DEA Proposes Cuts in Opioid Supply for Sixth Straight Year

By Roger Chriss, PNN Columnist

The U.S. Drug Enforcement Agency is proposing more cuts in the supply of opioids and other controlled substances in 2022. If adopted, it would be the sixth consecutive year the DEA has reduced production quotas for prescription opioids and other Schedule I and II drugs under the Controlled Substances Act.

Specifically, the DEA is proposing a 5.4% reduction in the supply of oxycodone, 3.9% for hydrocodone, 19% for morphine and 5.4% for prescription fentanyl. That’s in addition to the significant cuts already made since 2017. 

The DEA arrived at the quotas after consulting with the FDA, CDC, Centers for Medicare and Medicaid Services (CMS), and individual states to assess the medical, industrial and scientific need for controlled substances. The DEA also relied extensively on data from prescription drug monitoring programs (PDMPs) to identify “red flags” indicating the possible theft, illicit use and diversion of each substance.

Even though opioid prescribing has dropped significantly over the last decade, the DEA believes demand will fall even further in 2022.

“With regard to medical usage of schedule II opioids, FDA predicts levels of medical need for the United States will decline on average 18.88 percent between calendar years 2021 and 2022. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone,” the DEA said in a statement published in the Federal Register.

The proposed opioid production quotas are the smallest in nearly two decades. The trend lines for several common Schedule II prescription opioids can be seen in the chart below. Since their peak in 2013, production quotas have fallen by 63% for oxycodone and 69% for hydrocodone.

Although the DEA maintains the “medical need” for opioids has declined, demand for healthcare has risen significantly. The U.S. population was 281 million in 2000 compared to 331 million today, and in the interim Americans have become older and less healthy, and surgical interventions for cancer and other diseases have become more common, as has trauma care.

In addition, the U.S. has been facing a pandemic for the past year and a half that increased the need for ICU with intubation, for which sedation with opioids is necessary. In 2020, the DEA raised its quotas for some substances because of this unanticipated demand.

In other words, the U.S. is trying to do more with less, trying to manage pain in a larger population with a higher disease burden while using fewer opioid analgesics.

The goal of these ongoing reductions is to address the overdose crisis. But as the CDC reported last week, the U.S. has seen over 96,000 drug fatalities in the 12-month period ending in March 2021. Some of this spike in deaths is a result of to the pandemic, but the ongoing saturation of the country with illicit fentanyl is clearly playing a key role. The DEA recently issued a public safety alert warning of a surge in counterfeit medication made with illicit fentanyl.  

How much further the DEA can go with quota reductions remains to be seen. Surgical and cancer care have been greatly impacted, and rapid tapering of people on long-term opioid therapy is causing harm.

The DEA has not been forthcoming about its ultimate goals and the methods used to assess progress, as it continues to shrink the supply of opioids. At this rate, we will likely reach pre-1995 prescribing levels within another year.

To make a comment on the DEA’s proposed 2022 production quotas, click here. Comments must be received by November 17.

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

The Rx Opioid Most Likely To Be Misused May Surprise You

By Pat Anson, PNN Editor

For well over a decade, addiction treatment providers and public health officials have been touting the benefits of buprenorphine, an opioid that can treat both pain and addiction. When combined with naloxone in drugs like Suboxone that treat opioid use disorder (OUD), buprenorphine reduces cravings for opioids and lowers the risk of abuse.    

But a new study published in JAMA Network Open suggests that someone is far more likely to misuse buprenorphine than other opioids. In fact, the misuse rate for buprenorphine is over two times higher than misuse rates for hydrocodone, oxycodone and other opioid pain medications.

Researchers at the National Institute on Drug Abuse and the Centers for Disease Control and Prevention conducted the study, looking at data from nearly 215,000 people who participated in the National Surveys on Drug Use and Health from 2015 to 2019.

Respondents were asked if they misused prescription opioids “in any way that a doctor did not direct you to use them.” If they used someone else’s prescription or took opioids in greater amounts or more often than they were told by a doctor, that was considered “misuse.”

Researchers crunched the numbers and found that the vast majority of people do not misuse opioid pain medication and take it as directed. Oxycodone, for example, was misused by 12.7% of respondents who took it, followed by hydromorphone (11.8%), hydrocodone (11.6%), and prescription fentanyl (11.5%). Tramadol (7.8%) was misused the least.  

Addiction treatment drugs were misused the most. Buprenorphine was misused by 29.2% of the people who took it, followed by methadone at 22.2 percent. It’s not uncommon for someone getting OUD treatment to have relapses, so perhaps that finding is not altogether surprising.

% MISUSE RATES FOR PRESCRIPTION OPIOIDS

SOURCE: JAMA NETWORK OPEN

Although buprenorphine is misused at a rate over two times higher than other opioids, researchers chose to focus on the positive: a recent downward trend in buprenorphine misuse, despite increases in the number of patients receiving buprenorphine treatment.

“In 2019, nearly three-fourths of US adults reporting past-year buprenorphine use did not misuse their prescribed buprenorphine, and most who misused reported using prescription opioids without having their own prescriptions. These findings underscore the need to pursue actions that expand access to buprenorphine-based OUD treatment, to develop strategies to monitor and reduce buprenorphine misuse,” researchers concluded.

What Is Misuse?

Every study has its flaws, and this one is no exception. Findings based on self-reported survey results are subject to poor memories, recall bias and concerns about stigma. The researchers’ broad definition of “misuse” could also result in a diagnosis of OUD when none actually exists, according to a pain management expert.

“It is not really clear what any of the data means clinically because of the very broad definition of the word misuse,” said Lynn Webster, MD, Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript. “Behavior of taking an extra pill to control pain, despite it not being specifically directed by the prescribing provider, could be described as ‘misuse.’ This is not necessarily harmful, even if it is inappropriate. The implication is that simply taking an additional pill is an indication of OUD behavior. That would not be an appropriate characterization of the behavior. 

“In fact, the authors report the most common reason to misuse medication is to relieve pain in the OUD and non-OUD groups. This may imply that most people who are misusing their medications are experiencing undertreated pain.” 

The JAMA study is not the first to report a high rate of buprenorphine misuse. The DEA’s 2020 National Drug Threat Assessment reported that buprenorphine is misused more often than methadone or hydrocodone, and that it was poised to replace oxycodone as the most commonly misused prescription opioid. Unlike the JAMA study, the DEA said the misuse of buprenorphine was increasing, not declining.   

