We Are More Than Our Pain

By Carol Levy, PNN Columnist

I was referred to a neurologist who specializes in headaches. Trigeminal neuralgia is very different from a headache, but any port in a storm. I called to make an appointment and was told all new patients must agree to meet with a psychologist. If you refuse, you do not get the appointment.

This seemed like an inherent bias: Patients with head pain must have psychological issues. Does this mean the doctors are prejudging the truthfulness of their pain complaints?

Despite misgivings about seeing a psychologist, I made the appointment.

A few weeks later, the neurologist admitted me into the headache unit of the local hospital. Everyone in the unit had to have a one-on-one meeting with the psychologist.

“Tell me about your life,” she said.

I told her the most salient fact: “I am essentially alone in the world. My family abandoned me decades ago. And when you don’t work it is hard to make friends.”

Her suggestion: “You should go to counseling. They can teach you how to make friends.”

Well, there's a good idea. Except...

Before the pain started, I had no trouble making friends. Since the pain is a different story. Trying to make friends is hard when you don’t have the glue necessary to start a new relationship. I never married and I never had children because the pain took that part of my life away from me.

At my age, a senior citizen, that is often the opening question when you meet new people: “Are you married?” or “How many grandkids do you have?” No and none.

“Do you work? Are you still working?” Again, no. I haven't worked in over 40 years because of the pain.

If I am honest and say, “No to all of those. I have been disabled by a pain disorder since 1976,” the response tends to be a mouth falling open, followed by “Oh, I'm sorry.” Or a somewhat glazed look and a turn away to speak with someone else.

How do you overcome this? I haven't a clue.

But it started me thinking. When, if ever, did any of my doctors ask, “How are you dealing with this?”

I see this often mentioned in support groups: “My doctor never seems to have the time or the interest to find out about me, about how this is affecting my life.”

I am not sure if they don't ask because they don’t care or because it is something they can’t treat with a pill. Maybe they are afraid of hearing the truth for too many of us: “I'm not dealing well with it.”

Isn't part of being a healer taking the whole person into account? Doctors have precious little time to spend with us. Maybe they should take a few extra minutes to learn about the essence of who we are and what the pain has done to our basic core.

There is no medicine or surgery for the effect the pain has on our lives. But being able to say, especially to our doctors, what it has taken from us could help others see us as something more than our pain.  

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.

Always Check Your Medical Bills and Insurance Statements

By Barby Ingle, PNN Columnist

Recently I received a medical bill and noticed my insurance did not cover any of the costs of my treatment for an emergency care visit. This particular visit happened when I woke up in pain and feeling like I couldn’t take a full breath. I thought it might be a partial lung collapse, something that I have experienced before.

About a month after the emergency care visit, I receive a bill from the provider. The first thing that I checked on the bill was my vital information: name, address, phone and insurance card ID. They had the wrong first and last name and my social security number instead of my plan number.

No wonder the insurance company denied it! It looked like someone else was trying to be me and got the details wrong.

I have done many interviews and articles over the years about medical billing. If I didn’t know how to catch these mistakes, I would have gotten stuck paying the entire bill.

Studies show that 8 in 10 medical bills have at least one minor mistake. These mistakes add up and cost society more than $68 billion in unnecessary healthcare spending, according to Medliminal Healthcare Solutions, a company that helps patients find and fix medical billing errors.

When I checked into the emergency care center that day, I was not able to speak very well and my husband handled the check-in process. He presented my drivers license and insurance card.

When the nurse called me back, she said my name incorrectly, close but incorrect. I corrected her and told her to make sure it is correct in the system because if data such as my name is not correct, the insurance won’t pay. She confirmed my name and the spelling and updated her system. The billing still got it wrong.

When I went back to the emergency care center with the medical bill, the front desk lady said the information was in their system correctly, but billing is done by another group and sometimes data gets mixed up. She gave me the info to contact the billing company.

After returning home, I called the billing company. Their representative said they had my name correct but corrected my insurance information. They are going to re-bill my insurance. My co-pay portion should only be 20% of the bill.

It literally came down to multiple people making little mistakes that led to me receiving a bill that was incorrect. If I didn’t check and see the errors, I would have gotten stuck paying the full amount.

Over the years this has happened quite a number of times to me and I am sure it happens to others. If you don’t compare your explanation of benefits (EOB’s) and provider bills against each other, you could pay more than you should for medical services. This can also happen if you don’t check your medical records. If a medical record is incorrect, you may not care at the time, especially if you received the appropriate care.

But what if you’re in an emergency situation where you can’t check and verify what is in the system? You may end up being given medications that you no longer take due to out-of-date prescription and medical records. You may even be denied coverage because of misinformation in your records.

What billing data should you check? Start with your name, date of birth, date of service, services provided and insurance information. For your medical records, check your name and date of service. Make sure to view your lab results, radiology reports, surgical reports, follow-up care suggestions, and daily notes from nurses and providers.

Also check your insurance EOB’s to see if the co-pays and deductibles you’ve paid matches up with their data, and you get the maximum coverage under your plan. Always check and correct medical information and bills. If you are doing it by phone, record the call if you are in a state where that is allowed. If not, then take good notes. Be sure to keep a copy of every provider bill, EOB, email and letter for your records.

Over a lifetime of chronic illness, you’ll save yourself thousands of dollars and get access to better care.

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.

The Push for Stem Cell Censorship Has Begun

By A. Rahman Ford, PNN Columnist

A new study published in journal Stem Cell Reports, entitled “How to Peddle Hope: An Analysis of YouTube Patient Testimonials of Unproven Stem Cell Treatments,” looks at over a hundred videos by stem cell patients posted on YouTube. 

The study appears to have an underlying anti-democratic agenda – to shame YouTube and other internet platforms into removing positive patient testimonials about stem cell therapy (SCT).  Indeed, the use of the pejorative term “peddle” in the article’s title immediately undermines the study’s credibility.

