Telehealth Offers More Convenience and Options to Rural Patients

By Crystal Lindell

I live in rural northern Illinois, near the Wisconsin border, which means like a lot of people in my area, I cross the state line to get most of my medical care. 

My location also meant that when telehealth appointments became more common post-2020, I wasn’t allowed to do the call from my house. Hospital administrators told me that I had to be within the state of Wisconsin to see my doctor. 

Thus, anytime I had a telehealth video call, I got in my car and drove about 45 minutes north across the Wisconsin border – all so I could park my car at a truck stop and call the doctor. 

My doctor’s actual office is another 45 minutes away, so this method was still preferable to driving 90 minutes each way to see him in person. But it wasn’t ideal, especially in the winter. I remember being completely bundled up with a hat and a hood covering my head, trying to tell my doctor about my current health status as horns from semi trucks blared in the background. 

Yes, I probably could have just lied and taken the telehealth call closer to my house, but aside from the fact that I don’t like lying, I also didn’t know if the hospital’s telehealth software had GPS that could locate where I was. I didn’t want to risk it. As a patient who takes a controlled substance medication, I don’t have the luxury of bending rules, lest I get in trouble and potentially even risk my prescription.  

Thankfully, after doing this driving slog for a few telehealth appointments, something was worked out between Wisconsin and Illinois to where I am now able to do telehealth appointments from my home. And because a lot of doctor appointments for my chronic health condition are just check-ins, I have to tell you – telehealth is amazing. 

I truly love that it not only saves me from a long drive for appointments, it also means I don’t have to be exposed to whatever germs may be circulating at my doctor’s office. If there was any good to come from COVID, it’s that it finally pushed telehealth into the mainstream. 

Of course, with each advancement comes consequences. A recently updated study published in the Review of Financial Studies found some potentially bad news about telehealth: It hurts rural hospitals and medical providers, many of whom are already struggling.  

The researchers found that as rural patients opt for telehealth appointments with urban healthcare providers, rural healthcare systems lose patients. Then things start to spiral downward, as the loss of patients means they have less money to invest in both capital and staffing, which means they offer even fewer services. Then they lose even more patients to urban telehealth providers. 

“Rural hospitals are losing, on average, a lot of money,” says co-author Zihan Ye, assistant professor of finance at the University of Tennessee at Knoxville.

Ye says patients who choose remote healthcare primarily because of convenience should consider the long-term financial ramifications, as should policymakers who have the power to influence which providers can afford to offer telemedicine at all.

However, I have to point out, that’s a big ask for sick people. It should not be the job of patients to consider the “long-term financial ramifications” of providers. 

I would love to have a healthy, functional rural healthcare provider closer to me, but I also would counter that rural healthcare abandoned us long before we resorted to telehealth. 

I don’t drive 90 minutes each way to see my doctors because I enjoy road trips. I have been doing it since 2013 – long before telehealth appointments were a feasible option. 

And I do it because I tried and failed to find a doctor closer to me, who could handle the complex medical needs that come with having a chronic illness. Even if I could have found a primary care doctor near me, there aren’t many specialists in my area and there haven’t been for a long time.  

Ideally, governments and hospital systems will work to expand rural healthcare networks over the coming years. But patients, unfortunately, can’t count on that happening. Until we see real progress, the answer seems pretty straightforward: Using the tools we have right now to solve the problems we face today. 

For many rural patients, that means using telehealth appointments to their full potential. Even if it means sometimes attending them in a truck stop parking lot. 

'Screaming Woman' May Have Died in Agony 3,000 Years Ago

By Pat Anson

The ancient Egyptians were well practiced in using natural substances as medicine. Opium was used as an analgesic and to help people sleep. Willow tree bark (later used to develop aspirin) was used as an anti-inflammatory and pain reliever. Extracts from carob trees were used as antidepressants. And they rubbed moldy bread on infected wounds centuries before penicillin was discovered.

