Roseanne Shed Light on Chronic Pain

By Barby Ingle, PNN Columnist

The reboot season of the “Roseanne” show recently wrapped up and there won't be another. Lead actress Roseanne Barr put out a racist tweet that went viral and ABC immediately canceled her show.

Although Barr’s tweet -- or ‘bad joke’ as she calls it --- was a big disappointment to her fans and everyone involved in the show’s production, I think she did some good in Season 10. It shined a light on how chronic pain can affect a patient and their family, and how important access to proper and timely mental and physical care really is.

Roseanne (both her character and in real-life) is a chronic pain patient. As a child, she suffered a traumatic brain injury. Over the years she’s shared her mental health challenges, which include nervous breakdowns and a multiple personality disorder.

"I did have a few nervous breakdowns and was hospitalized several times. It was very difficult. Fame was difficult too," Barr said in an interview with 20/20.

In a 2015 interview with The Daily Beast, Roseanne talked about using marijuana to help relieve pain.

“It’s a good medicine, you know,” she said. “I have macular degeneration and glaucoma, so it’s good for me for that because I have pressure in my eyes. It’s a good medicine for a lot of things.”

Two years ago, Roseanne began using a cane after she slipped and broke her kneecap in three places during a trip to San Francisco's Golden Gate Park. Roseanne was prescribed opioid medication for her knee injury and her real-life story was an impetus for addressing chronic pain and opioids in her show this past season. Her character also had a knee injury and used a cane.

ROSEANNE BARR

Throughout the final season, Roseanne's knee injury and chronic pain were woven into the storyline. The last two episodes were the hardest hitting. I have read articles that talk about how she was trying to share the plight of people living with addiction. I have another take on that. I believe Roseanne was actually trying to show what many pain sufferers go through because of the lack of proper and timely care.

I watched and saw a woman in real pain. Roseanne and her husband Dan worked together to overcome some of the invisible challenges of living with chronic pain. They installed an electric stair chair in Episode 3. I get this. When my husband and I chose our house, we chose one with no steps. I was still in a wheelchair at the time  and needed to get around the house without my husband’s help.

Roseanne couldn’t move to a new house due to financial challenges her TV family faced for over 20 years. She helped demonstrate how people in chronic pain must make adjustments to their living spaces to accommodate mobility.

Throughout her final season, Roseanne used a cane, went to physical therapy, and used mindfulness exercises. She even brought up that she didn’t have the money to have a procedure on her knee or to even see the doctor as often as she needed. I get that. The treatments that help me the most are not covered by my health insurance.

I have hosted personal fundraisers with family and friends to help raise the money I needed to get proper care. I’ve also had to make many appeals to my insurance company over the years. I had to find options that work for me, just as Roseanne has in both real life and as her character.

In one episode, she didn’t have enough pain pills and wondered if someone was stealing them. It turned out that Roseanne was hoarding them. She was not taking extra pills as a person with addiction would do. She was stockpiling them because she was not receiving adequate pain care and didn’t know when the pills would be cut off or how long she would need to make them last.

Two and a half million Americans live with opioid addiction, but we must never forget that 100 million will face chronic pain at some point in their lives and 30 million will need opioid pain medication. The vast majority will never abuse it.

Roseanne Barr and her show did a great job showing the limitations of our healthcare system and what happens as result of poor care. I was looking forward to next season and seeing what happened to Roseanne’s health and whether her treatment improved.

We need more media examples of what the challenges are in chronic pain and how to overcome them. I hope to see them addressed properly in future TV shows so that we change the lives of many Americans in need of better healthcare.  

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.

Sessions: ‘Drug Overdoses Finally Started to Decline’

By Pat Anson, Editor

There are signs – very tentative signs –  that the U.S. is making progress in the so-called opioid epidemic. Attorney General Jeff Sessions alluded to some of them in a speech on Friday.  

“New CDC preliminary data show that last fall, drug overdoses finally started to decline.  Heroin overdose deaths declined steadily from June to October, as did overdose deaths from prescription opioids,” Sessions said at the Western Conservative Summit in Denver.

Overdoses from heroin and prescription opioids did indeed fall by about 4 percent during that five-month period, but what Sessions failed to mention is that deaths from illicit fentanyl and other synthetic opioids rose by 12 percent – more than making up for whatever gains were made in reducing deaths from heroin and painkillers. 

From October 2016 to October 2017, the CDC estimates that 68,400 Americans died from drug overdoses, a 12% increase from the previous 12-month period.

So overdoses have not “finally started to decline” as Sessions claims. And the Attorney General, who once urged chronic pain sufferers to take two aspirin and “tough it out,” continues to blame prescription opioids for much of the nation’s drug problems.

“This (Justice) Department is going after drug companies, doctors, and pharmacists and others that violate the law,” Sessions said. “Since January 2017, we have charged more than 150 doctors and another 150 other medical personnel for opioid-related crimes.  Sixteen of those doctors prescribed more than 20.3 million pills illegally.”

ATTORNEY GENERAL JEFF SESSIONS

The Drug Enforcement Administration, which Sessions oversees, is also seeking a rule change that could lead to further tightening of the nation’s supply of opioid medication -- in addition to the 45% in production cuts the DEA ordered over the last two years. The DEA wants to change the rules so it can arbitrarily punish drug makers who fail to prevent their opioid products from being diverted and abused.  

Sessions ‘Socially Irresponsible’

“I think they’re attacking it from the wrong end, to be candid with you,” says Tony Mack, the CEO and chairman of Virpax Pharmaceuticals. “Who is going to end up suffering is the real patients that have chronic pain and can’t get a hold of these opioids.”

Although Virpax is focused on developing non-opioid pain medication, Mack has a wealth of experience in opioid pharmaceuticals, having worked for Purdue Pharma, Endo and Novartis. In an unusually blunt interview for a drug company executive, Mack told PNN that Sessions’ focus on prescription opioids was “socially irresponsible.”

“I believe Attorney General Jeff Sessions needs to sit down and talk to some of these physicians who are pain specialists and understand that what he’s doing is going to put the chronic pain patient, the post-operative patient, and the patient that comes to the emergency room in serious jeopardy,” Mack said. “I think that Jeff Sessions is not educated well. I think he is picking on something that sounds good politically but doesn’t make sense socially. It’s socially irresponsible.”

Mack says pain patients would be caught in the middle if the DEA changes the opioid production rules and, for example, tells Purdue Pharma to stop selling OxyContin, its branded formulation of oxycodone.

“If you cut off that particular company, since they have more oxycodone out there than anyone, what will happen is patients will have to go to morphine or have to go to fentanyl,” Mack told PNN. “You’re not going to give patients the choices that they need to have in order to manage their pain. Not every single opioid works the same way for every single person. They all work differently."

Mack thinks the DEA’s earlier production cuts have contributed to nationwide shortages of IV opioid medications, which are used to treat hospital patients recovering from surgery and trauma.

