Young Women Abused as Children Have More Pain

By Pat Anson, PNN Editor

Young adult women with a history of being physically or emotionally abused as children report higher levels of pain than women not abused in childhood, according to a new study.

The link between child abuse and chronic pain in adulthood is a controversial one, but there are a number of studies that have found an association between the two. This was one of the first to follow abused adolescents into adulthood.

Researchers at Cincinnati Children's Hospital Medical Center recruited 477 girls between the ages of 14 and 17 and followed them up to age 19. About half the girls experienced neglect or maltreatment, such as physical, emotional or sexual abuse that was substantiated by child welfare records. The other half acted as a control group.

Five years later, researchers contacted the women again and surveyed them about their pain as young adults. Those who were maltreated as children reported higher pain intensity, a greater number of pain locations, and were more likely to have experienced pain in the previous week than those who were not mistreated as children.

The young women who experienced post-traumatic stress as teenagers had the highest risk of pain.

"Child maltreatment and post-traumatic stress symptoms (PTSS) in adolescence work together to increase risk of pain in young adulthood," says lead author Sarah Beal, PhD, a developmental psychologist at Cincinnati Children's Hospital Medical Center. "The link isn't simple and could be due to an increase in inflammation, maintaining a state of high-alert in activating stress responses, or a number of other psychological or behavioral mechanisms.

“Women with a child maltreatment history were significantly more likely to experience pain and report a higher number of pain locations in young adulthood. Furthermore, among women who experienced any pain, those who were maltreated reported somewhat higher pain intensity. Results also showed that elevated PTSS during adolescence were associated with pain in adulthood and more widespread pain.”

Beal, who reported her findings in the journal Pain, says identifying and treating childhood trauma at an early age could help prevent chronic pain from developing in adulthood.  

“By intervening to address stress symptoms and poor coping following maltreatment, we may be able to reduce the impact of maltreatment on young adult health sequelae -- at least for pain,” said Beal.

Previous research has found an association between childhood trauma and chronic illness in adults.

A recent study found that women who experienced physical or emotional abuse as children have a significantly higher risk of developing lupus, a chronic autoimmune disease.

Another study found that adults who experienced adversity or trauma as children were more likely to have mood or sleep problems as adults -- which in turn made them more likely to have physical pain.

And a large survey found that nearly two-thirds of adults who suffer from migraines experienced emotional abuse as children.

Can We Forget About Chronic Pain?

By Ann Marie Gaudon, PNN Columnist

I recently came across a clinical report which describe two patients with a lengthy history of chronic pain severe enough to warrant opiate therapy. Both patients experienced sudden memory loss and forgot about their pain – literally.

Central sensitization is a process known to occur in the spinal cord and brain where if short-term acute pain is allowed to persist, then changes occur within the central nervous system which can lead to chronic or intractable pain.

That’s what happened to me. I have a diagnosis of a visceral pain syndrome, as opposed to a progressive pain condition. I experienced one vicious organ assault and after more than 30 years of it being healed, I remain in pain.

Other patients who have experienced painful trauma may relive painful episodes that evoke recurring memories -- they experience their pain over and over again. That is a classic symptom of post-traumatic stress disorder (PTSD). Think of a war veteran or survivor of sexual violence.

Either way, neurophysiologic changes which relate to learning, memory and pain can result in a maladaptive learning process which leaves one in chronic pain. These intricacies happen outside of conscious awareness. We are not aware of or in control of this dysfunctional process while it is occurring within our brain and spinal cord circuits.

Here is an overview of the two patients discussed in the report:

Patient #1

The first patient is a 47-year old female with complicated health problems. She had undergone multiple surgeries and treatment modalities for gastric ulcers, endometriosis, thyroid cancer, hypothyroidism, seizure disorder, malnutrition and chronic abdominal pain over 10 years.

Her pain was managed with high doses of opiate medications in various forms, including intravenous, transdermal and oral. During a complex 12-month hospital stay, she had at least five seizures and suffered memory loss so severe she could not remember her entire stay in the hospital.

She did eventually become fully alert and oriented to the present, but she no longer complained of her pain symptoms and no longer demonstrated a need for consistent pain medication.

Six months after discharge, the patient was living at home in stable condition and only occasionally using tramadol. She reported her symptoms as minimal and 1-2 on the pain scale. She still has no memory of many aspects of her long hospitalization.

Patient #2

A 57-year old male was described as a “highly functioning architect” with a 10-year history of low back and right extremity pain. He had undergone many unsuccessful treatments for pain, including surgery, and was being admitted to hospital to have an intrathecal pump surgically implanted for pain control. He was taking no less than nine medications for pain including high doses of opiate therapy.

Initially after the pump was placed, he reported having a partial reduction of pain in his leg. However, in the next six months he was requesting higher doses of intrathecal as well as oral opiates.

One month after this, the patient was in a minor motor vehicle accident where he did not lose consciousness, but inexplicably had partial memory loss. His physicians felt the accident was not the cause, as the memory loss symptoms occurred long afterward. The cause of the amnesia was unknown and tests including a brain MRI showed as normal.

The patient could not remember the names of his doctors, where he lived, what type of work he did, or why he had a pain pump implanted. He was weaned off opiates without any complaint of increased pain and subsequently had the pump removed at his request.

Eight months later, this patient was found minimally responsive in his home. It is not known what occurred, but there was a suspicion that he had fallen and incurred a head injury. The patient experienced profound memory loss, with no memory of who he was, his family members or his back pain.

His pain medications were discontinued with no complaint of pain, but he required placement in a long-term care home due to severe amnesia. Over the next two years, this patient regained partial memory, along with some back and leg pain. He has not requested or required opiate therapy.

Emotions, Pain and Memory

We know pain perception can be caused by nociceptive stimuli, yet we also know that emotional and psychological factors can increase our perception of pain. A complex play of nerve fibers which transmit messages to the brain and spinal cord suggest there is a relationship between emotions, pain and memory. The best evidence that memory plays a role in pain is that of phantom limb pain.

The two cases presented here suggest that memory may influence the perception of pain, and that amnesia can be accompanied by a loss of or significant reduction of pain in the absence of any physical factors.

Treatments that reduce “pain memories” in the brain and spinal cord, along with a focus on preventing pain to reduce or eliminate these memories, may someday have a more widespread role in the management of chronic pain. To have a treatment or ability to effectively erase a maladaptive pain memory leaves me with just three words:

Count me in.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management. 

Ann Marie has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about her counseling services, visit her website.

This column 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.

Former CEO of U.S. Pain Foundation Sentenced to Year in Prison

By Pat Anson, PNN Editor

The founder and former CEO of the U.S. Pain Foundation has been sentenced to a year in federal prison for embezzling $1.5 million from the Connecticut-based charity and failing to report the income on his tax returns.

U.S. District Judge Victor Bolden sentenced Paul Gileno to 12 months and one day of imprisonment, followed by two years of supervised release. Gileno pleaded guilty to wire fraud and tax evasion in June.

The 47-year old Gileno is also required to pay full restitution to the charity and the Internal Revenue Service, as well as tax penalties and interest.