“The range of conditions treated and the various conservative and surgical treatments used are astounding,” a German oncologist wrote after spending a year studying the history of Egyptian medicine.

But those ancient remedies failed when it came to treating a middle-aged Egyptian woman who apparently died in agony 3,000 years ago. Her mummy was discovered in 1935 and soon became known as the “Screaming Woman” because her mouth was wide open, as if locked in a permanent scream.

Only recently have researchers used CT scans and other advanced imaging techniques to “virtually dissect” her body and learn more about her life and death. Their findings were recently published in Frontiers in Medicine.

“The Screaming Woman is a true ‘time capsule’ of the way that she died and was mummified,” said lead author Sahar Saleem, MD, a professor of radiology at Kasr Al Ainy Hospital of Cairo University.

Saleem and her colleagues estimate the woman was about 48 years old at the time of her death and suffered from mild arthritis of the spine.

Her body was unwrapped and in good condition – for a mummy – laying on her back, with her legs extended and her hands folded over her groin, with no obvious sign of injury or trauma.

Unlike other mummies, the woman still had all of her internal organs, including the brain, heart, lungs and kidneys, which are normally removed during the embalming process. She was missing several teeth, which were apparently removed before her death because her mouth had time to heal.

“Teeth lost during life may have been extracted. Dentistry had originated in ancient Egypt, with Hesy Re the first recorded physician and dentist in the world,” said Saleem.

Access to a dentist and the fact that the woman was embalmed in juniper and frankincense -- costly materials that were imported -- suggest she came from a wealthy family. She was wearing two gold and silver rings when her coffin was found and had a lengthy wig made from palm fibers. 

Researchers were unable to determine a cause of death, but speculate that she died during extreme physical or emotional pain that made her scream. Rigor mortis may have quickly set in after her death, locking her facial muscles and ligaments in place.

“The mummy's screaming facial expression in this study could be read as a cadaveric spasm, implying that the woman died screaming from agony or pain,” said Saleem.

Cadaveric spasm is a rare form of muscular stiffening, typically associated with violent deaths under extreme physical conditions and intense emotion. Other academics might dispute that interpretation, because decomposition or embalming could also alter a body’s facial expression.

“The true history or circumstances of the death of the woman… are unknown; hence, the cause of her screaming facial appearance cannot be established with certainty,” researcher concluded.

FDA Warning About Kratom Death Challenged by Critics

By Pat Anson

The FDA is warning consumers not to ingest a liquid kratom extract after the death of one person and “many reports” by users of other serious adverse events, including withdrawal, addiction, anxiety and aggressive behavior.

The FDA’s July 26th alert about Black Liquid Kratom, which is made by Optimized Plant Mediated Solutions (OPMS), contained no details about the death or any of the adverse events. It was soon challenged by the American Kratom Association (AKA), which said the “mistaken and misguided safety alert” should be withdrawn until the FDA independently verified claims about the death.   

In recent years, kratom has become a popular supplement in the United States, where it is used by millions of people to self-treat their pain, anxiety, depression and substance use problems. Although legal in most states, kratom has never been approved for medical use by the FDA.

“Products containing kratom have been marketed as foods, including dietary supplements, or drugs with claims of therapeutic benefits. However, the FDA has not approved any prescription or over-the-counter drug products containing kratom or associated compounds, mitragynine and the more potent metabolite, 7-OH mitragynine,” the alert warned.

“The FDA recently received an adverse event report of a person who died after using OPMS Black Liquid Kratom. This is one of many reports of serious adverse events individuals have reported experiencing after consuming OPMS Black Liquid Kratom.”

The agency released no other information about where or when the death occurred. Only one death involving 7-OH mitragynine is recorded on the FDA’s Adverse Events Reporting System. That case was reported in 2023, but the death may have occurred earlier.

In 2021, a Georgia man died after consuming Black Liquid Kratom. An autopsy concluded that 23-year old Ethan Pope died from cardiac arrest due to mitragynine intoxication. Pope’s family has filed a wrongful death lawsuit against OPMS, the AKA and other kratom vendors.