Ketamine Gets FDA Orphan Drug Designation for CRPS

By Pat Anson, PNN Editor

A Canadian biotech company has announced it has been granted orphan drug designation from the U.S. Food and Drug Administration to investigate the use of ketamine as a treatment for Complex Regional Pain Syndrome (CRPS)¸ a disorder of the nervous system that causes severe, intractable nerve pain. Currently, there is no FDA approved medication for CRPS.

Toronto-based PharmaTher Holdings specializes in the development of ketamine and other psychedelic drugs for mental health and pain conditions. The company also recently received an orphan drug designation for ketamine as a treatment for Amyotrophic Lateral Sclerosis (ALS), more commonly known as Lou Gehrig's disease.

“Receiving our second FDA orphan drug designation with ketamine for CRPS continues our momentum in building a specialty ketamine-based product pipeline for not only mental health disorders, but also for rare and near-rare conditions present in neurological, pain and inflammatory disorders,” Fabio Chianelli, CEO of PharmaTher, said in a statement.

Ketamine is not an opioid, but acts on pain receptors in the brain in a similar manner. Although the drug is only approved by the FDA for anesthesia and depression, a growing number of clinics provide off-label infusions of ketamine to treat difficult chronic pain conditions such as CRPS. In high-dose infusions, ketamine puts patients into a temporary dream-like state that can lead to hallucinations and out-of-body experiences.

The FDA first approved ketamine in 1970 and the medical patent on it expired years ago. The goal of PharmaTher is to develop its own propriety formulation of ketamine and expand its use. Orphan drug designation helps speed that process along by encouraging companies to invest in new uses for old drugs, often jacking up the price in the process.

If successful, PharmaTher says it would have seven years of exclusive marketing rights for its ketamine formulation, as well as potential tax credits and the waiver of $2.4 million in FDA filing fees.

In 2019, the FDA approved Spravato, a ketamine-based nasal spray developed by Janssen Pharmaceuticals, as a treatment for depression. A single dose of Spravato costs about $900.

“It seems they are doing something similar to what Janssen did with Spravato,” says Kimberley Juroviesky, a retired nurse practitioner who receives ketamine infusions for CRPS. Juroviesky co-chairs an advocacy group that’s trying to get more insurance coverage of ketamine.

“They are taking ketamine and changing it slightly to create a new drug. Then they can charge hundreds for it. We are hopeful though that maybe this can help us in our fight to get generic ketamine covered by insurance,” she told PNN in an email.

PharmaTher plans to launch a Phase 2 clinical trial of its ketamine formulation in 2022. In addition to treating CRPS, the company recently began a clinical study of ketamine as a treatment for Parkinson’s disease, and has filed a patent application for ketamine as a treatment for obesity and Type 2 diabetes. PharmaTher is also developing a microneedle patch for the delivery of ketamine and other psychedelic drugs.

While ketamine is emerging as a trendy pain reliever and many patients swear by it, medical societies urge caution. Guidelines from the American Society of Anesthesiologists, American Society of Regional Anesthesia and Pain Medicine, and the American Academy of Pain Medicine only support ketamine infusions for CRPS and post-surgical acute pain. The guidelines say there is no evidence supporting ketamine infusions for any other type of pain.

A 2019 study of nearly 300 patients who received ketamine infusions found that over a third reported significant side effects such as hallucinations and visual disturbances.

Cities Sued to Make Sidewalks Accessible for Disabled People

By Maureen O’Hagan, Kaiser Health News

From her Baltimore dining room, Susan Goodlaxson can see her neighbor gardening across the street. But while other neighbors stop to chat, Goodlaxson just watches from the window. She uses a wheelchair, and there isn’t a single curb ramp on her block.

If the 66-year-old wanted to join, she’d have to jump her wheelchair down the 7½-inch curb and risk a fall. Ditto if she wanted to wheel over to the library, a trip that would require riding in the street to avoid rampless curbs and broken sidewalks.

“I don’t feel like it’s asking too much to be able to move your wheelchair around the city,” she said.

Federal law backs her up. Since 1990, the Americans With Disabilities Act has required governmental entities to provide people with disabilities access to programs and services enjoyed by their nondisabled peers. That includes sidewalks and curb ramps that make it possible to safely cross the street.

In Baltimore and many other communities across the U.S., there has been widespread noncompliance with this part of the law.

“An awful lot of [communities] have either disregarded their obligations under the ADA or made it the last priority,” noted Tom Stenson, a lawyer with Disability Rights Oregon, a nonprofit advocacy group. “There’s a culture throughout America of not taking the needs of people with disabilities seriously.”

SUSAN GOODLAXSON

In Baltimore, just 1.3% of curb ramps meet federal standards, according to the city’s own figures. In Oregon, about 9% of corners maintained by the state transportation department are compliant. San Jose, California, counted 27,621 corners with faulty or nonexistent curb ramps. Boston estimates fewer than half of its curb ramps are compliant.

Class-Action Lawsuits

In recent years, there’s been a flurry of class-action lawsuits, including one filed against Baltimore in June, with Goodlaxson among the plaintiffs.

Philadelphia was sued in 2019 over the condition of its sidewalks. Chicago was sued the same year for failure to install audible pedestrian signals, more than a decade after settling a suit over curb ramps.

In 2018, Atlanta was sued. A survey there determined that only 20% of sidewalks were in sufficient condition to be used by people in wheelchairs or motorized scooters and about 30% had curb ramps. Seattle settled a class-action suit in 2017. San Francisco and Long Beach, California, were sued in 2014 to make their sidewalks more accessible to wheelchairs.

The city of New York and its transit authority have faced repeated major ADA lawsuits, some alleging the same lack of access for people with disabilities that was supposed to be addressed in a lawsuit that was filed in the 1990s and later settled.

Los Angeles settled what is believed to be the largest of these suits in 2015. Its problems with sidewalks and curb ramps were so widespread that the city estimated it would cost $1.4 billion and take 30 years to get into compliance. In the years leading up to the suit, the city wasn’t allocating money for sidewalk repairs, for the ADA or otherwise, even while paying out millions in injury claims.

In all, hundreds of jurisdictions have faced lawsuits or entered settlement agreements after failing to meet ADA requirements for pedestrians and mass transit users.

The sheer number of noncompliant sidewalks, curb ramps, pedestrian signals and subway stations illustrates the challenges for people with disabilities.