"By engaging in wire fraud and tax fraud, the defendant committed very serious crimes over the course of several years,” U.S. Attorney John Durham said in court documents.  

“As the Court is well aware, tax fraud undermines the public’s confidence in the tax system and relies on taxpayers to correctly report all taxable income.  As to the wire fraud offense, the defendant stole money from his employer for his own personal gain.  As such, the defendant’s conduct is very serious."

PAUL GILENO

Gileno faced up to 25 years in prison, but as part of his plea agreement prosecutors agreed to ask for a lesser sentence. In a sentencing memo, prosecutors said Gileno was in “relatively good physical and mental health” and was a hard worker committed to his family.

"I cannot even express how sorry I am for what  have done, I made mistakes, I screwed up majorly, I mismanaged, I was careless and I took money that was not mine, I used it for personal use and I was selfish," Gileno wrote in a letter to the judge. "I took the money and, in my mind, justified it by saying to myself I deserved it at the time and US Pain had it. I justified it in multiple ways."

Gileno's defense attorney also presented numerous testimonies from pain patients and advocates about the help they received from Gileno and his work in patient advocacy.

Gileno will report to prison on January 6, 2020. Until then he is free on bond.

Fraud Went Undetected for Three Years

The money embezzled by Gileno was used to pay his mortgage, car payments, loans to his brothers, and a visit to Universal Studios in Orlando, Florida. The misuse of funds allegedly went undetected for three years.

“I still find it difficult to believe that nobody else who’d been in upper management of the foundation for several years knew anything regarding the going out and coming in of money/funds,” former U.S. Pain board member Suzanne Stewart recently wrote in her blog. Stewart resigned from the board last year because she was concerned about how the charity was being run.

According to an audit and U.S. Pain’s tax returns, Gileno misappropriated over $2 million from the charity from 2016 to 2018.  Nicole Hemmenway, the current acting CEO, was vice-president and board chair at the time. Two other longtime board members, Wendy Foster and Ellen Lennox Smith, still serve as directors. And Lori Monarca remains as Executive Office Manager, according to U.S. Pain’s website.

The board asked for and received Gileno’s resignation in May 2018, although it wasn’t publicly disclosed for several months that financial irregularities were behind his departure.

Since Gileno’s resignation, U.S. Pain says it has taken steps to ensure there was more internal control and financial oversight of its expenses and cash flows.

According to U.S. Pain’s 2018 tax return (the organization’s 2016 and 2017 returns were delinquent and filed late), the charity spent over $1.2 million last year on salaries, employee benefits, lawyers, accountants, tax penalties and business losses. That means less than half of the $2.1 million raised by the charity was spent on programs and services for the pain community.

Earlier this month, U.S. Pain announced the appointment of Shawn Dickens to its board of directors, filling the seat vacated by Suzanne Stewart nearly a year earlier. Dickens is the first U.S. Pain board member who was not appointed by Gileno.

Surgery Patients in Vermont Getting Fewer Opioids or None at All

By Pat Anson, PNN Editor

The 2016 CDC opioid guideline was never intended to reduce the use of opioids for post-surgical pain. In fact, studies show that long-term use of prescription opioids after surgery is rare. Nevertheless, a number of states and hospitals have policies designed to reduce the use of opioids after surgery -- many of them modeled after the CDC guideline.  

Vermont was one of the first, adopting a rule in July 2017 that encourages doctors to use non-opioid pain relievers as first-line treatments for post-operative plan. If they do prescribe opioids, patients are initially limited to no more than 10 pills. The regulations also require doctors to discuss with patients the risk of opioid addiction and overdose.

This state-mandated policy has led to significant reductions in opioid prescribing to surgery patients at the University of Vermont Medical Center (UVMMC) without impacting patient satisfaction in pain management, according to a new study presented at the American College of Surgeons Clinical Congress.

The study evaluated opioid prescribing at UVMMC for 15 common operations for 12 months before the regulations went into effect and for 17 months afterward.

During that period, the daily morphine milligram equivalent (MME) dose declined by 33 percent, from 96 MME to 64 MME afterwards. The proportion of patients who did not receive any opioids after surgery more than doubled, from 12.7 to 26 percent. That’s one of every four patients.

Prescription refill rates for opioids increased from 5.5 percent to 6.3 percent, and the percentage of patients reporting an inadequate amount of pain medication also rose, from 11 percent to 12.3 percent. But those increases were not considered statistically significant by the researchers.

“The clear trend is that physicians are prescribing less, patients are using less, and there is no appreciable change in patient-reported pain control or satisfaction after implementation of these regulations,” said study presenter Mayo Fujii, MD, a clinical instructor in surgery at the University of  Vermont Larner College of Medicine.  

“That patients are using less may reflect the impact of patient education efforts to establish expectations of postoperative pain and use non-opioid pain management strategies, as well as public awareness of the opioid epidemic.”

Patient education about non-opioid analgesia increased from 82 percent to 98 percent during the study period, as did education on safe opioid disposal (19 percent to 52 percent).

“Patient education, particularly encouraging non-opioid pain management strategies was something that clearly increased after these regulations went into effect,” Fujii said. “It’s an intervention that’s easily implemented and may contribute to patients using less opioid medication than they otherwise would have.”

Vermont Overdoses Still Rising

The Vermont regulations appear to have been successful in reducing the frequency and amount of opioids prescribed to both acute and chronic pain patients. But what about their impact on addiction and overdose rates?  The evidence there is mixed at best.

According to state health officials, fatal overdoses in Vermont rose from 96 deaths in 2016 to 110 deaths last year. Most of those overdoses involve illicit fentanyl or heroin, not prescription opioids. Only 28% of the deaths in 2018 were linked to opioid painkillers, but it’s not known if the pills were prescribed or obtained illicitly.

A recent study in neighboring Massachusetts found that only 1.3% of overdose victims who died from opioid medication had an active opioid prescription – suggesting that the vast majority of pills were stolen, diverted or bought on the street.

As in other states, many doctors in Vermont have grown cautious about their opioid prescribing and some are aggressively tapering patients off opioids. A recent study of tapering in Vermont found only 5 percent of patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in three weeks or less, including about half who were cut off without any tapering. Many of those patients were hospitalized for severe withdrawal symptoms, including respiratory failure.

A new federal tapering guideline suggests tapers of 5% to 20% every four weeks, although slower tapers of 10% a month may be appropriate for patients taking opioids for more than a year.

Documentary Champions Holistic Approach to Chronic Pain

By A. Rahman Ford, PNN Columnist

A new, eye-opening documentary is challenging conventional wisdom about chronic pain treatment. Rather than treat pain as a purely biomedical issue, On a Scale of 1 to 10: The Silent Epidemic suggests a holistic, multi-disciplinary approach to pain treatment that addresses the physical, social, psychological and spiritual dimensions of who we are as human beings.

According to the film’s website, the motivation to make the documentary was to show people “a different path to regain their quality of life” without the use of prescription opioids and surgery. The film features clinics and wellness centers that use new diagnostic tools, innovative research and advanced products and therapies. 

