New Drug Reduces Rheumatoid Arthritis Pain

By Pat Anson, PNN Editor

Patients with moderate to severe rheumatoid arthritis (RA) may soon have a new treatment option.

Abbvie has announced positive results from a Phase 3 clinical study of its investigational drug upadacitinib and said it would file for FDA approval later this year.

Patients taking daily doses of upadacitinib for 14 weeks showed significant improvements in physical function, quality of life, pain and morning joint stiffness when compared with patients taking methotrexate, a standard first line treatment for RA.

Patients using upadacitinib reported reductions in pain and morning stiffness and better physical function as early as two weeks after starting treatment.

The results were announced at the annual meeting of the American College of Rheumatology (ACR) in Chicago.

"Upadacitinib as a monotherapy showed significant improvements in rheumatoid arthritis patients' ability to perform daily activities and overall health-related quality of life," said Marek Honczarenko, MD, vice president of global immunology development at AbbVie. "These results show that the improvements in clinical symptoms are accompanied by improvement in outcomes important to patients. These results reinforce upadacitinib's therapeutic potential across diverse rheumatoid arthritis patient populations and its use as a monotherapy treatment option."

Upadacitinib belongs to a class of medication known as JAK inhibitors, which block enzymes that cause inflammation.  The drug is also being investigated as a treatment for psoriatic arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.

RA is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing swelling, inflammation and bone erosion. Because RA is incurable, treatments focus on suppressing the immune system to reduce inflammation and slow progression of the disease.

Many RA patients do not respond to or cannot tolerate methotrexate, a drug that was first used in chemotherapy because of its ability to stop the growth and spread of tumors. Because it also acts as an immune system inhibitor, low doses of methotrexate became a first line therapy for rheumatoid arthritis in the 1950’s.

Until the late 1990s, one in three RA patients were permanently disabled within five years of disease onset. There has been significant improvement in RA treatment for many patients who receive biologic disease modifying drugs such as Enbrel and Humira. The cost of biologic drugs can be as much as $25,000 a year and many patients can’t afford them or have insurers unwilling to pay for them.

Prenatal Use of Acetaminophen Linked to Early Puberty

By Pat Anson, PNN Editor

The daughters of women who took acetaminophen during pregnancy tend to start puberty early, according to a new study by Danish researchers.  

The study is the latest indication that prenatal use of acetaminophen – more commonly known as paracetamol outside the U.S. -- can have long term effects on children.

Researchers at Aarhus University studied health data on about 100,000 Danish women who provided detailed information about their use of acetaminophen during pregnancy.

Nearly 16,000 children born to those mothers between 2000 and 2003 were followed from the age of eleven and throughout puberty, with surveys every six months about different aspects of their development.

The study, published in the American Journal of Epidemiology, found that girls on average entered puberty between one-and-a-half and three months earlier if their mothers took the over-the-counter pain reliever for more than 12 weeks during pregnancy.

"We found a 'dose-response' correlation. That is to say, the more weeks with paracetamol during pregnancy, the earlier puberty in girls, but not in boys," says lead author Andreas Ernst, a PhD student from the Department of Public Health at Aarhus University.

"While entering puberty one-and-a-half to three months earlier may seem unimportant, when taken together with the frequent use of paracetamol during pregnancy, our findings ought to make people take notice. Our results are certainly not the decisive factor that should change current practice, but the perception of paracetamol as 'the safe and harmless choice' during pregnancy ought to be challenged."

Early puberty development increases the risk of serious diseases in adulthood, such as obesity, diabetes, cardiovascular diseases and testicular and breast cancer.

The use of acetaminophen (paracetamol) has been increasing worldwide and studies have found that over half of pregnant women in the U.S. and European Union use the pain reliever at least once during their pregnancy. It is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications.

Previous research has shown that prenatal use of acetaminophen is associated with slow language development, autism and attention deficit problems in young children.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. The FDA label for products containing acetaminophen warns about the risk of liver damage and other side effects but does not specifically warn pregnant women about using the pain reliever. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

In its 2016 opioid prescribing guidelines, the CDC recommends acetaminophen as an alternative to opioid pain medication. The guideline only briefly mentions that acetaminophen is involved in hundreds of overdose deaths annually and can cause liver problems.

The CDC guideline does warn pregnant women -- at length -- that opioids can cause birth defects, poor fetal growth, still births and neonatal opioid withdrawal syndrome.

‘Benzo Crisis’ Keeps Not Happening

By Roger Chriss, PNN Columnist

A new study published in The Journal of Clinical Psychiatry has found that the misuse and abuse of benzodiazepine is relatively rare, even though the drug is sometimes hyped as the next overdose crisis in healthcare.

Benzodiazepines – often called “benzos” -- are a class of sedative that includes Valium and Xanax. The medications are usually prescribed to treat anxiety and insomnia.

Data on over 100,000 adults in the 2015-16 National Surveys on Drug Use and Health was analyzed by researchers, who found that benzodiazepines were used by 12.5% of American adults. Of those, about 17% “misused” the drug at least once, but only 2% had what was diagnosed as a benzodiazepine use disorder.