This research epitomizes how propaganda can masquerade as scientific research, and how data can be twisted to meet its masters’ agenda.

The study comes on the heels of a recent federal judge’s decision that the FDA could regulate stem cells made from adipose tissue – a patient’s own fat cells. Although SCT critics generally praised the ruling as a victory for government oversight, outlets like the Washington Post lamented that it would likely not deter clinics from offering the therapy. 

A New York Times article accused the FDA of not acting until patients were harmed, and using enforcement actions that consist only of warning letters without any real teeth.  

STAT News even criticized the National Institutes of Health for allowing stem cell clinics to “co-opt” the nation’s clinical trial database.

Stem cell critics have apparently realized that the three previous stages of their vilification campaign have failed. These stages were:

1. Vilify the patients:  Promote the condescending narrative that patients are desperate, ignorant and too stupid to research stem cell therapy for themselves and decide whether it is best for them.

2. Vilify the clinics: Stem cell clinics are run by shady charlatans who engage in duplicitous business practices that take advantage of desperate, ignorant and pitiful Americans by selling them “unproven” products that couldn’t possibly help them.

3. Vilify the federal government: Federal agencies have not acted quickly or robustly enough to enforce the regulations that govern regenerative medicine, thus tacitly approving the growing “wild west” of clinics offering SCT.

The Push for YouTube Censorship

Critics now appear to be setting their sights on a fourth vilification stage.  In their desperation, they have decided to take a more authoritarian turn towards internet censorship.

The new study’s authors examined 159 YouTube testimonials from patients who had SCT for ALS, multiple sclerosis, Parkinson’s, cerebral palsy and spinal cord injury.  Not surprisingly, they found that most of the videos were published by providers and nearly all discussed the benefits of SCT in improving pain, overall health and quality of life. 

The authors concluded the YouTube testimonials “may be a potent marketing tool” and “are likely to have a wider reach and significant impact on influencing health behavior.” 

The article’s final sentence reveals the authors’ true motive: “Adopting multiple approaches, including patient education, enhancing patient treatment options, and regulatory oversight, are required to make a significant dent in reducing the number of clinics providing unproven SCTs.”

Setting aside the numerous, glaring and egregious methodological shortcomings of the study, the more important issue is one of broader public policy.  These authors appear to be implicitly advocating that YouTube and other internet sites censor videos that are “misleading” or “deceptive” or not published by “reputable organizations.” 

And who or what is to determine whether any particular video meets this criteria?  Wired published an article with the ominous headline “YouTube Testimonials Lure Patients to Shady Stem Cell Clinics,” implicitly calling on YouTube to take action. The notion isn’t farfetched. YouTube has been in the news a lot recently for censoring videos, using nebulous criteria and subjective standards.   

Apparently, SCT critics have jumped on the YouTube censorship bandwagon.  It’s a wagon that seems to claim a new victim every day, and its victims are usually those who threaten the status quo.  Unfortunately, it’s a wagon that travels the pothole-riddled road of authoritarianism.  It’s a road patrolled by people in strange uniforms, with sophisticated and articulate weapons, who dispense a vicious propaganda, and who always claim to have your best interest at heart.

Please make sure to call, email and/or tweet your state and federal legislators to voice your support for the availability and affordability of stem cell therapy.  The people who suffer with pain and disability will not be silenced and will not be censored.  Our democratic voice will be the response to their authoritarianism.

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.

Kratom Helps Me with Pain and Addiction

(Editor’s note: The author of this column is using the pseudonym “Marc Smith’ because he fears his employment and healthcare could be jeopardized if his true identity were known.)

By Marc Smith, Guest Columnist

I have had a long and treacherous battle with health problems and substance abuse. Starting at age 14, I was diagnosed with multiple reoccurring bone tumors on my right leg below the knee. This led to six major surgeries; three for tumor removal and three for MRSA bacterial infection treatment and debridement.

My knee is completely damaged from the tumor destroying the top of my tibia and the bacteria completely eating away at my meniscus and cartilage. I have severe chronic and acute pain in that leg. I am not a candidate for a knee replacement due to the bone being too damaged and it is not a stable site for an artificial joint.

I have also been in a severe car accident that lacerated my left arm, broke the fibula in my left leg and tore the meniscus in my left knee.

The treatment of these ailments came with a lot of prescribed narcotic pain medications on a regular basis from age 14 on. My tolerance to these medications grew astronomically over 15 years until they stopped working effectively.

I eventually was buying OxyContin on the street and abusing it heavily. This led to IV heroin and cocaine use, and the loss of anything of real value I had.

I struggled with this crippling addiction for 18 years. I tried methadone, Suboxone, Vivitrol and complete abstinence -- with no significant success with any of them. Finally, I tried a strong 12-step recovery program. It worked temporarily, but the physical pain would become too much and I would relapse on opiates.

A year ago, I found kratom and decided to try it for pain relief. It helps me with pain, helps me sleep, curbs craving, and allows me to function and participate in daily life without being in extreme pain. I do not have extreme tolerance building problems with kratom like I did with opioids. The side effects are extremely minor and do not impair my judgment or ability to function.

I am up at 4:30 AM every day and at the gym by 4:45 cycling for an hour. I have found the recumbent bike does not hurt my leg that badly. I lost weight due to exercise and diet changes that kratom helped me make. I am much more positive about taking care of myself and am able to be present for life.

My pain hasn’t completely vanished, but it is manageable due to kratom. My spiritual growth has been a big factor as well in my 12 months of sobriety. These two things working in harmony have literally saved my life. I am a completely different person and my family has their son back.

