A Painkilling Brew for Whatever ‘Ales’ You

By Steve Weakley

When anesthesiologist Admir Hadzic, MD, isn’t putting patients to sleep he’s putting them in a better mood with his Dr. Blues Belgian Brews.

Hadzic brews a potent dark beer called “PainKiller” that has 10% alcohol content, an award-winning blonde ale named “NerveBlock” that will make you comfortably numb, and a pilsner IPA called “SuperPills” that’ll make you hoppy.

References to the medicinal benefits of beer date back to the ninth century. For a short period during Prohibition, doctors even prescribed “medical beer” for patients who could no longer buy their brew legally without a prescription.

Dr. Hadzic, who was born in Yugoslavia and is a naturalized U.S. citizen, came up with the idea for medically themed malts when he married a Belgian anesthesiologist and moved to her country.

Belgium is the largest beer exporting country in Europe and Hadzic quickly fell in love with its chief export. He partnered with two local brewers to produce his own line of specialty beers.

In addition to being a practicing anesthesiologist, Hadzic is a blues bassist and has his own band, the “Big Apple Blues.” His beers actually ferment to the recorded sounds of his slide guitar.

“Since I’m a doctor and I play blues music, I’ll call it Dr. Blues Belgian Brews,” Hadzic told Pain Medicine News.

In addition to PainKiller, NerveBlock and SuperPills, Dr. Blues makes a malty “PaceMaker” beer and the non-alcoholic “Placebo” beer -- for people who like the flavor but not the buzz and can’t tell difference anyway. Placebo is so popular it’s already sold out for the year.

Dr. Blues beers are only available online and while a lot of the marketing is tongue-in-cheek, they’re also careful not to encourage excessive alcohol consumption. The website links to a recent Lancet study that found no amount of alcohol improves health, as some studies have suggested.

“DR BLUES does not promote drinking. Instead, he brews his recipes for the lucky, consenting few, who like him, insist on a unique story & experience for special occasions,” the website cautions.

Hadzic maintains a website, “Dr. Blues.com” that has fascinating factoids about his favorite beverage. You may not know that China is the world’s largest beer consuming nation or that Scotland’s “Snake Venom” is the world’s most potent beer at 67.5% alcohol.  Snake Venom is also one of the world’s most expensive brews at $67 a bottle.

If you are ever in Belgium and in need of beer, blues or anesthesia, look up Dr. Blues. He’s your one stop for the best of all three.

Living with Chronic Pain: Acceptance or Denial?

By Ann Marie Gaudon, PNN Columnist

It’s commonly understood that chronic pain not only negatively influences our physical health, but also leads to changes in our sense of self, as well as how we experience the world around us.

An interesting Swedish study set out to explore these factors. Twenty people with long-standing musculoskeletal pain were involved. Each participant completed 20 “qualitative” interviews -- which means the questions were designed to lead to descriptive answers, not hard data such as numbers or graphs on a chart.

The opening question was asked like this: “Please describe your problems. I’m thinking of the problems that made you contact a physiotherapist?”

All of the questions were focused on the participant’s perception of his or her body and were open-ended enough to encourage them to provide a narrative of their lives. After the answers were collected and analyzed, four distinct typologies emerged.

Typology A: Surrendering to one’s fate

In this typology, subjects do not oppose their pained body. They accept that their pain cannot be eliminated, so why battle against it? They are aware of their limitations and adapted accordingly.

When you accept pain, you can still engage in more important (non-pain) aspects of life. The pained body becomes more integrated with life when the person trusts their ability to cope with the unpredictability of it. Listening to signals and adapting becomes the norm. One participant described it this way:

“No, I don’t rely on my body, because I never know when the pain will come… I always have to consider how to carry things through, what I am doing, why I do it… to prevent pain afterwards. It (the body) is with me and I am the one who decides”

Typology B: Accepting by an active process of change

In contrast to Typology A, in this typology people accept pain through deliberate and active coping strategies. Attitude is adapted in the face of the new reality of living with pain, and it becomes possible to undergo positive change and go on to a richer life.

The precondition for this change is believing that the body and soul are closely linked. Participants describe a previous total lack of body awareness that changes to a life where the body becomes a wise teacher. They look to the future with optimism, while realizing it will take great effort.

The integration of the aching body into life requires a trusting and hopeful cooperation between self and body; there is trust that the body will help even when in pain. The pain puts the body in the foreground. When pain is not being fought against, it enhances both body awareness and self-awareness. One description read like this:

“…growing consciousness is the only, the only way to take control of the pain.”

Typology C: Balancing between hope and resignation

Here researchers found that major changes in life brought on by constant pain put the subject into a state of ambivalence. There is a pendulum swing back and forth between accepting and rejecting the aching body. Hope sees a way forward, but time after time despair sets in.

Integrating the aching body into life becomes problematic and the relationship with the body seems unclear at best. The subject swings from listening to the body to avoiding it.

Accepting this burdened body is necessary to move forward, yet that change is not fully realized. Pain results in feelings of fear or worry. The cause of the pain is considered complex and the subject has a tendency to ignore warning signals.  An example of this:

“My pain started because I am too slender for cleaning work, I believe. This, I think, is how my pain all began but you go on and on and don’t listen to our body until it is too late.”