The study found several risk factors for benzo misuse, including younger age, male gender, lower levels of education, lack of health insurance or employment, and lower income levels — factors often associated with other substance use disorders.

The National Institute on Drug Abuse (NIDA) recently reported that most misusers obtained benzodiazepines from friends or relatives, with only about 20% receiving them from their doctor.

These findings, both the statistics and the specific risks factors and usage patterns, run counter to inflammatory media headlines such as “Xanax, Valium looking like America's next drug crisis” or “Benzodiazepines: our other prescription drug epidemic.”  

Instead, benzodiazepines are better viewed as part of an ongoing problem of drug abuse and addiction that primarily occurs outside of medical care. They are a factor in many drug overdoses, partly because of increasing rates of counterfeit Xanax and Valium being contaminated with illicit fentanyl, and because overdose rates increase when benzodiazepines are combined with opioids or alcohol.

Until recently, benzodiazepines were commonly co-prescribed with opioids to chronic pain patients, a practice that is now strongly discouraged by regulators and insurers.

There are indeed risks with benzodiazepines, including not only sedation and somnolence, but also cognitive effects and worsening of psychiatric symptoms. Moreover, chronic benzodiazepine use can lead to physiologic dependence independent of any abuse or addiction, and this dependence can make tapering off benzodiazepines difficult. Benzodiazepine withdrawal syndrome is sufficiently important to merit extensive treatment in the online guide known as the Ashton Manual.

But there are also benefits in using these drugs, even for long-term therapy. For instance, REM sleep behavior disorder is a sleep disorder in which people act out vivid, unpleasant dreams with violent arm and leg movements, often harming themselves or bed partners in the process. The benzodiazepine clonazepam (Klonopin) is the traditional choice for treatment for that. 

Stiff person syndrome is a rare neurological disorder involving intense muscle spasms in the limbs and trunk. The benzodiazepine diazepam (Valium) helps reduce those muscle spasms and stiffness.

There are also intriguing novel uses for benzodiazepines as well. Some researchers are investigating low-dose benzodiazepine therapy for people with treatment-resistant obsessive-compulsive disorder (OCD). This is not the cuddly version of OCD seen in TV shows like “Monk” but crippling dysfunction that renders a person incapable of leaving their bed for days at a stretch.

Benzodiazepines need careful consideration, but not a hyped crisis. In a reference to the opioid crisis, NIDA director Nora Volkow, MD, told Opioid Watch: “As always, science should be the driver of smart policies designed to reverse the course of this crisis.”

The same wisdom should be applied to all medications.

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

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

Patients at Ohio Hospital Have Surgery Without Opioids

By Pat Anson, PNN Editor

Would you want to go through a major surgery without the use of opioid pain medication?

Patients at an Ohio hospital are getting acetaminophen, gabapentin and nonsteroidal anti-inflammatory drugs (NSAIDs) to manage their pain before and after colorectal operations – and their surgeons say the treatment results in better patient outcomes.

“Over 75 percent of our elective colorectal patients underwent surgery without requiring narcotic analgesics postoperatively, including after discharge,” says Sophia Horattas, MD, of Cleveland Clinic Akron General Hospital.  “During this time period our patient satisfaction scores improved as well as patients' perceptions of pain control.”

All eight general surgeons at Akron General adopted the non-opioid treatment protocol in 2016, applying it to patients who had elective colon operations. Prior to surgery, the patients were all educated about pain management, non-opioid analgesics, and the risks associated with opioids.

Researchers evaluated 155 of the patients and presented their findings this week at the American College of Surgeons Clinical Congress in Boston.

Overall, 83 percent (128) of the patients did not need opioid medication after their operations. Among those who did, use of opioids before surgery was often an indicator that they would want them again. Nine of the 15 patients who had prior experience with opioids used them again after surgery.

Among the remaining 140 patients who did not use opioids before surgery, 85 percent (119) did not need opioid medication for pain relief.

The researchers found that patients who used opioid painkillers typically spent more time in the hospital; an average of 2.7 days vs. 2.3 days for the non-narcotic group.

“Patient education played a large role in protocol compliance, and patient satisfaction improved as they were able to avoid prolonged fasting, achieve improved pain control without the side effects of narcotic analgesia, and be discharged home earlier,” said Horrattas.

For pre-emptive analgesia before surgery, patients received one dose of acetaminophen, gabapentin, and the NSAID celecoxib (Celebrex).  In the operating room, patients received a nerve block and underwent anesthesia with the non-opioid pain relievers ketamine and lidocaine.   

Surgeons at Akron General have since adopted the non-opioid protocol for other major abdominal operations, such as bariatric procedures, gynecological and genital/urinary tract procedures, and liver and gall bladder operations.

“One of the great things about our protocol is its reproducibility.  Once we developed our program, we found that it could be standardized across departments with consistently reproducible results,” said Horattas.

Akron General’s protocol is similar to guidelines adopted by the American Pain Society (APS) for postoperative pain care. The APS also encourages the use of non-opioid medications such as acetaminophen, NSAIDs, gabapentin (Neurotin) and pregabalin (Lyrica).  