The film was produced by Citrus Pie Media Group and was written and directed by Laurent Goldstein and Executive Produced by Jennifer Unruh.

To set the inspirational tone for the film, Goldstein opens with his own personal story. As a result of a herniated disc, he had lower back pain so severe he could not walk, sit or stand without intense agony. He found his freedom from pain in chiropractic, spinal decompression treatments and a targeted anti-inflammatory regimen.

With this holistic approach, Goldstein was able to avoid surgery. His personal struggle and triumph over chronic pain, as well as the stories of other patients, motivated him to make the film.

Goldstein’s passion is particularly evident in the scenic snapshots of Canadian landscapes and seascapes that he strategically places throughout the film. They amplify and reinforce the film’s emphasis on natural modalities of healing.

The nearly two hour long documentary is well made and chock full of information, but also thoughtfully introductory in its tone, making it understandable to those new to holistic and integrative methods of healing. The film provides enough detail about what these treatments are and how they work, but not so much that it overwhelms the viewer with medical minutia and jargon.

The messages and themes in the film are compelling. Although it does get technical in some areas, the documentary is far from clinical in its presentation. On the contrary, the emotional success stories told by everyday people who have conquered their chronic pain make the film personal and relatable.

They made the conscious decision to liberate themselves from mainstream medicine because they were fed up with misdiagnosis, mistreatment and crippling financial expense.

Experts and Influencers in Alternative Health

Goldstein interviews health and wellness influencers such as psychiatrist Daniel Amen, Dr. Michael Klaper, Dr. Neal Bernard, psychologist Beth Darnall and Barby Ingle of the International Pain Foundation (iPain). Through conversation with these experts, a wide range of alternative medical approaches are discussed. These include nutrition, physical exercise, immune system function, hormone balancing, digestion, and vitamin/mineral supplementation.

Other therapies include laser therapy, stem cell therapy, medicinal herbs, sound/vibration therapy, floating therapy, light therapy, hypnosis, meditation and energy healing. All of these approaches are aimed at healing the underlying condition, not just masking the symptoms.

For example, a key focus of the film is the nutrient-deficient American diet, which is seen as a primary culprit in causing chronic pain. Meat and dairy are especially bad for human health, with one expert recommending “meat abstinence.” One pain sufferer was able to get off of all medications with a diet of fruits, vegetables, berries, nuts and seeds, and has remained medication-free for ten years.

All in all, the documentary is a thought-provoking window into the multifaceted causes of chronic pain and the novel approaches that fed-up pain sufferers are turning to. The film takes an expansive view of what pain is and challenges viewers to summon the courage to abandon preconceived notions of health and wellness, and to open themselves up to new avenues of healing.

On a Scale of 1 to 10: The Silent Epidemic will open the International Pain Summit in Los Angeles on November 14. iPain has recognized the film with its 2019 Community Impact Award.

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.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food.

The information in this column 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.

How CBD Helped End My Insomnia

By David Eaton, Guest Columnist

Due to a decrease in my opioid pain medication (to fall within the CDC guideline), my pain level increased to the point that I was unable to sleep. Of course, lack of sleep affects your overall health and so I began a downward spiral and needed something to break that cycle.

My son, who has been suffering acute pain from scoliosis in his neck, was having similar insomnia issues. He tried CBD oil and recommended that I do the same.

I knew little about CBD, so I talked to the very knowledgeable and helpful manager of a local CBD store. His recommendation was that I begin by researching CBD myself and then talk about it with the doctor at my pain clinic -- advice that impressed me as being very responsible.

After spending a day or two reading online articles, including some here on Pain News Network, I ran the idea past the physician’s assistant at my pain clinic.  She thought it was a great idea and asked me to try it before my next appointment with her in 4 days.

I placed another call to the manager at the CBD store and he recommended starting with a CBD infused "candy bar." My wife went there the next day and paid $25 for a white chocolate, peach and hazelnut flavored candy bar containing 120 mg of CBD.

DAVID EATON

The chocolate bar was scored in such a way that it can be divided into 4 servings, each with 30 mg of CBD. The manager’s suggestion was for me to try a single piece the first night and then take one and a half sections the following 2 nights. So that's what I did. 

Prior to trying the CBD, I had experienced a lot of pain-induced insomnia and found it difficult to sleep for more than an hour at a time.  It was not uncommon for me to wake up 10 times during a 12-hour effort to sleep. 

Most people do not realize how important a good night's sleep is to your health and well-being.  After my insomnia got severe, I installed an app on my phone (Sleep as Android) to track how much I slept each night.

After taking my nighttime meds and my last "dose" of CBD chocolate, I fell asleep around 8 pm.  According to the sleep app, which amazed me by its accuracy, I slept until 3 am, waking up feeling very rested and refreshed.

I decided to stay awake long enough to write this article before going back to sleep at 4 am. I slept until 10:45 that morning.

In all, I got about eleven and a half hours of deep sleep over the course of about 13 hours!   

As far as I am concerned, the use of CBD to reduce my pain and promote relaxation is an overwhelming success. I will be investing in a bottle of CBD oil on my next trip to town. 

David Eaton is disabled by chronic pain caused by degenerative disc disease, migraines and arthritis. He lives in Georgia.

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

The information in this column 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.

Seeing Red: How Colors Affect Pain

By Dr. Lynn Webster, PNN Columnist

It is a myth that the matador’s red cape -- the muleta -- incites rage in the bull and causes him to charge. The truth is, all cattle are colorblind.  The bull does not charge because of the color, but because of the movements of the matador and his cape.

It is not a myth, however, that color can affect the moods of humans. Researchers have studied how colors affect psychological states, such as anxiety, in people.

We now know that color also affects how people perceive pain. In this month’s issue of Pain Medicine, authors Karolina Wiercioch-Kuzianik and Przemyslaw Babel present “Color Hurts: The Effect of Color on Pain Perception,” exploring how color can affect the perception of pain.

A 2007 study reported more intense pain when a painful stimulation was preceded by a red color than a blue one. The new study builds on that work through two experiments.

In the first, 30 volunteers were shown six colors, one at a time, followed by mild electric shocks to their forearms – seven shocks with each color.

The participants, who knew in advance what the research would involve, reported their pain on a scale of 0 to 10 following each stimulation.

A black image was the control to which all the colors were compared. Black was chosen as the control because it is regarded as the absence of color.

The investigators found that the color red produced the most intense pain, followed by green and blue. Other colors were associated with less pain.

The results are not necessarily intuitive. Red may bring people joy when it takes the form of blooming roses, succulent berries, or wonderful memories of Christmas. But in this study, red increased pain levels.

The second experiment was designed to assess whether colors would affect the expectation of pain and pain intensity. Participants viewed a color and then received a series of mild electric shocks. Again, pain intensity was rated higher with some colors, particularly with red, blue and green. The investigators did not observe that specific colors influenced the participants' expectation of pain intensity.

Much has been written about how and why colors can affect our cognition and behavior. Our reactions to colors seem to be a result of biology and cultural imprinting. Interestingly, many people are aware that individuals supposedly have a “personality color.” Human resource professionals have even used color personality tests to assess job applicants.