It also leaves cities in a legal and financial squeeze, with the average curb ramp costing between $9,000 and$19,000. When the court requires a jurisdiction to build thousands of them to catch up, it can strain budgets.

Rosem Morton / for KHN

The ADA and the 1973 Rehabilitation Act resulted in significant changes that improved access and accommodations for people with disabilities. The ADA is clear that people with disabilities have the same right to pedestrian infrastructure as anyone else.

There are requirements covering a curb ramp’s width, slope and other specifications. Even a 1-inch lip can be too high for a wheelchair user to navigate. A slope that is a few degrees too steep can tip someone to the ground. Sidewalks that are crumbling, pothole-filled or otherwise obstructed — with utility poles, for example — force wheelchair users into the street for a dangerous ride.

No one expected the ADA to fix all these problems immediately. Under the law, new sidewalks must be built for accessibility. As for existing sidewalks, a federal appeals court in 1993 ruled that curb ramps must be installed or regraded when the road is altered — say, when it’s repaved.

Compliance Lags

Yet by 1999 it was clear many jurisdictions were ignoring the law. The U.S. Department of Justice began enforcement efforts, entering into settlement agreements with more than 200 non-compliant jurisdictions representing every state since 2000.

Still, compliance still lags.

Officials in Baltimore, New York and Los Angeles declined to comment for this article. Tony Snyder, manager of the Oregon Department of Transportation’s ADA program, said siloed funding sources, strict regulations and costs have been among the hurdles over the years.

“It wasn’t that ODOT doesn’t value accessibility,” he said. While fewer than 10% of the state’s ramps meet standards, he said, a lot of noncompliant ramps are nonetheless “usable.”

Kelly Lynch, deputy director and general counsel for the Montana League of Cities and Towns, an association that represents 127 municipal governments, agreed that costs can add up. She’s been working to help fellow Montanans —and, she hopes, officials in other jurisdictions across the country through the National League of Cities — find a path toward full accessibility, even if the steps are incremental.

Some changes, including educating road crews on the rules, are relatively simple. But a bigger problem is a widespread lack of spending on the nation’s infrastructure. “Our streets are falling apart, and so are our sidewalks,” Lynch said.

In August, the Senate defeated an amendment by Sen. Tammy Duckworth (D-Ill.) to a $1 trillion infrastructure bill that would have required state and local entities to describe how they would use federal dollars to improve accessibility for people with disabilities and for underserved communities. Sen. Pat Toomey (R-Pa.) called Duckworth’s amendment “politically correct virtue signaling” and argued that transit agencies don’t need that kind of federal oversight.

On top of the broader infrastructure issues, many officials don’t fully understand the ADA or its requirements, Lynch believes. And as the mother of a disabled son, she also said there’s another big factor at play: “People still discriminate against people with disabilities.”

As for Baltimore, Goodlaxson said she repeatedly called the city asking for curb cuts and sidewalk repairs. She remembers a crew coming to look at the sidewalks — and then nothing happening.

Advocacy organizations tried to negotiate with city officials, hoping to get Baltimore’s infrastructure brought into compliance on a timetable. When that didn’t work, they filed suit.

Most of these kinds of ADA cases begin similarly, with negotiations long before lawsuits. Some jurisdictions settled quickly and worked hard at improvements. Other cases go less smoothly. Oregon’s transportation department, which was also sued, is in danger of missing its construction deadlines under the settlement. Some repairs had to be redone because they still fell short of ADA requirements.

Sometimes cities try to get cases thrown out of court by pointing to the 1993 appeals court decision and arguing there’s no evidence the road has been altered since then, so ADA requirements haven’t kicked in. In New York, the transit authority argues in an ongoing lawsuit that while wheelchair users can’t ride, say, three-quarters of the city’s subways because there are no elevators, they can instead take the bus.

Some jurisdictions fight bitterly. Los Angeles spent five years in court before agreeing to settle. Linda Dardarian, one of the plaintiff’s attorneys, said cities don’t fully recognize sidewalk and curb ramp accessibility as a civil right. “They have viewed it as just another maintenance obligation, [like] grooming street trees.”

When the case was settled, the judge ordered Los Angeles to pay nearly $12 million to cover the other side’s legal fees and costs, on top of the estimated $1.4 billion it will cost to come into compliance.

Under these settlements, repairs often stretch a decade or more, and the city or town typically must pay for surveys, measurements and disability consultants to ensure compliance.

From the plaintiffs’ point of view, the challenge of these lawsuits is that there isn’t a huge hammer to hold governments accountable.

“If you don’t build the ramps, the penalty is you have to build the ramps,” said Stenson of Disability Rights Oregon, which provided legal representation to a plaintiff in the Oregon transportation department suit.

For those who can easily get around town, the issue can be invisible.

Goodlaxson didn’t see the problem until she began using a wheelchair five years ago, after surgery for a brain tumor. She remembers seeing people riding their wheelchairs in the street, thinking, “that doesn’t look safe. But I didn’t give it any more thought.”

Now, she realizes “people are terrified, but they can’t do it any other way.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

One in Four U.S. Adults Have Arthritis

By Pat Anson, PNN Editor

Nearly one in four American adults --- 58.5 million people – report having arthritis, according to a new study by the CDC that highlights both the aging of the U.S. population and the challenges that poses for the nation’s healthcare system.

Arthritis is a disease that causes joint pain and stiffness, which typically worsen with age, and is the leading cause of adult disability. The most common types of arthritis are osteoarthritis and rheumatoid arthritis.

Researchers found that over half of Americans aged 65 and older have arthritis (50.4%); along with adults who are disabled or unable to work (52.3%); and adults who rate their health as either fair or poor (51.2%).

The national prevalence of disability linked to arthritis – what the CDC calls arthritis-attributable activity limitations (AAAL) – has been steadily rising for nearly two decades. The trend appears to be accelerating due to aging, rising levels of obesity and reduced physical activity. The CDC estimates nearly 26 million Americans had AAAL in 2016-2018.

SOURCE: CDC

"AAAL prevalence continues to increase more rapidly than was projected. Because population aging and other contributing factors (e.g., obesity) are expected to sustain these trends, public health, medical, and senior and other service systems face substantial challenges in addressing the needs of adults with arthritis, who already account for nearly one quarter of U.S. adults," researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

To address the social, physical and economic challenges of arthritis, the report recommends an expansion of outreach programs to individuals and groups at high risk of arthritis. AAAL is common among adult American Indian or Alaskan Natives (60.7%); low income adults (53.3%); adults living near or below poverty levels (63.3%); disabled adults (82.6%); and those with serious psychological distress (76.3%).