Akron General gets below average ratings for patient satisifaction from Hospital Compare, a Medicare survey that asks patients about their experiences during a recent hospital stay. The hospital received only two of a possible five stars, which places it in the bottom third of hospitals nationwide. Only 68% of Akron General’s patients said they would definitely recommend the hospital.

According to Healthgrades, 3 percent of the patients died after a colorectal surgery at Akron General, which is slightly below the national average for that procedure.

Opioid Addiction Rare After Surgery

In recent years, many hospitals have shifted away from routinely giving patients opioids during and after major surgeries -- even though it is rare for patients to become chronic opioid users.

A large Canadian study found that only 0.4% of elderly patients that were prescribed opioids while recovering from a heart, lung, colon, prostate or hysterectomy operation were still using them a year after their surgeries.

Another large study published this year in the British Medical Journal found similar results. Only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Long-term opioid use after dental surgeries is also rare. A recent study published in JAMA found that only 1.3% of teens and young adults who were given opioids after wisdom teeth removal were still being prescribed opioids months after their initial prescription.

The vast majority of patients still prefer opioids and perceive them as the most effective form of pain relief after surgery. In a recent survey of over 500 adults who were scheduled to have surgery, researchers at Thomas Jefferson University Hospital in Philadelphia found that 77% expected opioids, 37% expected acetaminophen, and 18% expected a NSAID for pain relief.

"Patients often assume they will receive opioids for pain, believing they are superior, and therefore may pressure physicians to prescribe them after surgery," said lead author Nirmal Shah, DO, an anesthesia resident at Thomas Jefferson University Hospital.

"But research shows opioids often aren't necessarily more effective. Clearly, we need to provide more education to bridge that gap and help patients understand that there are many options for pain relief after surgery, including other pain medications such as acetaminophen and ibuprofen."

Childhood Abuse Raises Lupus Risk for Adult Women

By Pat Anson, PNN Editor

Women who experienced physical or emotional abuse as children have a significantly higher risk of developing lupus as adults, according to new research presented at the annual meeting of the American College of Rheumatology.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that causes inflammation in multiple organs. Most patients have times when the disease is active, followed by times when the disease is mostly quiet and in remission. Lupus is far more common in women than men.

“In prior work, exposure to stress and stress-related disorders, notably post-traumatic stress disorder, has been associated with increased risk of subsequently developing autoimmune diseases, including lupus,” said lead author Candace Feldman, MD, an Assistant Professor at Brigham and Women’s Hospital/Harvard Medical School.

“Exposure to adverse childhood experiences has specifically been associated with higher levels of inflammation, as well as with changes in immune function.”

To identify what kind of childhood trauma raises the risk of lupus, Feldman and her colleagues looked at health data for over 67,000 women participating in the Nurses’ Health Study II, an ongoing study of female nurses that began in 1989. There were 93 diagnosed cases of lupus among the women.

In detailed questionnaires, the women were asked whether and how often as children they experienced physical abuse from a family member, or yelling, screaming or insulting remarks from a family member. The women were also asked to recall incidents of sexual abuse by either adults or older children.

Researchers found that physical and emotional abuse were associated with a more than twofold greater risk of developing lupus. But the data did not reveal a statistically significant association between sexual abuse and lupus risk.

“The study’s findings suggest that the effects of exposure to physical and emotional abuse during childhood may be more far-reaching than previously appreciated,” said Feldman. “The strong association observed between childhood abuse and lupus risk suggests the need for further research to understand biological and behavioral changes triggered by stress combined with other environmental exposures. In addition, physicians should consider screening their patients for experiences of childhood abuse and trauma.”

This is not the first study to find an association between childhood trauma and chronic illness in adults. A recent study of 265 adults in New York City found that those who experienced more 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.

Another study found that children who witness domestic violence between their parents are significantly more likely to experience migraine headaches as adults. A large survey also found that nearly two-thirds of adults who suffer from migraines experienced emotional abuse as children.

Social Media Lowers Depression Risk for Pain Patients

By Pat Anson, PNN Editor

Seniors citizens who have chronic pain are significantly less likely to suffer from depression if they participate in an online social network, according to a new study.

Researchers at the University of Michigan reviewed the results of a 2011 survey of more than 3,400 Medicare patients aged 65 and older, in which respondents were asked about their depression, pain and social participation. About 17% of the seniors used an online social network in the previous month.

Researchers found that seniors who had chronic pain were often depressed, socially isolated and less likely to participate in activities that require face-to-face interaction.

However, online social participation appeared to buffer the impact of pain on depression. Seniors in pain who did not use an online social network were twice as likely to become depressed.

“The results suggest that for those in pain, it may be possible that online social participation can compensate for reduced offline social participation, especially where it pertains to the maintenance of mental health and well-being. This is critical because the onset of pain can often lead to a ‘downward spiral’ of social isolation and depression, resulting in adverse outcomes for the health of older adults,” wrote lead author Shannon Ang, a doctoral candidate at the U-M Department of Sociology and Institute for Social Research.