Our folklore and traditions bestow certain meanings to colors. Snow White represents purity and innocence, while Edgar Allen Poe used a black raven to symbolize death. The Great Gatsby and other stories use the color gold to suggest greed.

Colors affect us psychologically and physically. As the authors of the Pain Medicine study concluded, colors can also influence our perception of pain. Thus, it may be important for researchers and clinicians to recognize that a patient's reported pain could be affected by the colors of the exam room or even the ambiance of a clinic.

It may be time to for people in pain to consider how their choices of clothes, furnishings, and even paint and wallpaper may factor into their levels of comfort.

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

You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences.

Why America's Opioid Crisis Is Really a Drug Crisis

By Pat Anson, PNN Editor

A new report from the CDC challenges much of the conventional thinking about the opioid crisis, particularly the role played by prescription opioids. Other medications can be even more risky.

For example, twice as many Americans overdosed on the anti-anxiety drug alprazolam (Xanax) in 2017 than those who died after taking hydrocodone (Vicodin).

Gabapentin (Neurontin), a pain reliever thought to be safer than opioids, was linked to more fatal overdoses than tramadol (Ultram).

And here’s a shocker: the antihistamine diphenhydramine (Benadryl) is the 10th deadliest drug in the United States.

CDC researchers say illicit fentanyl, heroin and cocaine were involved in far more overdoses than any opioid medication. And methadone, an addiction treatment drug that’s supposed to prevent overdoses, was linked to more drug deaths than hydrocodone.

Only three opioid pain medications — oxycodone, morphine and hydrocodone — made the top 10 list of drugs involved in 2017 overdoses.

TOP 10 DRUGS INVOLVED IN 2017 OVERDOSES

SOURCE: CDC

CDC researchers used a text analysis to scan electronic death certificates to find which drugs were most commonly involved in overdoses. The methodology is imperfect, since it includes drugs that were not necessarily the cause of death, but it provides a more thorough picture of which drugs are driving America’s overdose crisis.

The analysis also uncovered distinct regional differences. Deaths from heroin in 2017 were highest in New England, New York, and the mid-Atlantic states, while methamphetamine was the deadliest drug in most of the West, Southwest and Mountain states.

The 2017 analysis is likely already dated, as counterfeit medications made with illicit fentanyl have caused hundreds of overdose deaths this year on the west coast, from San Diego to Seattle.     

Doctors Targeted for Opioid Prescribing

While legal prescription opioids are not involved in most drug overdoses, they continue to be the focus of the Department of Justice and other law enforcement agencies, which mine prescription drug databases looking for signs of suspicious prescribing.

We reported this week on the case of a California pain doctor who paid a $125,000 fine to settle DOJ allegations that he “illegally prescribed opioids.”

“It was extortion and there’s nothing I was able to do about it. It’s sad and pathetic,” said Dr. Roger Kassendorf.

Federal prosecutors built their case against Kassendorf by analyzing prescription data to identify five of his patients who were on relatively high doses of opioids. None of the five were harmed or overdosed while under the care of Kassendorf, who admits his medical records could have been better. He settled to avoid a more expensive court fight.

It’s a familiar story to other doctors who’ve been targeted by regulators or law enforcement.

“If you study every board case and every indictment, they claim inadequate medical records. It’s their fall back in every case, so in case they lose on the facts, they can save face by being the documentation police,” said Dr. Mark Ibsen, a Montana primary care physician. “As with overprescribing, they never define what under-documentation is.”

Ibsen was initially accused by the Montana medical board of overprescribing opioids, but his medical license was suspended for inadequate medical records. Ibsen had to go to court to get the suspension overturned.

“The prescription drug registry is an excellent document in support of the physician. Given that it is a database available to all physicians in each state, it is hard to claim inadequate documentation for any physician,” Ibsen said.

“There are many doctors and nurse practitioners targeted by law enforcement solely because of the amount of opioids they prescribe. This is inappropriate. No one can assess the quality of care by just looking at the amount of drugs a provider prescribes,” says Dr. Lynn Webster, a pain management specialist and PNN columnist. 

“Providers are often forced to accept plea agreements to avoid incarceration, because they don't have the resources to fight the system. They will often do this to protect their families. There are bad doctors who should be put away, but most are trying to do the best they can within a system that is biased against people in pain and opioids.”

The pressure on physicians is so intense that many have lowered doses or stopped prescribing opioids altogether. That’s forcing pain patients to seek treatment with other doctors — who then run the risk of being flagged as a “high prescriber” if they accept new patients who need opioids.

DEA Seeks to Cut Inventories of Opioid Medication

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has announced plans to significantly reduce inventories of opioid pain medication and other controlled substances that drug manufacturers are allowed to maintain. The inventory reductions are in addition to cuts in the production of opioids that the DEA is seeking in 2020.

The proposed regulations, published this week in the Federal Register, would limit “excess quantities of medications” being stored in inventory that might be vulnerable to diversion. Other rule changes would tighten DEA oversight of the manufacturing and distribution of controlled substances.

Under current regulations, drug companies are allowed to keep inventories on up to 50% of their annual sales quota for Schedule I and II controlled substances. That would be reduced to 30% under the proposed rules.

“Practically speaking, this equates to a reduction from half of a year's sales supply allowed to be held as inventory to nearly four months,” the DEA said.

The agency said the smaller drug inventory “is not expected to increase the likelihood of drug shortages,” because more manufacturers are available to increase production if shortages develop.

“The DEA believes a reduction of inventory allowance to 30%, with flexibility to produce up to 45% at any given point in a year, would have minimal impact on registrants while continuing to provide adequate inventory for registrants to respond to fluctuations in demand in pharmaceutical markets,” the agency said.

Last year the DEA allowed drug manufacturers to increase the production of injectable opioids after shortages developed at U.S. hospitals. The shortages became so acute that some hospitals were forced to use acetaminophen and muscle relaxants to treat surgery and trauma pain.

The FDA still has morphine, hydromorphone and fentanyl solutions on its list of drug shortages and there are anecdotal reports of hospitals continuing to ration injectable opioids. 

‘You Are Hurting Pain Patients’

The public has 60 days to comment on the DEA’s inventory proposal. The comments posted so far are mostly from pain patients critical of previous actions by the DEA.

“Why, why, why do you all keep taking meds from people? You are hurting the pain patients who need this medication. Start taking the drugs off the streets not from our doctors,” wrote Christy Ashford.

“The DEA has waged a war against the sickest and weakest members of American society,” wrote Kirsten Klang. “They know that almost all of the fatalities have to do with the integration of counterfeit fentanyl than any other chemical. Yet, the DEA clamps down where it's easy to do so... even if it's wrong... just because it's easy!”

“I would like to know why the DEA thinks it needs more power over the United States citizens. I mean really, don’t they think that they have tormented enough doctors and their patients through this so-called opioid crisis?” wrote Sheryl Cox. “They say that they have no control over the prescriptions that our doctors give us, and that is an outright lie. They do control our doctors by arresting them and prosecuting them needlessly, sending them to prison, and most do not deserve this kind of treatment and abuse.”