Typology D: Rejecting the body

In this typology, integrating the aching body into life is impossible and rejected. The word acceptance is considered an insult or a threat. The pain is impossible to accept. The aching body is an enemy, life is unfair and unsafe, and something worse may happen. The subject has no trust in the body and nothing helps.

Living in denial like this may be beneficial for overcoming a short-term crisis, yet the costs in the long run lead to an inability to cope. A quote from one participant:

“No, no, no, I won’t do it. No, I don’t know how my body will react in different situations… it is against me”

Clinical Implications

The results from this study indicate that chronic pain patients can be found along a broad spectrum from accepting to rejecting their aching bodies. Both body awareness and body reliance seemed to be important for acceptance to take place and for life to be manageable.

Reinforcing body awareness and reliance may be a possible way forward. Your body and life may not have played out how you had anticipated, but you can still adjust to life and living with a pained body.

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

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

Pain App Lets Patients ‘Paint’ Their Pain

By Pat Anson, PNN Editor

There are dozens of mobile apps that can help chronic pain patients track their symptoms, send reports to doctors, get health tips and even keep tabs on the weather.

GeoPain, a free app recently launched by a University of Michigan startup, takes the technology a step further. Instead of just giving a single number on a pain scale of zero to 10, patients can “paint” their pain on multiple locations on a 3D image of the human body.

The app’s creators say visually mapping the pain gives doctors a better idea of the pain’s location, severity, it’s possible cause and the best way to treat it.

“We can dissect the pain with greater precision, in one patient or several, and across multiple body locations,” says Alexandre DaSilva, co-founder of MoxyTech and director of the Headache & Orofacial Pain Effort Laboratory at the U-M School of Dentistry.

“Whether the patient has a migraine, fibromyalgia or dental pain, we can measure whether a particular medication or clinical procedure is effective for each localized or spread pain condition. Geopain is a GPS for pain health care.”

Patients can also use GeoPain to show their doctors a visual recording of a pain flare long after the flare has ended.

“What patients are responding to the most is the visual tracking of their pain over time. They have shared some great stories of how they can now cleary show doctors how their pain has changed, which helps give them credibility and speeds up treatment,” Eric Maslowski, MoxyTech’s co-founder and chief technology officer, wrote in an email to PNN.

“Many clinicians like the visual nature of the app and ease of use. What was surprising to us initially was their interest in it for documenting patient visits for insurance and liability.” 

The app was initially created to track pain in patients enrolled in studies on migraine and chronic pain at the University of Michigan. Research showed that GeoPain data directly correlates with opioid activity in the brains of chronic pain patients, suggesting it might be useful in clinical trials to measure the effectiveness of pain medication.

The free app is available at Google Play, Apple’s App Store and at GeoPain.com.

The War on Drugs Is a War Against People in Pain

By Liz Ott, Guest Columnist

First, I want to say that I absolutely love my pain management doctor. He's an extremely well trained and respected doctor who really cares about his patients. I can always tell when it's not good news for me when he walks into the exam room, because it visibly hurts him to be unable to help his patients. 

I have fibromyalgia, arthritis everywhere, torn and bulging cervical vertebrae, and had a total replacement of my left knee. I haven't done the right knee yet, which I'm afraid to even think about.

Earlier this year my doctor explained that he was required to reduce my pain medications. I was shocked. He explained that new opioid prescribing guidelines were requiring patients to be reduced across the board, regardless of their condition. My pain medication was cut by a third and I wasn't happy about it at all. Especially when I've signed a pain contract, never went to any other doctors seeking meds, followed their procedures, taken drug tests, etc.

Since the weather was warm, I figured I had time to adjust to the lower dose before it started getting colder. Little did I know, this was only the beginning. 

A few months later, the doctor had the same face and the same news. I had to be reduced again. Now I'm only getting about half the Percocet and morphine I was getting before. I could barely manage my pain in cold rainy weather even with the old doses.

I've gone from being a mostly well-managed pain patient to a woman living with the very real fear of one day going in and being told that I am not going to get any pain meds. Just take some aspirin and deal with it.

In addition to the two opiates, I also take gabapentin, a muscle relaxer and Celebrex to offset the reduction in opioids. They don’t work!

LIZ OTT

I have done nothing wrong, yet I'm being treated as an addict or criminal. I’ve been seeing the same pain management specialist since 2011. They know me. I don't abuse my meds, I take them as instructed and never had anything wrong with my drug screens. And yet I'm still being punished.

I've been out of work since 2017 and just got my medical retirement approved. I wasn't able to work even at my old dose. There have been emotional issues to contend with as well, like the sudden death of my husband.

Why are politicians making healthcare decisions for patients? Don't they know that this is going to cause the exact problem that they're trying to avoid? People who have been at the same doses for years who are suddenly not getting what they need will be desperate. They're going to resort to dangerous street drugs mixed with who knows what. Or risk breaking the law and use cannabis. They have no choice.

Yes, there is an opiate epidemic. I don't disagree with that. But chronic pain patients are being treated as addicts. They're being mandated into forced reduction by politicians, not doctors.

This must be dealt with another way or the statisticians will have another number to deal with: Suicides by pain patients who are unable to get relief. We would never limit insulin to a diabetic or heart medications to someone with heart disease. But it’s okay to keep cutting pain medications because they’re dangerous?

The black market street drugs have not been reduced at all. Just the legally prescribed pain meds. The war on drugs isn't against the illegal side. The real war is against people in pain.

Liz Ott lives in Texas.