“Existing self-management education and physical activity public health interventions that are arthritis-appropriate and inclusive of adults with disabilities have proven benefits, including improved aerobic activity, confidence, and self-rated health and reduced depression, fatigue, and pain. These positive effects might be bolstered by combination with medical management, particularly for joint symptoms and mental health,” researchers said.

One step arthritis sufferers can take to help themselves is to make greater use of the Americans with Disabilities Act (ADA), which is underused by people with rheumatic conditions. The ADA can help eliminate physical barriers and improve access to transportation, building access, and workplace accommodations. If you feel you've been discriminated against because of a disability, you can file a complaint with the U.S. Justice Department under the ADA.

The Job Accommodation Network is another free resource that can be used for confidential job counseling, employment advice, facilitation of workplace accommodations, and the resolution of disability-related employment issues.

General Anesthesia as Safe as Spinal Injections for Hip Fracture Surgery

By Pat Anson, PNN Editor

General anesthesia is just as safe as spinal anesthesia for patients undergoing hip fracture surgery, according to a large new study that dispels a common belief that patients who receive spinal injections have better outcomes.

Researchers from the Perelman School of Medicine at the University of Pennsylvania enrolled 1,600 mostly elderly patients having hip fracture surgery at 46 U.S. and Canadian hospitals, and randomly assigned them to receive either spinal or general anesthesia.

They found that rates of survival, delirium and functional recovery post-surgery were similar for patients, regardless of the type of anesthesia they received. The findings are published in The New England Journal of Medicine.

“Our study argues that, in many cases, either form of anesthesia appears to be safe," said lead investigator Mark D. Neuman, MD, an associate professor of Anesthesiology and Critical Care at Perelman. "This is important because it suggests that choices can be guided by patient preference rather than anticipated differences in outcomes in many cases."

During general anesthesia, inhaled and intravenous medications are used to make patients unconscious, which often requires a breathing tube during surgery. For spinal anesthesia, medications are used to numb the lower part of the body through an injection into the spinal column. Patients anesthetized this way are typically able to breathe on their own during surgery and rarely require a breathing tube.

About 250,000 people have hip fracture surgery annually in the United States. In the past, most would receive general anesthesia, but in recent years the use of spinal anesthesia for hip fracture surgeries has increased significantly, due in part to the belief by some anesthesiologists that it was safer for frail, older patients.  

To get a better idea of possible outcomes associated with both forms form of anesthesia, researchers looked at post-surgical death rates, whether patients regained the ability to walk, and if they experienced any cognitive decline.

Statistically, there was hardly any difference in outcomes between the two groups. Sixty days after surgery, 18.5% of patients assigned to spinal anesthesia had either died or were unable to walk; versus 18 percent of patients who received general anesthesia. About 21 percent of patients assigned to spinal anesthesia experienced delirium, versus 20 percent of those given general anesthesia.

"What our study offers is reassurance that general anesthesia can represent a safe option for hip fracture surgery for many patients," said Neuman. "This is information that patients, families, and clinicians can use together to make the right choice for each patient's personalized care."

Neuman and his research team say previous comparisons of general and spinal anesthesia came from studies that didn’t randomly assign patients, which creates self-selection bias. Some patients may have chosen spinal anesthesia with the goal of avoiding complications, while others opted for general anesthesia to avoid a spinal injection or because they feared inadequate sedation during surgery.

The most common types of medications used during spinal injections are anesthetics, opioids or corticosteroids. A recent study of patients with hip osteoarthritis warned of serious long-term complications for those given steroid injections. Patients who received steroids were 8.5 times more likely to develop rapidly destructive hip disease, a condition that causes the loss of blood flow and death of bone tissue in the hip.

Cannabis Oil Effective for UK Chronic Pain Patients

By Pat Anson, PNN Editor

Medical cannabis has been legal in the United Kingdom since 2018, but we’re only now getting the first evidence on the effectiveness of cannabis oil for UK chronic pain patients.

One hundred ten patients enrolled in the UK Medical Cannabis Registry reported significant improvements in their pain, discomfort and sleep quality after one, three and six months of treatment with cannabis oil. There was also statistically significant improvement in their health-related quality of life.

Due to strict rules, it is difficult to get a prescription for medical cannabis from the UK’s National Health Service. Patients can only be prescribed cannabis when conventional therapy has not provided adequate relief for conditions such as pain, anxiety and multiple sclerosis.

Most of the patients (65%) in the study had never used cannabis before. Their most common primary diagnosis was chronic non-cancer pain (48%), followed by neuropathic pain (24%) and fibromyalgia (16%).

“With the increasing number of prescriptions for medical cannabis in the UK, capturing patient outcomes and real-world evidence is essential for wider understanding and appropriate access for eligible patients,” Dr. Simon Erridge, head of research at Sapphire Medical Clinics, said in a statement.

“This research is the first of its kind in Europe and we continue to review condition and product-specific outcomes via the UK Medical Cannabis Registry. Though this is still observational data it will inform critical future research including randomised controlled trials.”

Sapphire Medical Clinics created the registry and surveyed patients to help fill some of the gaps in knowledge about medical cannabis. The findings were recently published in the Journal of Clinical Pharmacology.

“Despite promising preclinical data, there is a paucity of high-quality evidence to support the use of CBMPs (cannabis-based medicinal products). The evidence base, while broad, is inconclusive, variable across chronic pain types, and thus insufficient to inform guidelines, funders, and licensing agencies,” researchers said.

The cannabis oil used in the study is made by Adven, a subsidiary of Curaleaf International, Europe’s largest independent cannabis company. The median CBD dose was 20 mg per day, while the median THC dose was 1 mg per day, giving the oil a CBD/THC ratio of 20 to 1. Adverse events such as nausea, dizziness and constipation were reported by nearly a third of patients, with most symptoms being mild or moderate.

Sapphire Medical Clinics is planning further studies of cannabis products as more participants enroll in its cannabis registry.

‘Mother of All Cannabinoids’

Another study conducted in the U.S. found that people who use cannabis products that are rich in cannabigerol (CBG) reported significant improvement in their pain, anxiety, depression and insomnia.

CBG is known as the “mother of all cannabinoids” because it rapidly converts into THC and CBD. Only trace amounts of CBG are found in most cannabis plants, but in recent years cultivated strains rich in CBG have been grown in the Pacific Northwest.