“Absolutely, I do,” he said. “It’s just a domino effect to me. You’re going to send more patients home or you’re going to be postponing surgeries until they get opioids because they can’t do (surgeries) without it. It would be inhumane.”

Mack says efforts to limit opioid prescribing and production may have backfired, giving patients little choice but to turn to the black market for pain relief.

“I think they’re trying to throw the baby out with the bathwater here. They’re not thinking it through,” Mack said. “They’re probably going to increase the amount of (illegal) drugs out there. And patients aren’t going to try and get help, because they’re going to be on heroin. Not on a prescription medication. They’re going to be shooting up heroin.”

Lost in the debate over opioids and their role in the overdose crisis is this little known fact: A recent study by the Substance Abuse and Mental Health Services Administration (SAMHSA) found that psychotherapeutic drugs used to treat depression, anxiety and other mental disorders are now involved in more overdoses than any other class of medication. They include antidepressants, benzodiazepines, anti-psychotics, barbiturates and attention deficit hyperactive disorder (ADHD) drugs such as Adderall. Over 25,000 overdoses in 2016 involved psychotherapeutic drugs. That compares to 17,087 deaths linked to opioid pain medication.

The Difference Between Pain and Suffering

By Ann Marie Gaudon, Columnist

It’s very easy to increase your pain and suffering. That’s not a typo. Believe me, we do it all the time. 

In my field, we use the term “clean pain” to describe something that we don’t have any choice over. Clean pain is the biological pain that science just can’t seem to fix. My clean pain is a result of disease. Your clean pain may be a result of disease or injury, or perhaps a combination. In the context of chronic pain, clean pain is unavoidable.

Clean pain is influenced by many factors and culture is one of them. For example, some African women deliver their babies in total silence due to learned beliefs. Clean pain can also be influenced by context, such as athletes who feel no pain as they push through their training and competition. Only when it is over do they feel pain and get care.

Clean pain is influenced by anticipation and previous experience. For example, you tell yourself that it’s happened this way in the past, so it’s absolutely going to happen this way again. We catastrophize (“It’s going to be awful and I won’t be able to cope!”) or we ruminate and obsess over our pain thoughts.

Grieving over the past or imagining a catastrophic future are two long highways to hell for chronic pain patients. I’ve driven on both of them. It’s not a fun ride.

Clean pain is also influenced by emotional and cognitive factors such as fear, anxiety, anger, depression and distorted thinking (“I will die from this pain!”). 

Dirty Pain

Clean pain is unavoidable within the context of chronic pain. However, what psychotherapy sees as avoidable, and completely within our control, is a second layer of struggling that we add to our pain. This second layer is called “dirty pain.” 

This dirty pain accumulates when we focus our attention on the negative thoughts and feelings about the pain, as well as the stories we tell ourselves (“I cannot live my life until I am pain free!”), and the rules we make up about the pain (“I cannot exercise in any capacity at any time with this pain”).

Some of these beliefs have a bit of truth to them, while some are arbitrary with no evidence to support them. Yet we can come to buy into them hook, line and sinker. Let the suffering begin.

Just to be clear, we absolutely must try to help ourselves with medical treatment in an attempt to alleviate our clean pain. However, there comes a time when the pain will budge no more. When we’ve reached that limit, yet continually strive to control pain that is not controllable, our efforts then become maladaptive and we suffer even more.

This metaphorical “chasing your tail” is also added to the layers of dirty pain.

We are all allotted only so much time and energy. We have a choice: Spend this time and energy trying to change the unchangeable, or engage in activities and relationships that help give you a sense of purpose and well-being.  

The goal of therapy is to help pain patients increase their repertoire of behaviours, guided by what they see as important, their own goals, and what they value in their life. This is in direct opposition to a restricted, limited and socially isolated life where pain is lord and master. By helping people to change the way they experience their thoughts, feelings and pain sensations, there is an opportunity to drop the struggle with your pain and to connect to what really matters to you.

Therapy for chronic pain management is a tool, and a good one at that, especially within a multi-disciplinary setting where you also have access to a team of other professionals. Some people with mild pain do very well using just one or two tools. However, if you are moving toward severe pain, you will need to have a larger toolkit.

My own toolkit -- in alphabetical order -- contains diet, exercise, ice packs, lifestyle modifications (e.g. strategic scheduling of work), medications, psychotherapy, rest, and a support system of family members, friends, and colleagues.

Some tools help with my clean pain while others help with my dirty pain. They all work together so that I can disconnect from struggling and connect to what matters to me. It isn’t an easy thing to do – especially at first -- but it is doable, as countless others are doing it as well.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for 33 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit 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.

Do Anti-Opioid Ads Hammer Home Wrong Message?

By Pat Anson, Editor

People who take opioid pain medication are often accused of bad behavior – such as stealing, selling and diverting their drugs. Or being lost in a haze of opioid addiction.

Now pain patients are being depicted as self-destructive maniacs so hopelessly hooked on opioids they'll do anything for their next high.

Four government-sponsored ads released this week by the White House feature young people who deliberately and violently injure themselves to get opioid medication.

All four ads are cringe worthy.

Kyle smashes his hand with a hammer.

Chris breaks his arm by slamming a door on it.

Joe breaks his back when he crawls underneath a car and lets it fall right on top of him.

“They gave me Vicodin after my knee surgery," says Amy in the 4th ad. "They kept prescribing it, so I kept taking it.  I didn’t know it would be this addictive. I didn’t know how far I’d go to get more."

Amy then unbuckles her seat belt and drives her car into a garbage dumpster.

“Opioid addiction can happen after just five days. Know the truth, spread the truth,” an announcer solemnly warns.

The White House Office of National Drug Control Policy partnered with the Ad Council and the Truth Initiative to launch “The Truth About Opioids” campaign. The four 30-second ads are based on real life stories.

“After testing 150 different messages, we are all excited to launch four hyper-realistic ads that show true stories — not fictionalized and not embellished — true stories of four young adults who took extreme measures to get more prescription pills in order to feed their addiction,” said White House counselor Kellyanne Conway.

“The goal is for other young adults to see these ads and ask themselves how they can prevent their lives and others’ lives from going down a similar path.  We hope these ads will spark conversation to educate teens and young adults to talk to their doctors about alternatives to opioids.”

The White House was vague about when and where the ads will run, and dodged questions about how much the campaign will cost taxpayers. Most of the productions costs and airtime are being donated by Facebook, YouTube, Google, NBCUniversal and other media partners.

Like the CDC’s recent Rx Awareness Campaign, the four commercials focus exclusively on opioid prescriptions, while ignoring the rising death toll taken by illicit fentanyl and heroin. It is also rare for anyone to become addicted to opioid medication after a few days, as the ads suggest.

