Pilot Study Launched of Ketamine Tablet as Pain Reliever

By Pat Anson, PNN Editor

Ketamine has become a trendy alternative treatment for pain, depression, anxiety and post-traumatic stress syndrome (PTSD). But to get it, you’ll need to get a ketamine infusion, injection or nasal spray – usually under strict medical supervision.

But someday you may be able to take a ketamine tablet at home, just like you would most other medications. A pilot study is underway at a New York City hospital to see if an oral formulation of ketamine and aspirin could be a useful treatment for pain.

“For certain patients, ketamine could be a real game changer,” says Dr. Joseph Habboushe, an emergency room physician and founder of Vitalis Pharmaceuticals. “If you look at pain management and what we have available to send patients home with, it’s really limited. We have NSAIDs. We have opiates. We have other things that sedate. It’s a fairly limited in choice.”

Ketamine is not an opioid and does not suppress respiration, making it relatively safe to use. But in high doses, it puts patients into a dissociative, dream-like state -- making it inappropriate for outpatient use.

What Habboushe and his colleagues hope to demonstrate is that a low dose of ketamine, when combined with aspirin, can be an effective and non-addictive pain reliever that can be used safely at home.

Their observational study at Maimonides Medical Center will enroll 25 patients with acute musculoskeletal pain, who will receive 0.5 mg of oral ketamine administered simultaneously with 325mg of aspirin. Pain scores and adverse events will be recorded at various intervals for up to two hours.

The study is being led by Sergey Motov, MD, an emergency room physician who is passionate about finding alternatives to opioids.

VITALIS PHARAMCEUTICALS

"The need for safe and efficacious analgesics in the emergency department and on an outpatient basis is stronger than ever," Motov said in a statement. “Taking a novel approach to orally-administered ketamine has the potential to move physicians one step closer to successfully combatting the nation's ongoing opioid crisis.”

Vitalis has developed a proprietary formulation of aspirin -- called VTS-Aspirin -- that delivers faster and stronger pain relief than traditional aspirin. Preliminary research indicates that combining VTS-Aspirin with low-dose ketamine may boost its potency.

“This is a proof-of-concept study. If we can demonstrate that ketamine will work orally, then it can be used for acute pain, maybe later chronic pain, maybe depression and all the other indications,” Habboushe told PNN. “If we can achieve that, it will be a breakthrough that will absolutely drive a lot of value to patients by reducing opiate need and reducing their pain in a very significant way. And so, it’s worth studying.”

Vitalis is also studying the use of VTS-Aspirin with fumaric acid as a treatment for multiple sclerosis that has fewer side effects. Also undergoing research is a combination of VTS-Aspirin with niacin as a treatment for high cholesterol.

Medical Cannabis Needs Better Research

By Roger Chriss, PNN Columnist

Much of the uncertainty and reluctance about using medical cannabis stems from a lack of high-quality research. Instead of randomized controlled trials, surveys and data-mining are commonly seen, leaving clinicians and policymakers with little to work with.

That is the basis for the American Medical Association’s concerns about states legalizing medical cannabis.

“Scientifically valid and well-controlled clinical trials conducted under federal investigational new drug applications are necessary to assess the safety and effectiveness of all new drugs, including potential cannabis products for medical use,” the AMA declared in a policy statement.

Good research would help reduce such concerns. Unfortunately, a lot of recent research involves poor methodology and problematic funding, weakening potentially useful results.

For example, a recent study published in the journal Cureus found that cannabis was a “useful adjunct and substitute for prescription opioids” for chronic pain patients and had the added benefit of improving their physical function and quality of life.

To conduct the study, researchers surveyed 550 patients being treated at three licensed medical cannabis clinics in the northeastern United States, using an anonymous online survey consisting of 11 questions about medication use, pain levels and side effects.

This is very problematic. A convenience sample is a simple method for quickly grabbing data. Its downsides are that it isn't random and is subject to a lot of selection bias. And anonymous surveys are unreliable. As a 2018 Australian study showed, claims of prescription opioid use by people using medical cannabis are often very inaccurate.

Similarly, an observational study at 21 medical clinics in Canada found that the “high rate of cannabis use for chronic pain and the subsequent reductions in opioid use suggest that cannabis may play a harm reduction role in the opioid overdose crisis.”

But the study was sponsored by Tilray, a Canadian cannabis firm that has provided cannabis for clinical trials and is involved in the adult recreational-use market in Canada. Drug studies sponsored by industry need to be viewed with caution, since such studies are known to produce results favorable to the sponsoring organization.

In general, studies that collect data through convenience samples or anonymously via online surveys or apps are not reliable. And studies funded by industry may be biased.

What Happened to Sue Sisley’s Study?

Good studies do get done. However, their results are not always published.

In 2019 Sue Sisley, a psychiatrist at the Scottsdale Research Institute in Phoenix, finished a study on cannabis for post-traumatic stress disorder (PTSD) that took ten years to complete, promising that “the full results of the study, including all the data, will be publicly released."

But Sisley’s research still hasn’t been published. Last year she admitted the study findings may have been compromised by the poor quality of cannabis that the DEA allows for research.

“Most scientists end up with this mishmash of different strains (including stem sticks, leaves, etc.) — all of it seems to get thrown into a grinder in an overzealous effort to standardize the study drug batches for clinical trials," Sisley said.

Research results need to be published even if they are not positive. There is a tendency to promote positive results and hide negative findings. Publication takes a lot of time and effort, and negative results may impede the flow of research dollars.