The DEA began cutting the supply of opioid medication in 2016 during the Obama administration. The trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third.

Last month, the DEA proposed further cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances. If approved, the 2020 production quotas would amount to a 60% decrease in the supply of hydrocodone and a 48% percent cut in the supply of oxycodone since 2016.

Cuts in the supply of prescription opioids have coincided with a sharp increase in overdoses from counterfeit medication. In recent months, hundreds of people have died after taking “Mexican Oxy” – counterfeit oxycodone pills made with illicit fentanyl – which are being trafficked in the U.S. from coast to coast.

My Doctor Was Fired for Not Treating My Chronic Pain

By Chris Jolley, Guest Columnist

I was with my pain doctor for 20 years at the same clinic and on the same dosage until April 2017, when the medication that controlled my pain was stopped.  I had gone for a routine follow-up when a new doctor I had never seen walked into the exam room to tell me he was stopping all pain medication for each patient within one month.  

I have spina bifida, scoliosis, fibromyalgia, chronic kidney stones, and more. My worst pain is from migraines, including chronic cluster migraines, several ruptured discs from a back injury, and severe disc degeneration.  

Because of the migraines, my husband created a dark room and I spend most of my time in there.  My back pain makes me change positions every hour.  I do not get much sleep.  

Last year I had one of the worst cluster migraines. On its 5th day, I had a flare up from my disc rupture and my chronic kidney stones started dropping. I was in horrific pain.

I have a pain contract, so my son called the clinic to let them know he was taking me to the emergency room.  He was told he could take me, but under no circumstances could they give me any pain medication.

CHRIS JOLLEY

My son called 3 more times and on the third call was told we needed permission from the doctor, who had already left for the day. The next day, my son was told the same thing. The ER could not treat my pain.

No one should suffer horrific pain. But pain patients are being abandoned by doctors and profiled by pharmacists who refuse to fill our prescriptions, even for cancer.  A family pet would never be allowed to live in such pain.

Before April 2017, I was happy, able to work, involved in many craft projects, and saw my daughter and grandchildren often, even though they live 40 miles away.  

After months of appointments with the new doctor, I told him that I think about suicide every day and sometimes every hour because of the pain.  He did not even look at me and walked out the door.

This doctor was fired for what he did to me, and the doctor who replaced him put me back on pain medication. I was shocked by this.  

I took the new prescriptions to 3 large pharmacy chains and they refused to fill them, citing the 2016 CDC opioid guideline as law.  Fortunately, a few months later, I found a local pharmacy that had no problem filling the prescriptions. I am doing so much better now.

Chris Jolley lives in Utah.  

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

The information in this column 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.

Pain Doctor on DOJ Settlement: ‘It Was Extortion’

By Pat Anson, PNN Editor

A southern California doctor who paid a $125,000 fine to settle allegations of illegal opioid prescribing says federal prosecutors threatened to ruin his practice and reputation if he didn’t pay up.

“They could care less if I was innocent or guilty. They wanted to see how much they could gouge out of me,” said Dr. Roger Kasendorf, an osteopathic physician who specializes in pain management in La Jolla. “They tried getting $24 million from me until they saw my bank account. I had to hire a good lawyer and pay them too.

“It was extortion and there’s nothing I was able to do about it. It’s sad and pathetic.”

The U.S. Attorney’s Office in San Diego announced the settlement last week in a press release, alleging that Kasendorf “illegally prescribed opioids to his patients.”

“This investigation arose from data analytics tools which allow the Department of Justice to perform a variety of functions, including identifying statistical outliers, such as which doctors prescribe the highest opioid dosages and which doctors prescribe combinations of opioids and other drugs known to increase the risk of addiction, abuse, and overdose,” the office said in a statement.

“Based on the investigation, the United States contends that Dr. Kasendorf wrote prescriptions for opioids, including fentanyl, that were not issued for a legitimate medical purpose and while not acting in the usual course of his professional practice in violation the Controlled Substances Act and the False Claims Act.”

The DOJ statement makes no mention of any patients being harmed or overdosing while under Kasendorf’s care, and no formal criminal charges were filed against him.

Kasendorf says the DOJ’s case was based on inadequate medical records he kept on five of his sickest patients, who were prescribed relatively high doses of opioids for pain. One of the patients has since died from cancer.

“I didn’t know my EMR (electronic medical records) very well. I didn’t keep good notes. And as a result, they went through my notes and said, ‘Oh look you didn’t do this and you didn’t do this.’ I did, but I kept poor documentation,” Kasendorf told PNN.

“Nowadays, if you see any of my notes over the last three years, they’re perfect. But back in the day I didn’t have great notes.”

DR. ROGER KASENDORF

Kasendorf has a simple explanation for why he agreed to settle rather than defend himself in court.

“It was cheaper to pay it than defend it. So, I just paid it,” he said. “If I didn’t settle, they said they would call the DEA and then the state (medical) board. That’s what they said. ‘If you don’t settle, we’re going to make it a lot worse for you.’   

“If I defend myself, I’m risking my (medical) license, even though I don’t feel like I did anything wrong. Now I’m dealing with three separate entities and then I can’t work anymore. So I almost had no choice but to settle.”

“Without reviewing the medical records, I cannot assess the fairness of this outcome,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers. 

“If the physician were merely a big-data outlier because he took on patients with the most complex needs, and if his prescribing were CSA (Controlled Substances Act) compliant, then the behavior of the federal government would fall squarely under the Black’s Law Dictionary definition of extortion.”

That legal dictionary defines extortion this way: “Any oppression by color or pretense of right, and particularly the exaction by an officer of money, by color of his office, either when none at all is due, or not so much is due.”

Assistant U.S. Attorney Dylan Aste, who led the case against Kasendorf, did not respond to a request for comment. As for the doctor’s claim about extortion, a DOJ spokesperson told PNN, “We’re not going to have any comment about that.”

DOJ Threatens Criminal Prosecution

Kasendorf is the latest example of the DOJ’s heavy-handed tactics in fighting the opioid crisis. Dozens of doctors around the country have been arrested and prosecuted for illegal opioid prescribing, many of them targeted by DOJ task forces that use prescription drug databases to identify high-dose prescribers.

"Sometimes the only difference between a doctor and a drug dealer is a white coat," U.S. Attorney Jay Town told reporters after federal raids in April that resulted in criminal charges against 60 practitioners in seven states.

Those cases may be legitimate, but hundreds of doctors who face no charges are still being harassed by federal prosecutors – not because their patients became addicted or overdosed – but because their names turned up in a database search.

In February, U.S Attorneys in Wisconsin sent letters to 160 high-dose prescribers in the state, warning them that “prescribing opioids without a legitimate medical purpose could subject them to enforcement action, including criminal prosecution.” 

“The DOJ treats controlled-medication prescribers, especially big-data outliers, as though they are guilty unless proven innocent.”

— Michael Barnes, attorney

Similar warning letters have been sent to doctors in Georgia, Massachusetts and other states.