Researchers at Washington State University and the University of California Los Angeles surveyed 127 people who self-identified as consumers of CBG-dominant cannabis. Most reported their pain and other symptoms were “very much improved” or “much improved” by CBG.

About 75% said CBG-predominant cannabis was superior to conventional medications for chronic pain, depression, insomnia and anxiety. A little over half reported minor side effects such as dry mouth, sleepiness, increased appetite, and dry eyes. Most reported no withdrawal symptoms.

“This is the first patient survey of CBG-predominant cannabis use to date, and the first to document self-reported efficacy of CBG-predominant products, particularly for anxiety, chronic pain, depression, and insomnia. Most respondents reported greater efficacy of CBG-predominant cannabis over conventional pharmacotherapy, with a benign adverse event profile and negligible withdrawal symptoms,” researchers reported in the journal Cannabis and Cannabinoid Research. 

“This study demonstrates that CBG-predominant cannabis and related products are available and being used by cannabis consumers and demonstrates the urgent need for randomized controlled trials of CBG-predominant cannabis-based medicines to be studied rigorously to assess safety and efficacy.”

Preliminary research suggests CBG has antibacterial properties and might be useful in treating inflammatory bowel disease (IBD), glaucoma, Huntington’s disease and some forms of cancer.  

Do Infections or Vaccines Provide Better Covid Immunity?

By Arthur Allen, Kaiser Health News

Dr. Aaron Kheriaty, a University of California-Irvine psychiatry professor, felt he didn’t need to be vaccinated against covid because he’d fallen ill with the disease in July 2020.

So, in August, he sued to stop the university system’s vaccination mandate, saying “natural” immunity had given him and millions of others better protection than any vaccine could.

A judge on Sept. 28 dismissed Kheriaty’s request for an injunction against the university over its mandate, which took effect Sept. 3. While Kheriaty intends to pursue the case further, legal experts doubt that his and similar lawsuits filed around the country will ultimately succeed.

That said, evidence is growing that contracting SARS-CoV-2, the virus that causes covid-19, is generally as effective as vaccination at stimulating your immune system to prevent the disease. Yet federal officials have been reluctant to recognize any equivalency, citing the wide variation in covid patients’ immune response to infection.

Like many disputes during the covid pandemic, the uncertain value of a prior infection has prompted legal challenges, marketing offers and political grandstanding, even as scientists quietly work in the background to sort out the facts.

For decades, doctors have used blood tests to determine whether people are protected against infectious diseases. Pregnant mothers are tested for antibodies to rubella to help ensure their fetuses won’t be infected with the rubella virus, which causes devastating birth defects. Hospital workers are screened for measles and chickenpox antibodies to prevent the spread of those diseases. But immunity to covid seems trickier to discern than those diseases.

The Food and Drug Administration has authorized the use of covid antibody tests, which can cost about $70, to detect a past infection. Some tests can distinguish whether the antibodies came from an infection or a vaccine. But neither the FDA nor the Centers for Disease Control and Prevention recommend using the tests to assess whether you’re, in fact, immune to covid. For that, the tests are essentially useless because there’s no agreement on the amount or types of antibodies that would signal protection from the disease.

“We don’t yet have full understanding of what the presence of antibodies tells us about immunity,” said Kelly Wroblewski, director of infectious diseases at the Association of Public Health Laboratories.

‘Natural Immunity’

By the same token, experts disagree on how much protection an infection delivers.

In the absence of certainty and as vaccination mandates are levied across the country, lawsuits seek to press the issue. Individuals who claim that vaccination mandates violate their civil liberties argue that infection-acquired immunity protects them. In Los Angeles, six police officers have sued the city, claiming they have natural immunity.

In August, law professor Todd Zywicki alleged that George Mason University’s vaccine mandate violated his constitutional rights given he has natural immunity. He cited a number of antibody tests and an immunologist’s medical opinion that it was “medically unnecessary” for him to be vaccinated. Zywicki dropped the lawsuit after the university granted him a medical exemption, which it claims was unrelated to the suit.

Republican legislators have joined the crusade. The GOP Doctors Caucus, which consists of Republican physicians in Congress, has urged people leery of vaccination to instead seek an antibody test, contradicting CDC and FDA recommendations. In Kentucky, the state Senate passed a resolution granting equal immunity status to those who show proof of vaccination or a positive antibody test.

Hospitals were among the first institutions to impose vaccine mandates on their front-line workers because of the danger of them spreading the disease to vulnerable patients. Few have offered exemptions from vaccination to those previously infected. But there are exceptions.

Two Pennsylvania hospital systems allow clinical staff members to defer vaccination for a year after testing positive for covid. Another, in Michigan, allows employees to opt out of vaccination if they present evidence of previous infection and a positive antibody test in the previous three months. In these cases, the systems indicated they were keen to avoid staffing shortages that could result from the departure of vaccine-shunning nurses.

For Kheriaty, the question is simple. “The research on natural immunity is quite definitive now,” he told KHN. “It’s better than immunity conferred by vaccines.” But such categorical statements are clearly not shared by most in the scientific community.

Dr. Arthur Reingold, an epidemiologist at UC-Berkeley, and Shane Crotty, a virologist at the respected La Jolla Institute for Immunology in San Diego, gave expert witness testimony in Kheriaty’s lawsuit, saying the extent of immunity from reinfection, especially against newer variants of covid, is unknown. They noted that vaccination gives a huge immunity boost to people who’ve been ill previously.

Yet not all of those pushing for recognition of past infection are vaccine critics or torchbearers of the anti-vaccine movement.

Dr. Jeffrey Klausner, clinical professor of population and public health sciences at the University of Southern California, co-authored an analysis published last week that showed infection generally protects for 10 months or more. “From the public health perspective, denying jobs and access and travel to people who have recovered from infection doesn’t make sense,” he said.

In his testimony against Kheriaty’s case for “natural” immunity to covid, Crotty cited studies of the massive covid outbreak that swept through Manaus, Brazil, early this year that involved the gamma variant of the virus. One of the studies estimated, based on tests of blood donations, that three-quarters of the city’s population had already been infected before gamma’s arrival. That suggested that previous infection might not protect against new variants. But Klausner and others suspect the rate of prior infection presented in the study was a gross overestimate.

A large August study from Israel, which showed better protection from infection than from vaccination, may help turn the tide toward acceptance of prior infection, Klausner said. “Everyone is just waiting for Fauci to say, ‘Prior infection provides protection,’” he said.