A recent report by the Substance Abuse and Mental Health Services Administration (SAMHSA) warned that fentanyl and other black market opioids are now involved in more fatal overdoses than opioid medication. Drugs used to treat depression and anxiety are also linked to more deaths than painkillers. SAMHSA said that “widespread public health messaging is needed” about the rapidly changing nature of the overdose crisis.

Why then the continued focus on pain medication?  

“The fact is that the greatest amounts of misuse are happening among 18- to 24-year-olds.  Almost 6 million young people a year get prescribed opioids.  They are initiated into this.  And we know that most long-term heroin addiction starts among young people through a first experience with opioids.  So that is what we’re focusing on here because there is great need,” said Robin Koval, CEO and President of Truth Initiative.

But a recent study of high school heroin users found that most abuse a wide variety of substances – not just painkillers. Alcohol was the most common drug abused, followed by marijuana, ecstasy, LSD and other psychedelics, cocaine, amphetamines and tranquilizers. 

“The Truth About Opioids” campaign makes no mention of those other drugs.

"It may be inadequate to focus on heroin and opioid use in isolation,” said lead author Joseph Palamar, PhD, a  professor of population health at NYU School of Medicine. "A deeper understanding of how heroin users also currently use other drugs can help us to discern better prevention measures."

A Pained Life: An Open Letter to President Trump

By Carol Levy, Columnist

Dear Mr. President Trump,

I have had trigeminal neuralgia, a chronic facial pain disorder, since 1976. For the last 30 years, I’ve been able to get all of the pain medications my doctors prescribed for me, including codeine, Demerol, morphine, Percodan, hydrocodone, and even an 8-ounce bottle of tincture of opium.

For the latter, I only had to go to 2 pharmacies. The first one didn’t carry it. The second store gave me the bottle with no questions asked.   I was trusted. My doctor was trusted. My doctor trusted me.

Many of us are now losing our doctors, who are fearful of being raided or arrested by the DEA because they prescribe opioids. Pain sufferers who were once able to get out of bed in the morning to work, watch their kids, and be a part of the world are joining the ranks of the disabled because opioids are being reduced or withdrawn completely.

Often patients get little or no warning when their pain management doctors decide they can no longer treat them.  Many doctors have closed their doors or decided not to prescribe opioids, no matter what the patient's condition or if they benefited from them. Often there is no rhyme or reason for this abandonment, other than fear of the DEA.

The Justice Department, CDC, VA and other federal agencies continue blaming patients and physicians for the opioid crisis, when the true “epidemic” involves illicit fentanyl and heroin. It has little to do with prescriptions.

This blaming of patients and pain management physicians has caused untold additional suffering.  The worst part is the many anecdotal stories of patients committing suicide because the opioids that were helping them are no longer available in the same dosage, if at all.

The damage is not just physical from the increased pain, there is psychological pain as well.  Sources that once may have been a comfort become accusers.

Patients tell story after story: “My family now calls me an addict because I am on opioids.”

Or they fear letting their friends know they take opioids for pain: “Then they’ll think I am an abuser or an addict.”

Yes, some doctors overprescribe and some patients abuse their opioids.  But they’re a small number. We don't sell our prescriptions and we don't give them away like candy.  We take them because they help our pain.  Often, it is the only treatment or option left to us.  We would be fools to give away, sell or abuse that which is helping. 

It is time, past time, for the "compassionate conservatism" of the Republican party be put into use. And Democrats need to show that the compassion they talk about is real.

We have enough trouble dealing with our physical pain. Please stop making it worse by taking away our medications. Let our doctors doctor us, not the government.

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.

CDC Report Ignores Suicides of Pain Patients

By Pat Anson, Editor

The suicide rate in the United States continues to climb, with nearly 45,000 people taking their own lives in 2016, according to a new Vital Signs report by the Centers for Disease Control and Prevention.

The suicide rate in the U.S. is so high it rivals the so-called “opioid epidemic.” The number of Americans who died by suicide (44,965) exceeds the overdose deaths linked to both illicit and prescription opioids (42,249).  The nationwide suicide rate has risen by over 30 percent since 1999.

“Unfortunately, our data shows that the problem is getting worse,” said CDC Deputy Director Anne Schuchat, MD. “These findings are disturbing. Suicide is a public health problem that can be prevented.”  

Contrary to popular belief, depression is not always a major factor in suicides. The report found that less than half of the Americans who died by suicide had a diagnosed mental health issue. Substance abuse, physical health problems, and financial, legal or relationship issues were often contributing factors. So was the availability of firearms, which were involved in nearly half of all suicides.

But while CDC researchers can go into great detail about the methods, causes, demographics, ethnicity and even the drugs used by suicide victims, they did not investigate anecdotal reports of a growing number of suicides among pain patients.

“Our report found that physical health problems were present in about a fifth of individuals as circumstances considered to lead up to suicide," Schuchat said in a conference call with reporters. "That doesn’t differentiate whether it was intractable pain versus other conditions that might have been factors.”

Asked directly if lack of access to opioid medication may be contributing to pain patient suicides, Schuchat said that federal agencies were “working on comprehensive pain management strategies,” but they were not investigating patient suicides, such as the recent tragic death of a Montana woman.

“We don’t have other studies right now. But I would say that the management of pain is a very important issue for the CDC and Health and Human Services,” she said.

PNN asked a CDC spokesperson if the agency was conducting any studies or surveys to determine whether the CDC's 2016 opioid guideline was contributing to patient suicides, and what impact it was having on the quality of pain care. The boilerplate response we received essentially said no, and that the CDC was only tracking prescriptions. 

"Through its quality improvement collaborative and its work with academic partners, CDC is evaluating the impact of clinical decisions on patient health outcomes by examining data on overall opioid prescribing rates, as well as measures such as dose and days’ supply, since research shows that taking opioids for longer periods of time or in higher doses increases a person’s risk of addiction and overdose," Courtney Leland said in an email.

As PNN has reported, the CDC’s guideline may be contributing to a rising number of suicides in the pain community.  In a survey of over 3,100 pain patients on the one-year anniversary of the guideline, over 40 percent said they had considered suicide because their pain was poorly treated.

Most patients said they had been taken off opioids or had their doses reduced to comply with the  CDC guideline, which has been widely adopted throughout the U.S. healthcare system. Many patients say they can’t even find a doctor willing to treat them.

‘Making Plans to End This Life’

“I am scared to death as pain for me is unbearable. If I cannot get a prescription for relief I will probably be one of those (suicide) statistics because as far as I'm concerned, my quality life would be gone and no longer worth living. I will be sure to leave a note telling the CDC to go to hell too,” one PNN reader said.

“If my life is reduced to screams of agony in my bed while my father has to watch, if that happens and I can’t take anymore suffering, I will leave a note (probably a very long one), and in it I will say that the people who are making these guidelines into law, should be charged with my homicide,” another patient wrote.