I do not want to die and the fact that this harmless plant is being targeted makes me scared for my life. Let’s focus on rehabilitation and recovery methods. Let’s focus on illicit fentanyl and other synthetic chemicals, not a natural botanical. Please, take a step back and look at kratom success stories like mine.

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.

FDA Warns Kratom Vendors

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has issued two more warning letters to kratom vendors – Cali Botanicals of Folsom, California and Kratom NC of Wilmington, North Carolina – for making unproven claims that kratom can treat pain, addiction, depression, anxiety and other medical conditions.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years millions of Americans have discovered kratom -- including many who have lost access to opioid medication -- and found it to be an effective treatment.   

The FDA, however, considers kratom an unapproved drug that shouldn't be used to treat any medical condition.

“Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” said acting FDA Commissioner Ned Sharpless, MD.

“As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.”

What makes kratom dangerous? Sharpless cited FDA studies that found salmonella bacteria and heavy metals in a relatively small number of kratom products.  Kratom has also been linked to dozens of fatal overdoses -- although multiple substances were involved in nearly all of those deaths.

The FDA said Cali Botanicals and Kratom NC were using websites and social media to make unproven claims about kratom's ability to treat medical conditions. Cali Botanicals, for example, makes these claims about kratom's benefits:

• “Kratom is able to reduce the pain levels that reach the brain in a way that’s very similar to opioid drugs.”

• "Kratom is seen as life-saving by former addicts, who found kratom to be the only way they could overcome their addictions."

• “Consumption of kratom can reduce pain and swelling to an injury.”

• “Addicts can wean themselves off of their addictions by replacing their drugs with kratom. It has similar effects as opioids, but without the same dependency. Kratom also helps with the withdrawal symptoms.”

• “Kratom is used for energy, to increase attention/focus, to relax, and also to treat pain and addiction."

• “Some researchers have even claimed that kratom can protect you against cancer!”

With the exception of that claim about preventing cancer, those are the same benefits that many kratom users report anecdotally.

"For over two years now I have enjoyed drinking my kratom tea a couple of times a day. It helps promote my mood and energy like a cup of coffee would. The tea also relieves my aching joints and muscles, making my chronic fatigue and pain much more bearable," Kim DeMott wrote in a recent PNN column.  

"Kratom does not make me high, nor do I experience side effects. I am now clear minded without the sedation caused by narcotics. And I am devastated that the FDA is working to ban the only thing that has helped me in the past 28 years," fibromyalgia sufferer Mary Ann Dunkel wrote in another guest column.

Kratom has been banned in 6 states and dozens of counties and cities have enacted or are considering their own bans. Last year, the Department of Health and Human Services (HHS) recommended to the DEA that kratom be classified as a Schedule I substance – which would effectively ban it nationwide. Currently, the DEA doesn't even list kratom in its annual report on drug threats. 

Anxiety Is a Symptom, Not a Diagnosis

By Dr. David Hanscom, PNN Columnist

Every living creature on this planet survives by avoiding threats and gravitating towards rewards. The driving force is staying alive and survival of the species. This is accomplished by the nervous system taking in data from the environment through each body sensor and analyzing it.

The first step in this process is for your brain to define reality. A cat is a cat because your brain has unscrambled visual signals and determined the nature of the animal. A cat’s meow is analyzed from the auditory receptors. Your nervous system then links the two inputs together to associate the sound as one that emanates from a cat.

The reason why I am presenting the obvious is to make the point that nothing exists without your brain gathering data, unscrambling it and determining what is.

One of the responsibilities of the central nervous system is to maintain the delicate balance of the body’s chemistry. There are numerous chemicals to keep track of. When there is a threat, hormones will be secreted that increase your chances of survival.

Some of the core response hormones are adrenaline, noradrenaline, endorphins, histamines and cortisol. I won’t list the effects of each of these survival hormones, but the net result is an increased capacity to flee from danger.

All of these allow you to leap into action, but what compels you to do so? It is a feeling of dread that we call anxiety. It is so deep and uncomfortable that you have no choice but to take action.

Anxiety is a symptom, not a diagnosis, disease or disorder. Therefore, it isn’t treatable by addressing it as the problem. Once you understand anxiety is only a warning mechanism, you can address the causes of it.

The Curse of Consciousness 

The universal problem of being human is what I call the “Curse of Consciousness.” Recent neuroscience research has shown that threats in the form of unpleasant thoughts are processed in a similar area of the brain as physical threats and with the same chemical response.  

This curse is that none of us can escape our thoughts, so we are subjected to an endless hormonal assault on our body. This translates into more than 30 physical symptoms and many disease states, including autoimmune disorders and intractable pain. The worst symptom is relentless anxiety.  

In my personal experience and working with thousands of pain patients, it is the mental pain -- manifested by anxiety – that becomes intolerable. Anxiety is the essence of human suffering and physical pain is the final insult.  

Since this unconscious survival mechanism has been estimated to be a million times more powerful than your conscious brain, it isn’t responsive to rational interventions to manage or control it. Without anxiety that is unpleasant enough to compel you take action, you wouldn’t survive. Neither would you survive without the drive to seek physiological rewards. 

Direct Your Own Care

Try to view anxiety as the fuel gauge in your car. It lets you know that you are being threatened. Whether the threat is real or perceived doesn’t matter. But you have to allow yourself to feel it before you can understand and deal with it.  

If anxiety is the measure of your body’s survival hormones, then the only way to decrease it is to lower them. This can be accomplished directly through relaxation techniques or by indirectly lowering the reactivity of your brain to dampen the survival response.  

This is accomplished by stimulating your brain to rewire so the response to a threat results in a lower chemical surge and is of shorter duration. The term for this is “neuroplasticity.” Your brain changes every second with new cells, connections and myelin. 

By not wasting energy trying to treat or solve your anxiety, you now have the energy to pursue a new path with a remarkable surge in energy, life forces and creativity.   