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

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

Can a Rare Moss Be Used As a Painkiller?

By Pat Anson, PNN Editor

Cannabis, kava and kratom have some competition. Swiss scientists say a rare moss-like plant could be another natural substance that can treat pain and inflammation. And it’s completely legal.

Radula perrottetii is a member of the liverwort family that only grows in Japan, New Zealand, Tasmania and Costa Rica. It produces a molecule called perrottetinene (PET) that is remarkably similar to tetrahydrocannabinol (THC), the psychoactive ingredient found in cannabis. 

"It's astonishing that only two species of plants, separated by 300 million years of evolution, produce psychoactive cannabinoids," says Jürg Gertsch, PhD, a professor in the Institute of Biochemistry and Molecular Medicine at the University of Bern.

UNIVERSITY OF BERN

A few year ago, Gertsch learned that dried samples of liverwort were being advertised on the internet as incense that produces so-called "legal highs." At the time, little was known about the pharmacological effects of PET, so Gertsch and his colleagues set out to discover how the substance works.

In studies on laboratory mice, they found that PET reaches the brain very easily and that it activates the same cannabinoid receptors that THC does. PET also has a strong anti-inflammatory effect, which makes it potentially useful as a painkiller.

Because PET produces only a mild degree of euphoria, researchers believe it has low abuse potential and fewer side effects than THC.  

Gertsch and his colleagues recently published their findings in the journal Science Advances. They plan to conduct more extensive animal testing before any clinical trials on humans. And that could take years.

In the meantime, liverwort is already being used for medicinal purposes. “Despite serious safety concerns,” WebMD says liverwort is used to treat gallstones, liver conditions, varicose veins and menopause. Others uses include “strengthening nerves” and stimulating metabolism.

Amazon and eBay advertise liverwort – not as medicine – but to help decorate terrariums and aquariums.

Pain Patients and Doctors Have Civil Rights Too

By Richard Dobson, MD, Guest Columnist

In a recent column, I described the diversion of blame for the opioid crisis as an example of “Factitious Disorder Imposed on Another,” a psychiatric condition in which a person imposes an illness on someone who is not really sick.

Recently, the U.S. Department of Justice announced a plea deal in which a former police chief in Florida pleaded guilty to violating the civil rights of innocent people by making false arrests “under color of law.” I think there are some striking parallels between the way these innocent victims were treated and the way that chronic pain patients and their doctors are treated today.

For several years, Chief Raimundo Atesiano and officers in the Biscayne Park police department conspired to arrest innocent people, falsely accusing them of committing burglaries and robberies.  The arrests were based on phony evidence and confessions, all because Atesiano wanted to show he was tough on crime and solving cases.  Several officers plead guilty to the conspiracy and were prepared to testify against Artesiano when he entered his plea.

Let’s examine the logic of this case:

1. “A” is an innocent person who has committed no crime.

2. “B” is a criminal who has burglarized homes and cars.

3. “C” is a person in authority who blames “A” for the crimes committed by “B.”

“C” has not been able to apprehend “B” and does not have any leads on how to catch him.  However, by diverting blame to “A”, “C” can claim that he has a much higher rate of solving crimes. “C” is rewarded for this illegal behavior because the citizens of Biscayne Park believe the police department is doing a much better job than it actually is.

Now change the focus to the scenario of Factitious Disease Imposed on Another to chronic pain patients and their doctors.

Just as the police in Biscayne Park were charged with using factitious evidence to arrest innocent people, regulators and law enforcement agencies like the CDC and DEA are using misleading information and overdose statistics to go after prescription opioids, when the real problem is those who misuse black market drugs.

Doctors who still treat chronic pain are also being targeted to end the legitimate medical distribution of opioid medication to patients. They are sanctioned with loss of license and some are even imprisoned for “overprescribing.”

Meanwhile, the real source of the public health problem – drug dealers, addicts and recreational users -- are largely going unpunished. It is these non-medical users that account for the vast majority of overdoses.

It was a civil rights violation for Atesiano and his officers to falsely blame innocent people while ignoring the real criminals. In similar fashion, equal justice demands that it should be a violation of the civil rights of pain patients and doctors to be factitiously blamed for the crimes of illicit substance use and drug trafficking.

“The right to be free from false arrests is fundamental to our Constitution and system of justice,” Acting Assistant Attorney General John Gore said when announcing the plea deal with Atesiano.

“Law enforcement officers who abuse their authority and deny any individual this right will be held accountable. As the Chief of Police, Defendant Atesiano was trusted by his community to lead their police officers by example; he has failed his community and the officers of Biscayne Park.”

The same standard applied to Atesiano should be applied equally to those who falsely accuse pain patients and doctors whose constitutional rights are being violated today.

Richard Dobson, MD, worked as a physician in the Rochester, New York area for over 30 years, treating and rehabilitating people suffering from chronic pain, mostly as the result of work or motor vehicle accidents.  He is now retired.  

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.

Kratom Missing From DEA Report on Drug Threats

By Pat Anson, PNN Editor

The Drug Enforcement Administration has released the 2018 National Drug Threat Assessment, the agency’s annual report on drug trafficking and drug abuse in the United States.

Over 150 pages long, the annual report paints a grim picture of a nation overwhelmed by a tsunami of illicit fentanyl, heroin, prescription opioids, meth, marijuana, cocaine and other drugs that the DEA says are having “a devastating effect on our country.”