Kratom is normally sold as a dry unadulterated powder, but Black Liquid Kratom is a highly concentrated 50:1 extract containing up to 375mg of mitragynine — an alkaloid that acts on the same receptors in the brain as opioids.

A kratom vendor that sells Black Liquid Kratom warns the extract is “too strong for use on a daily basis.”

If the 2021 Georgia death is the one FDA is referring to in its safety alert, it raises questions about why the agency waited so long to warn consumers about the extract or why it was never recalled. Black Liquid Kratom can still be purchased from a number of kratom vendors.

"The consistently unreliable and often false statements about kratom issued by the FDA over the past decade, which is a part of its relentless and misguided pursuit of banning kratom products that is not supported by reliable science, are wrong and Commissioner Califf should hold his agency fully accountable," Mac Haddow, Senior Fellow on Public Policy at the AKA, said in a statement.

"The various autopsy reports that have claimed that kratom is the sole cause of deaths have been thoroughly refuted as incomplete, poorly documented, hastily concluded, or demonstrably incorrect."

Alert ‘Coordinated’ by Trial Attorneys

In 2016, the FDA and DEA tried unsuccessfully to ban kratom products nationwide by listing it as a Schedule I controlled substance. An Assistant Secretary for Health in the Trump administration withdrew the FDA’s scheduling request in 2018, saying it was based on “embarrassingly poor evidence & data.”

The AKA characterized the FDA’s alert as another effort to demonize kratom that was being “coordinated” by trial attorneys seeking to cash-in on product liability lawsuits. A New York law firm even cites the alert on its website, telling kratom users that it was “ready to represent you in your injury case.”

“Plaintiff’s trial attorneys have been openly encouraging clients and other anti-kratom advocates to submit complaints to the FDA on alleged deaths over the past few months and have taken to social media platforms to solicit others to do so. The FDA ‘safety alert on kratom’ appears to be the result of a coordinated effort by those trial attorneys who have a financial interest in litigation against the very company the FDA’s safety alert identifies,” the AKA said.

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps reduce the use of opioids, and has a low risk of adverse effects. Hundreds of deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  

A toxicology test on Ethan Pope found antihistamines and antidepressants in his system, but no illegal drugs or alcohol. The Georgia Bureau of Investigation classified his death as an accident.

The Link Between Collagen Deficiency and Arachnoiditis

By Dr. Forest Tennant

A major finding in our studies of adhesive arachnoiditis (AA) is that most AA patients also have hypermobile Ehlers-Danlos syndrome (hEDS) or a related disorder now called hypermobile spectrum disorder (HSD).

AA is a chronic inflammatory condition that causes nerves in the spinal canal to form adhesions that “glue” them together, while hEDS and HSD cause deficiencies in collagen and the immune system.

How are these conditions connected?

Normal collagen is in thick strands that hold connective tissues together and helps resist infections, tearing, and autoimmune degeneration. When collagen is deficient, the strands may be thin, broken, shortened or non-existent. This allows viruses and bacteria to invade, infiltrating tissues and causing more infections than in individuals with healthy immune systems.

Spinal tissue normally contains considerable amounts of collagen, but in patients with hEDS or HSD they are weak and susceptible to deterioration, inflammation, adhesions and scarring. These spinal tissues include intervertebral discs, vertebrae, spinal canal cover (dura and arachnoid layers), ligaments, and cauda equina nerves.

Weaknesses in spinal tissue make persons with hEDS and HSD more susceptible to AA. It’s also not uncommon for them to develop one or more of these conditions before AA:   

• Tavlov cyst

• Spinal fluid leaks

• Chiari

• Tethered spinal cord

• Herniated disc

• Back pain

• Neck pain

• Spinal arthritis

We have found that persons with hEDS and HSD are also susceptible to Lyme disease, cytomegalovirus, herpes 6 virus, and especially the Epstein-Barr virus (EBV). Almost everyone has EBV, which is typically dormant, but the virus may reactivate from its parasitic life in throat membranes or lymphocytes to infiltrate the brain and spinal tissues.

