The CDC, Opioids and Cancer Pain

By Roger Chriss, PNN Columnist

In 2016, the Centers for Disease Control and Prevention issued its controversial opioid prescribing guideline. Insurers, states and other federal agencies soon followed with mandatory policies and regulations to reduce the use of opioid pain medication. All this was supposed to exclude cancer-related pain care, but in practice that’s not what happened.

Dr. Judith Paice, director of the Cancer Pain Program at Northwestern University’s Feinberg School of Medicine, told the National Cancer Institute in 2018 that the opioid crisis “has enhanced fear — fear of addiction in particular” among both patients and doctors.

“Many primary care doctors no longer prescribe opioids. Oncologists are still prescribing these medications, but in many cases they’re somewhat anxious about doing so. That has led some patients to have trouble even obtaining a prescription for pain medication,” Paice said.

In 2019, the Cancer Action Network said there has been “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.” One out of four said a pharmacy had refused to fill their opioid prescription and nearly a third reported their insurance refused to pay for their opioid medication.

That same year, CDC issued a long-awaited clarification noting the “misapplication” of the guideline to patients it was never intended for, including “patients with pain associated with cancer.”  

Long Term Use of Opioids Uncommon

Cancer pain management in the U.S. has been severely impacted by the CDC guideline, even though rates of long-term or “persistent” opioid use are relatively low and stable:

• A major review of over 100,000 military veterans who survived cancer found that only 8.3% were persistent opioid users. Less than 3% showed signs of opioid abuse or dependence.

• A study of older women with breast cancer who were prescribed opioids found that only 2.8% were persistent opioid users.  

• A study of 276 patients with head or neck cancer found that only 20 used opioids long-term – a rate of 7.2 percent.

• And a study of nearly 23,500 women with early-stage breast cancer who had a mastectomy or mastectomy found that 18% of them were using opioids 90 to 180 days after surgery, while 9% were still filling opioid prescriptions 181 to 365 days later.

While any sign of opioid abuse or addiction is concerning, these studies show that long-term use of opioid medication is relatively uncommon among cancer survivors. The American Cancer Society says opioids are “often a necessary part of a pain relief plan for cancer patients” and “can be safely prescribed and used” for cancer pain.

Cancer patients and their doctors have been successfully managing opioid risks long before the CDC guideline or associated state laws and regulations. Perhaps it is time for lawmakers, regulators, insurers and pharmacies to learn from the cancer community rather than getting in the way of clinical best practices.

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. 

Virtual Reality Therapy Can Reduce Chronic Pain at Home

By Pat Anson, PNN Editor

Therapeutic virtual reality (VR) can reduce chronic pain, improve mood and help people sleep, according to a small study of 74 patients living with fibromyalgia or chronic lower back pain.

The research, published online in JMIR-FR, is one of the first to look at the effectiveness of VR therapy when self-administered at home by chronic pain patients. It was funded by AppliedVR , a Los Angeles based company that is developing therapeutic VR content to help treat pain, depression, anxiety and other conditions.

“People with chronic pain often have limited access to comprehensive pain care that includes skills-based behavioral medicine. We tested whether VR that was self-administered at home would be an effective therapy for chronic pain,” said Beth Darnall, PhD, a pain psychologist who is AppliedVR’s chief scientific advisor.

“We found high engagement and satisfaction, combined with clinically significant reductions in pain and low levels of adverse effects, support the feasibility and acceptability for at-home, skills-based VR for chronic pain.”

Participants in the study were given VR headsets and instructed to have at least one session daily for 21 days. Half of the patients listened to audio-only programming, while the other half watched “virtual” programs in which they could swim with dolphins, play games or immerse themselves in beautiful scenery.

The programs are designed to help patients learn how to manage their pain and other symptoms by using cognitive behavioral therapy (CBT) to distract them and make their pain seem less important.

A sample of what they saw can be seen in this video:  

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy, which worked significantly better than the audio-only format in reducing five key pain indicators:

• Pain intensity reduced an average of 30%

• Physical activity improved 37%

• Mood improved 50%

• Sleep improved 40%

• Stress reduced 49%

Previous VR studies have had similar findings, but have largely focused on patients in hospitals and clinical settings. 

“This study is a fundamental step for advancing a clinically proven, noninvasive and safe digital therapeutic like VR for chronic pain, and demonstrates our platform is both viable and efficacious,” said Josh Sackman, co-founder and president of AppliedVR.

“Living with and managing chronic pain daily can be a debilitating and costly challenge, and many patients suffering from it can feel hopeless and desperate for any relief. So, as we engage in and accelerate more in-depth clinical research, we want them to know that we’re committed to making VR a reimbursable standard of care for pain.”

AppliedVR products are being used in hundreds of hospitals, but are currently only available to healthcare providers. The company recently partnered with University of California at San Francisco to study how VR therapy can improve patient care for underserved populations.

AppliedVR is also conducting two clinical trials to see if VR therapy can reduce the use of opioid medication for acute and chronic pain. The National Institute on Drug Abuse recently awarded nearly $3 million in grants to fund the trials.

The company is currently recruiting patients with chronic lower back pain for an 8-week trial of VR therapy. Headsets and other material will be mailed at no cost to participants at their homes. No in-person visits are required.  

Researchers Developing Safer Version of Acetaminophen

By Pat Anson, PNN Editor

Researchers at Louisiana State University have created a new type of analgesic that is similar to acetaminophen but can relieve pain and reduce fever without the risk of liver or kidney damage.

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. Over 50 million Americans take acetaminophen each week, many unaware that excessive use can cause liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

Researchers at LSU Health New Orleans created 21 chemical compounds that are structurally similar to acetaminophen, but did not cause liver or kidney toxicity in tests on laboratory rodents. Their findings are published online in the European Journal of Medicinal Chemistry.

"The new chemical entities reduced pain in two in models without the liver and kidney toxicity associated with current over-the-counter analgesics that are commonly used to treat pain -- acetaminophen and NSAIDs. They also reduced fever in a pyretic model,” said senior author Nicolas Bazan, MD, Director of the LSU Health New Orleans Neuroscience Center of Excellence.   