Conspicuously absent from the report is kratom, the herbal supplement that the FDA blames for dozens of fatal overdoses and the DEA once tried to list as a dangerous controlled substance — the same substance that Ohio health officials call a “psychoactive plant” that produces a “heroin-like high.” Ohio will soon join five other states in banning the sale and possession of kratom.

But there’s not a word about kratom in the National Drug Threat Assessment. There never has been.

“It is not surprising.  Kratom is not the ‘dangerous opioid’ that the FDA has made it out to be,” says Jane Babin, PhD, a molecular biologist and consultant to the American Kratom Association, an organization of kratom vendors and consumers.  “It does not kill throngs of people like heroin and synthetic opioids. Everything we know about kratom is that people use it to avoid much more dangerous prescription and illicit opioids.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural pain reliever and stimulant. In recent years, millions of Americans have discovered kratom and use it to self-treat their chronic pain, addiction, anxiety and depression.  

As kratom has become more popular, the public health campaign against it has intensified. A small salmonella outbreak earlier this year in kratom products led to several recalls and stark warnings that “anyone consuming kratom may be placing themselves at a significant risk.”

Nearly 200 people were sickened in the outbreak, but no one died and the CDC never identified the source of the salmonella.

FDA commission Scott Gottlieb, MD, has taken to calling kratom an “opioid” (its active ingredients are alkaloids) and regularly tweets that consumers “should be aware of the mounting risks” of using the herb.

Yet there’s been no mention of kratom in the DEA’s annual assessment of drug risks in the United States.    

““Every year that goes by in which alleged ‘kratom-associated deaths’ don’t even merit a mention by DEA in this report further drives home the relative safety of kratom,” says Babin. “The only thing peculiar is that FDA refuses to acknowledge these facts.”

FDA Approves Controversial New Opioid

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved a controversial new opioid drug intended to relieve moderate to severe pain in wounded soldiers and trauma patients. 

Dsuvia is a tablet form of the potent opioid sufentanil. It was developed by AcelRx Pharmaceuticals and the Department of Defense – in part to treat battlefield wounds – but became embroiled in the national hysteria over opioid drugs and addiction.

Dsuvia was developed to fulfill an unmet need in military and civilian hospitals, where patients in acute pain are usually treated with opioids intravenously or with a pill.

Each Dsuvia tablet comes in a single dose plastic applicator. The tablet is taken sublingually under the tongue, where it quickly dissolves and is absorbed into the body.

“There is currently no way available to rapidly treat your pain without sticking you with a needle,” said Dr. Pamela Palmer, an anesthesiologist who co-founded AcelRx and is Chief Medical Officer.

ACELRX image

“If you broke your femur and are obese or elderly or on a blood thinner, that can be very painful with a lot of bruising. If you take a pill, you have to swallow it with water and wait for it to kick in, which could take up to an hour. Right now, that’s all that’s available. For the first time, we’ve developed a small tablet that goes under the tongue and dissolves in about six minutes.”

“The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds,” said FDA commissioner Scott Gottlieb, MD.

Dsuvia’s efficacy and safety were tested in two placebo-controlled studies with over 200 patients. The company said the drug was well-tolerated and effective across a range of patient ages and body sizes.

But because Dsuvia is so potent – it’s 10 times stronger than fentanyl – it drew the ire of critics who believe diversion is inevitable.

“We know from looking at other potent opioids that have been put on the market in the last four years that once these drugs get past the FDA, there’s very little, if any, control over them, no matter what the sponsor says prior to the time they come on the market,” Raeford Brown, MD, told ABC News.

Brown is chairman of the FDA advisory committee that voted 10-3 to recommend approval of Dsuvia.  Brown was not present for the vote, but called on the FDA to ignore the panel’s recommendation and stop the approval of “this dangerously unnecessary opioid medication."

“It doesn’t seem reasonable to place another potent opioid on the market at this time, especially when we’re currently still writing 200 million prescriptions for opioids a year,” said Brown.

Politicians also weighed in.

“An opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused and a thousand times more likely to kill,” said Sen. Ed Markey (D) Massachusetts. “It makes no sense to approve an opioid painkiller that has no benefits over similar medications and against the advice of experts.”

The FDA is requiring that Dsuvia not be dispensed for home use, should only be administered by a healthcare provider, and should not be used for more than 72 hours. Palmer says extra precautions would also be taken by distributors, wholesalers and hospitals to prevent theft and diversion.

“I’m not saying that drugs delivered to hospitals never get stolen or abused, but that’s a tiny sliver” of the opioid problem, she said.

Gene Therapy Eases Chronic Pain in Dogs

By Lisa Marshall, University of Colorado at Boulder

When Shane the therapy dog was hit by a Jeep, life changed for him and his guardian, Taryn Sargent.

The impact tore through the cartilage of Shane's left shoulder. Arthritis and scar tissue set in. Despite surgery, acupuncture and several medications, he transformed from a vibrant border collie who kept watch over Sargent on long walks to a fragile pet who needed extensive care.

"Sometimes he would just stop walking and I'd have to carry him home," recalls Sargent, who has epilepsy and relies on her walks with Shane to help keep her seizures under control. "It was a struggle to see him in that much pain."