Persons with hEDS or HSD who have back or neck pain for over 90 days should be screened with the new EBV 4 panel test and take measures to hopefully prevent AA. We highly recommended that they take collagen supplements.

In our studies of patients with MRI-documented AA, essentially 100% have EBV autoimmunity and about 70% show EBV reactivation. About half of those that we review do not know they have hEDS or HSD.

For more details on the link between AA, hEDS and HSD, our new book "The Ehlers-Danlos / Arachnoiditis Connection" is recommended.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis.

Readers interested in learning more about this research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can also subscribe to its bulletins here.  

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

AI in Healthcare: Designed for Progress or Profit?

By Crystal Lindell

As a pain patient, I take a controlled substance medication, which means every single time I need a refill I have to contact my doctor. 

It doesn’t matter that this refill comes every 28 days and that I have been getting it refilled every 28 days for years. It doesn’t matter that my condition has no cure, and that I will most likely need this medication refilled every 28 days for the foreseeable future.

No. I have to make sure to contact my doctor and specifically ask for it, every single time.  

There are ways to automate this process. They could give me a set number of automatic refills and have them sent to the pharmacy every 28 days. If we were even more practical, they could just give me 60 to 90 days worth of pills at a time, and save me from multiple trips to the pharmacy. 

But because of insurance rules, hospital policies and opioid-phobia legislation, all of those options are impossible. In fact, they actively work to make a process that could be automated into something that has to be done manually. 

Which is why I’m so skeptical of Artificial Intelligence (AI) in healthcare. 

The promise of AI is that it can automate away the mundane tasks so many of us hate doing. Many health related tasks could easily be automated. They just purposefully are not. 

The hospital I go to for my medical care, University of Wisconsin-Madison, recently released a report filled with recommendations for how AI should be integrated into healthcare. It was based on a recent roundtable discussion that included healthcare professionals from across the country. 

But while the participant list included doctors, IT staff, policy experts, and academics, there was one very glaring absence – the list of participants included exactly zero patients. 

UW Health was one of the organizers for the panel, along with Epic, a healthcare software developer. Their report includes some seemingly good recommendations. 

They ask that AI be used to supplement the work that doctors, nurses and other healthcare staff perform, as opposed to replacing the staff altogether. They say AI could be a great tool to help reduce staff burnout. 

They also recommend that the technology be set up in such a way that it also helps those living in rural areas, in addition to those in more metropolitan ones. The report also emphasizes that healthcare systems should prioritize “weaving the technology into existing systems rather than using it as a standalone tool.”

Additionally, the report stressed the need for federal regulations to “balance space for innovation with safeguarding patient data and ensuring robust cybersecurity measures.”

I don’t disagree with any of that. But it’s a little frustrating to see those recommendations, when some of those problems could already be solved if we wanted them to be. 

And while the panel’s report is new, UW Health’s use of AI is not. 

In April, UW Health announced that they were participating in a new partnership program with Microsoft and Epic to develop and integrate AI into healthcare. 

At the time they said the innovation would be focused on “delivering a comprehensive array of generative AI- powered solutions… to increase productivity, enhance patient care and improve financial integrity of health systems globally.”

That’s the real motivation to bring AI into healthcare: make more money by improving “financial integrity.” Something tells me that AI won’t be used to lower patient’s bills though. 

UW Health also recently shared that its nurses were using AI to generate responses to patients. Over 75 nurses were using generative AI, which assisted them in creating more than 3,000 messages across more than 30 departments.

“This has been a fascinating process, and one I’ve been glad to be part of,” said Amanda Weber, registered nurse clinic supervisor, UW Health. “I have found having a draft to start from helpful, and I’m glad I could provide feedback on improvements and features to ensure this can be a good tool for nurses and have a positive impact on our patients.”

Before I even knew about this program, I had a feeling that AI was involved. 