When Dr. Anthony Fauci, the top federal expert on infectious diseases, was asked during a CNN interview last month whether infected people were as well protected as those who’ve been vaccinated, he hedged. “There could be an argument” that they are, he said. Fauci did not immediately respond to a KHN request for further comment.

CDC spokesperson Kristen Nordlund said in an email that “current evidence” shows wide variation in antibody responses after covid infection. “We hope to have some additional information on the protectiveness of vaccine immunity compared to natural immunity in the coming weeks.”

A “monumental effort” is underway to determine what level of antibodies is protective, said Dr. Robert Seder, chief of the cellular immunology section at the National Institute of Allergy and Infectious Diseases. Recent studies have taken a stab at a number.

Antibody tests will never provide a yes-or-no answer on covid protection, said Dr. George Siber, a vaccine industry consultant and co-author of one of the papers. “But there are people who are not going to be immunized. Trying to predict who is at low risk is a worthy undertaking.”

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

More Evidence That Rapid Opioid Tapering Is Harmful

By Roger Chriss, PNN Columnist

The overdose crisis has motivated a sea change in prescribing practices. Opioid tapering is seen as a part of this change. But the risks and harms of tapering often outweigh its potential benefits, especially when tapering is rapid.

The risks of rapid tapers are well known. The CDC warns providers to “avoid abrupt tapering or sudden discontinuation of opioids,” with a dose decrease of 10% per month a “reasonable starting point.”

But more rapid tapers are very common. A new study looked at retail pharmacy claims for over 810,000 patients taken off high-dose opioids in 2017 and 2018, finding that 72% were tapered more rapidly than recommended by clinical guidelines. Rapid tapering was significantly more common among Medicare patients than in commercially insured ones. Critically, the study also found that counties with high overdose rates had more rapid opioid discontinuation.

The U.S. military health system has also significantly reduced opioid prescriptions. Among active-duty members, a recent study found a 69% decline in prescriptions filled for opioids at daily doses of 50 morphine milligram equivalents (MME) or more.

The Departments of Defense and Veterans Affairs adopted guidelines in 2017 that urge military doctors to taper or discontinue opioids for patients on high doses. But a recent Washington Post investigation found that the VA’s Opioid Safety Initiative was associated with a 75% increase in suicides among veterans living in rural areas and a 30% increase in suicides for veterans in urban areas.

Further, a recent JAMA investigation found that in a study of over 113,000 patients on stable, high-dose opioid therapy, tapering was “significantly associated with increased risk of overdose and mental health crisis.”

“This study highlights important potential harms that are associated with prescription opioid tapering in people with chronic pain,” Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab at Stanford University, told Practical Pain Management. “While work remains to understand these associations in greater detail, these findings reveal that patients with chronic pain need better protections within the healthcare system.”

There is, in other words, a clear pattern of harm here. Rapid tapers are destabilizing individual patients and are associated with increased rates of overdose and suicide. The goal of tapering was to reduce opioid-related risks and harms, but the data to date suggests the opposite is happening.

In general, the overdose crisis is getting worse fast. The latest data from the CDC shows over 96,000 drug overdose deaths in the 12 months ending in February, 2021. Opioid tapering has coincided with the rise in drug overdose deaths, though how and to what extent this happens is an open question that urgently requires attention.

There are, of course, risks to prescription opioids and patients may benefit from consensual tapering as described in a federal guideline for dosage reduction. Some people may also do better with non-opioid approaches to pain management.

But the current tapering efforts seem geared toward satisfying a statistical need to reduce prescriptions at the expense of individual welfare. As more and more public health data shows increasing harms without attendant benefits, it’s time to reconsider tapering practices and slow down deprescribing.

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

Researchers Warn of Serious Risks in ‘Unproven’ Stem Cells

By Pat Anson, PNN Editor

A new study is warning patients and healthcare providers of possible bacterial contamination and other serious risks in “unproven” stem cell products being marketed as treatments for chronic pain, arthritis and other medical conditions.   

The study findings, published in JAMA Network Open, are the outcome of an investigation that began in 2018 after public health officials began receiving reports of bacterial infections in stem cell patients. At least 20 patients in eight states developed serious infections after receiving stem cells derived from umbilical cord blood.

All of the infections were traced back to a single stem cell manufacturing lab in California, where over half the samples tested by the CDC were found to be infected with E coli and other bacteria. The contaminated products were recalled and the lab was ordered to improve its infection control procedures, but researchers say the risk of another outbreak remains.

“The findings from this outbreak underscore that unapproved and unproven stem cell products can expose patients to serious risks without clear benefit, including the possibility of product contamination,” wrote lead author Kiran Perkins, MD, an epidemiologist at the CDC Division of Healthcare Quality Promotion. “Patients and health care practitioners who are considering the use of unapproved products marketed as stem cell treatment should be aware of their unproven benefits and potential risks, including serious infections.”

The only stem cell products that are currently approved by the Food and Drug Administration are derived from umbilical cord blood, which are used to treat sickle cell disease and some cancers.

Despite FDA threats to crackdown on unproven stem cell treatments, over a thousand clinics have opened around the country, promoting stem cell injections and infusions to treat a wide variety of diseases and injuries. Many use stem cell products derived from a patient’s own body tissue – such as fat or bone marrow -- which clinic operators don’t consider a “drug” that falls under FDA jurisdiction.

Researchers say the clinics are taking advantage of desperate patients who want quick solutions to complex medical problems.

“Hundreds of clinics across the US unlawfully advertise stem cell treatments to patients as a cure for a variety of conditions for which there are currently no effective medical treatments, including certain neurological disorders, autism, and aging. Although some patients may be willing to risk unproven stem cell treatment over surgery for conditions such as chronic pain and degenerative joint diseases, this investigation demonstrates the potential risk associated with the use of these products,” Perkins and her colleagues wrote.

“Manufacturers of unlicensed products, such as those associated with this outbreak, violate the law for profit at the expense of public health. Many create market confusion by erroneously describing their products as novel therapies that do not require FDA premarketing review or approval. That is not the case.”

Of course, just because a treatment is unapproved or unlicensed doesn’t mean it’s ineffective. There are numerous examples of stem cells being used successfully to treat serious neurological conditions such as arachnoiditis and paralysis. Professional athletes have also embraced stem cells and platelet injections as therapies for stubborn muscle and joint injuries, often traveling overseas for treatments they can’t get in the U.S.