How is this accomplished? Learning tools to calm and rewire your nervous system is the core of the Direct your Own Care (DOC) project. These approaches have been known for centuries, but have been buried under the weight of modern information overload and the rapid pace of life.  

DOC is a four-stage process for you to understand the nature of your pain and relevant issues that allows you to figure out your own version of a solution. The clarity you get will help you connect to your own capacity to heal by developing skills to auto-regulate your body’s chemistry from anxiety to relaxed.  

Success in learning to adjust your body’s chemical makeup is based on awareness and openness to learning so change can occur. It is remarkably simple and consistent. Join me in living your life in a manner that you could not conceive was possible – even better than before you were crushed by pain. 

Dr. David Hanscom is retired spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

In his book Back in Control, Hanscom shares the latest developments in neuroscience research and his own personal history with pain.

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.

How West Virginia Became the Epicenter of the Opioid Crisis

By Douglas Hughes, Guest Columnist 

Aggressive promotion by the distributors of OxyContin, the best pain medication ever formulated (when properly used), led to excessive prescribing by West Virginia doctors. 

This caused a methamphetamine drug problem in the state to morph into a prescription opioid epidemic, mostly due to unused opioids squirreled away in medicine cabinets.  Adolescents ignored by their guardians had complementary party favors of these excess opioids. This is why so many families were affected. 

After a few years of this, once the addiction problems were exposed, the excess prescribing stopped. Those desiring to misuse OxyContin went to pain clinics and lied to receive more.  Since we don’t have tachometers on our foreheads to gauge real subjective pain, lying to doctors was effective for many to get drugs to abuse.  

Not wanting to assist pain specialists and willing to deny legitimate intractable pain treatment, the West Virginia legislature passed the “Chronic Pain Clinic Licensing Act.”

When implemented on January 1, 2015, the goal to deny licenses to a dozen new and existing pain clinics was achieved. This left only pills being hoarded in medicine cabinets, which were quickly depleted.  

OxyContin distribution was suspended to pharmacies in most of West Virginia in 2015. 

These two efforts stopped most OxyContin prescribing and decimated legitimate disabled intractable pain sufferers in West Virginia, the state with the highest incidence of industrial and worker compensation injury cases. 

For the sake of argument, let’s estimate pain clinic patients were 50% legitimate pain sufferers and 50% abusers lying in order to get opioids.  Each of those twelve pain clinic closures turned a thousand or more patients onto the streets.  Some wanted to abuse, while others desperately sought to replace critical pain treatment denied to them by state law.  Some turned to street drugs as their answer. 

In 2015, West Virginia police departments reported that pain pills seized from drug arrests fell a remarkable 89 percent. The opioid crisis was shifting rapidly to heroin, as the drug sub-culture always does when a drug source changes. The prescription opioid epidemic in West Virginia essentially ended in 2015.  There was no memo from the CDC.

Those thousands of good and bad patients from pain clinics were both naive to the strength and use of heroin.  Dosing, once regulated by prescription, now was more lethal. Learning how to prepare and inject heroin without becoming infected, overdosing and dying was problematic. There were record overdose deaths in 2015, even though there were fewer pain pills. 

Counterfeit medication and heroin laced with illicit fentanyl appeared and record overdose deaths continued in 2016 and 2017 because there were so many inexperienced street drug users.  

Since 2015, West Virginia has wasted millions of dollars annually chasing imaginary diversion and investigating and prosecuting good physicians. This satisfied everyone except legitimate pain patients, who were left suffering and dying in their beds.  A suicide epidemic ensued.

West Virginia lacks a prevention component to their drug crisis response, which insured the re-occurrence of another epidemic. Apparently, we are satisfied with this catastrophe. May we have another?   

Douglas Hughes is a disabled coal miner and retired environmental permit writer in West Virginia.

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.

FDA Seeks Feedback on Opioid Blister Packs

By Donna Gregory Burch

I’ve been hoarding a bottle of oxycodone tablets from my back surgery last year. I probably shouldn’t admit it, but I keep them tucked away in the back of a bathroom drawer in case my chronic back and fibromyalgia pain gets so intense that I need something stronger than the tramadol or medical marijuana I normally use for daily pain.

I’m doing exactly what the Food and Drug Administration doesn’t want me to do. In fact, if an FDA proposal is adopted, there will be far fewer patients like myself with stashes of leftover opioids.

The FDA is soliciting public comments on a proposal to require drug makers to manufacture certain opioids in “blister packs” for acute pain situations such as patients recovering from injuries and minimally-invasive surgery. Opioids listed in the FDA’s Federal Register notice include hydrocodone, tramadol, oxycodone and codeine.

In a nutshell, the FDA would like doctors to have the option to prescribe 5, 10 or 15-count opioid tablets in foil wrappers, similar to those annoyingly difficult-to-open packages used for cold-and-flu medications.

If you’ve ever been sick as a dog with a cold and used all of your strength to wrestle a Dayquil capsule out of its foil wrapper, then you know the type of packaging I’m talking about.

The FDA’s proposal is intended to reduce the number of unused opioids that could wind up in the hands of children and others who might abuse or divert them. Based on published studies, most “opioid naïve” patients who are new to opioids don’t actually take all of the tablets prescribed to them for acute pain. The FDA believes all of those leftover pills stashed in medicine cabinets could be contributing to the so-called opioid crisis. 

“In the post-surgical setting, following several common minimally or less-invasive surgical procedures, most opioid-naïve adults who used an opioid analgesic appeared to use only one to three days’ worth, or 15 or fewer, opioid analgesic tablets or capsules despite receiving prescriptions exceeding the number they used,” reads the FDA’s notice for public comment.  

“(We) anticipate that utilization of these fixed-quantity unit-of-use blister package configurations would substantially reduce the quantity of opioid analgesics dispensed per prescription compared to the status quo.”.