The intellectual property behind the acetaminophen analogs has been licensed to South Rampart Pharma. The company expects to file an investigational new drug application with the Food and Drug Administration in the third quarter 2020, which would pave the way for clinical studies.

"Our primary goal is to develop and commercialize new alternative pain medications that lack abuse potential and have fewer associated safety concerns than current treatment options,” said Bazan. "Given the widespread use of acetaminophen, the risk of hepatotoxicity with overuse, and the ongoing opioid epidemic, these new chemical entities represent novel, non-narcotic analgesics that exclude hepatotoxicity, for which development may lead to safer treatment of acute and chronic pain and fever.”

Bazan said the development of safer pain relievers and fever reducers is particularly important because of the COVID-19 pandemic. Current treatments have led to kidney and liver disease in critically ill SARS-CoV-2 patients.

Acetaminophen is a key ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – from Excedrin and Tylenol to Theraflu and Alka-Seltzer Plus. It’s also used in opioid pain medications such as Vicodin. Nearly two-thirds of the world’s supply of acetaminophen comes from China.

Healthcare Workers Plead for Americans to Wear Masks

By Anna Almendrala, Kaiser Health News

When an employee told a group of 20-somethings they needed face masks to enter his fast-food restaurant, one woman fired off a stream of expletives. “Isn’t this Orange County?” snapped a man in the group. “We don’t have to wear masks!”

The curses came as a shock, but not really a surprise, to Nilu Patel, a certified registered nurse anesthetist at nearby University of California-Irvine Medical Center, who observed the conflict while waiting for takeout. Health care workers suffer these angry encounters daily as they move between treacherous hospital settings and their communities, where mixed messaging from politicians has muddied common-sense public health precautions.

“Health care workers are scared, but we show up to work every single day,” Patel said. Wearing masks, she said, “is a very small thing to ask.”

Patel administers anesthesia to patients in the operating room, and her husband is also a health care worker. They’ve suffered sleepless nights worrying about how to keep their two young children safe and schooled at home. The small but vocal chorus of people who view face coverings as a violation of their rights makes it all worse, she said.

That resistance to the public health advice didn’t grow in a vacuum. Health care workers blame political leadership at all levels, from President Donald Trump on down, for issuing confusing and contradictory messages.

“Our leaders have not been pushing that this is something really serious,” said Jewell Harris Jordan, a 47-year-old registered nurse at the Kaiser Permanente Oakland Medical Center in Oakland, California. She’s distraught that some Americans see mandates for face coverings as an infringement upon their rights instead of a show of solidarity with health care workers.

“If you come into the hospital and you’re sick, I’m going to take care of you,” Jordan said. “But damn, you would think you would want to try to protect the people that are trying to keep you safe.”

Mixed Messages

In Orange County, where Patel works, mask orders are particularly controversial. The county’s chief health officer, Dr. Nichole Quick, resigned June 8 after being threatened for requiring residents to wear them in public. Three days later, county officials rescinded the requirement. On June 18, a few days after Patel visited the restaurant, Gov. Gavin Newsom issued a statewide mandate.

Meanwhile, cases and hospitalizations continue to rise in Orange County.

The county’s flip-flop illustrates the national conflict over masks. When the coronavirus outbreak emerged in February, officials from the U.S. Centers for Disease Control and Prevention discouraged the public from buying masks, which were needed by health care workers. It wasn’t until April that federal officials began advising most everyone to wear cloth face coverings in public.

One recent study showed that masks can reduce the risk of coronavirus infection, especially in combination with physical distancing. Another study linked policies in 15 states and Washington, D.C., mandating community use of face coverings with a decline in the daily COVID-19 growth rate and estimated that as many as 450,000 cases had been prevented as of May 22.

But the use of masks has become politicized. Trump’s inconsistency and nonchalance about them sowed doubt in the minds of millions who respect him, said Jordan, the Oakland nurse. That has led to “very disheartening and really disrespectful” rejection of masks.

“They truly should have just made masks mandatory throughout the country, period,” said Jordan, 47. Out of fear of infecting her family with the virus, she hasn’t flown to see her mother or two adult children on the East Coast during the pandemic, Jordan said.

But a mandate doesn’t necessarily mean authorities have the ability or will to enforce it. In California, where the governor left enforcement up to local governments, some sheriff’s departments have said it would be inappropriate to penalize mask violations.

This has prompted some health care workers to make personal appeals to the public.

After the Fresno County Sheriff-Coroner’s Office announced it didn’t have the resources to enforce Newsom’s mandate, Amy Arlund, a 45-year-old nurse at the COVID unit at the Kaiser Permanente Fresno Medical Center, took to her Facebook account to plead with friends and family about the need to wear masks.

“You better pray that all the nurses aren’t already out sick or dead because people chose not to wear a mask. Please tell me my life is worth a LITTLE of your discomfort?”

— Amy Arlund, Nurse

“If I’m wrong, you wore a silly mask and you didn’t like it,” she posted on June 23. “If I’m right and you don’t wear a mask, you better pray that all the nurses aren’t already out sick or dead because people chose not to wear a mask. Please tell me my life is worth a LITTLE of your discomfort?”

To protect her family, Arlund lives in a “zone” of her house that no other member may enter. When she must interact with her 9-year-old daughter to help her with school assignments, they each wear masks and sit 3 feet apart.

Mask Shaming

Every negative interaction about masks stings in the light of her family’s sacrifices, said Arlund. She cites a woman who approached her husband at a local hardware store to say he looked “ridiculous” in the N95 mask he was wearing.

“It’s like mask-shaming, and we’re shaming in the wrong direction,” Arlund said. “He does it to protect you, you cranky hag!”

After seeing a Facebook comment alleging that face masks can cause low oxygen levels, Dr. Megan Hall decided to publish a small experiment. Hall, a pediatrician at the Conway Medical Center in Myrtle Beach, South Carolina, wore different kinds of medical masks for five minutes and then took photos of her oxygen saturation levels, as measured by her pulse oximeter. As she predicted, there was no appreciable difference in oxygen levels. She posted the photo collection on June 22, and it quickly went viral.