“My suicidal ideation has increased exponentially. I have now resorted to cutting and punishing myself in order to distract from the physical chronic pain I suffer with,” said another patient. “I am struggling terribly and can’t even get sleep. I have been making plans to end this life and if the pain continues without treatment, it will not be hard to do.”

“My wife has been talking about suicide as the only option to escape her chronic pain and migraine headaches. I am starting to think the same thoughts,” wrote a man who also suffers from chronic pain. “Many chronic pain patients left without a doctor or opiate painkillers will commit suicide to escape the pain and suffering. My wife and I included.”

British Columbia Revising Its Guideline

The Canadian province of British Columbia was one of the first to adopt the CDC guideline as a standard of practice for physicians. In April 2016, British Columbia declared a public health emergency because overdose deaths from illicit fentanyl, heroin and prescription drugs were soaring. In response, the College of Physicians and Surgeons of British Columbia released new professional standards and guidelines that were closely modeled after the CDC’s.

Two years later, the British Columbia guidelines are now being revised because too many patients were being denied care or abandoned by doctors fearful of prescribing opioids.

“Physicians cannot exclude or dismiss patients from their practice because they have used or are currently using opioids. It’s really a violation of the human rights code and it’s certainly discrimination and that’s not acceptable or ethical practice,” college registrar Heidi Oetter told The Globe and Mail.

Under the old guidelines, British Columbia doctors were strongly encouraged to keep opioid doses below 90 milligrams of morphine a day – the same recommendation as the CDC’s. Now they’re being told to use their own discretion and to work with patients in finding an effective dose.

“Hopefully it’s clear to physicians that the college is really expecting that they exercise good professional discretion, that they are really engaging patients in informed consent discussions and that patients are really aware of the potential risks that are associated with opioids, particularly if they’re taking them in conjunction with alcohol or sedatives,” Oetter said.

Not only were the old guidelines harmful to patients, they were ineffective in reducing overdoses. British Columbia still has the highest number of overdoses in Canada, with 1,448 deaths last year.

Overdoses also continue to soar in the United States – mostly due to illicit fentanyl and other street drugs. Will the CDC change its guideline -- as promised -- because it is harming patients and failing to reduce overdoses?

"CDC will revisit this guideline as new evidence becomes available," the agency said in 2016. "CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

Today’s report on suicides indicates the agency has no plans to do either.

I Wasn’t Looking for Addiction, I Wanted Pain Relief

By Denise Pascal, Guest Columnist

Five botched back operations, a cracked pubic bone and fibromyalgia led me to OxyContin 20 years ago.

I stayed with my doctor for 15 of those years, voluntarily titrating my dosage down from an initial 280mg of OxyContin a day to only 40mg.

Last June, my doctor suddenly decided to take me off opioids. I was given 6 WEEKS to get off Oxy with nothing for my pain or the effects of rapid titration off opioids. 

I now have to fight for my prescription lidocaine patches (which insurance doesn’t cover), my nightly Ambien and two lousy valiums for panic attacks.

My body is completely confused. Everyday feels like I am moving through mud. The pain is indescribable. Everyday things I could do last year on Oxy are gone. I can’t grocery shop. I can’t walk my dog. If something falls on the floor, it stays there because I can’t bend from the knees due to osteoarthritis.

For ten months I have had diarrhea, my brain is totally confused, and even simple tasks like paying bills are overwhelming. THIS IS YOUR BRAIN NOT ON DRUGS.

DENISE PASCAL

My withdrawal cost me almost $5 thousand in out-of-pocket expenses from visits to random specialists to manage my symptoms, prescriptions, and people I have had to hire to do simple errands.

This is what happens to those of us left with no family who can’t function. I am over 62 and have been legally disabled since 42. I wasn’t looking for an addiction, I was looking for relief. We were caught in a net by people who abused a drug that gave us some semblance of normalcy.

Suicide enters my thoughts often now. I can’t stand the pain. And just maybe that was the desired end result of this false narrative. 

Denise Pascal lives in New Mexico.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

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

New Campaign Against Bogus Online Pharmacies

By Pat Anson, Editor

The U.S. Food and Drug Administration has launched yet another campaign against illegal online pharmacies, sending warning letters to the operators of 53 websites that they must stop marketing oxycodone, tramadol and other opioid medications.

"This illegal online marketing of unapproved opioids is contributing to the nation’s opioid crisis,” said FDA Commissioner Scott Gottlieb, MD.  “Opioids bought online may be counterfeit and could contain other dangerous substances. Consumers who use these products take significant risk with their lives.”

Gottlieb said the FDA would take additional steps in coming months to stop the online sale of opioids and their shipment through the mail. The agency also plans to hold a summit June 27 with internet stakeholders, researchers and advocacy groups to find new ways to work collaboratively to address the problem.

Last September, the FDA sent similar warning letters to over 500 online pharmacies as part of an international operation called Pangea X. Interpol said it seized over $51 million in illicit and counterfeit medications as a result of the investigation. Over 400 people were arrested worldwide and 3,584 websites shut down.

The problem with these law enforcement efforts is that many of the bogus pharmacies are quickly back online under different names and website addresses.  

Some of websites being targeted in the latest FDA crackdown operate brazenly, offering opioids and other controlled substances without a prescription.

“One advantage of buying medication through our website is that it’s cheap and exciting. Sometimes, what happens is that the drug can only be bought with a prescription, and getting prescription is not that simple,” one operator claims. “(We provide) the solution to this. We don’t require any prescription or proof of recommendation. If you need any sort of medication, just go to our website, log in and place the order. After the payment is made, the order is finalized and shipped to your place.”

Another website claims “you won’t need a written prescription from a doctor as we have doctors within our team who will write your prescription free of cost.”

Online Pain Pharma then displays images of four smiling “doctors” with specialties in radiology, emergency care, radiology and rheumatology. The names appear fictitious and the pictures are stock photo images that can be purchased from a website that sells images of “Smiling Medical People With Stethoscopes.”

image from onlinepainpharma.com

Dr. Anna Mariya may be a radiologist for Online Pain Pharma, but on a pediatrician's website she’s an orthopedic specialist named Dr. Bagavativarasyar.  

The FDA warning letters were sent to nine online pharmacy operators, most of which have multiple websites. They were given 10 working days to respond.

• AnonShop
• Eassybuyonline
• Instabill ECS-Rx
• Medstore.biz
• One Stop Pharma
• RemedyMart
• RxCash.Biz
• TramadolHub
• XLPharmacy

"The public needs to know that no one is authorized to sell or distribute opioids via the internet in the U.S., with or without a prescription," said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "Drug dealers and rogue website operators are using the internet to fuel the opioid crisis, heartlessly targeting millions of Americans struggling with opioid use disorder.”

According to one estimate, as many as 35,000 online pharmacies are in operation worldwide. About half are selling counterfeit painkillers and other fake medications. About 20 illegal online pharmacies are launched every day.