Today, 10-year-old Shane's pain and reliance on medication have been dramatically reduced and he's bounding around like a puppy again, 18 months after receiving a single shot of an experimental gene-therapy invented by CU Boulder neuroscientist Linda Watkins

shane and taryn sargent (casey cass/cu boulder)

Thus far, the opioid-free, long-lasting immune modulator known as XT-150 has been tested in more than 40 Colorado dogs with impressive results and no adverse effects. With human clinical trials now underway in Australia and California, Watkins is hopeful the treatment could someday play a role in addressing the nation's chronic pain epidemic.

"I'm hoping the impact on pets, their guardians and people with chronic pain could be significant," said Watkins, who has worked more than 30 years to bring her idea to fruition. "It's been a long time coming."

The Role of Glial Cells

Watkins' journey began in the 1980s when, as a new hire in the department of psychology and neuroscience, she began to rock the boat in the field of pain research.

Conventional wisdom held that neurons were the key messengers for pain, so most medications targeted them. But Watkins proposed that then-little-understood cells called "glial cells" might be a culprit in chronic pain. Glial cells are immune cells in the brain and spinal cord that make people ache when they're sick. Most of the time, that function protects us. 

Watkins proposed that in the case of chronic pain, which can sometimes persist long after the initial injury has healed, that ancient survival circuitry somehow gets stuck in overdrive. She was greeted with skepticism.

"The whole field was like 'what on Earth is she talking about?'"

She and her students hunkered down in the lab nonetheless, ultimately discovering that activated glial cells produce specific inflammatory compounds which drive pain. They also learned that, after the initial sickness or injury fades, the cells typically produce a compound called Interleukin 10 (IL-10) to dampen the process they started.

"IL-10 is Mother Nature's anti-inflammatory," she explains. "But in the onslaught of multiple inflammatory compounds in chronic pain, IL-10's dampening cannot keep pace."

Over the years, she and her team experimented with a host of different strategies to boost IL-10. They persisted and, in 2009, Watkins co-founded Xalud Therapeutics. Their flagship technology is an injection, either into the fluid-filled space around the spinal cord or the site of an inflamed joint, that delivers circles of DNA in a sugar/saline solution to cells, instructing them to ramp up IL-10 production.

With financial help from the National Institute of Neurological Disorders and Stroke, the MayDay Fund and CU's Technology Transfer Office – which has provided intellectual property support, assistance with licensing agreements, and help obtaining a $100,000 research grant in 2018 – Watkins is edging closer to bringing her idea to clinical practice.

She has teamed up with veterinary chronic pain specialist Rob Landry, owner of the Colorado Center for Animal Pain Management in Westminster, to launch the IL-10 research study in dogs.

Their results have not been published yet. But thus far, the researchers say, the results look highly promising.

"They're happier, more engaged, more active and they're playing again," said Landry, as he knelt down to scratch Shane's belly after giving him a clean bill of health.

With Shane able to accompany her on her walks again, Sargent has also seen her quality of life improve. Her seizures, which increased in frequency when Shane was injured, have subsided again.

linda watkins with shane (casey cass/cu boulder)

Human Studies Underway

Because the treatment is so localized and prompts the body's own pain-killing response, it lacks the myriad side effects associated with opioids – including constipation and dependency – and it can last for many months after a single injection.

Ultimately, that could make it an attractive option for people with neuropathic pain or arthritis, Watkins says.

This summer, Xalud Therapeutics launched the first human study in Australia, to test the safety, tolerability and efficacy of the compound. Another one-year clinical trial of 32 patients with osteoarthritis of the knee is now underway in Napa, California.

More research is necessary in both pets and people, Watkins stresses. But she's hopeful.

"If all goes well, this could be a game-changer."

Feds Funding Study of Cannabis as Opioid Alternative

By Pat Anson, PNN Editor

Columbia University has been awarded a grant from the National Institute on Drug Abuse (NIDA) to investigate whether medical cannabis can reduce the use of opioids and overdose risk in chronic pain patients.  

The grant was awarded after researchers with Columbia Care completed a small pilot study that found nearly two-thirds of patients with chronic nerve pain were able to reduce or stop their opioid use. Columbia Care is a private medical marijuana company not affiliated with the university that operates a chain of cannabis dispensaries around the country.

“There is an urgent need to investigate the potential impact of cannabinoid use on limiting opioid overdose risk and to determine whether specific products are more beneficial for certain populations of patients with pain and opioid use,” said Arthur Robin Williams, MD, a professor in the Division on Substance Use Disorders in the Columbia University Department of Psychiatry.

The pilot study involved 76 neuropathy patients in New York State who were given Columbia Care’s dose-metered cannabis products for nine months. By the end of the study, 62 percent of the patients were able to reduce or stop using opioid pain medication.

Columbia Care makes a variety of medical cannabis products that come in tablets, tinctures, suppositories, topical formulations or can be used in vaporizers. 

“We have seen through this pilot study the power of our proprietary formulations to reduce our patients’ dependence on opioids in a defensible, scientific manner,” said Rosemary Mazanet, MD, chief science officer and chair of the scientific advisory board at Columbia Care.

DRUG POLICY ALLIANCE

Although medical marijuana is often touted as a possible solution to the nation’s opioid crisis, research findings so far have been mixed.

A recent study by the RAND Corporation found little evidence that states with medical marijuana laws see reductions in legally prescribed opioids. While some pain patients may be using or experimenting with medical marijuana, RAND researchers do not believe they represent a significant part of the opioid analgesic market.

