CDC did not respond to a request for comment.

“That no one at CDC anticipated that the guideline would be misinterpreted and misapplied in this way is hard to swallow,” said Twillman. “I would have hoped that they would be vigilant for such occurrences, and taken action swiftly and effectively when they became apparent.”

A Pained Life: Fearful Fortunes

By Carol Levy, PNN Columnist

I love fortune cookies, but have no faith in the fortunes themselves. I opened a cookie recently and out came this message: “Listen to what you know instead of what you fear.”

I am going through a bad time recently. For 19 years I have had a spontaneous remission of the worst of my trigeminal neuralgia pain.

The trigeminal nerve now seems to be regenerating and it worries me. I get sporadic tingling sensations in the numbed areas of my face, the result of a procedure done in 1979. Within the last few months, the spontaneous pain has also started coming back, not in the same way, and only one or two flares were horrific.

I am very fearful all the pain will return.

My new neurologist specializes in headaches. My situation is an unknown to him. He is very nice but is essentially throwing drugs at me, a new one each time the one he just prescribed doesn't help or gives me terrible side effects. He is throwing things at the wall and hoping something will stick. I fear nothing will.

I finally found someone who specializes in trigeminal neuralgia and facial neuropathy, my disorders. She asked for a copy of my medical records so she can decide if she will accept me as a patient.  I fear she will refuse. Or if she agrees to see me will be unable to help — like almost all the others.

A woman I know has fibromyalgia and Complex Regional Pain Syndrome (CRPS). For years she has been on high dosages of Dilaudid and another strong opioid. Her doctor decided he would halve her dosages of both. She was appropriately fearful of being tapered. But to her astonishment she found she could tolerate the reductions. She is happily doing just as well on the lower dosages as she had been on the higher amounts.

A lot of what we go through is often based on fear. It is legitimate. We know what the pain is like, we know what the medications do, we know what we can and cannot do. A lot of our choices are fear based: It hurts when I do this, so therefore I will never do it again.

I am able to do so much more, feel so much better when I am on this particular medication and this particular dosage, so I will refuse any changes. I am used to this doctor/physical therapist/specialist being involved in my treatment, even though I am not always happy with them, so I will stay anyway.

It is hard to give up the fear. Pain is not like painting a room a new color and then deciding you don’t like it. You can always just repaint. But change what I am used to doing to deal with the pain? That is not so simple. My pain may increase and be even more unbearable, more daunting.

But what if I take the chance and find I am okay?

Our minds and bodies have been programmed to do all we can to avoid pain. Fear is one of the ways we deal with it. As a kid you touch a hot stove and feel the excruciating pain of a burn. You very quickly learn to fear a hot stove, the fear keeping you from hurting yourself in the same way again.

It is almost counter intuitive to heed the fortune: “Listen to what you know instead of what you fear.”

What we know is why we fear. Maybe, at least for us, the fortune should read: “'Listen to what you know, but take the chance of fear anyway.”

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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.