Obviously, physicians already have the authority to prescribe smaller quantities of opioids, but the FDA says these blister packages would encourage more rational “right-size” opioid prescribing. The notice stipulates that blister packs would not be required and that other options would still be available.

Other potential benefits of blister packaging cited by the FDA include:

• Reducing accidental childhood poisoning

• Being able to include additional labels on packaging on how to safely use and dispose of opioids

• Making it easier for patients and caregivers to determine if a third party has taken their opioid medication

The FDA is soliciting comments on its proposal through July 30. Read the public comment notice here. The notice includes instructions for submitting comments online, by email or in paper form.

So, what do you think? Would prescribing opioids in blister packaging for acute pain help curb the opioid crisis? Am I the only person who breaks out in a sweat when I have to pry medications from that kind of packaging? Share your thoughts (and struggles) in the comments! 

Donna Gregory Burch lives with fibromyalgia and chronic Lyme disease. Donna covers news, treatments, research and practical tips for living with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter.

Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

How Opioid Critics and Law Firms Profit From Litigation

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

— Dr. Andrew Kolodny

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

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

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

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

Compensation Not Disclosed

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

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

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

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

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

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

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

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

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

PharmedOUT’s Paid Expert Witness

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

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

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

DR. ADRIANE FUGH-BERMAN

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

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

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

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

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

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

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

Lobbying and Campaign Donations

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

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

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

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

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

5 Million U.S. Cancer Survivors Live with Chronic Pain

By Pat Anson, PNN Editor

Over five million cancer survivors in the United States live with chronic pain, a fast-growing population that is expected to double by 2040 due to the aging of the population, early cancer detection and advances in treatment, according to a new study by the American Cancer Society.

Chronic pain is one of the most common side effects of chemotherapy and other forms of cancer treatment, but until now there has been little information on its prevalence among cancer survivors.

Researchers looked at data from the National Health Interview Survey from 2016-2017 and found that about a third of cancer survivors (34.6%) have chronic pain. About one in six (16.1%) have “high impact” chronic pain (HICP) – defined as pain that limits life or work activities on most days.

Based on that survey data, researchers estimate the total number of cancers survivors in the U.S. at 15.5 million. About 5.39 million of them have chronic pain and 2.51 million have high impact chronic pain.

“We found the prevalence of chronic pain and HICP among cancer survivors to be almost double that in the general U.S. population. Chronic pain and HICP were more prevalent in survivors who were unemployed and who had low socioeconomic status, inadequate insurance, and had some specific types of cancer,” researchers reported in JAMA Oncology.

“The patterns of chronic pain that we observed in cancer survivors may be explained by barriers to cancer care and pain management as well as by the type and extent of cancer treatment received.”

One barrier to pain management stems from efforts to rein in opioid prescribing to prevent abuse and addiction. While the 2016 CDC opioid guideline is intended for “noncancer” patients, it is also applies to patients “who have completed cancer treatment, are in clinical remission, and are under cancer surveillance only.”

Two experts in oncology and palliative care at the University of Pennsylvania say the CDC’s inclusion of cancer survivors was a mistake because it is not uncommon for cancer pain to persist long after a cancer is treated.  

“Unfortunately, this arbitrary distinction is not consistent with the evidence of pain trajectory in cancer survivors,” Neha Vapiwala, MD, and Salimah Meghani, PhD, wrote in an op/ed also published in JAMA Oncology. “Similar levels of pain were reported in survivors who were still receiving cancer treatment and those who had completed active cancer treatment.”

It’s not uncommon for cancer patients undergoing active treatment to be denied pain medication. Many doctors are reluctant to prescribe opioids, regardless of the diagnosis.

“My cancer doctor will no longer prescribe pain meds for me because I now see a pain doctor. The pain doctor doesn't understand the new cancer drug I'm on and that the side effects of this drug are pain, so he is very reluctant to manage my cancer pain,” a patient with lymphoma told us. “Many days I wonder if it would just be better to let the cancer take its course than to be scrutinized and treated like a criminal.”

April Doyle is being treated for Stage 4 terminal breast cancer, but a Rite Aid pharmacist refused to fill her prescription for Norco because he was worried about being fined or even losing his job. April’s video about the experience went viral.

“I have to take 20 pills a day just to stay alive,” she 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.”

The American Cancer Society study found that chronic pain was most common among cancer survivors treated for bone, kidney, throat-pharynx and uterine cancers.  About half still had pain after their cancer treatment ended.

Employers Adding Stem Cell Options to Insurance Plans

By Liz Szabo, Kaiser Health News

A Midwestern grocery chain, Hy-Vee, is taking an unusual approach to reducing health care costs. Before employees in certain cities can undergo knee replacement, they first must visit a stem cell provider.

Hy-Vee has contracted with one of the United States’ leading stem cell companies — Regenexx, based in Des Moines, Iowa — that claims injections of concentrated bone marrow or platelets can help patients avoid expensive joint surgery.

Regenexx has persuaded over 100 employers to include its services in their health insurance plans. In a marketing booklet, Regenexx, whose injections range in price from $1,500 to $9,000, notes that its treatments cost a fraction of major surgery.

A single knee replacement ranges from $19,000 to $30,000 in the U.S.

Health insurance typically doesn’t cover stem cell injections, with the exception of certain accepted treatments, such as bone-marrow transplants for cancer and aplastic anemia.

Aetna, the United States’ third-largest health insurer, dismisses stem cells and platelet injections as experimental; Anthem, the country’s second-biggest health insurance provider, classifies the injections as “not medically necessary.” Without insurance coverage, patients are forced to pay out-of-pocket or forgo treatment.