But if the benefits and risks of medical cannabis are to be better understood, we need all the results. And researchers should get full credit for their work, even if the results aren’t what advocates or enthusiasts were hoping for.

Medical cannabis needs more high-quality research. Surveys of people recruited from a medical cannabis dispensary cannot be generalized to the population at large, and studies sponsored by industry must be treated with caution. Improving medical cannabis research will go a long way toward helping people use medical cannabis safely and effectively.

Roger Chriss suffers from 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.

Finding Strength in Little Things

By Mia Maysack, PNN Columnist

It’s a New Year, but that doesn’t necessarily mean all that much to those of us who continuously hurt. We are seemingly living in a perpetual state of Bill Murray-like Groundhog Days -- experiencing the same painful occurrences over and over and over.  

Yet there are limitations to becoming accustomed to the inevitable, because the ailments themselves are ever changing and evolving, requiring us to adapt to them.  

As a result of COVID-19, millions of people who couldn't begin to imagine what it's like to be housebound all day, missing out on important gatherings and enjoyable outings, know what it’s like to have a disease threatening their physical and emotional health.  

It's a unique opportunity to bridge a gap with people who were once unable to relate to me. They learned how I've existed for years: shut-in, limited, alone, and cautious of potential harm or consequences.  

Despite the obstacles, I chose to fixate on gifts of other sorts, the “little” things such as life itself. There is always an amount of suffering that plays a role in my everyday existence, but isn’t that just how life goes in general?  

Some moments are better than others, which I am extraordinarily grateful for. Especially after having lived a majority of my years when there was no improvement, almost leading to complete hopelessness. 

If I did not greet another sunrise, it's true there would be no more discomfort. But it would also mean no more beauty either. Rain, for example, is a necessary requirement for anything to prosper. And the individual storms we all experience in unique ways are intended for personal growth. They heighten our empathy, compassion, understanding and acceptance.

Through the trauma of persistent agony, I've learned how to meet others by both respecting and honoring their journeys, despite the differences between us. Incurable and untreatable circumstances can produce a special humbleness that permits clarity in seeing each other as equals, regardless of the circumstances.  

Being faced with so much difficulty in activities of daily living is daunting to say the least. There were times when I have been swept up and consumed by all that I cannot do, hindering the possibility of investing energy and thought into what I can do. Or how to face challenges in more creative ways, as opposed to merely accepting “no” for an answer.  

Honoring my conditions has helped me to surpass them in some regards. This has assisted in strengthening an ability to fully appreciate what I'm able to accomplish, even if it's minor. Because everything we make it through is a victory in its own right.  

When reflecting upon all we've endured, there should be a tremendous amount of pride in our refusal to give up -- despite how tempting it has been and may still be at times. When we're in need of a reminder, bear witness to how far we've come and the power we have to make it through anything. Though be it far from easy, the quality of our lives is the most worthwhile investment.

Had we not been dealt the hand we received, we would not be who we are. Each of us harbors so much value to offer one another and the world through our experiences. There is always something to be learned and taught.

The treachery of pain continues to test me, but knowing I am not alone provides a sense of relief -- not that I'd wish this on anybody. I've gained a lot that I can now turn around and offer back to the world through legislative action, community involvement, public service and educational efforts. None of which would be possible without each and every twist and turn on this road we call life. 

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.

Breakthrough Medical Devices to Receive Medicare Coverage

By Pat Anson, PNN Editor

Medical device manufacturers are cheering a decision by the Centers for Medicare & Medicaid Services (CMS) to have Medicare begin covering hundreds of “Breakthrough Devices” certified by the Food and Drug Administration.

The FDA’s Breakthrough Device Program was launched in 2018 to speed up the development of innovative technology for the treatment and diagnosis of life-threatening or debilitating medical conditions such as chronic pain. But FDA approval was then followed by a lengthy and costly review process for Medicare coverage, which delayed patient access to the devices.

The Medicare Coverage of Innovative Technology (MCIT) rule change allows Medicare to begin covering breakthrough devices simultaneous to FDA approval, making them immediately available to over 60 million Medicare beneficiaries. The rule change goes into effect March 15.

“Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices,” CMS Administrator Seema Verma said in a statement. “CMS remains committed to transforming the health care delivery system through initiatives like MCIT that focus on results, removing government barriers to advancing innovations, fostering competition, and ensuring quicker access to the most advanced therapies for Medicare beneficiaries while providing them with better value and outcomes.”

The rule change benefits companies like San Francisco-based Bone Health Technologies, which announced last month that its OsteoBoost Vibration Belt had received breakthrough device approval as a treatment for osteopenia, a precursor to osteoporosis.

“We are thrilled by this announcement as it will help us get our potentially life-changing device, affordably into the hands of patients who need it much more quickly,” said Laura Yecies, CEO of Bone Health Technologies. “There is a lack of safe, effective treatments for osteopenia, a condition that effects over 40 million Americans. It is exciting that CMS is supporting the efforts of companies working to solve these important unmet needs."

Another company likely to benefit is AppliedVR, which announced in October that its virtual reality headset had received breakthrough device approval as a treatment for fibromyalgia and chronic intractable low back pain.

“This new rule change means that Medicare recipients in need of pain relief will have access to our novel chronic pain therapy,” said Josh Sackman, co-founder and president of AppliedVR, who believes Medicare reimbursements will help speed up coverage of breakthrough devices by private insurers.  