“Some of our officials and leaders have not taken the best precautions,” said Hall, who hopes for “a change of heart” about masks among local officials and the public. South Carolina Gov. Henry McMaster has urged residents to wear face coverings in public, but he said a statewide mandate was unenforceable.

In Florida, where Gov. Ron DeSantis has resisted calls for a statewide order on masks despite a massive surge of COVID-19 cases and hospitalizations, Cynthia Butler, 62, recently asked a young man at the register of a pet store why he wasn’t wearing a mask.

“His tone was more like, this whole mask thing is ridiculous,” said Butler, a registered nurse at Fawcett Memorial Hospital in Port Charlotte. She didn’t tell him that she had just recovered from a COVID-19 infection contracted at work. The exchange saddened her, but she hasn’t the time to lecture everyone she encounters without a mask — about three-quarters of her community, Butler estimated.

“They may think you’re stepping on their rights,” she said. “It’s not anything I want to get shot over.”

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

Gabapentinoids Ineffective for Pain Relief After Surgery

By Pat Anson, PNN Editor

Would you want to take Lyrica (pregabalin) or Neurontin (gabapentin) for pain relief after a major surgery? Both drugs belong to a class of nerve medication called gabapentinoids that are increasingly being prescribed to patients perioperatively (after surgery) as an alternative to opioid medication.

But gabapentinoids also have risks and there is little evidence to support their use for postoperative pain relief, according to a large new study by a team of Canadian researchers.  

“No clinically significant analgesic effect for the perioperative use of gabapentinoids was observed. There was also no effect on the prevention of postoperative chronic pain and a greater risk of adverse events. These results do not support the routine use of pregabalin or gabapentin for the management of postoperative pain in adult patients,” wrote lead author Michael Verret, MD, a resident at Laval University in Quebec City.  

Verret and his colleagues conducted a meta-analysis of 281 clinical trials involving nearly 25,000 patients undergoing a wide range of surgeries, including orthopedic, spinal and abdominal operations.

Their findings, recently published in the journal Anesthesiology, indicate that the analgesic benefits of pregabalin and gabapentin after surgery are negligible, regardless of the dose or type of operation. Gabapentinoids were also ineffective in preventing chronic pain from developing after surgery, one of the primary justifications for using the drugs postoperatively.

“Gabapentinoids were also associated with a greater incidence of adverse events, namely dizziness and visual disturbance, while other major adverse events such as respiratory depression and addiction are not reported or are underreported,” said Verret.

The findings contradict guidelines published by the American Pain Society (APS) in 2016,  which advocate “around the clock” use of gabapentin, pregabalin and other nonopioid drugs both before and after surgery.

“The panel recommends use of gabapentin or pregabalin as part of a multimodal regimen in patients who undergo surgery. Both medications are associated with reduced opioid requirements after major or minor surgical procedures, and some studies reported lower postoperative pain scores,” the APS guideline states.

“The panel suggests that clinicians consider a preoperative dose of gabapentin or pregabalin, particularly in patients who undergo major surgery or other surgeries associated with substantial pain, or as part of multimodal therapy for highly opioid-tolerant patients.”

‘Evidence of Harm’

Although opioid addiction is relatively rare after surgery, dozens of U.S. hospitals followed the lead of the APS and other medical guidelines by stopping the use of opioids for certain surgeries.

Cleveland Clinic Akron General Hospital, for example, adopted a policy of only using gabapentin and other non-opioid analgesics for colorectal operations.

“It is now clear that over the past two decades, evidence of benefit from routine perioperative administration of gabapentinoids has diminished, while evidence of harm has increased.”

— Dr. Evan Kharasch

Critics say gabapentinoids have become a trendy alternative for post-surgical pain relief, even though evidence supporting their use is minimal.

“It is now clear that over the past two decades, evidence of benefit from routine perioperative administration of gabapentinoids has diminished, while evidence of harm has increased. If any potential benefits exist in ‘special populations,’ published reports have yet to identify the benefits or the populations,” lead author Evan Kharasch, MD, Editor-in-Chief of Anesthesiology, wrote in an editorial.

“The good intentions that led to routine gabapentinoid use should be redirected to lead the way out. The French Society of Anesthesia and Intensive Care Medicine now states that gabapentinoids should not be used systematically or in outpatient surgery. Other societies should follow. As the weight of evidence has shifted and the risk–benefit balance tilted away from benefit, evidence-based practice impels revising if not eliminating the routine use of perioperative gabapentinoids in adults.”

It's too late for the APS to change its guideline. The organization filed for bankruptcy in 2019, ironically because of the high cost of legal fees in defending itself against opioid litigation.

While the CDC’s controversial opioid guideline does not advocate using gabapentinoids for post-surgical pain, it does recommend their use in treating chronic pain -- with little to no mention of their side effects.

One of the co-authors of the CDC guideline, Dr. Roger Chou, also played a significant role in drafting the APS guideline. Chou is currently heading much of the research being conducted by the CDC as it prepares to update and possibly expand its 2016 guideline.

VA Studying Laughing Gas as Treatment for Veterans With PTSD

By Pat Anson, PNN Editor

The U.S. Department of Veterans Affairs is sponsoring a small study to see if nitrous oxide – commonly known as laughing gas – could be used as a treatment for veterans suffering from post-traumatic stress disorder (PTSD), pain and depression.

The placebo-controlled Phase 2 study will be held at the VA Palo Alto Health Care System in California this fall. Investigators plan to recruit 104 veterans with PTSD to participate. Half would inhale a gaseous mix of nitrous oxide and oxygen, while the other half would be given a placebo.

Although PTSD is the primary focus of the study, researchers also hope to learn if nitrous oxide could be used to treat pain and other symptoms.