“Online social participation serves as a way to possibly arrest the development of pain toward depression through this pathway, by ensuring that older adults remain socially connected despite the presence of pain.”

Social media may also preserve cognitive function and psychological well-being in the elderly, researchers said. The findings are significant in an aging society where social isolation and loneliness are key determinants of well-being.

"Our results may be possibly extended to other forms of conditions (e.g., chronic illnesses, functional limitations) that, like pain, also restrict physical activity outside of the home," Ang said.

The survey data did not identify what types of social media – such as Facebook or Twitter – were more effective in warding off depression and social isolation.

The study was published in the Journals of Gerontology.

Pain Researchers Say Let Sleeping Dogs Lie

By Pat Anson, PNN Editor

Most people with chronic pain recognize the importance of good sleeping habits. A night spent tossing and turning can mean a day full of aches and pains.

For that reason, dog lovers are often told they shouldn’t sleep with their pet. One survey of pet owners found that over half said their dogs tend to wake them at least once during the night. Sleeping with a pet can also be unsanitary and lead to behavioral problems.   

"Typically, people who have pain also have a lot of sleep problems, so usually if they ask their healthcare provider about a pet, they're told to get the pet out of the bedroom. But that standard advice can actually be damaging," says Cary Brown, PhD, a Professor of Rehabilitation Medicine at the University of Alberta.

Brown is co-author of a small study, published in the journal of Social Sciences, in which seven chronic pain patients who slept with their dogs were asked about their pets’ impact on their sleep. Brown said the response was "overwhelmingly positive."

"They liked the physical contact with their dogs—cuddling before bed, and how it distracted them from feeling anxious about being alone at night. They felt more relaxed and safer, so they weren't anxious as they were trying to sleep," said Brown.

"A sense of relaxation and caring are emotions that release positive hormones in our bodies that will help us sleep better."

Having our pets sleep with us can also help ward off loneliness. A dog can take on a significant role for the chronically ill when friends drift away and social circles shrink.

“I’ve got my buddy and I’ve got my companion hanging out with me and I don’t get that loneliness,” one patient said.

“I always have got somebody to cuddle and make me feel loved when I am lonely and in pain and when I am trying to sleep,” said another.

Researchers say doctors need to have deeper conversations with their patients before suggesting that a pet sleep somewhere else.

"When you ask people to remove an animal they are in the habit of co-sleeping with, it could have consequences the health-care provider hasn't considered," Brown said. "For some people with chronic pain, their relationship with their pet could be the only one they have and the comfort that dog or cat produces would be lost."

For some patients, it’s also a reciprocal relationship. They try to help their dogs sleep and comfort them when they have pain.

“She [the dog] has days when she experiences lots of pain, I make myself get down on the floor at her level …. I will sit with her and talk with her and very softly, very calmly, I make a point of massaging her ever so gently,” one woman said. “I find this brings down her heart rate, she’s not in pain, the pain is starting to go down. I can physically see the changes in her and eventually she nods off to sleep.”

Although dogs have been living with people for thousands of years – and often sleeping with them – surprisingly little is known about the emotional and physical benefits of sharing a bed.

“This small study shines a light on this important and yet neglected area of research. It reveals that for these participants their dog appears to enhance their sleep in many ways. Further research is warranted to explore more fully the ways in which pet dogs influence sleep for people with chronic pain,” said Brown.

Should Roseanne Have Died From an Opioid Overdose?

By Pat Anson, PNN Editor

Roseanne Barr is the latest victim of America's opioid crisis. Or to be more precise, Roseanne Conner is.

The fictional matriarch of ABC’s cancelled “Roseanne” show was killed off in the opening episode of “The Conners” Tuesday night, with her family struggling to come to terms with her death. What was initially thought to be a fatal heart attack turns out to be an accidental overdose of prescription opioids.

TV audiences had last seen Roseanne Conner hiding her addiction to opioid painkillers while waiting for long-delayed and costly knee surgery. But that storyline ended when Roseanne Barr was fired by ABC for a racist tweet and the network had to come up with a way to explain her absence.

“We firmly decided against anything cowardly or far-fetched, anything that would make the fierce matriarch of the Conners seem pathetic or debased,” Executive Producer Bruce Helford explained in The Hollywood Reporter.

“I wanted a respectful sendoff for her, too: one that was relevant and could inspire discussion for the greater good about the American working class, whose authentic problems are often ignored by broadcast television.”

ABC

"I AIN'T DEAD BITCHES," Barr tweeted after watching the show. She followed up with a longer joint statement with her spiritual advisor, Rabbi Shmuley Boteach.

“We regret that ABC chose to cancel 'Roseanne' by killing off the Roseanne Conner character,” the statement said. "That it was done through an opioid overdose lent an unnecessary grim and morbid dimension to an otherwise happy family show.”

It was also a bit of a cliché. The popular perception that most opioid overdoses are due to prescription painkillers is now largely a myth.  According to the Centers for Disease Control and Prevention, nearly 49,000 Americans died from opioid overdoses in 2017, but over half of them were due to illicit fentanyl and heroin, not prescription opioids.