“The MCIT rule change doesn’t directly impact coverage from commercial payers. They will continue to have their own standards for evidence and require new products to follow the existing evaluation process. However, the mandatory Medicare coverage will accelerate products getting into the market, where real world evidence will be collected on the value of those Breakthrough Devices,” Sackman explained in an email to PNN. 

“This data is extremely valuable for commercial payers to assess coverage. This should have a halo effect with payers that see the benefits of a breakthrough device in their Medicare book of business and may help them choose to expand coverage to their other lines of business, including commercial plans.”

Medicare coverage of a breakthrough device will initially be limited to four years. After the coverage period is over, CMS will reevaluate the devices based on clinical evidence of their effectiveness. Importantly, the four-year window also creates a revenue stream for manufacturers to continue improving their devices or invent new ones.

California Doctor Reluctantly Agrees to Probation for Opioid Prescribing

By Pat Anson, PNN Editor

After a two-year battle with the state medical board, a northern California doctor accused of overprescribing opioid pain medication has agreed to a settlement that allows her to continue practicing while under probation for the next 35 months.

“I settled because I could not afford the legal fees to fight it further and because I was offered a deal that allowed me to continue to prescribe as I see fit, so that no one would get cut off their meds suddenly,” says Corinne (Connie) Basch, MD, a primary care physician in Arcata, a small city in rural Humboldt county.

“I was afraid if I went to a hearing and tried to appear pro se (without an attorney) and somehow pissed off the judge I might wind up with a settlement that prohibited prescribing for a year, which was their initial proposal, and that there might be preventable deaths in my patient population as a result.”

If Basch’s medical license was suspended or revoked, all 1,500 of her patients would have to find new doctors, not a simple task in a remote community where healthcare choices are already limited, especially for pain patients.

The 2019 complaint against Basch by the Medical Board of California centered on her treatment of five patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication.

Although Basch tried to taper the patients to lower doses, the complaint alleges their dosages were still excessive and placed them at risk of overdose. No allegations were made that any of Basch’s patients were harmed while under her care.

DR. CORINNE BASCH

“I have a number of people who have been absolutely unsuccessful with every attempt to taper, for whom I was afraid,” Basch wrote in an email to PNN. “I also read some old decisions, basically convictions of doctors in my region. I read how the judges made their decisions: basically going completely on the credibility of this or that expert witness, imputing expertise on state expert witnesses who had not seen any patients for multiple years. 

“It was becoming increasingly clear to me that nobody was going to actually read any of the medical literature that objects to forced tapers and so on — that this whole thing was not going to be argued on its merits, that I was going to be perceived as a defensive miscreant, not as someone bound by conscience to make a different choice.”

Under the strict terms of her settlement, which takes effect today, Basch is required to keep detailed records of all controlled substances she prescribes, which must be “available for immediate inspection and copying” by board investigators. She must also take a series of educational classes on safe prescribing and medical record keeping, and have her practice monitored by another physician throughout her probation – all at her own expense.

Basch is worried about how she will pay for it all -- her entire income last year was $50,000 – but feels obligated to her patients to keep practicing.

“I have some guilt about caving, and also some fear about whether I can actually survive the financial costs of the probation, particularly in the middle of this pandemic which has been so incredibly expensive and challenging for my practice already, but ultimately I felt that I was going to be best able to protect my patients with this choice,” she said.

“As you can tell, I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.” 

Doctors Shamed for Prescribing Opioids

The California medical board has come under fire in recent years for its controversial “Death Certificate Project,” which resulted in threats of disciplinary action against hundreds of doctors who wrote opioid prescriptions for patients who fatally overdosed, sometimes years later.

The goal was to shame doctors to reduce opioid prescribing, but a recent study found that overdose deaths actually increased in the state after the project was launched. Many of the deaths involved street drugs, not prescription opioids.

Critics say the Death Certificate Project and other enforcement actions have had a chilling effect on doctors statewide.

“I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.”

— Dr. Corinne Basch

“Through your project, you have attacked many prominent, respected physicians, publicly shaming them as careless prescribers and threatening any doctors who had ever prescribed opioid pain medications for someone who ultimately died. This ‘witch hunt’ has caused many deaths and much suffering,” Kristen Ogden and other patient advocates with Families for Intractable Pain Relief wrote in a recent letter to the medical board.

“When you consider how many California physicians have left the practice of pain care, only a small percentage of the patients harmed have managed to continue to receive pain care at all. Most have not found any pain care, and are suffering agonizing lives for no reason. A few patients we knew have committed suicide because they did not find adequate care and were unable to live with the agony of untreated severe, constant intractable pain.”

The Death Certificate Project is now under review by the medical board and has been given the less inflammatory name of “Prescription Review Program.”

Basch was not targeted under program, but believes the board’s disciplinary actions against her and other doctors have only made the opioid crisis worse.  

“I feel there is a significant parallel to the medical board claiming to ‘do something about the opioid crisis’ and in fact doing the exact wrong thing, taking stable patients off of predictable prescribed medications and throwing them out to street supply which is increasingly adulterated and hazardous. This triumph of appearance over substance is at the root of so many wrongs in our current system,” Basch said.

“I do feel that the medical board should in some way be held accountable for their own negligence, for making policies and not monitoring the outcome, for doubling down on these policies even when the error has been pointed out to them. I am not sure how to get politicians interested in the situation, because it implies understanding the situation with enough depth to see that ‘opioids – bad’ is not a well- conceived policy.”