Why I’m Leaving My Spine Surgery Practice

By David Hanscom, MD, PNN Columnist

From the day I entered medical school, I wanted to be an orthopedic surgeon. I was planning on practicing internal medicine, but on a whim I applied for an orthopedic residency and, much to my surprise, was accepted.

I came out of my residency and fellowship in 1985 on fire, ready to solve the world’s spine problems with my surgical skills.

About six months ago, something shifted deep within me. In the three decades I’ve practiced spine surgery in the Seattle area, I’ve tried to address the whole patient. But I didn’t yet have a clear idea about all the factors that affect a person’s physical and mental health.

In fact, for the first eight years of my practice, I was part of Seattle’s movement to surgically solve low back pain with lumbar fusions. A new device had been introduced that ensured a much higher chance of a successful fusion. Our fusion rate for low back pain was nine times that of New England’s. I felt badly if I couldn’t find a reason to perform a fusion.

Then a paper came out in 1993 documenting that the success rate for fusion in the Washington Workers Compensation population was only between 15 to 25 percent. I had been under the impression that it was over 90 percent. A lumbar fusion is a major intervention with a significant short and long-term complication rate. I immediately stopped performing them.  

I also plunged into a deep abyss of chronic pain that many would call a burnout. I had no idea what happened or why. I had become a top-level surgeon by embracing stress with a “bring it on” attitude. I was fearless and didn’t know what anxiety was.

What I didn’t realize was that my drive for success was fueled by my need to escape an abusive and anxiety-ridden childhood. I was a supreme master of suppressing anxiety until 1990, when I experienced a severe panic attack while driving on a bridge over Lake Washington late one night.

Although I was skilled at consciously suppressing my anxiety, my body wasn’t going to let me get away with it. Anxiety and anger create a flood of stress hormones in your body. Sustained levels of these hormones translate into over 30 possible physical symptoms. I descended into a 13-year tailspin that almost resulted in my suicide.  

DAVID HANSCOM, MD

I can’t express in words how dark my world became. I experienced migraines, tension headaches, migratory skin rashes, severe anxiety in the form of an obsessive-compulsive disorder, burning feet, PTSD, tinnitus, pain in my neck, back and chest, insomnia, stomach issues, and intermittent itching over my scalp.

In 2002, I accidentally began my journey out of that dark hole by picking up a book that recommended writing down thoughts in a structured way.  For the first time I felt a shift and a slight decrease in my anxiety. I learned some additional treatments and six months later, I was free of pain. All of my other symptoms disappeared.

I began to share what I learned with my patients and watched many of them improve. Addressing sleep was the first step. Slowly I expanded it to add medication management, education about pain, stress management skills, physical conditioning, and an improved life outlook.

I still didn’t know what happened to me or why. Then in 2009, I heard a lecture by Dr. Howard Schubiner, who had trained with Dr. John Sarno, a physiatrist who championed the idea that emotional pain translates into physical symptoms.

Within five minutes of the beginning of Dr. Shubiner’s lecture, the pieces of my puzzle snapped into place. I realized that sustained levels of stress hormones can and will create physical symptoms. I also learned how the nervous system works by linking current circumstances with past events. If a given situation reminds you of past emotional trauma, you may experience similar symptoms that occurred around the prior event.

I felt like I had been let out of jail. I’ll never forget that moment of awareness.

What’s puzzling is that these concepts are what we learned in high school science class. When you’re threatened for any reason, your body secretes stress chemicals such as adrenaline and cortisol. You’ll then experience a flight, fight or freeze response, with an increased heart rate, rapid breathing, sweating, muscle tension and anxiety. When this chemical surge is sustained, you become ill. It’s been well documented that stress shortens your life span and is a precursor of chronic diseases.

Modern medicine is ignoring this. We are not only failing to treat chronic pain, but creating it.

Spine surgeons are throwing random treatments at symptoms without taking the time to know a patient’s whole story.  It takes just five minutes for a doctor to ask a simple question, “What’s going on in your life over the last year?” Answers may include the loss of a job, loved one, divorce, or random accident. The severity of their suffering is sometimes beyond words. But once we help them past this trauma, their physical symptoms usually resolve.

What has become more disturbing is that I see patients every week who have major spine surgery done or recommended for their normal spines. It often occurs on the first visit. Patients tell me they often feel pressured to get placed on the surgical schedule quickly. At the same time, I am watching dozens of patients with severe structural surgical problems cancel their surgery because their pain disappears using the simple measures I’ve learned.

I love my work. I enjoy my partners as we help and challenge each other. My surgical skills are the best they’ve been in 30 years. My clinic staff is superb in listening and helping patients heal. I’m also walking away from it.

I can’t keep watching patients being harmed at such a staggering pace. I have loved seeing medicine evolve over the last 40 years, but now I feel like I am attempting to pull it out of a deep hole. I never thought it would end this way. Wish me luck.

Dr. David Hanscom 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.

More information can be found on his 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.

FDA Monitors Social Media for Drug Abuse Trends

By Pat Anson, Editor

A recent letter in The New England Journal of Medicine sheds some light on how the Food and Drug Administration tracks changing patterns of drug use on Facebook, Twitter and other social media.

The FDA began monitoring social media – what it calls “proactive pharmacovigilance” – about a decade ago, primarily as an early warning system for adverse events involving medication.

More recently, the agency has used active surveillance of social media to study the abuse of opioid painkillers and gabapentinoids, a class of nerve medication that includes gabapentin (Neurontin) and pregabalin (Lyrica). Gabapentinoids are increasingly being prescribed as “safer” alternatives to opioids.

“To understand why usage patterns are shifting, the FDA used a social media ‘listening platform’ to set up a dashboard to track traditional social media sites (such as Twitter, Facebook, Instagram, blogs, and forums) that we monitor for conversations about opioids,” explained FDA commissioner Scott Gottlieb, MD, and co-authors Douglas Throckmorton, MD, and Janet Woodcock, MD, two senior FDA officials.

“When we find mention of additional substances on social media or elsewhere, we conduct more specific searches for relevant, publicly available conversations through our listening platform, as well as through Reddit, Google, and various online forums that don’t require registration or subscription. These may include forums associated with drug misuse or abuse, such as Bluelight.org and talk.drugabuse.com.”

What did the FDA learn about gabapentinoids on social media? Preliminary findings indicate the abuse of gabapentinoids isn’t widespread, but their use continues to increase, especially for gabapentin.

The FDA is also actively monitoring the social media sites of kratom vendors. As PNN reported last month, one vendor received a warning letter from the FDA for sharing on its Facebook page a CNN story about the herbal supplement as a possible treatment for pain and opioid addiction. The vendor only said the story was “positive news for kratom,” but the FDA said that amounted to the illegal marketing of an unapproved drug.

“The FDA thus faces challenges as we confront the opioid crisis and monitor changing patterns of use, abuse, and misuse of other products,” Gottlieb wrote. “The right approach to regulating these substances is best determined through a multifaceted system of pharmacovigilance, using various tools to mine traditional and new sources of epidemiologic data, assess products’ pharmacologic properties, and evaluate the social contexts in which substances are being used.”