A more accurate way to depict Roseanne’s death would have been through an overdose of heroin or counterfeit painkillers laced with fentanyl. That’s how thousands of Americans are dying. Roseanne Conner could have even been driven to suicide by untreated pain. Imagine what an eye-opening show that would have been.

Instead, the Conner family discovers that Roseanne was hiding painkillers all over the house and sharing them with a group of friends, all of them struggling with pain and addiction. The show makes it appear like opioid medication is easy to obtain, something real pain patients know is no longer true.

The only thing missing from the hackneyed script was someone saying, “If only Roseanne had tried yoga and taken Tylenol, she’d still be alive!”

Executive producer Bruce Rasmussen told Variety last week they thought carefully about how to end Roseanne's character. "You don't want to be flip about how you do this," said Rasmussen.

But that’s exactly how it came across to some PNN readers.

“The media can't seem to get the other side of the story out, nor can they print the truth about exactly how many deaths are the result of PRESCRIPTION opiates,” wrote Stephen Johnston.  “Now millions of folks will be watching as more gas is poured onto the fire. That same fire that's burning up what's left of people like myself and millions of others for whom opiate pain medications are the only relief from whatever traumatic accident or terrible malady has befallen them.”

“It was bad enough when they made pain meds a focus of the rebooted show when the first episode of the show's return aired. Now we have the added stigma, as intractable pain people, of them choosing to have Roseanne die from opioid misuse,” said Jack.

“Don't give the writers, actors, producer, the network hacks, etc., anything that isn't OTC when they have occasion to need pain relief — chronic or acute. Tylenol 3's would be much too generous, as many of us don't even get those.”

You can watch the first episode of “The Conners” by clicking here.

UK and Canada Legalizing Cannabis

By Pat Anson, PNN Editor

There’s a lot of hype this week about Canada becoming the second and largest country to legalize recreational marijuana. The first was Uruguay.

But the bigger news for the pain community may be in the United Kingdom, which has some of the strictest marijuana laws in Europe. Home Secretary Sajid Javid made a surprise announcement last week that medical cannabis products would be rescheduled on November 1 and become available by prescription to treat chronic pain, epilepsy and chemotherapy-induced nausea.

Javid agreed to review the scheduling of medical cannabis in June, after a public outcry over the seizure of CBD oil flown into Heathrow Airport for a 12-year old boy who has epilepsy. Although the oil primarily contained cannabidiol – the non-psychoactive ingredient in marijuana – it was still technically illegal under UK drug laws.

“I stressed the importance of acting swiftly to ensure that where medically appropriate, these products could be available to be prescribed to patients,” Javid said in a statement.

“I have been clear that this should be achieved at the earliest opportunity whilst ensuring that the appropriate safeguards were in place to minimise the risks of misuse and diversion.”

Javid was also clear he has no intention of supporting the legalization of recreational marijuana in the UK. Smoking cannabis in any form will also remain illegal. Even so, it was a big step forward for marijuana supporters..  

“This is a major victory for our campaign and will mean a lot of people will have a much better quality of life,” Clark French, a multiple sclerosis patient and cannabis activist, told Leafly.

“It does look that this could be the most open, accessible medical cannabis policy in Europe, if they get it right and we keep guiding them in the right directions,” said Jon Liebling of United Patients Alliance, a medical marijuana advocacy group.    

The rollout of CBD-based medicines in the UK will go slowly. It could take up to a year before the National Health Service comes up with guidelines to govern the distribution of CBD-based products. Initially, only medical specialists will be allowed to prescribe cannabis, although the guidelines are expected to eventually include general practitioners.

Activists are urging the Home Office to allow medical cannabis for all patients, not just those with pain, epilepsy or nausea.

“We do believe that everybody should have access,” said Liebling. "When you're talking about cannabis as a medicine, you really do have to compare the risks associated with cannabis that we're aware of versus the risks of those drugs that patients are already taking.” 

Legalization Worries Canadian Medical Association

Medical cannabis has been legal in Canada since 2001 and about 330,000 Canadians are registered and already have access to it.  But some health officials are less than enthused about the October 17 legalization of recreational cannabis.

"Given the known and unknown health hazards of cannabis, any increase in use of recreational cannabis after legalization, whether by adults or youth, should be viewed as a failure of this legislation," wrote Dr. Diane Kelsall, interim Editor-in-Chief, in an editorial in the Canadian Medical Association Journal.

Kelsall points to the stampede of Canadian and American companies looking to get into the cannabis industry and predicts many will brazenly advertise their products to young people.

“Cannabis companies may initially focus on attracting current consumers from black-market sources, but eventually, to maintain or increase profits, new markets will be developed as is consistent with the usual behaviour of a for-profit company. Marketing efforts may include encouraging current users to increase their use or enticing a younger demographic. The track record for tobacco producers has not been encouraging in this regard, and it is unlikely that cannabis producers will behave differently,” Kelsall warned.

Kelsall said the Canadian government needs to carefully track cannabis use and should have the courage to amend the law if problems arise.