Recently, when I messaged my doctor about my upcoming refill, I received an overly-formal, odd response that felt very much like generative AI writing to me. Which is fine. I honestly don’t mind if my doctor saves time by using AI to respond to patient emails. Heck, I myself have used AI to write first drafts of some emails. 

But my doctor and his staff wouldn’t even need to reply to my emails if he was allowed to set up automatic refills of my long-time medication instead. 

There are many ways to improve health care, and tools like generative AI are likely among them. But AI can’t solve problems that exist on purpose. 

Unless patients are at the forefront of the conversations about these tools, I fear they’ll only be used to solve the sole problem hospital administrators actually care about: how to make more money. 

What Doctors Really Mean When They Say It’s an ‘Easy Surgery’

By Crystal Lindell

Back in 2009, I had an “easy surgery” to get my gallbladder removed after multiple excruciating gallbladder attacks. Before the operation, my surgeon went on and on about how easy the surgery would be. He emphasized multiple times how simple it was.

I went into that operating room completely underestimating what I would experience when I came out of the anesthesia. 

I woke up from that surgery vomiting so much that the single hour I was scheduled to spend in post-op recovery turned into eight hours. And instead of the three days I was told that I’d need for recovery at home, I spent seven days in excruciating pain, unable to get off the couch without wanting to scream. 

That’s when I realized that a “simple” surgery just means simple for the doctor to perform. It’s also when I started to realize that this logic applies to all the ways doctors explain health issues. 

In fact, when doctors describe any health issues, they aren’t talking about the patient’s experience at all – they are talking about how they themselves experience it. They love to use terms like mild, simple, and easy. But patients should understand that they are not describing the patient experience when they say these things. 

Mild case of the flu? That just means they don’t have to see you in person to treat you. But it could still mean you’re unable to get out of bed for a month. 

Easy surgery? That means it’s easy for them to perform. It has no relation to how difficult recovery will be for you. 

Post-op discomfort? Yeah, it’s super uncomfortable for the doctor to have to see you in so much excruciating pain before they send you home in agony. 

This even applies to the ways doctors often describe medications. They’ll often say a prescription is “a very strong drug” – but only because it’s difficult for them to prescribe because of things like health insurance denials and DEA paperwork. Meanwhile, the side effects from what they call a “common” generic medication could ruin your body and your life. 

This is a lesson that patients often have to learn the hard way. I have. But now, as someone with a chronic illness, I understand. 

While I have only been hospitalized overnight one time since I first got really sick in 2013, doctors would tell you this means I have a “mild” case of intercostal neuralgia and that my Ehlers-Danlos Syndrome is “mild.”

Yet chronic pain and EDS have impacted every single aspect of my life. From my career, to my love life, to how often I’m able to shower. It’s impacted what clothes I can wear because tight shirts are so painful that I can’t leave the house if I try to wear them. I’ve had to quit jobs because I couldn’t work through the pain. And the guy I was dating when I first got sick eventually broke up with me because my health issues were too much for him to handle.

Hearing doctors describe my health issues as “mild” feels both insulting and disorientating. But worse than that, it can also impact how willing doctors are to investigate and treat my health problems. It’s likely why, despite how urgent chronic pain has been for me from the start, it still took doctors five full years to even diagnose me with Ehlers-Danlos Syndrome. As long as I didn’t need emergency medical care, there was no rush on their end. 

I’m not sure it’s worth it for patients to push back on these types of health descriptors. In my experience, it doesn’t usually change how doctors are responding to you. But understanding it yourself – knowing that how a doctor describes your health problem isn’t necessarily indicative of how severe it is to experience it as the patient – can itself be freeing. 

And sometimes, you may even run into a good doctor, who makes this type of thing clear to you as a patient. They are rare, but they do exist. 

You can also take comfort in the fact that if the doctors who don’t make it clear to the patient ever have to endure what you’ve been through, they will come to understand how inaccurate and insulting their descriptors were. Afterall, nothing about something like surgery is ever easy for the patient.