“Specifically, the investigators will first assess whether nitrous oxide treatment improves PTSD symptoms within 1 week. In parallel, the investigators will explore whether the treatment improves co-existing depression and pain,” researchers said. “In addition, the investigators will explore nitrous oxide's effects on a PTSD-associated impairment that is often overlooked - disruption in cognitive control, a core neurobiological process critical for regulating thoughts and for successful daily functioning.”

Military veterans suffering from PTSD often experience pain, anxiety, anger and depression. About one in five veterans who served in the Iraq or Afghanistan wars developed PTSD within a year of coming home.

In a small pilot study funded by the VA, three veterans with PTSD inhaled a single one-hour dose of nitrous oxide through a face mask. Within hours, two of the patients reported a marked improvement in their symptoms. The improvement lasted one week for one patient, while the second patient's symptoms gradually returned over the week. The third patient reported an improvement two hours after his treatment, but his symptoms returned the next day.

"While small in scale, this study shows the early promise of using nitrous oxide to quickly relieve symptoms of PTSD," said anesthesiologist Peter Nagele, MD, chair of the Department of Anesthesia & Critical Care at University of Chicago Medicine and co-author of a study recently published in the Journal of Clinical Psychiatry.

Nitrous oxide is a colorless and odorless gas that is commonly used by dentists to manage pain and anxiety in patients. It was once widely used in American hospitals to relieve labor pain, but fell out of favor as more Caesarean sections were performed and women opted for epidural injections and spinal blocks.

Some hospitals are now reintroducing nitrous oxide as a safer and less invasive option. The gas makes patients less aware of their pain, but does not completely eliminate it.  Recent studies have shown that about 70% of women who receive nitrous oxide during labor wind up using another analgesic due to inadequate pain relief.

"Like many other treatments, nitrous oxide appears to be effective for some patients but not for others," explained Nagele. "Often drugs work only on a subset of patients, while others do not respond. It's our role to determine who may benefit from this treatment, and who won't."

If findings from the VA’s pilot study are replicated in further research, it may be feasible to use nitrous oxide for rapid relief from PTSD, while longer-term treatments like psychotherapy and pharmaceutical drugs are also implemented.

Study Finds Cannabis Effective for Treating Depression

By Pat Anson, PNN Editor

Consuming dried cannabis flowers significantly reduces symptoms of depression and works much faster than pharmaceutical antidepressants, according to a new study of over 1,800 cannabis consumers.

The study findings, published in the Yale Journal of Biology and Medicine, is the latest research derived from the Releaf App, a free mobile software program that collects self-reported, real-time information from people on their use of cannabis and its effect on chronic pain, depression and over two dozen other medical conditions.

This particular study excluded the use of cannabis edibles, lotions and oils, and focused solely on cannabis buds that were smoked or inhaled through a vaporizer.

Over 95% of participants in the study reported a decline in depression within hours of ingesting cannabis, with an average reduction in symptom intensity of nearly 4 points, based on a numerical zero to 10 depression scale.

Relief from depression did not vary by the strain of cannabis consumed, but flowers with high levels of tetrahydrocannabinol (THC) were the strongest predictors of symptom relief. THC is the main psychoactive ingredient in cannabis. Levels of cannabidiol (CBD) were generally unrelated to changes in depression.

“Almost all patients in our sample experienced symptom relief from using Cannabis to treat depression and with minimal evidence of serious side effects in the short run,” researchers reported.

“One of the most clinically relevant findings from this study was the widely experienced relief from depression within 2 hours or less. Because traditional antidepressants have times-to-effect in weeks, short-term Cannabis use might be a solution to these delays in treatment or could be used to treat acute episodes associated with suicidal behavior and other forms of violence.”

Prescription drugs used to treat depression include sedatives such as benzodiazepines and antidepressants such as selective serotonin-reuptake inhibitors and tricyclics, as well as anticonvulsant medicines. Most normally take several weeks or months to cause significant relief and have potential side effects such as sedation and suicidal thoughts. Benzodiazepines have become particularly difficult for many pain patients to obtain if they are also prescribed opioid medication.

Medical marijuana is legal in 33 U.S. states and Washington, DC, but depression is not generally recognized as an approved condition under state-regulated medical marijuana programs.

“With no end to the depression epidemic in site, and given the limitations and potential severe negative side effects of conventional antidepressant medications, there is a real need for people to be able to treat mood disturbances with natural, safe, and effective medications, and cannabis checks off all three boxes,” co-author Jacob Vigil, PhD, a University of New Mexico psychology professor, told Forbes.

An earlier study by Vigil using data from the Releaf App found that cannabis flowers rich in THC reduced pain levels an average of three points on a 0 to 10 pain score. Those who ingested cannabidiol (CBD) did not experience similar pain relief.

Another study derived from ReLeaf App data found that cannabis can provide relief from a wide range of symptoms associated with chronic pain, including insomnia, seizures, anxiety and fatigue.

A significant weakness of these studies is that they rely on cannabis users to subjectively self-report their symptoms outside of a clinical setting. There is also no control group or way to measure the quality or quantity of the cannabis they are ingesting.   

A Painful Privilege: Your Right to Protest

By Mia Maysack, PNN Columnist

I used to think I maintained a pretty solid grasp on the concept of being hurt. But being confronted by prejudice and oppression has broadened my horizons regarding what else pain can and really does mean.  

Recently PNN published a column by Dr. Lynn Webster that highlighted an interesting point regarding pain sufferers and our experiences with prejudice in the healthcare system. Not that the Black Lives Matter movement is about us, but there is much we can learn from it. For example, how protesting in numbers gets the sort of attention that could actually drive real change.  

The fact is pain patients are often mistreated, but the discrimination minority patients face is deeper and far greater.  This isn't intended to lessen or take away from anyone's experience, but to keep things in proper perspective -- which we’re in need of now more than ever.

After attending a Headache on the Hill lobbying event in early February, I self-quarantined for months due to my health and in consideration for the health of others. But when George Floyd died, it was a last straw that drove me out despite the potential for consequences.  

It's understandable that not everyone is able to venture out in the ways that I have, and I'm grateful to have done this work to the extent that my ailments allow. But a simple fact remains at the bottom of any civil rights moverment:  there is always something that can be done. It is simply a matter of following through on doing it.  