A Pained Life: Torn Between Hope and Fear

By Carol Levy, PNN Columnist

Tonight, I feel like the character Pushmi-pullyu from Doctor Dolittle. You know, the animal that has a head at both ends; one head pulling to go to the right, the other head raring to go to the left.

I’m also feeling torn between hope and fear.

Although I have trigeminal neuralgia, which is not a headache, I am going to be admitted tomorrow to the headache inpatient unit at one of the city hospitals.

The treatment I will receive is a 24-hour a day IV lidocaine drip, for 4 to 5 days.

Many years ago, I had lidocaine infusions but they were for only 3 to 4 hours each time. I tried it a few times, a few weeks apart, but there was never any benefit. On the upside, there were also no side effects.

“doctor dolittle”

As I read the information online about getting lidocaine for a protracted period, I am getting nervous. Hallucinations? Uh oh. I don't think so. That scares me.

I already know about the potential heart risks. The doctor told me I will have to be tethered to a heart monitor the whole time as a precaution. A sudden drop or increase in blood pressure, unconsciousness and even seizures are possible.

I did not know about the potential for deep vein blood clots until I read the information the clinic sent me. I will have to wear anti-clot stockings the whole time.

There is a list of other “moderate” and “mild” side effects: a metallic taste, tinnitus (ringing in the ears), lightheadedness, agitation, drowsiness, problems focusing, slurred speech, and numbness of the mouth and tongue.

The more serious side effects worry me. Nothing happened when I tried lidocaine the other times, but maybe having it 24 hours a day for a few days in a row vs. 3 to 4 hours every few days makes a difference.

That’s where the Pushmi-pullyu comes from. I do not know if I want to do this.

This will be the first time in the last 13 hospitalizations where I will not be going in for brain surgery to treat my trigeminal neuralgia. I have to admit, there is probably an unconscious aspect of feeling as though I am allowing myself to do one more potentially really dangerous procedure, like another surgery, and I am putting that feeling of danger on the lidocaine.

On the other hand, the reason to go ahead is pure and simple. Bathing the nerves in anesthetic for 72 hours, maybe slightly longer, makes sense to me. The nerves will be numbed or at least calmed down. How can that not work?

My bags are packed. I'm ready to go.  So once again, hope wins out over fear.

Is that a good thing or bad? I won't know for a few days, but I wonder if instead of Pushmi-pullyu for those of us in pain, it should be Fearmi-hopeyu -- with the “hopeyu” being the stronger of the two.

(10/23/18 update: Carol reports the lidocaine infusion did relieve her pain for a while, but by the 3rd day, “I had some bad reactions that altered my reality perception, not what I would think of as hallucinatory but close cousin so we had to stop it.” Carol says she is very disappointed by the outcome, but it was “definitely worth the trying. And thank you to all who asked.”)

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

New Lyme Disease Test Could Lead to Earlier Treatment

By Pat Anson, PNN Editor

At long last, scientists are close to developing a new test to detect Lyme disease weeks sooner than current tests -- allowing patients to begin treatment earlier.

Lyme disease is a bacterial illness spread by ticks. Left untreated, it can lead to chronic conditions such as joint and back pain, chronic fatigue, fibromyalgia and neuropathy.

Borrelia burgdorferi was first identified as the bacteria that causes Lyme disease in 1983.  The antibody tests currently used to detect Borrelia were developed a decade later and have a number of shortcomings. They can take up to three weeks to get results and cannot distinguish between an active infection or an old one.

A team of scientists recently reported in the journal Clinical Infectious Diseases that advances in molecular diagnostics should make a new DNA test for Borrelia technically feasible.

“These direct tests are needed because you can get Lyme disease more than once, features are often non-diagnostic and the current standard FDA-approved tests cannot distinguish an active, ongoing infection from a past cured one,” said lead author Steven Schutzer, MD, a physician-scientist at Rutgers New Jersey Medical School.

“The problem is worsening because Lyme disease has increased in numbers to 300,000 per year in the United States and is spreading across the country and world.”

Early symptoms of Lyme disease include fever, chills, headaches, fatigue, muscle and joint aches, and swollen lymph nodes. A delayed rash often appears at the site of the tick bite, which resembles a ring or bulls-eye. When there is no rash, a reliable laboratory test is needed to detect an active disease.

“The new tests that directly detect the Lyme agent’s DNA are more exact and are not susceptible to the same false-positive results and uncertainties associated with current FDA-approved indirect tests,” said Schutzer.

Lyme disease is usually treated with antibiotics, but some patients experience complications that lead to Lyme disease syndrome (PTLDS), with long-term symptoms such as fatigue, muscle and joint pain and cognitive issues. Autoimmune diseases have also been associated with chronic Lyme disease.

Supplements Often Tainted by Hidden Drugs

By Pat Anson, PNN Editor

Hundreds of dietary supplements – including some marketed to relieve joint and muscle pain – are tainted with pharmaceutical drugs, according to a new study published in JAMA Network Open.  