Insurance Claims Show Lyme Disease More Widespread

By Pat Anson, PNN Editor

A new analysis of insurance claims by the Centers for Disease Control and Prevention suggests that Lyme disease may be far more widespread in the United States than current estimates.

CDC researchers looked at data from MarketScan, a large commercial insurance claims database, and found that Lyme disease diagnoses from 2010 to 2018 were six to eight times higher than the number of cases reported to a federal disease surveillance program.

Lyme disease is a bacterial illness spread by ticks. When left untreated, it can lead to chronic disorders such as fatigue, muscle and joint pain, cognitive issues and other symptoms that are often diagnosed as fibromyalgia, neuropathy and autoimmune disorders.

Most reported cases of Lyme disease occur in 14 states in the Northeast, mid-Atlantic and upper Midwest, especially during the summer months when more people spend time outdoors. Recent studies show Lyme is spreading to neighboring states and is no longer just a seasonal disease, possibly do to the effects of climate change.

The CDC analysis of insurance claims filed by nearly 23 million Americans identified over 140,000 people who were diagnosed with Lyme disease during the study period. That works out to a nationwide rate of 73 cases for every 100,000 people, a rate substantially higher than the 9 cases per 100,000 reported by the surveillance program.

“Age and sex distributions among Lyme disease diagnoses in MarketScan were similar to those of cases reported through surveillance, but proportionally more diagnoses occurred outside of peak summer months, among female enrollees, and outside high-incidence states,” wrote lead author Amy Schwartz, an epidemiologist in the CDC’s Bacterial Diseases Branch.

Schwartz and her colleagues say the larger number of Lyme cases reported by MarketScan may be the result of misdiagnoses, but the volume of claims warrant further investigation.

“Although Lyme disease diagnoses identified from claims data are not supported by the robust evidence of infection required for surveillance reporting, they are a consistent indicator of trends in the healthcare system. In addition, the sheer volume of data available through MarketScan provides potential for new insights into the epidemiology of Lyme disease diagnoses in the United States,” they said.

The CDC findings are similar to a 2017 analysis of insurance claims by the non-profit FAIR Health, which found an unexpected surge in Lyme disease cases during the winter and early spring.

Early symptoms of Lyme disease include fever, chills, headache, fatigue, muscle and joint aches, and swollen lymph nodes. A delayed rash often appears at the site of the tick bite. The rash grows in size and sometimes resembles a bulls-eye. Lyme disease is usually treated with antibiotics.

About 30,000 cases of Lyme disease are reported annually by state and local health departments to the surveillance program. The CDC acknowledges, however, that the actual number of cases is probably much higher and that about 300,000 Americans may become infected every year.

Skin Patch Reduces Pain Without Use of Drugs

By Pat Anson, PNN Editor

A drug-free skin patch that uses nanotechnology to help dial down pain levels provided significant relief to people living with arthritis, neuropathy and musculoskeletal pain, according to the results of a small study.

The Kailo pain patch contains billions of tiny nanoparticles made with copper, silver and silicon that help transmit electromagnetic signals from the nervous system. In theory, the nanoparticles act as a “bridge” over inflamed nerve pathways and restore their ability to transmit pain signals properly.

The patch is made by Utah-based Pain Relief Technologies, which claims in marketing material that its patented technology provides “natural relief anywhere on your body, in seconds.”

In the study, 66 patients wore the Kailo patch while continuing to take oral analgesic medications such as opioids and non-steroidal anti-inflammatory drugs (NSAIDs).

After 30 days, self-reported pain levels dropped significantly and 98 percent of patients said they reduced or stopped using oral medication. Their mood, sleep, walking ability, and other quality of life measures also improved.

The study findings, published in the journal Anesthesia and Pain Research, suggest that the analgesic effects of the Kailo patch are long lasting. About one in every four patients said their pain did not return after the patch was removed. Over half said it took at least a day for the pain to resume.

CLARITY SCIENCE IMAGE

“Modern science has allowed the incorporation of nanotechnology into topical patch systems, minimizing, and in the case of Kailo, eliminating the need for drugs/pharmacological agents. The interim results of this study are incredibly positive, and we look forward to providing the next phase of data that we have collected from patients with mild, moderate or severe pain,” lead investigator Jeffrey Gudin, MD, said in a statement.

Gudin was compensated by Clarity Science for conducting the study. You may recognize him from TV commercials for SalonPas, a rival pain relief patch.

An anesthesiologist by training, Gudin has become a prolific researcher, consultant and public speaker for dozens of companies involved in pain management, including Purdue Pharma, Salix, BioDelivery Sciences and Quest Diagnostics. He’s been paid over $1.5 million for his services since 2013, according to the OpenPayments database. In an email to PNN, Gudin said most of the money has been used for research and consulting on new analgesic therapies.

The Kailo patch is reusable and can be purchased without a prescription for $119. Reviews on Amazon for Kailo are mixed.

“Immediately upon placing it on my low back I could feel a warmth and my pain decreased rapidly. I was able to go to work the next day with relative comfort,” wrote one buyer who suffered pain from a hamstring injury.

“Did not reduce pain actually increased pain level,” said a disappointed user.

“Nothing else has worked for me but this significantly reduced my pain. It does not completely remove the pain, so don't expect that. But it reduced it enough that I can play with my kids, mow the lawn, work, essentially be a normal human being without medication,” said another user.

“I used it for a week, received no relief whatsoever,” wrote another buyer. “I am very dissatisfied and would like my money back.”