“The DOJ treats controlled-medication prescribers, especially big-data outliers, as though they are guilty unless proven innocent,” said Barnes. “Detailed medical records are the only affordable way for a provider to prove his innocence — or at least make the prosecutor think twice about proceeding with criminal charges.”

Although the DOJ lacked credible evidence that any of Kasendorf’s patients were harmed by his care, the lack of detailed medical records was enough to intimidate the doctor into settling on the advice of his attorney. 

“Dr. Kasendorf’s ability to provide high quality pain management to those in need of treatment never was questioned. No charges ever were filed against Dr. Kasendorf,” said attorney Robert Frank. “The government’s allegations arose from an incomplete story of Dr. Kasendorf’s care for a few patients.  No patients suffered any adverse outcomes or complications from his care.   

“Economically, it made sense for Dr. Kasendorf to put an end to yet another Government pursuit of a physician successfully treating patients for true chronic pain problems, in what now has become an opiophobia world brought on by the overzealous promotion of opioids by pharmaceutical companies and misuse of them by relatively few physicians, Dr. Kasendorf excluded.“ 

‘Glad I Found Dr. Kasendorf’

Kasendorf continues to practice medicine and remains in good standing with the Osteopathic Medical Board of California. The board has no record of any disciplinary actions, malpractice judgments or citations against him.

Online reviews of Kasendorf by patients are largely positive.  

“I am so glad I found Dr. Kasendorf. I have dealt with debilitating neck pain for years. Dr. K treated my neck and my pain not only went away, but my headaches and numbness in my fingers went away also. He is very good at what he does,” wrote Gina in a Yelp review.  

“Dr. Kasendorf is one of the most caring pain management doctors I have ever seen, and I have seen a lot of them. He is truly empathetic towards his patients which is very hard to find. He is very strict about his opiate contract rules, but most pain management doctors are nowadays,” wrote Natalie. 

“He fired me from treatment with opiates despite a chronic painful condition,” wrote Gary, who said Kasendorf cut his opioid medication in half and then dropped him for being non-compliant.

“He is afraid the DEA is going to threaten his practice. Suggest you find an MD with the integrity to stand by his patients and stand by his past decision to prescribe opiates.” 

Guilt by Association 

Federal prosecutors initially became interested in Kasendorf not because of his prescribing practices, but because of his association with Insys Therapetics, a controversial Arizona drug maker.  

Insys’ founder and four former executives were recently convicted of bribing doctors with millions of dollars in kickbacks to prescribe the company’s flagship product: Subsys, a potent fentanyl spray that costs about $5,000 for a single day’s supply.

Subsys is only FDA approved for the treatment of cancer pain, but like other drugs it can be prescribed off-label for other pain conditions. Because of its high cost, Medicare and other insurers often wind up paying for Subsys.

Some doctors were paid lucrative speaking fees by Insys to promote Subys, while others were wined and dined at upscale restaurants or taken to a strip club for free lap dances.   

Kasendorf was a promotional speaker and consultant for Insys from 2013 to 2017. For that he was paid over $167,000, according to ProPublica.

“I was starting my practice. I had no money. The fact I was able to earn money through speaking was a miracle for me. That’s what kept me afloat and my family when I first moved here,” said Kasendorf, who moved to California from the east coast after his home was destroyed by Hurricane Sandy.

“And I was actually good at it. They wanted me to go all over the place because they felt I did a good job and was very thorough. I made it entertaining. I’m a very good speaker and I’m very proud of that.”

In addition to Insys, Kasendorf also did promotional speaking and consulting for several other drug companies, including Purdue Pharma, Egalet, Pfizer, Pernix and Indivior. But it was his work for Insys that federal prosecutors focused on.

“I never took bribes. I never got lap dances or all this stuff they were talking about,” Kasendorf told PNN. “This company did a lot of bad things and I completely agree. The problem is their product happens to be very, very good.”  

Subsys was so effective at pain relief that Kasendorf prescribed it to all five patients who were flagged by DOJ investigators.

“After all this time and all this effort, I think DOJ was upset I didn’t have more money.”

— Dr. Roger Kasendorf

It’s not the first time the DOJ has gone after a doctor for prescribing Subsys and making speeches for Insys. In 2017, the DEA raided the home and clinic of Dr. Forest Tennant, alleging that he took kickbacks from Insys and ran a “drug trafficking organization.” Like Kasendorf, no charges were filed against Tennant, who decided to retire on the advice of his attorneys rather than fight a protracted legal case.    

According to Kasendorf, the DOJ initially wanted him to pay a $24 million fine, but prosecutors settled for far less.

“They were so upset when they saw they could only get $125,000. But I sent them all my records and they could see I literally had no money in the bank,” said Kasendorf. “I had to borrow $100,000 from my parents to pay them.

“They almost put me out of business. But after all this time and all this effort, I think DOJ was upset I didn’t have more money.”

Researchers Urge Caution on Ketamine Infusions

By Pat Anson, PNN Editor

With many chronic pain patients losing access to opioid medication, some are turning to ketamine as an alternative. Ketamine is approved by the FDA for depression, anesthesia and post-surgical acute pain, but a growing number of clinics provide off-label infusions of ketamine to treat difficult chronic pain conditions such as Complex Regional Pain Syndrome (CRPS).

Researchers at Duke University say doctors and pain patients should be cautious in their use of ketamine. In a study of nearly 300 patients who received ketamine infusions, over a third reported significant side effects such as hallucinations and visual disturbances.

The study findings were presented this week at the annual meeting of the American Society of Anesthesiologists (ASA).

"Despite the U.S. Food and Drug Administration's approval of ketamine for multiple uses, including general anesthesia and treatment of depression, the effects of using the drug at low doses to treat pain have not been extensively studied," said lead author Padma Gulur, MD, a  member of ASA's Committee on Pain Medicine and a professor of anesthesiology at Duke.

"Our research aimed to determine both short- and long-term side effects of low dose ketamine when used for pain treatment."

Gulur and her colleagues found 20 percent of the pain patients who used ketamine alone had side effects, while 15% experienced side effects from using ketamine in combination with other drugs.

Side effects directly linked to ketamine include hallucinations, vivid dreams, out-of-body experiences and unusual thoughts; while those who used ketamine and other drugs experienced sedation, visual disturbances and urinary dysfunction.

"More than one in three patients reported significant side effects from ketamine infusions that required ongoing monitoring or resulted in discontinuation of therapy. More research on the impact of ketamine use for pain on the population is needed," said Gulur.

Guidelines from the ASA, the American Society of Regional Anesthesia and Pain Medicine, and the American Academy of Pain Medicine only support ketamine infusions for CRPS and short-term acute pain. There is weak or no evidence from clinical trials to support ketamine infusions for spinal cord injury pain, neuropathic pain, phantom limb pain, postherpetic neuralgia, fibromyalgia, cancer pain, ischemic pain, migraine headache or low back pain.

“Excluding CRPS, there was no evidence supporting ketamine infusions for intermediate or long-term improvements in pain," the guidelines warn.