Researchers with the California Department of Public Health looked at 746 supplements that the Food and Drug Administration found to be adulterated from 2007 to 2016. About half of the supplements remained on the market, even after the FDA found they contained potentially harmful drugs.

"The FDA didn't even bother to recall more than half of the potentially hazardous supplements," Pieter Cohen, MD, a Harvard Medical School professor told NPR. "How could it be that our premier public health agency spends the time and money to detect these hidden ingredients and then doesn't take the next obvious step, which is to ensure that they are removed from the marketplace?"

Over half of American adults take dietary supplements that contain minerals, vitamins, herbs, fish oil and other “natural” substances.  Most of the adulterated supplements were marketed for sexual enhancement, weight loss or muscle building.

Of the 14 supplements that were promoted as treatments for arthritis, muscle and joint pain, osteoporosis or other painful conditions, half contained diclofenac, a nonsteroidal anti-inflammatory drug (NSAID) and five contained dexamethasone, a steroid used to treat inflammation.

One supplement promoted as a treatment for arthritis – Pro ArthMax -- was found to contain four different NSAIDs, as well as a muscle relaxant and a non-narcotic pain reliever that was never approved for use in the United States. The manufacturer of Pro ArthMax voluntarily recalled the supplement in 2014 after being warned by the FDA.   

Cohen chided the agency for relying on voluntary recalls to get tainted supplements off the market and accused the FDA of “dereliction of duty” in a JAMA commentary. He called on Congress to change the federal law that exempts the $35 billion dollar supplement industry from pre-market safety and clinical studies that are required for pharmaceutical drugs.   

“More than FDA action will be required to ensure that all adulterated supplements are effectively and swiftly removed from the market,” Cohen wrote. “The process that the FDA is required to follow to remove supplements from the marketplace (is) cumbersome and time-consuming; nevertheless, the agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk.”

Dietary supplements that are tainted with hidden drugs may interact with other medications and raise the risk of adverse events, particularly when consumers already may be using NSAID-containing products.  

Cannabis Somewhat Effective in Treating MS

By Pat Anson, PNN Editor

Medical cannabis is mildly effective in relieving pain and other symptoms in patients with multiple sclerosis (MS), according to a new study published in JAMA Network Open.

Spanish researchers analyzed 17 clinical trials involving over 3,100 patients – one of the largest reviews to date on the efficacy of cannabinoids in treating MS. Overall, they found that cannabis was safe, but had limited effectiveness in relieving pain, muscle spasticity and bladder dysfunction.

“Small but statistically significant differences were found in favor of cannabinoids for all 3 symptoms,” Marissa Slaven, MD, and Oren Levine, MD, of Ontario’s McMaster University said in a JAMA commentary. “The authors conclude that cannabinoids provide a mild reduction in subjective outcome assessment of uncertain clinical significance and that they are safe.”

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain.

Medications and disease modifying drugs currently used to treat MS can cost tens of thousands of dollars a year – so a low-cost alternative treatment would be welcomed by many patients.

Four different medical cannabinoids were used in the 17 trials that were evaluated. They contained different levels of cannabidiol (CBD) and tetrahydrocannabinol (THC), the active ingredient in marijuana that makes people high. A lot of uncertainty remains about whether CBD or THC are more effective in relieving MS symptoms – something the JAMA study failed to resolve.

“It is critical that researchers gain a deeper understanding of both of the major (THC and CBD) and minor components of this therapy to unlock its full potential,” said Slaven.

“Given the relative safety of these agents, lack of strong evidence of other effective treatment options, and increasing access in some jurisdictions, it may seem appealing to include cannabinoids in the armamentarium of therapies for MS. But carefully conducted, high-quality studies with thought given to the biologic activity of different cannabis components are still required to inform on the benefits of cannabinoids for patients with MS.  

"The bottom line is there is certainly something happening with cannabinoids in regard to symptoms," Nicholas LaRocca, vice president of healthcare delivery and policy research at the National Multiple Sclerosis Society, told HealthDay. "In spite of very strong interest in cannabinoid therapy, we really have relatively little in terms of good research to guide us in terms of what does and what doesn't work, what works for which types of individuals, and so forth."

A small study was recently launched in Australia that might answer some of those questions. Emerald Health Pharmaceuticals of San Diego is using a synthetic version of CBD – called EHP-101 -- to treat about 100 people who suffer from MS or scleroderma, another autoimmune disease. The placebo controlled Phase I trial is meant to determine whether EHP-101 is safe and has any side effects. Results are expected next year.

A Beautiful Catastrophe

By Mia Maysack, PNN Columnist

Having lived my last 18 years with chronic migraines, I have my fair share of headache and migraine "poses." Yet I must admit, they're never as glamorous as what one can find in a fashion magazine. 

There’s a trend in the world of fashion to direct photo shoots in a way that brings attention to the structure of the model’s face or to exaggerate their make-up. They often to do this by framing a model’s face as if they’re experiencing head pain.

This has become known as the “migraine pose” or “headache pose” and they recently caused quite a stir on Instagram and Twitter among those that truly endure these ailments.