New Non-Opioid Analgesic Gets Priority Review from FDA

By Pat Anson

The Food and Drug Administration could approve an experimental non-opioid analgesic early next year, potentially making it the first new medication for acute pain in over two decades.

Vertex Pharmaceuticals says the FDA has accepted its New Drug Application for suzetrigine, giving the drug a priority review with a target action date of January 30, 2025. Suzetrigine has previously been granted FDA Fast Track and Breakthrough Therapy designations for the treatment of moderate-to-severe acute pain.

“Today’s FDA filing acceptance for suzetrigine marks a critical milestone toward bringing this new, transformative non-opioid analgesic to the millions of patients,” Nia Tatsis, PhD, an Executive Vice President and Chief Regulatory and Quality Officer for Vertex, said in a statement.

“The FDA’s granting of a priority review further reinforces the high unmet need in treating acute pain, and the filing brings us one step closer to our objective of filling the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.”

Suzetrigine is designed to block pain in the peripheral nervous system, rather than the brain. That means it won’t have the “liking” effects of opioids or be as addictive.  

In Phase 3 clinical studies, suzetrigine was more effective in reducing post-operative pain than a placebo after minimally invasive surgeries.  Over 80% of patients rated suzetrigine as good or excellent in treating acute pain, but it was not more effective than a combination of the opioid hydrocodone and acetaminophen, more commonly known as Vicodin.

Vertex hopes suzetrigine will eventually be approved for a variety of pain conditions, not just post-operative pain.  The company has been studying the drug as a treatment for pain caused by diabetic peripheral neuropathy.

“In my 24 years practicing medicine, I have seen firsthand the desperate need for new non-opioid therapies for treating pain. Too many people today are either undertreated, dealing with negative side effects of currently available therapies or foregoing pain medications altogether for fear of becoming dependent on opioids,” said Scott Weiner, MD, a Vertex consultant and Associate Professor of Emergency Medicine at Harvard Medical School.

The Biden Administration has been under pressure from lobbyists, politicians and anti-opioid activists to have the FDA approve more non-opioid medications like suzetrigine. The new analgesics are expected to be far more expensive than opioids and other older pain relievers.

If the FDA approves suzetrigine in January, it will coincide with implementation of the NOPAIN Act, which will expand access to non-opioid analgesics in outpatient surgical settings by making them eligible for higher Medicare reimbursement rates.

Mental Health Needs of Chronic Pain Patients Often Go Untreated

By Pat Anson

People who live with chronic pain often experience anxiety and depression, but they are far less likely to have access to mental healthcare in the U.S. than those who do not have persistent pain, according to a new study.

Nearly 52 million American adults have chronic pain – about one in every five. Over 43% of them have a need for mental health treatment, compared to just 17.4% of adults who do not have chronic pain.

“People living with chronic pain may form a distinct population with special mental health care needs,” said lead author Jennifer De La Rosa, PhD, strategy director for the University of Arizona Health Sciences Comprehensive Center for Pain & Addiction. “Improving health care for people with chronic pain includes not only connecting people to care, but also addressing a disproportionate failure to achieve relief.”

De La Rosa and her colleagues reviewed findings from the 2019 National Health Interview Survey, which collected health information from a representative sample of nearly 32,000 U.S. adults. Their findings, recently published in the journal PAIN, show that just 44.4% of those with chronic pain, anxiety and depression had their mental health issues adequately treated, compared to 71.5% of those without pain.

“There are many possible reasons an individual with chronic pain might have suboptimal mental health experiences, including the accessibility of care and the feasibility of attending appointments,” De La Rosa said in a statement. “Additionally, few mental health providers are trained in chronic pain, so only a small percentage of people living with chronic pain are likely receiving mental health treatment that is designed to address their needs.”

It is not specifically addressed in the U of A study, but many patients on opioid pain medication no longer have access to benzodiazepines – a class of anti-anxiety medication that includes Xanax and Valium. Once commonly prescribed together, insurance companies and medical guidelines now strongly discourage that practice, due to fears that the two drugs raise the risk of an overdose.