The FDA has been slow to take action against stem cell clinics and manufacturers, due in part to a “grace period” the agency adopted in 2017 to give them more time to submit new drug applications for FDA review. The grace period ended in May 2021, with no indication that many stem cell providers took the agency up on its offer.      

A recent report from the Pew Charitable Trust identified 360 patients who had adverse events involving stem cells over a 17-year period. While that pales in comparison to the number of Americans who die every year from medical errors -- over 250,000 --  Pew said it was time for “increased FDA enforcement action” against stem cell clinics.

Can Psychotherapy Treat Chronic Back Pain?

By Pat Anson, PNN Editor

Anyone who has lived with chronic back pain knows how difficult it is to treat. Pain medications provide only temporary relief, and surgeries and injections can be risky.

An extensive review of back pain treatments by The Lancet concluded that many were of “dubious benefit” and that most people with low back pain would respond to “simple physical and psychological therapies” that keep them active.

A small study recently published in JAMA Psychiatry lends some support to that belief, finding that two-thirds of chronic back pain patients who received a novel psychological treatment called Pain Reprocessing Therapy (PRT) were pain-free or nearly pain-free after four weeks. Most continued to experience relief for a year.

The researchers behind the study liken chronic pain to an alarm clock stuck in the “on” position long after the initial injury has healed.

“For a long time we have thought that chronic pain is due primarily to problems in the body, and most treatments to date have targeted that,” said lead author Yoni Ashar, PhD, a postdoctoral associate at Weill Cornell Medical College. “This treatment is based on the premise that the brain can generate pain in the absence of injury or after an injury has healed, and that people can unlearn that pain. Our study shows it works.”

PRT therapy was developed by Alan Gordon, a Los Angeles-based psychotherapist and author of a new book on healing chronic pain called “The Way Out.”

PRT is based on the premise that patients can reduce or even eliminate chronic pain by changing the way they think about it, using mindfulness and cognitive behavioral therapy. The goal is to eliminate fear and avoidance techniques that many patients have about their pain.

“The idea is that by thinking about the pain as safe rather than threatening, patients can alter the brain networks reinforcing the pain, and neutralize it,” Ashar explained.

For the randomized controlled trial, Ashar and his colleagues recruited 151 people who had low to moderate back pain for at least six months, with an intensity of at least four on a pain scale of zero to 10.

Those in the treatment group received 8 one-hour sessions of PRT, in which they were encouraged to reappraise the severity of their pain by engaging in movements they were afraid to do. This helped them overcome some of the negative emotions they had about pain. 

After four weeks, 66 percent of patients in the treatment group were pain-free or nearly pain-free, compared to 20% in a placebo group and 10% who received no treatment.

The findings were confirmed post-treatment by MRI brain scans, which showed that brain regions associated with pain processing – such as the anterior insula and anterior midcingulate — had quieted significantly in those who had PRT therapy. 

“The magnitude and durability of pain reductions we saw are very rarely observed in chronic pain treatment trials,” Ashar said.

The study focused only on PRT therapy for back pain, so future studies are needed to determine if PRT would produce similar results for other types of chronic pain. 

“This study suggests a fundamentally new way to think about both the causes of chronic back pain for many people and the tools that are available to treat that pain,” said co-author Sona Dimidjian, PhD, a professor of psychology and neuroscience at CU Boulder. “It provides a potentially powerful option for people who want to live free or nearly free of pain.”

Study Identifies Medications Most Involved in ER Visits

By Pat Anson, PNN Editor

Here’s a question for you: What type of medication is most likely to be involved in a visit to a hospital emergency room?

1. Opioid pain relievers

2. Blood thinners

3. Psychiatric drugs

4. Insulin

5. Antibiotics

Given the well-publicized risks of addiction and overdose associated with opioids, you might assume it was opioid pain relievers. You’d also be wrong, according to a large new study that looked at medications associated with emergency department (ED) visits in the U.S. from 2017 to 2019.

CDC researchers looked at a representative sample of nearly 97,000 cases of adverse events involving medication and found that warfarin (Coumadin) and other anti-coagulant blood thinners – typically prescribed to reduce the risk of heart attack and stroke -- were the leading cause of ED visits.

Among patients of all ages, insulin was the second leading cause of medication-related adverse events, followed by psychiatric drugs, antibiotics and the over-the-counter pain relievers ibuprofen and acetaminophen. The opioid oxycodone came in last on a Top 10 list of drugs involved in ED visits.

TOP 10 MEDICATIONS INVOLVED IN EMERGENCY DEPARTMENT VISITS

SOURCE: CDC

The study findings, published in JAMA, help dispel many of the myths associated with the risks of opioids — at least in comparison to other widely used medications.

There are many reasons for someone to have an adverse reaction to medication, ranging from allergies to dosage errors to taking drugs intended for someone else. About a third of the ED visits were so serious, the patient was admitted for hospitalization.

Compared to seniors age 65 and older, young adults were significantly more likely to abuse a medication or to use it for intentional self-harm. Seniors were far more likely to only take a drug for its intended therapeutics use.

SOURCE: jama

The age of a patient also plays a significant role in the type of drug they have an adverse reaction to. For example, the antibiotic amoxicillin was the leading cause of medication harm for patients under the age of 14; while the anti-anxiety drug alprazolam (Xanax) was the leading cause of adverse events for patients aged 15 to 44.  Insulin ranked first for patients aged 45-64; while warfarin was first for patients aged 65 and older.

Analgesics, sedatives and antidepressants were the drugs most likely to be abused. About 63% of adverse events involving prescription opioids were cases of “non-therapeutic” abuse, while 89% of cases involving benzodiazepines were classified as abuse. The vast majority of cases involving blood thinners, insulin or antibiotics were for their intended therapeutic use.    

The role of opioids in ED visits has been falling for over a decade. A 2017 study showed a significant decline in the number of patients admitted to U.S. hospitals for abusing opioid medication. Hospital admissions for overdoses from opioid medication started falling in 2010, the same year that opioid prescriptions peaked in the U.S.

Surprise Discovery Could Lead to Vaccine for Rheumatoid Arthritis

By Pat Anson, Editor

A surprise discovery at a university laboratory could lead to a vaccine that can prevent rheumatoid arthritis, a chronic and incurable disease in which the body’s own immune system attacks joint tissues.