Topical Gel Shows Promise as Treatment for Neuropathic Pain

By Pat Anson, PNN Editor

An experimental gel developed to prevent skin damage caused by aging and ultraviolet light is showing promise as a treatment for chronic neuropathic pain, according to research underway in Australia.

The topical gel – known as RM191A – contains a copper-based compound that is absorbed by the skin and prevents the buildup of free radicals that cause skin damage associated with aging and skin cancer.

In a study recently published in the journal Redox Biology, RM191A was found to have potent antioxidant, anti-inflammatory and wound-healing properties in laboratory mice.

The gel is currently being evaluated in 24 patients at a Sydney hospital as a treatment for chronic nerve pain caused by surgery, chemotherapy, trauma and diabetes.  Results are expected later this month.

“Early sample uses of this topical formulation indicated it could be a significant in the management of certain types of chronic nerve pain,” says Llewellyn Casbolt, chief scientist and co-founder of Sydney-based RR MedSciences, which is developing the gel.

“In many ways, scientists see our discovery as a new class of anti-inflammatory that acts by the modulation of free radicals as well as reducing several inflammatory cytokines, providing a drug that can be therapeutically useful where the reduction of inflammation, as well as cellular and tissue healing - indeed pain relief - is also advantageous for a patient.”

The company plans to release an over-the-counter version of its gel in the next 12-18 months as a treatment for skin damage. It will take longer to get regulatory approval for the gel as a treatment for nerve pain and may require a prescription.

RR MedSciences (RRMS) plans to conduct further trials and is seeking additional partners and funding to accelerate the gel’s development.

“The management of pain, often related to conditions of inflammation or trauma that results in nerve or chronic pain is an area of great need.  Advancing the ability for people to modulate their pain, in a safe and effective manner that improves quality of life, is a core objective,” said Helena Libershal Casbolt, CEO and co-founder of RRMS.

A subsidiary of RRMS is currently selling a copper-based body cream called Blue Healer Care as a treatment for damaged skin and for relief from skin irritation and muscle soreness.

Mild Withdrawal Common Among Pain Patients Who Use Cannabis

By Pat Anson, PNN Editor

About 10 percent of patients who use medical cannabis to relieve chronic pain develop more severe withdrawal symptoms, according to a new study that found most patients have only mild symptoms and remain stable after long-term cannabis use.

Researchers at the University of Michigan Medical School and the VA Ann Arbor Healthcare System followed 527 Michigan residents with chronic pain for two years, asking whether they experienced any of 15 different withdrawal symptoms – such as craving, nausea, irritability and aggression - when they had gone a significant amount of time without using cannabis.

At the start of the study, most had only mild (41%) or moderate (34%) withdrawal symptoms, with 25% of the patients classified as having severe withdrawal.  Researchers say many patients were not even aware they experienced withdrawal, attributing symptoms such as fatigue and poor sleep to their underlying pain conditions, not to any dependence on cannabis.

"Some people report experiencing significant benefits from medical cannabis, but our findings suggest a real need to increase awareness about the signs of withdrawal symptoms developing to decrease the potential downsides of cannabis use, especially among those who experience severe or worsening symptoms over time," says lead author Lara Coughlin, PhD, an addiction psychologist at U-M Medical School.

After one year, about 13% of the patients experienced more withdrawal symptoms, with 8% reporting more severe symptoms after two years. People who were younger, smoked cannabis, used larger doses, and had poor mental health were more likely to have severe symptoms.

However, the vast majority of cannabis users did not experience more withdrawal symptoms, with those who reported mild symptoms likely to stay that way. About 20% of patients reported fewer symptoms after one year and 14% had fewer symptoms after two years. Older age and vaping were associated with lower odds of having severe symptoms.     

“The majority of participants remained in their initial withdrawal class throughout the 2-year study period, with the highest stability among those with mild withdrawal symptoms at baseline. Of those who transitioned to another symptom class, transitioning to milder symptoms was slightly more common than transitioning to more severe symptoms,” researchers reported in the journal Addiction.

“For the majority of patients, the current findings indicate that the severity of withdrawal symptoms are likely to remain stable over time.”

Poor sleep was the most common withdrawal symptom, followed by depressed mood, decreased appetite, craving, restlessness, anxiety and irritability. The study did not assess whether cannabis was effective for pain relief or what form of ingestion worked best.

Cannabis Not Perceived As Risky

Most Americans believe cannabis has less abuse potential than alcohol and many commonly prescribed anti-anxiety and pain medications, according to survey results recently published in the journal Addictive Behaviors.

Researchers at the University of Delaware and Michigan State University surveyed over 1,000 adults in 2019 about their views on cannabis products such as hemp, CBD, THC and marijuana. The vast majority felt cannabis products have a valid medical use and have less abuse potential than hydrocodone, oxycodone, Xanax and Valium.

source: addictive behaviors

“These results suggest that consumers perceive CBD as more like an over-the-counter pain reliever such as Tylenol or Advil and less like prescription opioids,” researchers found. “They perceive CBD and hemp as medicinal and as having little potential for abuse, making them an attractive replacement for addictive pain relievers.”

The researchers acknowledged that there is little clinical evidence to support these views, but blame the lack of studies on the federal government’s classification of marijuana as a Schedule I Controlled Substance, saying it has “severely limited research.”

A longtime critic of federal marijuana policy was not surprised by the survey findings.