"If anything, states that adopt medical marijuana laws... experience a relative increase in the legal distribution of prescription opioids,” researchers found.

Another study of Medicare and Medicaid patients found that prescriptions for morphine, hydrocodone and fentanyl dropped in states with medical marijuana laws, while daily doses for oxycodone increased. A second study found a 6% decline in opioid prescribing to Medicaid patients in states with medical marijuana laws.  Both studies were conducted during a period when nationwide opioid prescribing was already in decline.

A 2014 study published in JAMA Internal Medicine found that opioid overdoses declined by nearly 25 percent in states where medical marijuana was legalized.

Overdoses Soar in 2 States Despite Fewer Rx Opioids

By Pat Anson, PNN Editor

New studies from two of the states hardest hit by the opioid crisis – Massachusetts and Pennsylvania -- are throwing a damper on recent speculation that drug overdoses may have peaked.  

Researchers at Boston Medical Center released a startling study that found nearly 5 percent of people over the age of 11 in Massachusetts have an opioid use disorder.

The Drug Enforcement Administration also admitted in a Joint Intelligence Report that reducing the supply of prescription opioids in Pennsylvania failed to reduce the state’s soaring overdose rate and may have even increased demand for counterfeit painkillers. Pennsylvania had 5,456 fatal overdoses in 2017, a 65% increase from 2015.  

“Implementation of legislation influencing prescription opioid prescribing has resulted in a decrease in availability; however, a corresponding decrease in demand is less certain,” the DEA report found.

“Practitioners may be offering non-opioid alternatives to pain management to their patients, but this is most likely due to increased scrutiny of prescribing habits, as well as legislated changes, not due to requests from patients seeking non-opioid products.”

Prescription opioids were involved in only 20% of Pennsylvania’s overdoses. Most of the deaths involve a combination of illicit drugs such fentanyl, heroin, cocaine and counterfeit medication.

“The increasing presence of counterfeit opioid CPDs (controlled prescription drugs) in Pennsylvania is an indicator of strong demand for opioid CPDs in the illicit market. Traffickers use substances such as heroin, fentanyl, and tramadol to create tablets that look like the opioid CPDs most commonly purchased on the street (e.g., oxycodone 30 milligram tablets). The tablets are often exact replicas with the shape, coloring, and markings consistent with authentic prescription medications,” the report found.

The DEA said heroin and fentanyl could be found in 97% of Pennsylvania’s counties and called the city of Philadelphia a “wholesale market” for illicit drugs from China and Mexico.

Opioid Use Disorder in Massachusetts

Illicit fentanyl is also blamed for a soaring number of fatal overdoses in Massachusetts, where researchers used a new method to estimate how many people have opioid use disorder (OUD).  

Instead of relying on insurance claims for addiction treatment, researchers used a database that links information from 16 state agencies on other forms of healthcare use. Researchers were then able to identify patients who have OUD and estimate those who have the disorder but aren't seeking treatment. Individuals with substance use disorders are often less likely to seek medical care or be insured. Many are also reluctant to admit they have a drug problem.  

"There are many people with opioid use disorder who do not encounter the health care system, which we know is a barrier to understanding the true impact of the opioid epidemic," said Joshua Barocas, MD, an infectious disease physician at Boston Medical Center, who was lead author of the study published in the American Journal of Public Health.

Barocas and his colleagues found the prevalence of opioid use disorder in Massachusetts rose from 2.72% in 2011 to 4.6% in 2015. People between the ages of 11 and 25 experienced the greatest increase in OUD – a demographic much younger than a typical chronic pain sufferer, who is usually middle aged.

In 2012, Massachusetts was one of the first states where insurers and healthcare providers took steps to reduce the supply of prescription opioids – measures that have yet to have any meaningful impact on the state’s overdose rate.  

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

Massachusetts was also one of the first states to use toxicology screens from coroners and medical examiners to get a more accurate assessment of the drugs involved in overdoses.

According to the most recent report from the first quarter of 2018, nearly 90% of Massachusetts overdoses involve fentanyl, 43% percent involve cocaine, 42% involve benzodiazepines and 34% involve heroin. Prescription opioids were involved in only about 20% of the Massachusetts overdoses, the same rate as Pennsylvania.

Preliminary estimates released by the CDC last week show a modest 2.3% nationwide decline in opioid overdoses from September 2017 to March 2018. Over 48,000 people died from opioid overdoses during that period, with most of those deaths involving illicit fentanyl, heroin and other street drugs.

Social Media’s Role in the Opioid Epidemic

By Douglas and Karen Hughes, Guest Columnists

Drug epidemics since 1900 are dynamic and our hyper-information age makes ours even more pronounced. The so-called “opioid epidemic” is contingent upon socioeconomic demand and available drug supply. To fully understand it, we must look beyond opioid medication as the sole contributing factor.

Social media could be one cause that everyone has overlooked.

Overprescribing of opioids was initially the problem and it helped fill numerous medicine cabinets. Coincidentally, this occurred at about the same time as the explosion of cell phones, texting and social media, and the resultant peer-driven social narrative.

Instantaneous information exchange brought teenagers into contact with “high school druggies” — which their pre-cell phone parents knew only as a separate social group. Contact with them was taboo. Today, however, everyone is part of the larger social narrative.