The FDA recently approved a ketamine-based nasal spray to treat depression, even though 2 out of 3 short term trials failed to prove its effectiveness. The Spravato nasal spray was effective in a longer trial, but only when taken with a conventional antidepressant.

Because of the risk of abuse and side effects, Spravato can only be administered in a doctor’s office, where patients can be observed for two hours after taking a dose. A single dose will cost about $900. Spravato is not recommended for pain.

There is some debate in the medical community about whether ketamine is an opioid, because it acts on opioid receptors in the brain. Stanford researchers urge caution about the long-term use of ketamine until more can be learned about possible side effects such as addiction. Some depressed patients taken off ketamine have shown signs of withdrawal and became suicidal.  

A recent review of ketamine found that it was a “superb drug” for short-term medical procedures that require anesthesia and was relatively safe as a treatment for chronic pain.

“There is a wealth of evidence indicating the value of ketamine in the treatment of severe pain including conditions such as trauma, fractures, abdominal and flank pain, low back pain, and extremity pain,” said lead author Jorge Palacios, MD, an anesthesiologist at Kaweah Delta Medical Center in Visalia, CA.  

“It is safe and effective to use in combination with injectable nonsteroidal pain medications as well as opioids and has gained greater acceptance as concern has grown with regard to opioid use.”

More Bad Data on Rx Opioids from Health Canada

By Marvin Ross, PNN Contributor

Canadian health officials are still blaming opioid prescriptions for Canada’s overdose crisis. A new report by the Canadian Institute for Health Information (CIHI) that was funded by Health Canada points out that more than 9,000 people died from opioid-related overdoses between January 2016 and June 2018.

“While many of these harms may be due to the use of illicit opioids, such as heroin or fentanyl, prescription opioids are also contributing to the public health issue,” the CIHI report found.

The data the report presents shows significant declines in opioid prescribing, but no evidence that prescriptions are to blame for the overdoses.

For example, the total quantity of opioids prescribed in Canada between 2016 and 2017 dropped more than 10 percent, while the number of prescriptions fell more than 400,000.

From 2013 to 2018, there was an 8% decrease in the number of people prescribed opioids.

Fewer Canadians are taking opioids long-term and the number on daily doses over 50 MME (morphine milligram equivalent) also declined, which is likely the result of people being tapered.

There were signs of aggressive tapering. The proportion of patients taking over 90 MME fell significantly, from 25.7 percent to 16.6 percent. And more people stopped taking opioids for at least 6 months than ever before.  

But there was no discussion anywhere in the CIHI report of whether these decreases were medically beneficial for the patients involved -- which surely must be a consideration. Healthcare should be about improving care for people, not just cutting them off.  

We do know anecdotally that these changes are making pain care worse. I personally experienced the reluctance to treat pain when I recently cracked a knee cap.

“What about pain control?” I asked the ER doc. Over-the-counter Tylenol was her answer. She said Tylenol 3 – which contains codeine -- would give me constipation, so she would not prescribe it. Anything stronger, she said, would make me fall down and that would not be to my benefit.

The Toradol shot she gave me worked for a few hours. Fortunately, I had some Tylenol 3 at home leftover from a tooth extraction. Thank goodness for dentists, but taking the Tylenol 3 for something other than what it was prescribed for made me an opioid abuser.

Evidence Lacking

As for prescriptions being a significant cause of the crisis, the CIHI report provided a footnote to a report from the Public Health Agency of Canada, which states that illicit fentanyl and its analogues appear to be fueling the crisis. Males between the ages of 30 and 39 were the most prevalent victims of overdose death. Further, 82% of the deaths involved multiple drugs.

What do those figures have to do with chronic pain patients who tend to be older and female?

Here is their proof: In 2016, over 20 million prescriptions for opioids were dispensed, which is equivalent to nearly one prescription for every adult over the age of 18, making Canada the second-largest consumer of prescription opioids in the world after the United States.

That’s an interesting fact, but it does not show that prescribing to people who need analgesics has fueled the increase in overdose deaths. It only means there are a lot of Canadian adults in pain.

They also cite a 2015 survey, which found only 2% of those who had a prescription for opioids misused them. A more recent 2017 survey found that nearly a third of people who used opioid medication did not have a prescription. That proportion increased to almost 50% for teens under the age of 18, and 88% of those were illegal drug users.

As for the source of these unprescribed drugs, the Public Health Agency states:

“There are many routes that allow for prescription opioids to be diverted for nonmedical use, including sharing with family members, ‘double doctoring,’ prescription fraud and forgery, street drug markets, thefts and robberies and Internet purchases, making it difficult to estimate the proportion diverted. Through its surveys, Health Canada found that the most common source of opioids used without a prescription was a family member.”

They have no idea how these drugs get out there and admit there are many routes, but conclude that most come from family members who have a prescription for them.

What proof do they put forth? This is the reference they provide in a footnote to prove something that is contentious and disputed:

“Health Canada. Baseline survey on opioid awareness, knowledge and behaviours for public education research report. Ottawa (ON): Prepared by Earnscliffe Strategy Group for Health Canada; 2017. Unpublished report.”

When they say unpublished, I assume that this report was never submitted to a peer reviewed journal. Or if it was, then it was rejected. Scientific research should be published in peer reviewed journals where a panel of experts in both methodology and subject matter determine if the study is any good and will add to our collective knowledge of the topic. That is how science is advanced.

Regardless, the Earnscliffe report is buried on a government website and they tell us it cost almost $100,000. The report is largely based on an online survey with self-selected participation. Because of this, “no estimates of sampling error can be calculated, and the results cannot be described as statistically projectable to the target population.”

In other words, they cannot claim that any of their findings are valid. Just saying that opioid prescriptions are diverted from family members does not make it true. As the report indicates, even the teens who participated in the survey were conflicted about where illicit prescription opioids come from:

“The most common way of obtaining opioids illegally was from a friend or relative with a prescription, and the most common reason for taking them was pain relief. When teens were asked where they thought people their age get illegal opioids, the most common source was a drug dealer or other stranger.”

So much for the alleged proof that the illegal market is mostly comprised of drugs diverted from legal prescriptions. The findings here are similar to my experience, where I used a prescription given for tooth pain for a knee fracture. If I did not have the pills leftover, I would have obtained what I needed from a relative.

The initial published report went on to disprove their own hypothesis on the role of opioid prescriptions by saying that about 2% of Canadians used illegal drugs in 2015, including the “use of crack, cocaine, ecstasy, speed or methamphetamines, hallucinogens or heroin and therefore was not specific to opioids.”

The Canadian government is simply blowing smoke when it comes to proof that prescribing is fueling opioid overdoses. Canadians can only hope that after the federal election we get a new health minister who is a bit more logical. But I am not holding my breath.

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 is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Is Laughing Gas the Best Medicine for Labor Pain?

By Pat Anson, PNN Editor

A century ago, nitrous oxide – more commonly known as laughing gas -- was widely used in American hospitals to relieve labor pain during childbirth. But laughing gas fell out of favor as more Caesarean sections were performed and women opted more often for epidural injections for pain relief.  