“The overwhelmingly majority of Americans have long abandoned the federal government’s ‘Flat Earth’ position that marijuana is highly dangerous substance without any therapeutic efficacy,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“It is time for Congress to jettison this intellectually dishonest position as well and remove cannabis from the Controlled Substances Act in a manner similar to alcohol — thereby ending the existing state/federal conflict and permitting state governments, not the federal government, to be the primary arbiters of cannabis policy.”

Serious Complications Caused By Poorly Treated Pain

By Forest Tennant, PNN Columnist

Most anyone will tell you that blood pressure goes up due to pain. What is almost unrecognized in medical practice today, however, is that untreated or undertreated pain has such profound and devastating effects on the cardiovascular and endocrine systems that it will inevitably shorten the lifespan of individuals with intractable pain syndrome (IPS).

Constant pain elevates adrenaline and glucose at the same time that it overstimulates the autonomic nervous system, resulting in these cardiovascular (CV) complications:

• High Blood Pressure (Hypertension)               

• Elevated Pulse Rate (Tachycardia)                             

• Elevated Cholesterol (Lipids)                       

• Arteriosclerosis  

• Angina Pectoris

• Cardiac Arrythmias

• Heart Attack

• Sudden Death

The body needs a rest from constant pain to rejuvenate and re-energize the body’s CV and endocrine systems. The first goals of pain treatment must include the attainment of at least some pain free or nearly pain free hours, which enables the body to sleep and let the CV and endocrine system recuperate.

Calcium Complications

For many years, patients, families and doctors were bewildered when a chronic pain patient developed osteoporosis, scoliosis, arthritis, or even their teeth fell out. Now we know why. It is primarily because IPS causes multiple abnormalities in the endocrine system that lower calcium levels. 

Intractable pain is a huge stress that never shuts off, so it causes constant demand on the body’s glands to elevate the “Big 3” hormones: insulin, cortisol and adrenaline. This is made worse if pain is untreated or undertreated. 

Over time, the constant elevation of cortisol causes calcium to dissolve and leave the tissues of the teeth, joints and spine. Vertebrae may become so fragile with osteoporosis that the spine may collapse in places and give you scoliosis. When calcium leaves the joints, you get arthritis. People with IPS frequently have fractured hips and knee joints that have to be replaced. 

When cortisol is raised too long by constant pain, testosterone and estradiol levels may drop, and these two hormones are critical to prevent osteoporosis as they function to build bone, joints and teeth.

When cortisol is too high for too long, glucose and insulin are also raised, causing a nutritional state that may reduce vitamin D, magnesium, and other nutrients critical for tooth and bone maintenance.  

All persons with IPS and their families need to know about the cardiovascular and endocrine complications from untreated or undertreated pain. You may also need to inform your medical and dental practitioners about these health risks. Ask them to test you for high blood pressure, elevated pulse rate, high cholesterol and glucose levels. Most can easily test you for osteopenia (early osteoporosis), endocrine function and vitamin D levels.

Forest Tennant is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

The Tennant Foundation has given financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Cannabis Significantly Reduced Rx Opioid Use in Chronic Pain Patients

By Pat Anson, PNN Editor

Nearly half of chronic pain patients using medical cannabis reported significant improvement in their pain levels and most were able to reduce or stop their use of opioid pain medication, according to a large new study.

The findings, recently published in the journal Cureus, involved 550 chronic pain patients being treated at three licensed medical cannabis clinics in the northeastern United States. The study is one of the first to look at patients who were prescribed opioids for at least three months and continued to use opioids after starting cannabis therapy.

“Our results show a remarkable percentage of patients both reporting complete cessation of opioids and decreasing opioid usage by the addition of medical cannabis, with results lasting for over a year for the majority,” wrote lead author Kevin Takakuwa, MD, an emergency medicine physician affiliated with the Society of Cannabis Clinicians.

“We hypothesize these effects may be due to the reported synergistic decrease in pain that has been shown with adding cannabis to opioids. Likely, as a result, the majority expressed not wanting opioids in the future, particularly those in the younger age group.”

Pain patients enrolled in the study initially took a small amount of cannabis orally (a balanced blend of THC and CBD) and titrated to a higher dose until it had an effect.

Almost half (48%) reported a significant decrease in their pain, and most said they had improved quality of life (87%) and better physical function (80%) while using medical cannabis.

Most reported they either stopped using prescription opioids (40%) or reduced their opioid use (45%).  Nearly two thirds said they sustained the change for over a year (65%) and did not want to take opioids again (63%).  

“One reason for our impressive results may be the focused protocol employed by the study sites, which recommends a small amount of oral cannabis taken in conjunction with each opioid medication dose with small increments to titration, in a motivated patient population,” wrote Takakuwa.

“There has never been a randomized controlled human trial examining how to use medical cannabis in combination with opioids and there is no established protocol that exists. Experts disagree on how to manage opioid prescriptions in patients with chronic pain who use cannabis, and many clinicians defer to the patient or dispensary agent on decisions regarding specific cannabis products and dosages.”

But some doctors take another approach and simply get rid of patients after learning they use cannabis. It’s worth noting that nearly one in four patients (24.8%) enrolled in the study reported losing access to prescription medication or medical care as a result of their cannabis use or after testing positive for THC.

The Centers for Disease Control and Prevention specifically recommends that doctors not test for THC or dismiss patients for their cannabis use “because this could constitute patient abandonment and could have adverse consequences for patient safety” by forcing them to live with untreated pain or turn to street drugs.