Relating the euphoria of opioid use in open forums caused adolescents, who already feel indestructible, to rebel by trying them. These impressionable youth become attracted to opioids in the same way their parents were attracted to alcohol, tobacco and marijuana. This sent teens scrambling to find a free sample in grandmother’s medicine cabinet.

Many renowned physicians believe addictive personalities are actually formed by a genetic predisposition to addiction. All that is needed is some substance to abuse. Alcohol is usually the gateway drug for adolescents, the “first contact” for many teens. Forgotten opioids in a medicine cabinet only come later. Addicts will often say, “My drug use began with a prescription opioid.” But addiction experts know the battle was already lost if there was no intervention after “first contact” with drugs.

Society has long blamed overprescribing for the opioid epidemic, but the last three years have proven that to be a red herring. The mass closing of pill mills in 2015, the CDC opioid guideline in 2016, and the steep reduction in opioid production that followed in 2017 have only accelerated the epidemic. Forcing disabled intractable pain sufferers to suffer or self-medicate was not the solution.

The Centers for Disease Control and Prevention postulated that overprescribing caused the opioid epidemic because they only had clinical evidence for short term opioid therapy. Instead of opening a wider dialogue and seeking more evidence, the lack of critical long-term studies was used as an excuse to limit prescribing. Statistical manipulation of overdose deaths was used to confirm this errant policy.

This is emblematic of all investigations into our present drug problems. Society ran the fool’s errand that one blanket policy could be found for hundreds of diverse regional and local drug problems.

The opioid epidemic most likely emanated from widely accepted alcohol use and the social lure of opioids by adolescents. It has little to do with patients.

Douglas and Karen Hughes live in West Virginia. Doug is a disabled coal miner and retired environmental permit writer. Karen retired after 35 years as a high school science teacher.

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

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

Will Cannabis Change the Candy Industry?

By Crystal Lindell,  PNN Columnist

A bag of Heady Harvest CBD Gummies sold by CBD Genesis doesn’t look that much different than any other bag of gummies in the candy aisle — sleek packaging, a clear front panel to show the product and a well-designed logo. And you can find bags just like them hanging right there on the shelf in many gas stations, not too far from the energy drinks and lottery tickets.  

It’s exactly the type of packaging that’s making CBD go mainstream. In fact, the only thing that makes them any different than a regular bag of gummies is the price — $24.99 for just 20 bears.

CBD, which stands for cannabidiol, is a compound found in marijuana plants, and the product is typically sold over the counter in the form of drops, candy and other products.

“The natural compound, called cannabidiol, is one of more than 100 cannabinoids found in the cannabis plant,” says BDS Analytics. “On its own it won’t get people high. But researchers are finding more and more medical applications for CBD, and consumers and companies increasingly are exploring the compound.” 

The firm says that while the broad marijuana edibles category grew by 36 percent for much of last year in Colorado, Oregon and Washington, high-CBD edibles expanded by 110 percent. 

And high-CBD chocolates reached 217 percent growth on $11.45 million in sales, while high-CBD candy grew by 169.5 percent last year, compared to 51 percent for candy in general, according to BDS.  

Legally, it's still very much a gray area, though. 

According to recent article in the Wall Street Journal, “DEA spokesman Melvin Patterson says CBD-containing product appearing on shelves ‘is there illegally,’ but enforcement is not a priority for the agency, which is focused on the opioid crisis. In the states that have legalized cannabis use, ‘DEA is not after that. That would take a lot of manpower that DEA doesn’t have,’ he says.” 

And with the product being sold over the counter in many places, it can be confusing for consumers who think they’re buying something that’s totally above board. 

It’s that kind of murky gray area that understandably makes it hard for more mainstream candy companies to get involved in the market. But as the products grow in popularity, it’s hard to ignore their potential financial impact. 

It’s not that crazy to picture a day when Hershey, Mars or other major manufacturers are launching their own lines of CBD candy. How long that takes may only depend on how long for-profit companies want to ignore what is clearly becoming a for-profit market segment. 

This article originally appeared in Candy Industry and is republished with permission.

Crystal Lindell is a journalist who lives in Illinois. She eats too much Taco Bell, drinks too much espresso, and spends too much time looking for the perfect pink lipstick. Crystal has hypermobile Ehlers-Danlos syndrome. 

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

What Will Support Act Mean for Pain Patients?

By Pat Anson, PNN Editor

President Trump this week signed into law the Support for Patients and Communities Act, a comprehensive and mostly bipartisan legislation that combined over 70 bills passed by Congress aimed at fighting the opioid epidemic.

"Together we are going to end the scourge of drug addiction,” Trump said at a bill-signing ceremony at the White House. “Or at least make an extremely big dent in this terrible, terrible problem.”

While most of the Support Act is aimed at slowing the flow of illicit drugs and subsidizing the $35 billion dollar addiction treatment industry, there are some key elements that will affect millions of Americans who take opioids for chronic or acute pain.

Most are designed to limit access to opioid medication and further reduce the supply, which has nearly been cut in half since 2016.

The new law authorizes the Food and Drug Administration to require that some opioids be dispensed in so-called “blister packs” to limit the number of pills that can be prescribed and dispensed at one time. That type of packaging would primarily be for patients with short-term, acute pain who need only a few days’ supply. But it could also lead to a standardization of doses and make refills more difficult for patients who are slow to recover from surgery or trauma.