So instead of dealing with disapproving insurance executives, Regenexx appeals directly to employers large enough to fund their own health plans. These businesses have the freedom to customize their plans, covering services that aren’t part of a standard insurance package.

In a statement, Regenexx said its goal is to “replace more invasive surgical orthopedics” with nonsurgical options, noting that recent research has found many joint operations are ineffective. On its website, Regenexx claims its procedures “repair and regenerate damaged or degenerated bone, cartilage, muscle, tendons, and ligaments.”

In a bone marrow stem cell procedure, for example, a doctor withdraws bone marrow cells from a patient’s hip, concentrates them, then reinjects them into a problem area, such as an arthritic knee. Doctors target the exact location in the joint using ultrasound. For a “platelet-rich plasma” treatment, doctors draw blood, concentrate the platelets, then inject them into the target area.

Regenexx, previously known as Regenerative Sciences, is one of the oldest stem cell companies in the U.S. When it opened its doors in 2005, it had only a handful of competitors.

Today, there are more than 1,000 stem clinics in the U.S., said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics, who has published a series of articles describing the stem cell market.

At times, Regenexx has clashed with the Food and Drug Administration. In 2010, for example, Regenexx sued the FDA, claiming the agency lacked the authority to regulate its procedures, which involved culturing stem cells before reinjecting them into patients. Regenexx lost its case and was countersued by the FDA, which charged that Regenexx was marketing an unapproved drug. In 2014, the U.S. Court of Appeals in Washington sided with the FDA, forcing Regenexx to stop performing the controversial procedures.

Today, Regenexx performs this procedure only in the Cayman Islands, where the government allows it. The Cayman Islands, where there is less government regulation of health care, has become known as a medical tourism destination, Turner said.

Regenexx says that the treatments offered at its U.S. clinics comply with FDA regulations, which require that cells injected into patients undergo no more than “minimal manipulation.”

On its website, Regenexx lists more than two dozen studies led by its doctors. For example, its chief medical officer, Dr. Chris Centeno, published a small study last year that found patients with knee arthritis who received bone marrow and platelets fared better than those randomly assigned to exercise therapy.

Other research suggests stem cells and platelets may work no better than placebos. In a recent analysis, over 80% of patients with knee arthritis experienced a noticeable improvement in pain after receiving simple saltwater injections.

There’s also no definitive evidence stem cells and platelets can regrow lost cartilage. A 2018 review concluded platelets have “marginal effectiveness,” and experts note that most published studies are so small or poorly designed that their results aren’t reliable.

Corporate Boosters

Corporate executives have become some of Regenexx’s biggest boosters. Hy-Vee’s former chairman and CEO, Ric Jurgens, appears in a Regenexx marketing brochure and says that he turned to Regenexx because of heel pain. The brochure, which was removed from a Regenexx website after Kaiser Health News began reporting this story, quotes Jurgens as saying, “I knew that giving our employees the chance to explore options besides surgery was in their best interest.”

Hy-Vee did not make Jurgens or other employees available to interview.

Perhaps Regenexx’s best-known corporate client is Des Moines-based Meredith Corp., which owns multiple TV and radio stations, as well as magazines such as Better Homes & Gardens.

Steve Lacy, Meredith’s former CEO and current board chairman, said he underwent a Regenexx procedure two years after his company began covering stem cell treatments. He had been facing knee surgery and thought stem cells were worth a try.

The procedure got him back to doing everything he wants to do, Lacy said, even running several days a week. He also has done daily physical therapy for over two years. “The rehab and recovery is far less onerous” with the Regenexx procedure than with surgery, Lacy said. “If the procedure doesn’t work for an individual, there’s no harm.”

Meredith has spent about $400,000 in four years on 85 employees who have had Regenexx treatments, or about $4,700 a patient, said Meredith spokesman Art Slusark. That’s a small share of the roughly $75 million a year that Meredith spends on its medical plan, he said.

At its headquarters, Meredith has promoted Regenexx procedures through email, posters and “lunch-and-learn” sessions in the office, said Jenny McCoy, Meredith’s corporate communications director.

McCoy herself has become a poster child for Regenexx’s benefits. She and two other Meredith employees appear with Lacy in a marketing video on the Regenexx site:

Although McCoy had begun to experience knee and hip pain during exercise, she said in an interview that her pain was not severe enough to need surgery. McCoy underwent platelet injections two years ago and is pain-free today, she said.

“I thought, ‘If Meredith is covering it, I might as well have it done early before [the pain] causes me too many problems,’” said McCoy, 52. Given the price tag, she said, “I would not have done it otherwise. I wouldn’t have even known about it.”

‘Very Pushy’ Marketing

Some employers are, in fact, skeptical. The Des Moines Public Schools has opted not to add Regenexx to its employee health plan, said Catherine McKay, director of employee services for the school system. She said a salesman for a local stem cell clinic, which has since merged with Regenexx, told her the treatments could save the school system lots of money. McKay wasn’t sold.

“My experience with them has not been great, in terms of marketing and sales. They’re very, very pushy,” McKay said. “They claim they can get people back to work earlier” than surgery. “But if I still need knee surgery a year down the road, that doesn’t cut my costs.”

The Des Moines school system has agreed to consider covering Regenexx procedures as part of its workers’ compensation program on a case-by-case basis, McKay said. The school system has not signed a contract with Regenexx, however, and hasn’t included Regenexx in its health plan.

McKay said she knows of two school employees who have tried Regenexx. While one employee was satisfied with the results, McKay said, another “went through a couple procedures and ended up needing surgery anyway.” 

In response, Regenexx noted that many patients who undergo knee surgery are also unhappy with the results. Research suggests that up to one-third of those who have knees replaced continue to experience chronic pain, while one-fifth report that they are dissatisfied with the results of their surgery.