Rare Disease Education: Paget’s Disease

By Barby Ingle, PNN Columnist

One of my personal missions is to educate others on the rare diseases and conditions that cause chronic pain. This year I will be posting a series of monthly articles on 12 different rare and ultra-rare conditions.

According to the National Human Genome Research Institute, a rare condition is generally considered a disease when it affects fewer than 200,000 people in the United States. Just because a person has a rare disease does not mean that they are alone. Altogether, rare disease affects up to 30 million Americans.

There are about 7,000 rare diseases, but less than 5 percent of them have an FDA approved treatment option. I have seen some great improvements over the past few years in recognizing rare diseases and in developing new treatments.  

The first condition being looked at in this series is Paget’s disease of bone. I do not know anyone with this condition personally, but I thought it was a good place to start. My hope is you will recognize some of these symptoms and can pass them on to give someone hope, help and a place to start a conversation with their health providers.

Paget’s disease causes the body to generate new bone tissue faster than normal, resulting in bones that are softer, weaker and more fragile. According to the Mayo Clinic, risk factors for Paget’s disease include being over the age of 40, male, having a family history of the condition, and being of European descent. Researchers suspect a combination of environmental and genetic factors contribute to the disease.

They test for Paget’s disease in three ways to get a diagnosis: x-rays, blood tests and bone scans. In its early stages, most people have no symptoms, so Paget’s disease is sometimes found by accident, such as when one of the tests is done for another reason and they end up with Paget’s as the final diagnosis.

Symptoms of Paget’s disease include difficulty walking, bone deformities, bone fractures, bowlegs, headaches, and joint stiffness. The chronic pain associated with Paget’s disease typically shows up first in the back, hip, legs or skull.

The pain and other symptoms worsen over time. Initially, patients often have a “pins and needles” sensation in their extremities, but the pain can become very unpleasant over time. Bone pain is typically described as extreme tenderness and aching, and is present whether you are moving or not.   

Currently there is no cure for Paget’s disease but there are some treatments that may be helpful, such as bisphosphates and dietary supplements to help strengthen bones. As with many rare and chronic diseases, early intervention is best, but a lifetime of care is important.

There are a few online support groups for patients with Paget’s disease, such as the Facebook page of the Paget's Association. You can also check out this video that helps explain the condition further.

I will be back next month to continue this series with a new rare condition.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website.  

Does Chronic Pain Lead to Hoarding?

By Pat Anson, PNN Editor

People living with chronic pain often face stigmas in their daily lives. In addition to being unfairly labeled as drug seekers, pain sufferers are often perceived as lazy malingerers who use their pain as an excuse to stay home, avoid social activities and not work.

Unfair or not, there is some truth to the notion that people in pain are less active physically – and for some that’s led to compulsive hoarding, according to a new study at the University of Florida.

Researchers surveyed over 20,000 people about their hoarding habits and identified over 2,600 cases of “hoarding disorder,” a condition characterized by difficulty in parting with possessions because of a compulsive need to save them. These extreme hoarders were more likely to have chronic pain and other potentially life-shortening medical conditions such as obesity, diabetes, heart problems, high cholesterol and sleep apnea.

On average, compulsive hoarders were about 17 pounds heavier than people without the disorder. They were also more likely to be women, less likely to have a college degree, less likely to see a doctor, and more likely to suffer falls in their home. 

“Hoarding behaviors are associated with limited activity involvement, an increased risk of falls and difficulties with self-care — all of which likely contribute to substantial functional impairment and reduced physical well-being,” lead author Sara Nutley, a data analyst at University of Florida Health, reported in the Journal of Psychiatric Research. 

Hoarding disorder is more than just collecting or being unwilling to part with a few cherished mementos. The American Psychiatric Association says compulsive hoarders save everyday items that most people consider worthless and become emotional at the thought of getting rid of them. Hoarded items are often stored haphazardly, leading to clutter that causes health and safety issues and disrupts hoarders’ lives and living space.

Hoarding not only contributes to health issues, Nutley and her colleagues say medical problems like chronic pain can lead to even more hoarding.

“First, it is possible that profound functional impairment and low levels of health care utilization contribute to the progression of medical comorbidity among individuals with hoarding disorder,” they wrote. “Second, it is possible that individuals with existing medical conditions experience increased impairment in daily self-care activities that lead to the build-up of clutter.

“Medical conditions may worsen hoarding behavior and the underlying causes of hoarding behavior may be a risk factor for both hoarding disorder and medical morbidity.”

The Mayo Clinic says the treatment of hoarding disorder is difficult because many people don’t recognize the impact of hoarding on their lives. If hoarded items are removed, people become frustrated and angry, and start collecting again. The main treatment for hoarding disorder is cognitive behavioral therapy and medications to treat anxiety and depression.  

It’s High Time to Stop the Hurt

By Leslie Bythewood, Guest Columnist

Imagine waking up one morning with the worst pain you could ever dream up.

That’s what happened to me in 2000, only it would take another seven years before my now retired doctor broke the news that I had Arnold-Chiari malformation, a rare and incurable disease that causes unrelenting head pain.

A brain MRI revealed that my skull was squeezing my brain like a sponge, putting extreme pressure on the arteries in my brain. “It herniates out,” my doctor explained.

Fortunately, he was willing to prescribe opiates and my pain was well-managed for the next decade.

But in 2017, the year I became eligible for Medicare, I learned my doctor had opted out of that federal program, forcing me to find a new primary care physician. That’s when my life suddenly took a nosedive.