To be clear, the FDA’s surveillance of social media isn’t very different from what private enterprise is already doing. NUVI, for example, provide social media monitoring to companies “to get real-time insights into what people are saying about your brand online.”  Companies also sell software that track keywords, hashtags and user profiles on social media. And PatientsLikeMe, the largest online patient network with over 600,000 members, sells some of its data to the FDA and healthcare industry.

At PNN, we do stories all the time about opioids, kratom, gabapentinoids and other drugs. Is Pain News Network under surveillance by the FDA? Are reader comments on our website and social media being monitored? We don’t know. But in an age of growing concern about Internet privacy and the sharing of personal data, we thought you should know that the answer could be yes.

The Grim Future of the Opioid Crisis

By Roger Chriss, Columnist

The opioid crisis continues to be misunderstood. In a speech last week in Tennessee, President Trump said the nation was making progress “getting rid of the scourge that’s taking over our country.”

“The (opioid prescription) numbers are way down. We’re getting the word out — bad. Bad stuff. You go to the hospital, you have a broken arm, you come out, you’re a drug addict with this crap. It’s way down. We’re doing a good job with it,” Trump said.

Indeed, prescription opioid levels are falling. In that sense, and only that sense, the numbers are down. But addiction stemming from medical treatment was never a significant factor in the crisis to begin with. A new review from the British Journal of Anesthesiology found that opioid dependence or abuse occurs in less than 5 percent of patients prescribed opioids for pain.

By most other measures, the opioid crisis is rapidly getting worse. The number of people addicted to heroin is rising, the number of ER admissions for overdoses is increasing, and the number of fatal overdoses from all drugs -- legal and illegal --  has skyrocketed to nearly 64,000 a year.

Drug deaths linked to illicit fentanyl and heroin now outnumber those from prescription opioids, as do overdoses involving medications used to treat depression and anxiety.

The CDC, DEA and FDA increasingly recognize that illegal drugs, including diverted prescription opioids, are the key features of the current crisis. But stopping this flow has become a nightmarish challenge.

The significance of illicit fentanyl in the crisis cannot be underestimated. Fentanyl is spreading throughout the black market as an adulterant or ingredient in counterfeit pills, cocaine, heroin and other illicit substances. The National Institute on Drug Abuse estimates there are 15 to 30 different fentanyl analogues circulating in the drug supply. Fentanyl is so potent it is usually shipped in such minute amounts that detecting them in vehicles, the mail, or FedEx and UPS shipments is close to impossible.

Online drug markets serve as middlemen who find customers for illicit manufacturers in China and distributors in Mexico and Canada. No cartels, street corner dealers, or vats of drugs being snuck across borders. Just high-speed Internet connections and cryptocurrencies. 

“This is what makes the opioid crisis so unique and dangerous,” Peter Vincent, who led international operations for Immigration and Customs Enforcement (ICE) during the Obama administration, told The New York Times. “Traditionally, law enforcement has focused on large quantities of drugs like marijuana and cocaine. But very small amounts of opioids can bring tremendous profits.”

In other words, we are fast approaching a point at which supply-side interventions will be virtually pointless. Back in the 19th century, we could control the supply of morphine. In the 20th century, we could, to some extent, control the supply of heroin. But in the 21st century, we can’t do the same for fentanyl and its chemical cousins.

Even if borders and ports are secured, fentanyl can be manufactured inside the U.S. And if the Postal Service and commercial couriers like FedEx are closely monitored and inspected, private networks and ad hoc distribution systems -- the modern equivalent of old bootlegging operations -- can move drugs around the country with ease.

Thus, a bill that would impose a national 3-day limit on opioid prescriptions for acute pain, as proposed by Sen. Robert Portman (R-Ohio), is off target. And efforts to combat the opioid crisis by using aromatherapy in ambulances are naive at best.

Instead, drug addiction treatment in the form of medication assisted therapy (MAT) needs to be available everywhere. Medications like methadone have existed for decades, but as David Courtwright notes in his book “Dark Paradise” on the history of opioids in America, methadone "never emerged as a coherent national response to heroin addiction.”

The national response is still not coherent. There is little interest in developing an infrastructure to treat people with substance use disorders or programs to reduce the risks of addiction. Instead we see a continuing, misguided focus on prescription opioids as both the cause and solution. Until that changes, the future of the crisis remains grim.

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.

Taking Stem Cells to the Bank

By A. Rahman Ford, Columnist

There’s a lot of hope and hype surrounding stem cells – the latest being the idea of “banking” them -- harvesting and storing your own stem cells for future use.

A biotech start-up called Forever Labs maintains that young adults have healthier cells that can be used when they are older to fight arthritis and other age-related diseases – or perhaps even help them live longer with a booster shot of younger cells. 

“Research suggests the decline in the number and viability of bone marrow stem cells plays a role in the physical decline associated with aging. In fact, simply injecting genetically-matched young stem cells into aged mice significantly increases their lifespan,” the company claims on its website. “To have access to young, genetically-matched stem cells in the future, store yours today.”

Collection of bone and bone marrow stem cells is done by a Forever Labs physician in a 15-minute out-patient procedure that costs about $2,000.  Your cells are then cryogenically frozen and stored for $250 a year.  

Another company, called LifeVault, offers a similar service at a lower price: $995 to have a blood sample drawn and shipped to a lab in New Jersey, where the blood will be processed into stem cells and stored for $95 a year. 

“We believe, and medicine is starting to believe, that this is really going to be a part of your health hygiene,” LifeVault CEO Trevor Perry told STAT News. He called the company’s test kit a form of “biological insurance.”

“You insure a lot of things in your life, but have you taken out a policy on yourself?” Perry asked.

LifeVault and Forever Labs are indicative of a larger trend in the fast-growing stem cell industry. As hundreds of stem cell clinics have opened around the country – offering treatment for everything from back pain to neuropathy – stem cell banking has moved beyond its original use for research toward commercialization for everyday people.  

The global stem cell banking market is projected to reach $9.3 billion by 2023, according to the research firm MarketsandMarkets, with the personalized banking segment projected to account for most of that growth.

In addition to blood and bone marrow, stem cells from a variety of other sources can be banked, including dental tissue, umbilical cord blood, placental tissue, adipose fat tissue and fetal tissue.

Umbilical cord blood and adipose tissue are currently the most commonly banked sources of stem cells.  This is largely because of practical concerns such as low cost, ease of access to the tissue, and the ability to harvest large amounts of stem cells.  

Cord blood contains primarily hematopoietic stem cells, along with a mixture of other cell types that may be suitable for treating certain rare genetic diseases.  Adipose tissue contains an abundance of mesenchymal stem cells (MSCs), a type of stem cell with immune and regenerative capabilities.  Both types have been used to treat orthopedic, neurological and cardiovascular conditions.