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

A Gut Feeling About Fibromyalgia

By Pat Anson, PNN Editor

Over the years there’s been a lot of speculation about what causes fibromyalgia – everything from gluten and genetics to childhood trauma, spinal fractures and a weakened immune system.

About 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, mood swings and insomnia. It can take years for a patient to be diagnosed and treatments are often ineffective – in part because of uncertainty about what actually causes fibromyalgia.

For the first time, researchers at McGill University Health Centre in Montreal have found an association between gut bacteria and fibromyalgia. It’s not clear whether the microbes cause fibromyalgia or if they are a symptom, but the discovery opens the door to new forms of treatment and diagnosis. The findings are being reported in the journal Pain.

"We found that fibromyalgia and the symptoms of fibromyalgia — pain, fatigue and cognitive difficulties — contribute more than any of the other factors to the variations we see in the microbiomes of those with the disease,” said lead author Amir Minerbi, MD, of the Alan Edwards Pain Management Unit at McGill University Health Centre. 

“We also saw that the severity of a patient's symptoms was directly correlated with an increased presence or a more pronounced absence of certain bacteria - something which has never been reported before."

Minerbi and his colleagues enrolled 156 women in their study – about half had fibromyalgia and the rest were a healthy control group. Participants were interviewed and gave stool, blood, saliva and urine samples, which were then compared.

Researchers found that the two groups had strikingly different types and amounts of gut bacteria. Nineteen different species of bacteria were found in either greater or lesser quantities in the gut microbiomes of fibromyalgia patients than in the healthy control group.

For example, Faecalibacterium prausnitzii, one of the most abundant and well-studied bacteria in the human gut, was found to be depleted in fibromyalgia patients. It is believed to block pain and inflammation in the intestines.

Other bacteria associated with irritable bowel syndrome, chronic fatigue syndrome and interstitial cystitis were found to be abundant in the fibromyalgia patients, but not in the healthy control group.  

The bacterial differences don’t appear to be related to diets, lifestyles or genetics, since some of the healthy participants lived in the same house as the fibromyalgia patients or were their parents, offspring or siblings.

"We used a range of techniques, including Artificial Intelligence, to confirm that the changes we saw in the microbiomes of fibromyalgia patients were not caused by factors such as diet, medication, physical activity, age, and so on, which are known to affect the microbiome," says Minerbi.

Researchers say it's not clear whether the changes in gut bacteria seen in fibromyalgia patients are simply markers of the disease or whether they play a role in causing it. Because fibromyalgia involves a cluster of symptoms, the next step will be to investigate whether there are similar changes in the gut microbiome of patients with other types of chronic pain, such as back pain, headaches and neuropathic pain.

“This is the first evidence, at least in humans, that the microbiome could have an effect on diffuse pain, and we really need new ways to look at chronic pain." said senior author Yoram Shir, MD, Director of the Alan Edwards Pain Management Unit

If their findings are confirmed, researchers think their discovery could speed up the process of diagnosing fibromyalgia.

"By using machine learning, our computer was able to make a diagnosis of fibromyalgia, based only on the composition of the microbiome, with an accuracy of 87 per cent. As we build on this first discovery with more research, we hope to improve upon this accuracy, potentially creating a step-change in diagnosis," says Emmanuel Gonzalez, PhD, Canadian Center for Computational Genomics and the Department of Human Genetics at McGill University.

Several previous studies have suggested an association between diet and fibromyalgia. Donna Gregory Burch says her fibromyalgia symptoms improved when she went on a gluten-free diet. Studies show that consuming food additives such as monosodium glutamate (MSG) can worsen symptoms, while foods rich in Vitamin D can help reduce joint and muscle pain.

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

By Pat Anson, PNN Editor

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

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

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

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

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

PAUL GILENO

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Lessons from ‘The United States of Opioids’

By Roger Chriss, PNN Columnist

Harry Nelson’s new book “The United States of Opioids: A Prescription for Liberating a Nation in Pain” looks closely and productively at the opioid overdose crisis. It comments on origins and causal factors, and offers pragmatic policy ideas for addressing it. The book is succinct and well-organized, designed for easy reading and reference.

Nelson starts with a dire description of addiction and overdose, calling the U.S. opioid crisis “American healthcare’s self-inflicted wound.” He then gives a brief history of opioids, explaining the three waves of the crisis, culminating in illicit fentanyl and “an increasing crackdown on physician overprescribing.”

Nelson touches on the history and science of opioids, then looks at causes of the crisis. These include not only Purdue Pharma and the Sacklers, but also drug distributors, retailers and health insurers. Institutional and regulatory failures on opioids are not ignored.

“The overarching problem when it comes to physician overprescribing has been insufficient training and education on how to prescribe opioids,” he writes. “The FDA approved these drugs and oversaw the data concerning the risks of their misuse, abuse, addiction, and overdose.”

But Nelson digs deeper, looking at the underlying social and cultural determinants that play into the longer term. He cites a 2018 University of Pittsburgh study that underscores that opioids are part of a broader trend in which abuse of multiple drugs and a rising drug overdose rate “that shows no signs of slowing, with sub-epidemics of different drugs over time.”

Unlike other books, Nelson writes in depth about how to address the crisis: “I believe that our attention should first be focused on a host of intersecting trends that point to suffering in America — parallel crises that include suicidality, anxiety, depression, and pain.”

He explores other options for pain management, from NSAIDs and nerve blocks to non-pharmacological techniques: “It is critical to push insurers and government programs to cover non-opioid treatment, even if it means spending more to achieve this priority.”

Nelson includes a whole chapter on cannabis and other alternative therapies for opioid addiction, in particular kratom and psychedelics. He is optimistic but tentative about cannabis: “Despite the potential to address health issues, consumers need to be cautious about both the claims and contents of cannabis products.”