Traveling to a place like Washington D.C. to lobby for better migraine care or even just to the state capitol in my own city for a BLM protest takes just about everything I've got out of me. I held my fists up for so long, I still cannot lift my arms. But the work has to be done by somebody.

So instead of complaining and contributing to the very stigma we attempt to escape, why don’t we show up and support each other in ways that we can?  

Being immunocompromised was mentioned at a recent protest I attended. Someone stood up to speak on behalf of another person who couldn't be there. I respected that. It was a way for that person's voice to still be heard regardless of the fact they weren't there to speak. It was a beautiful example of how we're still able to contribute meaningfully despite our limitations. 

The same is true for any cause. There are always options, such as donating to those you can trust your dollars with, contacting your elected representatives, making a call, sending a letter or signing a petition. At the very least, aim to recognize and release any privilege or ego.   

You don't need to have a different shade of skin to ask for justice.  At a recent protest, a black woman spoke so much wisdom. One of the things she said was, “Women are the most oppressed among us all.”

We need to recognize that when any of us is held back or down in any way, it impacts us all. When someone's life or rights are threatened, it's only a matter of time before the same thing could be done to you or someone you care about.  

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

Study Finds Microdosing THC Reduces Pain Levels

By Pat Anson, PNN Editor

Very low doses of inhaled THC – the psychoactive ingredient in cannabis – can significantly reduce pain levels in chronic pain patients, according to a small study conducted in Israel.

The concept of “microdosing” cannabis isn’t new, but this was the first clinical study to demonstrate its effectiveness in temporarily relieving pain. The study was sponsored by Syqe Medical, an Israeli medical technology company that makes an inhaler designed to deliver microdoses of cannabis and other drugs.

The study involved 27 patients living with neuropathy, radiculopathy, phantom limb pain or Complex Regional Pain Syndrome (CRPS), who self-reported pain levels of at least 6 on a zero to 10 pain scale. Participants were randomly assigned to three groups that inhaled either a placebo or two different microdoses of THC.  

The most effective dose to relieve pain was just 500 micrograms of THC, inhaled 3-4 times per day. Participants reported a 2 to 3 point reduction in their pain levels for 150 minutes.  

A typical cannabis patient might consume 150,000 micrograms of THC per day – about 75 times more than the highest dose used in the study. Researchers say their findings, published in the European Journal of Pain, suggest that pain patients can benefit from dramatically lower doses.

"We can conclude from the study results that low doses of cannabis may provide desirable effects while avoiding cognitive debilitations, significantly contributing to daily functioning, quality of life, and safety of the patient,” said lead researcher Elon Eisenberg, PhD, Director of the Multidisciplinary Pain Relief Unit at Rambam Health Care Campus in northern Israel.

“The doses given in this study, being so low, mandate very high precision in the treatment modality. This precision is unique to the Syqe drug delivery technology, enabling cannabis dosing at pharmaceutical standards."

There were side effects from inhaling microdoses of THC. About 20% of patients reported feeling “high” or experienced dizziness, sleepiness, nausea, cough or dry mouth. But researchers said there was “no evidence of consistent impairment” in any of the participants.

The risk of impairment from THC is one reason researchers and cannabis companies have largely focused on the medical benefits of cannabidiol (CBD), a compound also found in marijuana. CBD is not psychoactive, while THC can make people impaired – at least in high doses.

"This study is the first to show that human sensitivity to THC is significantly greater than previously assumed, indicating that if we can treat patients with much higher precision, lower quantities of drug will be needed, resulting in fewer side effects and an overall more effective treatment,” said Perry Davidson, CEO of Syqe Medical.

“The Syqe drug delivery technology is also applicable to opioids and other compounds that, while potentially effective, are notoriously associated with dangerous side effects. The introduction of a tool to prescribe medications at such low doses with such high resolution may allow us to achieve treatment outcomes that previously were not possible."

In addition to cannabis, the company is also exploring the use of its inhaler to deliver other drugs for treating pain, sleep, anxiety and cancer. The Syqe inhaler is sold in Israel by Teva Pharmaceuticals. Approval is also being sought to begin sales in Europe, Canada and Australia. Syqe is planning to submit a medical device application to the Food and Drug Administration in the United States.

A Pained Life: The Language Barrier

By Carol Levy, PNN Columnist

Many years ago, I was in Brazil. I only spoke “pigeon” Portuguese. I walked into a diner, looked at a menu and saw something that looked good.

The counterman came over. I thought I said, “I would like the egg sandwich.” But I must have said something bizarre, because he walked away, twirling his finger by his ear and said, “Ella es loco.” She's crazy.

“No, no. Yo soy Americano,” I said. I am American.

Suddenly all eleven customers in the diner crowded around me asking, “Voce quiero que?” What do you want?

They figured it out and ordered for me. We continued to “talk” using hand signals and some of my “Portuguese.”

That memory reminds me of an episode of the TV show “Scrubs” in which a doctor asks his patient, “What level is your pain?”

The patient makes a face, mouth turned down, eyes almost crossed, forehead scrunched up. The doctor looks at a pain scale chart, the one that has faces going from “I’m okay” to “My pain is horrid.” The man's expression matches the face that shows he’s really hurting. “Ah. Your pain is severe,” the doctor says.

In both instances, the language gap is breached.

Things would be so much easier for us if this was how it worked between doctors and patients; having a communal experience in understanding our pain.

So many different pain scales are out there, all essentially the same: 0 = no pain and 10 = the worst pain imaginable.

I think adjectives express it better than numbers or faces, but using words like stabbing, aching, pulling and torture may actually harm us. “Torture” to me means horrendous pain, but to a doctor it may sound like exaggeration or hysteria. To me, “twinge” means painful, but to a doctor it may be pain that is not that bad and can be dismissed.

My recent brain implant made my pain much worse. I have never been good about talking about my pain. I rarely mention it, the level or how it feels. My doctors know what it is, they know from my history the effect it has had on my life. They know I am housebound for 80% of the time in an effort not to make the pain worse.