Researchers at The University of Toledo years were studying a protein called 14-3-3 zeta and its role in immune system pathologies. Previous studies have suggested the protein could be a possible trigger for rheumatoid arthritis (RA) and other autoimmune conditions that cause pain, inflammation and bone erosion.

But researchers found just the opposite. The team discovered that 14-3-3 zeta proteins may actually help prevent arthritis. When they removed the proteins through gene-editing technology, it caused severe early onset arthritis in laboratory animals.

Realizing that the proteins may be beneficial, the team developed an experimental vaccine using purified 14-3-3 zeta protein grown in a bacterial cell. They found the vaccine promoted a strong, immediate and long-lasting response in rodents that protected them from RA.

"Much to our happy surprise, the rheumatoid arthritis totally disappeared in animals that received a vaccine," said Ritu Chakravarti, PhD, an assistant professor at UToledo College of Medicine and lead author of research published in the journal Proceedings of the National Academy of Sciences. "Sometimes there is no better way than serendipity. We happened to hit a wrong result, but it turned out to be the best result. Those kinds of scientific discoveries are very important in this field."

In addition to suppressing the immune system response, the vaccine also significantly improved collagen content and bone quality — findings that suggests there could be long-term benefits following immunization.

Currently, rheumatoid arthritis is treated with steroids or medications that suppress the immune system, such as biologics and biosimilar drugs. While those therapies can alleviate pain and reduce inflammation, they can also make patients more vulnerable to infection and, in the case of biologics, are expensive. Biologic drugs can cost $25,000 a year.

“We have not made any really big discoveries toward treating or preventing rheumatoid arthritis in many years,” Chakravarti said. “Our approach is completely different. This is a vaccine-based strategy based on a novel target that we hope can treat or prevent rheumatoid arthritis. The potential here is huge.”

RA affects about 1.5 million Americans and about one percent of the global population. Women experience RA at a rate three times greater than men, have more severe symptoms and increased disability.

“In spite of its high prevalence, there is no cure and we don’t entirely know what brings it on. This is true of nearly all autoimmune diseases, which makes treating or preventing them so difficult,” said Chakravarti. “If we can successfully get this vaccine into the clinic, it would be revolutionary.”

Chakravarti and her colleagues have filed for a patent on their discovery and are seeking pharmaceutical industry partners to fund more research and preclinical trials.

FDA Approves Another Expensive Migraine Drug

By Pat Anson, PNN Editor

The highly competitive and lucrative market for migraine drugs will grow more crowded this month when AbbVie introduces Qulipta (atogepant), an oral CGRP medication developed for the prevention of episodic migraines.

The Food and Drug Administration approved Qulipta after seeing the results of a Phase 3 clinical trial that found the drug was 50 to 100% effective in preventing migraines.

"During the trial while taking Qulipta, I had many fewer migraine days. For the first time ever, I don't have difficulty doing my daily activities and I don't have to worry as much that a migraine attack will cause me to miss important events with family and friends," said Kelsi Owens, a trial participant who has lived with migraine for nearly three decades.

Like other CGRP inhibitors, Qulipta blocks proteins called calcitonin gene-related peptides from binding to nerve receptors in the brain and causing migraine pain. Since 2018, the FDA has approved over half a dozen CGRP medications, most of which are injected monthly.

Qulipta is a pill meant to be taken daily that comes in three different doses. Like other CGRP inhibitors, Qulipta is expensive. The wholesale price for a patient without insurance is $991 for 30 pills, according to Abbvie. Insured patients or those enrolled in an AbbVie patient support program will pay less.     

"Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients," said study investigator Peter Goadsby, MD, a neurologist and professor at University of California, Los Angeles. “I'm particularly encouraged by the convenience of the oral daily use of Qulipta, its rapid onset of significant efficacy, and its safety and tolerability as well as its high patient response rates.”   

Qulipta is expected to compete directly with Nurtec, an oral CGRP inhibitor made by Biohaven Pharmaceuticals that is approved for both migraine prevention and treatment. A supply of eight Nurtec tablets costs about $941, depending on insurance coverage. Since it was introduced in 2020, Nurtec has generated about $200 million in revenue for Biohaven, with over 750,000 prescriptions filled.

AbbVie says Qulipta will be available in early October. Wall Street analysts project Qulipta sales will reach $1 billion by 2030.

Side effects from Qulipta include nausea, constipation, fatigue and loss of appetite. AbbVie is currently conducting a clinical trial to seek if Qulipta should also be approved for the prevention of chronic migraine – patients who have 15 or more headaches per month.

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

What Pain Patients Should Know About the GABA Neurotransmitter

By Forest Tennant, PNN Columnist

“GABA” is short for the neurotransmitter, gamma aminobutyric acid. GABA is the natural (endogenous) biochemical substance in the brain, spinal cord, and all nerves that control electrical conduction.

Without proper GABA function, we experience pain. New research also shows that low levels of GABA make it harder to keep negative emotions such as fear, worry, anxiety and depression in check. 

All Intractable Pain Syndrome (IPS) patients have nerve damage somewhere in their brain, spinal cord, or nerves. Consequently, IPS patients will either need extra GABA or a GABA surrogate to force damaged nerve tissue to correctly function and relieve pain. 

GABA Surrogates

Without realizing it, you may already be taking a GABA surrogate. And you may have found that your pain gets worse without one. Here are the most effective prescription surrogates:

• Gabapentin (Neurontin)

• Carisoprodol (Soma)

• Diazepam (Valium)

• Alprazolam (Xanax)

• Lorazepam (Ativan)

There are also herbs and amino acids available without a prescription that can be used as GABA surrogates:

• Valerian root

• Ashwagandha

• Taurine

• Brahmi

• Bacopa

Glutamine: GABA’s Precursor

The term “precursor” refers to nutrients or raw material that help make a neurotransmitter. Glutamine is the precursor of GABA. A dose of 2000 mg or more of glutamine a day when taken on an empty stomach with vitamin B6 (2mg or more), will increase your natural level of GABA and probably reduce your pain levels. 

Pure GABA is available as a tablet, capsule or in sublingual (under-the tongue) form in most health food stores or online. Unfortunately, when swallowed in tablet or capsule form, GABA may be digested just like food or fail to cross the blood-brain barrier, and be rendered ineffective.

But sublingual GABA is well absorbed by the body and should be given a thorough trial by every person with IPS. You can take 100 to 300mg sublingual GABA to treat pain flares, or 100 to 200mg of GABA simultaneously with an opioid medication or GABA surrogate for added pain relief.

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 gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.