He also looks at addiction treatment, including AA-type abstinence programs and medication-assisted therapy, and notes that “the biggest challenge in addiction treatment is the complexity of addiction itself.”

Nelson is highly critical of much of the response to the crisis to date: “When I think about the government and health system’s approach for taking on the opioid crisis, the thing that strikes me most is how much it feels tactical rather than strategic.”

Nelson condemns the rampant fraud and patient brokering in the recovery industry. But he also points out that addiction treatment itself needs improvement.

“We will know that addiction treatment has ‘arrived’ in terms of its integration into healthcare when we have relatively uniform professional and program licensure requirements from state to state — something seemingly decades away,” he wrote.

Nelson lists seven general recommendations for the crisis in his OPIOIDS acronym:

• Outreach for prevention and early intervention

• Physician improvements

• Innovation in pain and addiction care

• Overdose interventions

• Interdiction off illicit opioids

• Data analytics to better track the crisis

• Strengthening access to addiction care

He emphasizes the value of harm reduction, improving social capital, and organizing prevention in schools and the workplace — instead of “stop gap” measures that do little beyond preventing fatal overdoses.

“The key to solving the opioid crisis lies in not being satisfied with tackling the overdose death issue, but in addressing two of the fundamental problems that got us here: the inadequate management of ongoing issues for people living with chronic pain, which overlaps with the second problem of people living with an opioid use disorder (OUD),” he writes.

Finally, Nelson gives a warning: “If we think about the opioid crisis as the ‘canary in the coal mine,’ it’s warning us that we need to address a much bigger, toxic set of problems.”

For all the book offers, it also has problems. Nelson overstates the number of people with opioid use disorder, misrepresents the complex nature of opioid initiation, and misconstrues the varied trajectory of heroin addiction. Most importantly, Nelson gives little attention to rising rates of cocaine and methamphetamine overdose deaths, and ignores that most overdoses involve multiple drugs.

“The United States of Opioids” offers a suite of tools and ideas for moving forward, a refreshing change from the many righteous rants or poignant laments about the crisis.

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.

Chronic Pain Patients in Alberta Revolt

By Marvin Ross, Guest Columnist

Last week the Chronic Pain Association of Canada issued a press release calling upon the Alberta health minister to investigate the College of Physicians and Surgeons of Alberta (CPSA) for “its unwarranted and secret cautioning and sanctioning” of doctors who prescribe opioid medication.

The press release came after a public meeting of pain patients in Edmonton organized by the group Help Alberta's Pain. Numerous patients showed up to complain about the poor quality of pain care in Alberta.

The meeting was so successful that the organizer, Tracy Fosum, told me that more meetings are being arranged in Edmonton, Calgary, Sherwood Park, Lethbridge and one in Northern Alberta.

An estimated 1.25 million Albertans suffer from chronic pain and 125,000 have long used opiate analgesics in order to function. In March, an Edmonton pain practice shutdown, throwing nearly 1,000 of these patients out of care.  

“Thousands of Albertans with pain have lost specialist and primary care because the College of Physicians and Surgeons of Alberta has forced doctors to stop prescribing opiates. The province's pain specialists are retiring in large numbers, citing College intimidation,” Barry Ulmer, Executive Director of the Chronic Pain Association of Canada said in a statement.

In response, the CPSA issued a statement from Registrar Dr. Scott McLeod calling such claims “misinformation” and denying there was an exodus of pain physicians from the profession.   

“Many Albertans suffer with severe daily pain and need medical assistance to allow them to live productive lives with their family, friends and in the workplace. We understand the challenges these Albertans face and encourage physicians to work with their patients to find a sustainable solution,” McLeod said. “Responsible prescribing does not include abrupt discontinuation or tapering of opioids or abandoning patients who use opioids.”

McLeod said the CPSA has been successful in reducing overdoses and opioid prescriptions. Accidental overdose deaths in Alberta from prescription opioids have been cut in half, there has been a 20% decline in opioid prescribing since 2016, and 13% fewer patients received an opioid in 2018 compared to 2016.

Patients Denied Treatment

Tracy Fosum recently appeared on the Roy Green syndicated radio show to talk about her personal experiences as a long time chronic pain patient in Alberta. Suffering from what even I recognized as the classic signs of a heart attack, she went to a local Edmonton hospital. Staff were suspicious of Tracy because of her high opioid use and, after a cursory exam, suggested she go home and take some NSAIDs for what they decided were chest muscle spasms.

Later, Tracy went to another hospital emergency room, where she was forced to wait for six hours as, she contends, they mistook her for a drug seeking addict. While trying to convince them to do an EKG, she went into cardiac arrest and collapsed. Fortunately, Tracy survived but ended up with heart damage because she had to wait too long.

Meanwhile, the Ontario College of Physicians and Surgeons is in the process of revising their opioid prescribing guidelines. A new draft policy states: “Physicians must not taper patients inappropriately or arbitrarily. Physicians are reminded that it is not always possible or appropriate to taper below a specific dose, nor is it usually appropriate to suddenly or rapidly taper prescriptions.”

The proposed guideline also states that “arbitrarily refusing to prescribe these drugs in all cases and without consideration for the circumstances of the patient may lead to inadequate patient care.”

While this is a step in the right direction, the problem is that patients have little recourse other than filing a formal complaint if a doctor provides poor treatment. A formal complaint can take months to years to resolve and ruins a doctor/patient relationship.

I am personally familiar with one case where a chronic pain patient was refused care by a doctor unless she agreed not to take any opioid medication. That doctor was sanctioned for refusing a patient on narcotics and refusing to prescribe narcotics, but the sanction was simply “Don't do that. You cannot refuse.” That patient now has no doctor because no one will take her on.

The Colleges can revise their rules and recommendations all they want, but they also need to ensure that doctors adhere to them.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He is a regular contributor to the Huffington Post.

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.