I called my neurosurgeon and used words he has never heard me speak, “I can’t take it anymore. It is almost unbearable. Please, take it out.”

Despite the pandemic and the ban on elective surgery, he scheduled the implant removal surgery within two weeks of our call. He understood me.

Probably no other doctor would have. My pain scale is not 0 to 10. Ten is the lightning, searing, knife-like pain I got from trigeminal neuralgia. Absent that, which thankfully I no longer have, nothing can or will ever reach 10.

My pain doesn’t slide. If I don’t use my eyes, which is what triggers my pain, I can be at 0. But once I start using them, I can go from 0 to 10 in the span of a few minutes. There is no ratcheting up little by little. If I don’t stop using my eyes, I will be in trouble. The pain will be out of control.

In my 42 years of living with this pain, at no time did a doctor ask me to explain how my pain works. They ask, “What kind of pain is it? How does it feel?” and so on, but never, “Can you let me know how you rate your pain so we will be talking the same language?”

How we communicate our levels of pain is often the decisive factor in the treatments and medications offered, dosages and the kind of opioid prescribed.

But if we don’t speak the same language, how can we understand each other? How can the proffered treatments or doses be what we need?

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.”

Playing With Fire: Should I Have Cancer Surgery?

By Cynthia Toussaint, PNN Columnist

As a woman with high impact pain for 38 years, I was stunned last July to receive a triple-negative breast cancer diagnosis. Seriously, God, how much more can I endure? I felt the tumor for a year before being checked because, with Complex Regional Pain Syndrome (CRPS) and 15 co-morbidities, I didn’t think cancer treatment was an option.

It took me half a year before plunging into the impossible – and I started chemotherapy in January. With triple-negative cancer (the worst prognosis), the only prospect of living includes chemo. If I was responsive to the drugs, I believed I had a shot -- if pain didn’t destroy me first.

I’d done my shopping and found an oncologist willing to follow my integrative doctor’s advice for the best outcome with fewest side-effects. That meant lower and slower dosing, no Neulasta (a wicked drug that keeps your immune cells robust at the cost of intense bone pain), infusion breaks, supplements to ward off neuropathy, and acupuncture before each infusion.

I was also diligent about my healthy, cancer-fighting life style choices – a plant-based diet, daily intensive exercise, regular mindfulness meditation, removal of toxic people and excellent sleep hygiene.   

It worked! My oncologist’s dream goal of 18 infusions is one away from being in the books (most people stop at twelve) and I can’t stop smiling as my follow-up imaging is crystal clear.

Despite every western oncologist chiding me along the way for doing my chemo “less effectively” with complementary integrative therapies, I’ve had a clinical complete response. This is the hope of everyone with triple-negative.

Conversely, the only person I’ve met with this rare sub-set of breast cancer relied solely on western medicine – and her cancer has already metastasized to her brain. 

Hardest Decision

CYNTHIA TOUSSAINT

Now my oncologists insist on doing a “minor” surgery to sample tissue from the “tumor bed” and previously effected lymph nodes. If the tissue confirms a pathological complete response, as everyone expects, I’ll have a 90% plus chance of survival for the next 5-10 years. If they find any leftover cancer cells that will embed and begin to grow, we’ll continue treatment.

I can feel those of you with CRPS grimacing. Yes, of course, I want to avoid surgery at all cost, but this is my life, and the hardest decision I’ve ever had to make.

My track record with CRPS and surgery stinks to high hell. As a young woman, I was given an unnecessary LEEP procedure for cervical dysplasia, which I’ve since learned usually fixes itself. As a result of that minor surgery and cauterization, my CRPS spread, and subsequently I was unable to have a baby – which is one of the great tragedies of my life.

When I was 40, I was diagnosed for the first time with breast cancer and told that without surgery, chemotherapy and radiation, I had just a few months to live. I was terrified, but didn’t trust western medicine anymore.

After researching my diagnosis, ductal carcinoma in situ (DCIS), and learning that these calcifications in the milk duct almost never become invasive, I chose to “watch and wait.” Even when my mom broke down, crying and begging, “Please, Cynthia, I just want them to take the cancer out of you!” -- I didn’t budge for fear of a CRPS blow up. The calcifications never grew and to this day I warn women about the over care of DCIS.

About a decade ago, a physical therapist wanted to try to straighten my CRPS-contracted right arm. The therapy seemed far too risky, and I only relented when she promised to work exclusively on my head, neck and back. But she cheated and yanked, breaking my right arm. I was at a level ten pain again. It took a year to get an x-ray and correct diagnosis because I was labeled a “catastrophizing” patient.

The orthopedic surgeon told me that without elbow surgery I’d never use my right arm again. In the end, I didn’t trust the medical professionals who broke my arm to “fix” it. Instead, I got into my beloved YMCA swimming pool, did mirror therapy and strengthening exercises in the surrounding area – and my arm slowly regained near-full function.

Fortunately, I’ve forever had the gut instinct to pass on multiple recommendations for spinal cord stimulators and intra-thecal pumps, knowing the surgeries would do far more harm than good.

So here I am again, having to decide on surgery or not. But this time the stakes are much higher.

With the exception of one surgeon I know who understands CRPS because he’s triggered it with breast surgeries, every western doctor is consistent. They’re horrified by the prospect of me not doing the standard of care surgery to confirm or rule out a complete response. When the surgeon heard my plight, he responded with, “Cynthia, this surgery could very well destroy your life.” Damn right.

In my research to glean wisdom for this impossible decision, I’ve come upon two recent, small studies. They support the protocol of post-chemo, minimally-invasive biopsy or “watch and wait” as an effective substitute for surgery to confirm a complete response. This may be the future for treating triple-negative cancer. But in 2020, taking this unproven route would leave me with the terrible anxiety of not knowing. Worse yet, I could suffer a quick recurrence.

What fire do I play with this go around? Do I potentially reignite my CRPS or my cancer embers? All I can do is go with my gut and heart, and call in the good karma chips from the universe I’m certainly owed.