Nitrous oxide is still commonly used in Europe and Australia to manage labor pain, and is beginning to regain popularity in the U.S. The inhaled anesthetic gas helps reduce anxiety and makes patients less aware of their pain, but does not eliminate it. 

“Nitrous oxide is easy for patients to use, relatively inexpensive, and will attract more patients looking for a birthing center, or more homelike type of delivery experience,” says Barbara Orlando, MD, an assistant professor of anesthesiology, perioperative and pain medicine at the Icahn School of Medicine at Mount Sinai, New York.

Orlando and her colleagues reviewed the medical records of nearly 2,000 women who used nitrous oxide during labor in five large university hospitals.

Many gave laughing gas high marks for pain control. The mean patient satisfaction rate for nitrous oxide was 7.4 (on a scale of 0 to 10). Their babies also had no adverse health effects.

Curiously, however, nearly 70 percent of the women who tried nitrous oxide switched to an epidural or another pain management method.  

“The high patient satisfaction rate and safety profile that we found should motivate other institutions nationwide to offer nitrous oxide as a pain management option to women in labor,” said Orlando, who presented her findings at the annual meeting of the American Society of Anesthesiologists (ASA).

“Although nitrous oxide did not prevent women in labor from requesting other pain management options like an epidural, we received positive feedback from patients who said they like laughing gas as an option to manage their pain.”

Epidurals injections allow mothers to stay awake and alert throughout delivery. But they are not without risks. A poorly placed needle can damage the spine permanently, as Dawn Gonzalez discovered a few years ago.

“The blind insertion of the epidural during birth is basically playing roulette for spinal damage. Normally birthing mothers are told the only side effect possible during epidurals is a spinal headache that lasts a few days,” said Gonzalez, who developed adhesive arachnoiditis, a chronic and disabling inflammation of her spinal nerves.  

The ASA has defended the use of epidurals, calling them “one of the most effective, safest and widely used forms of pain management for women in labor.”

In a large study of over a quarter million epidurals, the risk of complications was found to be low. An “unrecognized spinal catheter” – what Dawn Gonzalez experienced – occured in only one of every 15,435 deliveries. She thinks there are better odds and safer alternatives.

“Laughing gas, Lamaze, hypnotism, meditation, water birthing and even some medications are the absolute safest and most effective forms of labor pain relief. Every woman deserves to know that when she opts for any kind of invasive spinal anesthesia, the risks are very grave and by far much more common than anybody realizes,” Gonzalez said.

A Very Uncharitable Pew Stem Cell Policy Report

By A. Rahman Ford, PNN Columnist

The Pew Charitable Trust – an institution whose stated mission is to “encourage democratic participation” in accordance with its founders’ “emphasis on innovation” – has released a 52-page report on the FDA’s framework for regulating stem cells and regenerative medicine.

Far from democratic, the report is really a thinly-veiled hit piece on stem cell therapy – one of the few fields of medicine where innovation is actually occurring.

“In many cases, there is little reliable evidence to support claims that these so-called stem cell treatments will have any effect—or indeed that they contain stem cells at all, despite the claims made about them,” the Pew report found. “Beyond the potential physical, psychological, and financial harm to patients, the widespread availability of these unproven treatments could negatively affect the entire field of regenerative medicine.”

On its surface, the report’s professed aims of consumer safety and regulatory clarity are laudable and necessary. However, the report is clearly biased against stem cell clinics and fails to seriously consider the patient perspective in policymaking. And Pew’s curious selection of regenerative medicine “stakeholders” not only diminishes the report’s legitimacy, but reveals troubling undercurrents of industry and agency influence.

Ambiguity and Controversy in Regulatory Policy

The Pew report begins innocuously enough, by laying out the general landscape of regenerative medicine, federal regulation and FDA guidance. The report correctly notes the “complex and rapidly evolving” nature of regenerative medicine, as well as the legal ambiguity that pervades the FDA’s jurisdiction over enforcement.

The report accurately describes the controversy surrounding the FDA’s interpretation of “minimal manipulation” and “homologous use” standards, which determine whether a stem cell product is exempt from the agency’s pre-market approval requirements. It also notes that the FDA’s examples of what uses do or do not meet those standards – as stated in its guidance – are “inconsistent or arbitrary.”

The report’s recommendations are entirely based on stakeholder interviews. All 11 stakeholders supported the FDA’s crackdown on clinics, even though there are plenty of critics who think it is stifling innovation and patient access to stem cell therapy.

Rather than reduce regulation, Pew suggests that additional stakeholders like the Federal Trade Commission, National Institutes of Health and state governments should assist the FDA in its crackdown, adding even more layers of regulatory control.

The report also endorses the online censorship campaign against clinics and goes out of its way to essentially classify Texas and Alabama as “rogue states” for trying to actually expand the availability of stem cell therapy.

Rather than support a balanced and judicious approach that would both promote safety and innovations such as autologous stem cells, the report calls for “tighter control of the industry” to “lend legitimacy to the field and provide regulatory certainty, both of which are essential for developers seeking investment, as well as for payers that will eventually make insurance coverage decisions for these new treatments.”

To be sure, the resolution of regulatory ambiguity is a good thing for all parties. But the ambiguity should not be resolved in a manner that disadvantages the sick and disabled, as well as the small clinics that lack economic leverage to influence agency rule-making. Unfortunately, the Pew report privileges the wealth and influence of the healthcare industry in determining what policies are best. Patients and their interests are unceremoniously relegated to the back of the policy-making bus.

A Suspicious Selection of Stakeholders

As previously stated, the Pew report’s recommendations were derived from stakeholder interviews. Quite laughably, the report maintains that a “broad range of perspectives” were included. Of course, no practicing clinicians were included. Nor were any patient advocates interviewed. However, industry and academia were represented. In fact, one stakeholder was the former Chief Biotechnology Officer and Head of Scientific Strategy and Policy for Johnson & Johnson. Yes, that Johnson & Johnson.

The same Johnson & Johnson that, according to the New York Times, faces more than 100,000 lawsuits over its products. The same Johnson & Johnson that currently faces thousands of lawsuits over claims its baby powder has caused mesothelioma and ovarian cancer. The same Johnson & Johnson that recently agreed to pay a $117 million settlement for deceptive marketing of pelvic mesh implants and $8 billion for playing down the risks of the antipsychotic drug Risperdal. And yes, the same Johnson & Johnson that was found liable in the Oklahoma opioid trial.

So when the Pew report argues that stem cell clinics should be censored and persecuted for offering “dangerous” products and engaging in “deceptive” marketing practices, it is the absolute height of hypocrisy.

To make matters worse, that same former J&J “stakeholder” – who now sits on the board of biotech firm MacroGenics – worked for the FDA for 20 years reviewing and approving biologic products. This is the epitome of policymaking incest.

To appreciate the Pew report’s true motives, all one need do is peruse its references. The report’s end-notes are littered with citations to the work of the most public and commonly interviewed stem cell critics, all of whom are on the record as card-carrying regulationists.

Pew’s cherry-picking of sources reveals its true agenda. It is a meticulously-manicured industry-slanted propaganda piece masquerading as rational, objective stem cell policy.

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.

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 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.