Several factors impact the use of cells stored in stem cell banks.  First, the source of the stem cells must be taken into consideration.  Autologous stem cells --- which come from the patient being treated -- are easier from a medical and regulatory point of view because the risk of immune system rejection is lower, as is the risk of running afoul of FDA regulations. 

Methods of collection and processing are also critical.  In the case of cord blood, most companies use small bags to collect the blood at the time of birth. Cord tissue can also be collected, stored and used later for regenerative purposes.  

Adipose tissues are obtained through liposuction procedures or by syringe under local anesthetic.  The adipose fat must be processed and preserved within 36 hours of harvesting.  The material is washed with saline and ultimately stored in a liquid nitrogen freezer.  

While still relatively new, stem cell banking is poised for healthy growth.  That growth is buttressed by the unfortunate rise in chronic diseases among both children and adults.  Growth and competition should also result in lower costs, a factor which surely deters many interested clients from taking out that “biological insurance” policy on themselves. 

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.

New Treatments on Horizon for Chronic Pain

By Steve Weakley

Patients and doctors have long complained that there are few new treatments for chronic pain. And those that do come along are often reformulations of old medications or have unwelcome side effects.

Two developments this week suggest that trend may be changing. A new drug application has been submitted to the Food and Drug Administration for an “opioid of the future” that is less addictive, and research has uncovered a new way to treat neuropathic pain long term with a single injection.

In experiments on laboratory mice, researchers at the University of California at San Diego discovered a new method to block the root cause of pain with the injection of a naturally occurring protein, apolipoprotein A-I binding protein (AIBP). 

AIBP “turns off” a receptor called TLR4 that sits on the surface of nerve cells and searches for signs of infection or tissue damage.  Researchers say turning off the receptor prevents and even reverses inflammation and other cellular processes that create the sensation of pain.

A single spinal injection of AIBP relieved neuropathic pain associated with chemotherapy in the mice for two months with no side effects, according to findings published in the journal Cell.

“What’s so special about our new approach, inhibiting the TLR4 receptor with AIBP, is that it actually modifies the pain processing systems themselves," says study co-author Tony Yaksh, PhD, a professor and vice chair for research in the Department of Anesthesiology at UCSD School of Medicine.

"So, if you think of neuropathic pain as a disease, then we see this as truly disease-modifying. We’re blocking the underlying mechanism that causes pain, not just masking the symptoms.”

Neuropathic pain is a common side effect of chemotherapy treatments for cancer. Chemotherapy not only inhibits the growth of cancer cells, it can permanently damage nerve cells and make people sensitive to even the slightest touch. Opioids and other medications such as gabapentin (Neurontin) are commonly prescribed for neuropathy, but both have unwelcome side effects.

“If it comes down to a choice between living with chronic pain or getting a spinal injection once every few months, we think most people would take the injection," said co-author Yury Miller, MD, a professor in the UCSD Department of Medicine. “As it stands now, AIBP could be developed as therapy for unremitting severe pain that only responds to high dose morphine. AIBP would remove the need for opioids, and reduce the potential for drug abuse.

"We're not saying we shouldn't use opiates to treat chronic pain, or in particular cancer pain—that would be a tragedy.” Yaksh said. "But it would also be a greater tragedy if we didn't support work to find a substitute for systemic opiates.”

“Opioid of the Future”

While AIBP is still in its experimental phase and could be years away from being available for treatment, Nektar Therapeutics’ so-called “opioid of the future” is one step closer to market.  Nektar has completed over a dozen clinical trials on NKTR-181 and applied to the FDA for approval of the drug as a treatment for chronic low back pain.

PNN has previously reported on NKTR-181, a new type of opioid that shows promise in relieving moderate to severe pain with less risk of abuse and addiction of traditional opioids like oxycodone or hydrocodone.

Because of its slow rate of entry into the central nervous system, NKTR-181 significantly reduces the “high” or euphoric effect that recreational drug users crave. Many pain sufferers don't feel that high when taking opioid medication, they just get pain relief.

In trials, NKTR-181 showed a 65% reduction in low back pain vs. placebo in tablets taken twice a day. Safety studies found recreational drug users had significantly less “drug liking” of NKTR-181 -- even at high doses -- when compared to oxycodone. Participants also had less daytime sleepiness and fewer withdrawal symptoms.

nektar therapeutics

If it receives FDA approval, Nektar hopes to launch the drug commercially as early as next year. The company has yet to announce a partnership with a larger pharmaceutical company to help produce and commercialize NKTR-181 -- which is when the no-name "opioid of the future" will get a makeover with a branded name to make it more marketable.

CEO of U.S. Pain Foundation Resigns

By Pat Anson, Editor

The founder and CEO of the U.S. Pain Foundation – an advocacy group representing chronic pain patients -- has resigned under pressure.

Paul Gileno resigned Tuesday, May 29th at the request of the foundation’s board of directors, according to a statement released on Thursday by U.S. Pain. It is highly unusual for a non-profit’s board of directors to remove its CEO. No explanation was offered for Gileno’s sudden departure

Nicole Hemmenway, U.S. Pain’s chairperson, has been appointed as interim CEO. A search for Gileno’s replacement is underway.

“The organization is stable and excited to be moving forward on its mission – to empower, educate, connect and advocate for people living with chronic conditions that cause pain,” said  board member Ellen Lenox Smith. “The Board has complete faith in Nicole and the wonderful staff that makes up our organization.”

U.S. Pain has recently faced criticism over its relationship with Insys Therapeutics, an Arizona drug maker under investigation for its marketing of Subsys, an oral fentanyl spray blamed for hundreds of overdose deaths. Former Insys executives and sales representatives have been charged with racketeering and bribing doctors to prescribe Subsys off-label. A four day supply of Subsys can cost nearly $24,000.

In recent years, Insys has donated over $3.1 million to U.S. Pain, with most of the money going to a prescription discount program to help patients pay for Subsys and other medications prescribed for breakthrough cancer pain. Critics say the program was primarily designed to benefit Insys by allowing the company to bypass Medicare rules governing illegal kickbacks.

“Co-pay assistance programs (also called copay charities) were created to get around this restriction. Medicare allows copay charities to cover Medicare co-pays, so pharmaceutical companies funnel money through these groups to cover co-pay costs for Medicare patients while bilking Medicare, which bears the full cost of unnecessarily expensive drugs,” a group of critics said in a blog post by The Hastings Center.  

Last week Pfizer agreed to pay a $24 million fine to resolve federal charges that it used a similar co-pay assistance program to pay kickbacks to Medicare patients. “Pfizer used a third party to saddle Medicare with extra costs," said U.S. attorney Andrew Lelling.

In a statement released in February, Gileno defended U.S. Pain’s acceptance of funding from Insys for the co-pay assistance program.