For the next year, four different physicians would attempt to taper me off opiates without my consent, causing my chronic pain to escalate exponentially and inflicting all sorts of adverse side effects from the anticonvulsants and antidepressants they prescribed.

I eventually found a caring doctor who understood my pain and immediately put me back on the tried-and-true opiate treatment plan that enabled me to function.

LESLIE BYTHEWOOD

One year later that doctor was forced to abruptly surrender his DEA license without justification, preventing him from prescribing opiates to any of his patients, including me. Nevertheless, undeterred and refusing to leave his patients in the lurch, he provided a soft landing by referring all of us to new doctors, enabling me to carry out my daily activities with no pain or intolerable side effects.

Opiates are the only class of medication that work for me and millions of other Americans with intractable pain, but it’s hard for many of us to find doctors willing to prescribe them. What caused the vast majority of doctors to go running the other way with their tails tucked between their legs was the 2016 CDC opioid guideline, which encourages cautious prescribing and arbitrary 90 MME dose limits.

Almost immediately after the guideline was released, patients could no longer count on their doctor to make informed clinical decisions about whether to prescribe opiates. The CDC had driven a big fat wedge between the doctor and the patient.

Many doctors never considered the CDC guideline as voluntary and viewed it as an unbending rule that tolerates no wiggle room. They gave their patients two choices: either taper off opiates or be dismissed for good.

The truth of the matter is that only a small percentage of patients become addicted to opiates. The vast majority take their medications as prescribed and are never at risk for addiction or overdosing. And that’s exactly why, despite the fact that opioid prescribing is at a 20-year low, the number of U.S. overdose deaths continues to soar, driven by street drugs such as heroin, cocaine, illicit fentanyl and methamphetamines, not pain medication.

The blame for this lies squarely with the CDC, DEA, Department of Justice and the news media, who continue to point the finger at doctors for “overprescribing” when the real culprit is street drugs. We don’t have an “opioid epidemic” at all. What we have is a street drug overdose epidemic, plain and simple.

The harm that’s been inflicted on millions of chronic pain patients needs to be rectified by throwing out the misguided CDC guideline and leaving it to the Food and Drug Administration to publish a new set of guidelines that do not encourage arbitrary dosage limits and restore the doctor-patient relationship.

But scrapping the CDC guideline doesn’t go far enough.

We desperately need federal and state laws that protect doctors and patients from the unwarranted, overreaching scrutiny of the DEA and ensure that patients with serious and debilitating diseases get adequate care without delay. Forced tapering and leaving people to suffer in pain are not the answer.

Once and for all, the war on drugs must come to a screeching halt. Restricting legitimate patients from access to opiates is not going to end the street drug overdose epidemic.

Leslie Bythewood is a freelance writer who lives in North Carolina.

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

Opioid Prescribing Limits Failed to Reduce Overdoses in British Columbia

By Pat Anson, PNN Editor

British Columbia’s opioid guideline failed to have any significant impact on overdoses, hospital admissions or deaths in the year after it was adopted, according to new research published in CMAJ Open. The study is the latest to show that opioid prescribing limits have been misdirected and ineffective in slowing North America’s opioid crisis.

The College of Physicians and Surgeons of British Columbia released strict professional guidelines for the “safe prescribing” of opioids and sedatives in 2016, after the Canadian province was hit by a wave of overdoses and deaths. The BC guidelines, which are similar to the CDC’s opioid guideline in the United States, warn doctors to be cautious about opioid prescribing and to avoid increasing doses over 90 morphine milligram equivalents (MME) per day.

Researchers at the University of British Columbia wanted to see how effective the BC guideline was in reducing overdoses, so they analyzed health data on over 68,000 patients on long term opioid therapy. A previous study by the same research team found a “modest” reduction in opioid use in the 10 months after the guideline was introduced, as well as more tapering.

Did the reduced prescribing result in fewer overdoses?  No.

Researchers found no significant change in opioid overdose hospital admissions, opioid overdose mortality, all-cause emergency department visits, all-cause mortality, or all-cause hospital admissions after the BC guideline was adopted. They also found no evidence that pain patients turned to street drugs after their opioid prescriptions were reduced or stopped.

“Concern has been expressed that policies focused on reducing prescribing of opioid analgesics could increase opioid-related deaths if patients unable to access prescription opioids for adequate pain relief turned to street drugs and were exposed to dangerously high levels of synthetic opioids. Our study did not find evidence that the standards and guidelines had the unintended consequence of increasing opioid overdose hospital admissions or opioid overdose mortality,” wrote lead author Richard Morrow, a senior research analyst at UBC.

Critics say the lack of evidence is proof that opioid prescribing has little to do with British Columbia’s overdose crisis.   

“The results are not unexpected and demonstrate the folly of limiting opioids to pain patients in a futile attempt to deal with overdoses from illicit street drugs. The policy has created considerable pain and anxiety along with a worsening quality of life for nothing,” said Marvin Ross, a patient advocate with the Chronic Pain Association of Canada. 

British Columbia’s Coroners Office expects 2020 to be a record breaking year for overdoses in the province, with about five drug deaths every day. A recent study found that the vast majority of BC’s overdoses involved illicit fentanyl and other street drugs. Only 2.4% of the nearly 1,800 fatal overdoses in BC from 2015 to 2017 involved opioid medication alone.

Stricter opioid prescribing policies have also been ineffective in slowing the overdose crisis in the United States. Prescription opioid use in the U.S. is at its lowest level in 20 years, while more Americans are dying from overdoses than ever before.