“The doses dispensed in the packs could be designed to align with evidence-based recommendations on what the proper dosing should be for common indications. These packs could then become the default option for more post procedure uses and could discourage physicians from prescribing long durations of use in situations where the evidence shows that short durations are clinically appropriate,” said FDA commissioner Scott Gottlieb, MD, in a statement.

“Ultimately, this approach could reduce the overall number of drugs in circulation and potentially lower the rate of new opioid addiction. It could also address the problem of excess supply, leading to fewer pills left in medicine cabinets that could be inappropriately accessed by family members, including children.”

The Support Act also gives the FDA the authority to require that opioids be dispensed with a mail-back pouch or other safe disposal options. The goal again is to get unused medications out of medicine cabinets where they could be stolen or diverted.

The new law also supports an effort recently launched by Gottlieb to develop opioid guidelines for acute pain. The guidelines won’t replace or change the CDC’s controversial guideline for chronic pain, but they will be developed with more transparency. Gottlieb has instructed the National Academies of Sciences, Engineering, and Medicine to hold a series of public meetings and to seek input from "a broad range of stakeholders" from different medical specialties. The CDC guideline was initially developed with no public hearings and with little input from pain management experts.

The Support Act also gives more authority to the FDA to require longer post-market studies on the safety and efficacy of drugs. Current evidence on the long-term use of all pain medication – not just opioids – is extremely limited. That has led to exaggerated claims from opioid critics that there is “no evidence” that opioids are safe or effective long term. Those same critics often call for greater use of non-opioid medications, such as gabapentin and pregabalin, when there is little long term evidence to support their use either.

The Support Act also calls on other federal agencies to enact measures to prevent the diversion and abuse of opioids and other controlled substances:

• All prescriptions for controlled substances covered under Medicare Part D or Medicare Advantage must be transmitted electronically starting Jan. 1, 2021.

• The Department of Health and Human Services (HHS) will develop guidelines for pharmacists to decline to fill prescriptions they think may be fraudulent or questionable.

• Medicaid programs will be required to have “safety edits” in place for opioid refills and to monitor the concurrent use of opioids with potentially risky drugs such as benzodiazepines.

• A web portal will be created to allow communication between HHS, CMS and Medicare Advantage insurers to share information about providers under investigation for inappropriate prescribing of opioids.

• HHS will develop guidelines to allow the inclusion of opioid addiction history in patient electronic health records.

One pain management expert cautioned that some provisions of the Support Act put too much of an emphasis on opioid medication.

“Excessive focus on reducing opioid supply in the legislation can lead to more harm than good. We cannot continue to ignore the needs of people in pain at the expense of preventing illicit drug use,” Lynn Webster, MD, past president of the American Academy of Pain Medicine told Pain Medicine News.

“We have seen draconian steps by the VA (Department of Veterans Affairs) and other payors to force opioid reduction in patients who have been stable and functional for years. This is cruel and simply not right. My hope is that the act is implemented with compassion for people with addiction and pain, but that they allow science and not prejudices and politics to inform policy.”

Sessions: Opioid Prescriptions at 18-Year Low

By Pat Anson, PNN Editor

Opioid prescriptions in the United States fell by 12 percent in the first eight months of 2018 and will decline even further in coming years, according to Attorney General Jeff Sessions.

“We now have the lowest opioid prescription rates in 18 years.  And we’re going to bring them a lot lower,” Sessions said in prepared remarks at the National Opioid Summit in Washington, DC.

Opioid prescriptions have indeed been falling for many years, but the trend appears to be accelerating as many doctors lower doses, write fewer prescriptions, or simply discharge and refuse to treat chronic pain patients.

Sessions pledged to continue fighting “the deadliest drug crisis in American history” by reducing opioid prescriptions by another third over the next three years. That’s in addition to a 44% reduction in opioid production that the DEA began in 2016.

Sessions also promised to step up efforts against healthcare professionals alleged to have overprescribed opioids. He said the Trump Administration has charged 226 doctors and 221 medical personnel with “opioid-related crimes.”

“These numbers will continue to rise,” Sessions predicted, because of new federal prosecutors and a data analytics team focused on tracking opioid prescriptions.

ATTORNEY GENERAL JEFF SESSIONS

“This team follows the numbers—like which doctors are writing opioid prescriptions at a rate that far exceeds their peers; how many of a doctor's patients have died within 60 days of an opioid prescription; and pharmacies that are dispensing disproportionately large amounts of opioids,” Sessions said.

“They will help us find the doctors, pharmacists, and other medical professionals who are flooding our streets with drugs—and put them behind bars.”

At no point in his speech did Sessions discuss the impact the opioid crackdown was having on millions of chronic pain patients, who are increasingly bedridden or disabled due to lack of access to effective pain care. Earlier this year, Sessions suggested they should “tough it out” by taking aspirin.

While opioid prescriptions have fallen dramatically in recent years, they’ve yet to have much of an impact on the nation’s overdose rate.  Preliminary estimates released by the CDC this week show a modest 2.3% decline in opioid overdose deaths from September 2017 to March 2018. Over 48,000 people died from opioid overdoses during that period, with most of those deaths involving illicit fentanyl, heroin and other opioid street drugs, not prescription opioids.

Sessions said the Justice Department was taking “unprecedented action” against fentanyl traffickers at home and abroad, including the recent indictments of three Chinese nationals and dozens of Mexican drug traffickers.

“China could do more to stop these drugs from coming here.  Frankly, they’re not doing enough.  They must do more,” he said.