"This funding, like any funding we receive, does not influence our values,” Gileno said. “The funding we receive is not used to promote one type of treatment over another.”

According to a report released by Missouri Sen. Claire McCaskill, U.S. Pain received $2.5 million from Insys in 2017 – an amount three times larger than what the non-profit received from all donors in 2015.

(Update: U.S. Pain has a statement on its website saying its copay assistance program with Insys ended “as of August 2018” and that “U.S. Pain will not accept funding from Insys going forward.”)

Gileno founded the Connecticut Pain Foundation in 2006 after a back injury forced him to abandon his catering business. In 2011, he launched U.S. Pain, which now claims to be the nation’s largest patient advocacy group. It's growth was fueled by marketing partnerships and donations from dozens of pharmaceutical companies and healthcare organizations.

In its 2016 promotional material, U.S. Pain claimed to have over 90,000 members and over 225,000 social media followers, including 59,000 followers on Twitter. However, that was reduced to less than 14,000 followers in early 2018 after Twitter purged from its system millions of fake accounts.

(Update: U.S. Pain has revised the way it counts actively “engaged members.” The organization now says its has over 15,000 members, 1,500 volunteers and a social media reach of more than 217,000 followers.)

In 2015, Gileno was paid a salary of nearly $404,000, according to U.S. Pain's tax return. Gileno says the 2015 compensation was for “back pay” from 2006 to 2012. The foundation has not publicly released its tax returns for 2016 or 2017, so we don’t know how much Gileno was paid for those years.

In a 2018 New Year’s message to U.S. Pain members, Gileno said he “would never sell out.”

“Not once has the creation of this foundation been about boosting my ego, finding public notoriety or obtaining fame. I am here to serve you. I will never jeopardize our mission or passion to gain five minutes of fame for myself," Gileno said.

"The work of U.S. Pain Foundation is 100% genuine. There are no strings attached or ulterior motives. All that I care about is further enhancing the lives of people suffering with pain, and we will continue to do so in a discreet and powerful manner."

PAUL GILENO

Gileno has been criticized by some in the pain community for a passive approach to patient advocacy that avoided public controversy and protest. Some say he also has an overbearing personality that rubbed people the wrong way.

“There are so many reasons I could cite as to why it’s good to have Paul out, but I am biased because he was one of my biggest bullies and a thief to others in the chronic pain community,” a longtime patient advocate who asked to remain anonymous told PNN. “I am hoping the leadership at U.S. Pain Foundation will do better than they have in the past.”

Interim CEO Nicole Hemmenway has been a key member of U.S. Pain since its inception. She has lived with Complex Regional Pain Syndrome (CRPS) most of her life.

“We’re very focused on the future. We have a lot of wonderful programs and events coming up – a training program for chronic pain support group leaders in June; our Pain Awareness Month campaign and related activities this September; and our first retreat for pediatric patients this November,” Hemmenway said in a statement.

Is CDC Opioid Guideline Harming Cancer Patients?

By Pat Anson, Editor

It was only intended for primary care physicians who treat chronic non-cancer pain, but the CDC’s opioid prescribing guideline has had a sweeping effect on the practice and quality of pain management in the United States.

The guideline is also causing confusion among oncology specialists who treat cancer and adding to the “already appalling burden of unrelieved cancer pain,” according to an op/ed being published in JAMA Oncology.

Two experts in oncology and palliative care at the University of Pennsylvania say some of the CDC’s recommendations are based on weak evidence and conflict with national cancer pain guidelines.

"This lack of evidence, coupled with conflicting and competing contemporary guidelines from diverse authoritative agencies and organizations carry the potential to confuse, if not seriously jeopardize, pain management for patients with cancer who are living with moderate to severe pain, adding to an already appalling burden of unrelieved cancer pain," wrote Neha Vapiwala, MD, and Salimah Meghani, PhD.

Meghani is a Professor of Nursing and Chair of Palliative Care at the University of Pennsylvania School of Nursing, while Vapiwala is a Professor of Radiation Oncology and Vice Chair for Education in the Perelman School of Medicine at the University of Pennsylvania.

Although the CDC guideline is intended for chronic pain patients outside of active cancer treatment, it includes patients “who have completed cancer treatment, are in clinical remission, and are under cancer surveillance only.”

Meghani and Vapiwala say the CDC’s inclusion of “cancer survivors” is a mistake because it is not uncommon for cancer pain to persist long after the cancer is treated.  

“Unfortunately, this arbitrary distinction is not consistent with the evidence of pain trajectory in cancer survivors,” the wrote. “More important, similar levels of pain were reported in survivors who were still receiving cancer treatment and those who had completed active cancer treatment.”

The CDC guideline also conflicts with the guideline of the National Comprehensive Cancer Network (NCCN), which is widely used by oncology physicians. The NCCN recommends that doctors use both short and long-acting opioids when treating flares from cancer pain, while the CDC recommends against long-acting opioids because of the potential risk of addiction.

The CDC also recommends that non-pharmacologic therapy such as meditation and non-opioid drugs such as gabapentin (Neurontin) be used for chronic pain. But Meghani and Vapiwala say there is little evidence those therapies work in managing moderate to severe pain.  They're urging the CDC, NCCN, American Medical Association and other organizations to develop more uniform guidelines based on solid evidence.

"Many of the current recommendations around opioid prescribing practices stem from expert consensus rather than empirical research, which is urgently needed to generate and develop informed guidelines for patients with chronic cancer-related pain," they wrote. "Clinicians who care for patients with cancer are frustrated by an increasingly overwhelming set of institutional, regulatory, and policy requirements around opioid prescribing that can interfere with being good stewards and advocates for their patients with pain.”

Cancer Patients Denied Opioids

Some cancer patients say the CDC guideline has interfered with their treatment.

“I had a painful radical surgery for cancer and was only provided 3 days of low-dose opioids per CDC guidelines and suffered terribly for 2-3 months. Still have persistent pain 5 months later due to poor acute pain control,” one PNN reader told us.

“My brother in law was just diagnosed with stage 4 pancreatic cancer with metastasis to the liver and his first oncologist refused to treat his pain adequately due to the CDC guidelines, telling him I'm not risking my license for you,” another reader said.

“I have a family friend who is a cancer patient in her mid-sixties. Her doctor pulled her off of her morphine without warning, and she has been left to suffer,” wrote another.

“I'm stuck with a bad physician in order to get pain management. No other doctor in this county will do pain management,” said a patient who has to drive 45 miles to get treatment. “My doctor misdiagnosed my stomach illness and missed my cancer all together.”

Other patients say their pain is just as bad or worse than cancer pain – and don’t understand why they are treated differently under the CDC guideline.

“These are guidelines, not meant for all patients. And to exclude ONLY cancer patients is outrageous,” wrote one patient who was born with a rare and painful digestive disease. “Why should I have to be penalized because I have a rare disease and not cancer? These rules and regulations that are coming out make me wish I had a cancer diagnosis.”