Can anyone thread the CRPS-cancer needle? I guess I’m going to find out.                              

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has had Complex Regional Pain Syndrome (CRPS) and 15 co-morbidities for nearly four decades. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.” 

FTC Takes Dim View of Light Therapy Device

By Pat Anson, PNN Editor

Low level light therapy (LLLT) – also known as “laser therapy” – has been touted for years as a treatment for arthritis, neck and back pain, fibromyalgia, neuropathy and even spinal cord injuries.

But in the first case of its kind, the Federal Trade Commission is going to court to get the makers of a light therapy device called the Willow Curve to stop making deceptive claims that it can treat chronic pain.

“When LLLT sellers say their devices will relieve pain, they’d better have the scientific proof to back it up,” Andrew Smith, Director of the FTC’s Bureau of Consumer Protection, said in a statement. “People looking for drug-free pain relief deserve truthful information about these products.”

In a complaint filed in federal court against the inventors and marketers of the Willow Curve, the FTC alleges that Dr. Ronald Shapiro and David Sutton “personally made deceptive claims about the health benefits” of the device and falsely claimed it was approved by the Food and Drug Administration to treat chronic pain, severe pain and inflammation.

Willow Curve is a curved plastic device that delivers low-level light and mild heat to painful areas. It’s been sold online and through retailers and healthcare professionals since 2014, most recently at a price of $799.

In a 2016 commercial, television personality Chuck Woolery said the Willow Curve offers “drug free pain relief for the digital age” and personally promised that “the Curve could change your life.”

Other advertisements tout Willow Curve as “clinically proven” and the “world’s first digital biosensory, biotherapeutic laser smart device” — even though there is no scientific evidence to support those claims, according to the FTC complaint.

The FTC also alleges that Shapiro and Sutton deceptively claimed Willow Curve comes with a “risk free money back” guarantee. In reality, consumers who returned the device had to pay shipping and handling costs, and often did not receive a refund at all or had to wait more than a year to get their money back.

The settlement imposes a $22 million judgment against the defendants, which will be partially suspended if Shapiro and Sutton each pay $200,000. It also asks the judge to issue a permanent injunction to prevent future false advertising of the Willow Curve. The complaint was filed in the U.S. District Court for the Eastern District of Michigan.

White Privilege and People in Pain

By Dr. Lynn Webster, PNN Columnist

I am a beneficiary of white privilege. That doesn't mean I was born into money. On the contrary, I grew up in a poor, uneducated family in a rural community. I felt the world looked down on my family because of our socio-economic circumstances.

As a child, I feared I would never escape poverty or its stigma. The system seemed to favor those with money and education. Yet I was able to climb out of poverty because of a supportive family.

In retrospect, I believe the opportunities that opened up to me were due to more than family support. Although I had good grades in college, my acceptance to medical school may have been due, in part, to where I grew up.

The medical school to which I applied hoped to increase the number of family physicians willing to set up practices in rural communities. Their strategy was to choose students who had grown up in rural areas, assuming they would be likely to return to those communities to practice medicine.

I was never aware of a similar strategy for enticing doctors to practice in inner city or other predominately African American communities. There were no African Americans in my class of 120.

Shortly before entering medical school, I was in a serious car accident. I rolled my car during a thunderstorm on the highway from Lincoln to Omaha, Nebraska. The seat belt I was wearing saved my life, but in doing so, it produced a compression fracture of a lumbar vertebra. I was in excruciating pain until the emergency room physician gave me morphine.

If I had been of a different race, would I have been treated with the same compassion? Research today suggests I probably would not have been.

Myths About Black People and Pain

For centuries, there has been a false belief that blacks could tolerate more pain than whites. In 1851, a prominent southern physician wrote in the New Orleans Medical and Surgical Journal that due to “physical peculiarities of the Negro race,” black slaves were “insensitive to pain when subject to punishment.”

Even today, a young black man who goes to the emergency room with an injury is likely to be treated differently than a young white man. For example, a 2000 Annals of Emergency Medicine article reported that in an Atlanta emergency department, 74% of white patients with bone fractures received an opioid, but only 57% of African American patients with the same condition received the same treatment.

A 2016 study in The Proceedings National Academy of Sciences reported that a significant number of University of Virginia medical students believed there was a biological difference in pain perception between blacks and whites. The study exposed myths such as the common belief that "black people’s nerve endings are less sensitive than white people’s." In fact, 40% of first- and second-year medical students in the study agreed with the statement, "Black people’s skin is thicker than white people’s."

Another way of expressing the same opinion is to say that whites are more sensitive to pain than blacks. These myths are embedded in American culture and have been fomented by institutional racism.

A more recent study found that black children with appendicitis were less likely to be prescribed an opioid for their pain than white children.

Since blacks who are in pain are regarded with greater suspicion than whites, they tend to underplay the intensity of their pain in clinical settings. They are also more inclined than their white counterparts to try to pray their pain away or to consider pain to be a personal failing.

Despite common folklore, African Americans and Hispanics are less likely than white people to abuse prescription opioids. Yet blacks of all ages usually receive less pain medication than their white counterparts. They wait longer in emergency rooms for painkillers and receive less effective pain management when in hospice care.

The disturbing belief that blacks are more tolerant of pain is a form of racism. However, ER doctors who discriminate against blacks may not be racists. Their behavior, instead, may be due to the systemic racism in our culture. The difference is this: A racist acts upon an intent to discriminate based on race or ethnicity. Racism, on the other hand, is when actions are based upon false beliefs.

As Cory Collins writes in Teaching Tolerance, "Having white privilege and recognizing it is not racist."

Racism Isn't Over

On November 4, 2008, Barack Obama was elected as the first African American president of the United States. He said, at the time, "Change has come to America," and many Americans wanted to believe it had. Many hoped the election signaled that, finally, Americans perceived blacks as equal to whites, and racists had lost their influence in this country.

However, according to the Pew Research Center, Americans’ views of racist behavior have become polarized along party and racial lines. In 2019, about 58% of all Americans believed that race relations were bad and unlikely to improve. Then came the killing of George Floyd and the subsequent protests about the racial disparity demonstrated by law enforcement.