“If you don’t have migraine disease please don’t use #migrainepose,” a poster warned a makeup artist who shared some of her work.

“Wow. Talk about insensitive to true migraine sufferers. Migraines look nothing like this primped model. AWFUL,” wrote another.

“Please admit your ignorance to migraine disease and show your support by instead posting a picture for #shadesformigraine. Help teach others that diseases of any kind should not be mocked,” said another migraine sufferer.  

I don’t look like any of these models when I have a bad migraine. Ordinarily, I may be hooked up to an IV machine due to severe dehydration or I might be kneeling to the porcelain Gods attempting to combat overwhelming nausea.

There's also light and sound sensitivity, dizziness, vision disturbances, vomiting and fatigue. I describe my pain as a continuous “brain freeze” or feeling like my head was slammed against a wall.

Here are six poses that I have when I go through various stages of defeat, despair, distress, misery, grief and agony.

My most infamous pose of all? I'm nowhere to be found because I remain barricaded in a pitch black, silent room as I pray for the strength not to lose that last shred of sanity I have left and resist the urge to put an end to all of this already.

That image isn't sexy enough to sell magazines, is it? Nevertheless, that's the reality that millions of Americans are forced to live with and there is absolutely nothing pretty about it. 

When experiencing that level of discomfort, people are debilitated and focusing on any task can be impossible. To top it off, there is often no way of knowing how long an attack may last.

Then there's the heavy emotions, such as guilt for missing out on things or feeling as though we are a burden and letting others down. And there’s the frustration and anger of being sick and tired of being tired and sick.  

People who are not experienced with enduring this type of pain likely don't stop to consider these things. Although we wouldn't wish this lifestyle on anyone, there is a priceless value and basic human need in being validated, acknowledged and understood. We need a pose for that.  

Mia Maysack lives with chronic migraine, cluster headaches 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.

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

Cutting Rx Opioid Supply Is Not Stopping Diversion

By Roger Chriss, PNN Columnist

Drug diversion is an increasingly important factor in the opioid overdose crisis. A new report from Protenus found that 18.7 million pills, valued at around $164 million, were lost due to drug diversion in the United States during the first half of 2018. This represents a vast increase over 2017, when 20.9 million pills were diverted during the entire year.

As we’ve described previously, drug diversion in the supply chain is a vast, complex and old phenomenon. And it is rapidly worsening.

According to the textbook, “Prescription Drug Diversion and Pain,” drug thefts from hospitals “have increased significantly within the past decade as street prices have climbed sharply for diverted prescription opioids and benzodiazepines.”

In other words, the steep cuts in opioid production that began in 2017 aren’t working. And Attorney General Jeff Sessions was wrong when he said, "The more a drug is diverted, the more its production should be limited." A tightening supply has actually resulted in more diversion.

Drug diversion can be broadly divided into three categories: clinical diversion, personal diversion and industrial diversion. The first, according to Protenus, is drug diversion by healthcare workers. The second is the sale or transfer by a patient who received a legitimate prescription to a third party. And the third is everything else, from diversion by employees at manufacturing facilities to theft in distribution centers or pharmacies.

Personal diversion has gotten substantial attention in recent years. Prescription drug monitoring databases, pain agreements, and urine drug testing are all intended to help prevent such diversion.

Clinical drug diversion is a long-standing problem in healthcare that has garnered more interest recently. The bipartisan opioid bill recently passed by Congress includes a provision that allows hospice workers to destroy opioid medication that has expired or is no longer needed by a patient. The National Institutes of Health has also awarded a grant to further expand efforts to detect opioid and other drug theft in hospital systems.

Industrial diversion is less well known, but appears to be a longstanding problem. In the book “Dopesick,” journalist Beth Macy writes that as early as 2001 the DEA was investigating lax security standards at Purdue Pharma manufacturing plants after the arrest of two Purdue employees accused of trying to steal thousands of pills.

Between 2009 and 2012, over 63,000 thefts of opioids and other controlled substances were reported to the DEA. Pharmacies (66%) and hospitals (19%) accounted for the vast majority of those drug thefts.

And in 2007, an audit of CMS Medicare Part D payments identified 228,000 prescription payments with invalid prescriber identifications for Schedule II drugs.

In other words, tens of thousands of drug thefts and hundreds of thousands of fraudulent prescriptions are occurring annually, leading to millions of prescription pills entering the illegal market. This may help explain how OxyContin entered the black market so quickly and completely.

As Beth Macy writes: “The town pharmacist on the other line was incredulous: “Man, we only got it a month or two ago. And you’re telling me it’s already on the street?””

The National Association of Drug Diversion Investigators and the DEA Diversion Control Division are attempting to address industrial diversion. But available evidence suggests there is much more work needed to secure the entire prescription drug supply chain.

As the opioid overdose crisis continues to evolve toward poly-drug substance abuse, drug diversion will play an increasingly significant role in the illegal supply of prescription pharmaceuticals unless the entire supply chain is secured. This will require far more than the easy tasks of checking a prescription database or legislating pill counts. The hard part of reducing drug diversion remains to be done.

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

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