Increased awareness of the pervasiveness of institutional racism throughout our culture may be growing, but racism is certainly not over. Research clearly shows that racism, unconscious or not, keeps people of color from getting the pain treatment they need and deserve. White medical students and health care professionals must recognize the role white privilege plays in passive but brutal discriminatory practices, and actively work to rectify and remedy them.

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

Long-Term Use of Muscle Relaxants Has Tripled

By Pat Anson, PNN Editor

Long-term use of muscle relaxants has nearly tripled in the U.S. since 2005, according to a new study by researchers at the University of Pennsylvania, who say the drugs are often prescribed inappropriately for chronic pain and to older adults.

Skeletal muscle relaxants (SMRs) like carisoprodol (Soma) and metaxalone (Skelaxin) were approved years ago for short-term treatment of muscle spasms and back pain. Researchers believe many doctors are now prescribing the drugs as an alternative to opioids for long-term pain management.

"There are few studies on the short-term efficacy and safety of skeletal muscle relaxants, and almost no data on their long-term effects, so it is very concerning that patients, and particularly older adults, are using these drugs for an extended period of time," said Charles Leonard, PharmD, an assistant professor of Epidemiology at Perelman School of Medicine. "Providers seem to be reaching for them despite incomplete information on their potential benefits and risks."

Medical guidelines generally recommend limiting the use of muscle relaxants to three weeks because they have not been shown to work for muscle spasms beyond that duration. The drugs can also have side effects such as falls, fractures, vehicle crashes, abuse and dependence. Because of those risks, muscle relaxants should be avoided altogether in elderly patients, according to the American Geriatrics Society.

To measure national trends in muscle relaxant prescribing, researchers analyzed the number of office visits that resulted in muscle relaxant prescriptions from 2015 to 2016. They found the number of new prescriptions remained stable at about 6 million per year. But office visits for renewals of muscle relaxant prescriptions tripled -- from 8.5 million in 2005 to 24.7 million in 2016.

Over two-thirds (67%) of the patients getting renewals for muscle relaxants in 2016 were also taking opioid medication, despite an FDA warning that co-prescribing the drugs could lead to respiratory depression and overdose. Older adults accounted for about one in four (22%) office visits for muscle relaxants.

"For older adults, I think the message should be to avoid using muscle relaxants, especially when we consider the side effects and increased risk of falls and fractures, and to find alternatives for pain management," said first author Samantha Soprano, MPH, a research coordinator and student in Penn's Master of Behavioral and Decision Sciences program.

In addition to potential side effects, researchers say muscle relaxants may not be any more effective in managing pain than medications like Tylenol or Advil.

"Muscle relaxants' place in therapy is really limited. Based on most guidelines, they're normally reserved as second- or third-line therapies," Leonard said. "Our findings suggest that prescribers may be reaching for these drugs sooner than that."

The findings are published in JAMA Network Open.

Overdose Deaths Are Rising Again and the Pandemic Is Making It Worse

By Roger Chriss, PNN Columnist

The nation’s overdose crisis seemed to ease a bit in 2018, when fatal drug overdoses dropped 4.1% compared to 2017. This was heralded as a turning point in the crisis, a possible light at the end of the tunnel of overdoses that rose annually for nearly three decades.

But new data from the CDC shows that 2019 saw increases that almost wiped out the drop in 2018. Although provisional, the data shows a 3% increase in overdose deaths between November 2018 and November 2019.

Overdoses are rising but the drugs are largely the same: Illicit fentanyl is involved in the vast majority of deaths, with an uptick in overdoses involving cocaine and other psychostimulants, too. Deaths involving prescription opioids and heroin both fell a little. Overdoses rose in the West, Midwest and South, while declining in New England and Mid-Atlantic states.

SOURCE: cdc

The early data for 2020 is mixed. Rhode Island’s preliminary data show a 22% increase in drug overdose deaths in the first quarter compared to the same period in 2018. Other states were doing better, at least until March.

Then came the coronavirus pandemic. State-mandated lockdowns, combined with reduced access to addiction treatment and talk therapy, along with loss of work and social support, were quickly seen as a perfect storm of risk factors for substance use problems, relapse and overdose, accidental or otherwise.

And that’s what is happening. Psych Congress reports that drug overdoses are up 16.5% nationwide from January to April 2020. Fatal overdoses rose by 11.4% during that period and nonfatal overdoses by 18.6%. This trend continued in early May, too.

The risks of the pandemic were recognized early. In March, Buzzfeed predicted that fatal overdoses were likely to increase during the pandemic because of disruption to recovery routines and access to treatment.

“The people who were getting help aren’t really getting any help right now at all,” said Danny Pont, who is part of an opioid treatment program in Rhode Island. “I suspect there will be a lot of relapses — and with a lot of relapses, there’s going to be an uptick in overdoses.”

National Public Radio also reported that treatment options are even more scarce during the pandemic, with inpatient and outpatient programs ill-equipped to operate under physical distancing rules.

All of this and more is now happening. The Well Being Trust has forecast an additional 75,000 deaths from overdose, alcohol abuse and suicide resulting from the socioeconomic stress of the pandemic, so-called deaths of despair.

The American Medical Association is trying to “reignite the fight” against the opioid crisis amid Covid-19. The AMA is calling on states to adopt new federal rules for telemedicine prescribing; removing prior authorizations or step therapy for treating opioid use disorder; removing arbitrary barriers on dose, quantity, and refill requirements; and allowing harm reduction strategies.

But the federal and state response to Covid-19 is a fragmented patchwork of policies, according to The Atlantic. The country cannot even agree on whether or not the pandemic exists, let alone if people should wear masks in public or engage in social distancing. And the rapidly shifting outbreaks, hotspots and epicenters of the pandemic make what little agreement there is transitory at best.

Sadly, the American response to the pandemic echoes the response to the overdose crisis. Too little science and too much ideology muddies what should be a clearly focused public health effort. As a result, 2020 may become the worst year for the opioid overdose crisis.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.