In 2016, the CDC warned doctors to avoid co-prescribing opioids and benzodiazepines “whenever possible.” That same year, the FDA updated its warning labels to state that taking the drugs concurrently could result in “profound sedation, respiratory depression, coma and death.”

Even when mental health medications or therapy are offered, pain patients may be reluctant to accept them.

“Some patients may interpret mental health screening as potentially discrediting perhaps reflecting provider's doubts as to the legitimacy of self-reported pain,” the U of A researchers said. “Patients may also fear that acknowledging mental health comorbidity will reduce the likelihood of being prescribed opioids. The heightened mental health treatment stigma experienced by patients with chronic pain may lead many patients to resist the conceptualization of their chronic pain as having any emotional or mental components.”

A recent study by the same research team estimated that 12 million U.S. adults with chronic pain have  anxiety or depression so severe that it limits their ability to work, socialize and complete daily tasks. To improve patient outcomes, researchers say the routine evaluation of pain patients for anxiety and depression should become “a cornerstone of mental health policy.”

AARP Should Stop Blaming Pain Patients for the Opioid Crisis

By Carol Levy

Toast and jam. Cake and coffee. Peanut butter and jelly. Pain patients and the opioid crisis.

One of these things is not like the others. But to most people, they all go together. Even when research shows little correlation between opioid prescriptions and overdose deaths.

We’ve been hearing that same old tired narrative for years, often from “experts” who speak with absolute certainty.

“Two major facts can no longer be questioned. First, opioid analgesics are widely diverted and improperly used, and the widespread use of the drugs has resulted in a national epidemic of opioid overdose deaths and addictions,” Nora Volkow, MD, Director of the National Institute on Drug Abuse, and Thomas McLellan, PhD, founder of the Treatment Research Institute and a scientific advisor to Shatterproof, wrote in a joint op/ed in The New England Journal of Medicine in 2016.

“Second, the major source of diverted opioids is physician prescriptions. For these reasons, physicians and medical associations have begun questioning prescribing practices for opioids, particularly as they relate to the management of chronic pain.”

We now know that prescription opioids play a minor role in the overdose crisis and that only about three-tenths of 1% are actually diverted. Illicit fentanyl and other street drugs are responsible for the vast majority of overdose deaths, not pain medication.

But the same tired and misinformed narrative continues, with patients who need opioids paying the price when their doses are reduced or taken away.

Recently, the American Association of Retired Persons released an AARP bulletin, with the main headline being “The War on Chronic Pain.” Wow!  I was excited. Maybe some new information that I can use?

My heart sank as I read the article and quickly came upon these words: “Our attempts to treat chronic pain with medication have led to an opioid abuse epidemic so severe that overdoses are now among the leading causes of death for adults ages 50 to 70. “

The stereotype wins again. Prescription opioids caused the crisis.

I was curious to see what else AARP had to say about pain management and found several articles over the years with a glaringly obvious bias against opioids.

“Americans over 50 are using narcotic pain pills in surprisingly high numbers, and many are becoming addicted,” a 2017 AARP article warned. “A well-meant treatment for knee surgery or chronic back troubles is often the path to a deadly outcome.”

The article went on to claim that older Americans had become “new opioid dealers” who fueled the opioid crisis by “selling their prescription painkillers to drug pushers.”

A 2019 AARP article took a more nuanced approach to pain, claiming that “science was homing in on better ways to treat it,” such as non-opioid drugs, exercise and cognitive therapy.

“If the opioid crisis has provided an excellent example of how not to treat chronic pain, advances in brain science are leading to a fuller understanding of how to more safely find solutions,” AARP said.

Five years later, science has brought us no real solutions. Opioids are still the most potent and reliable medications for pain. For patients in severe pain, they are often the only treatment that works.

The sad part is, if AARP had simply asked the American Medical Association, they would have found that prescription opioids are not the main cause of overdoses and deaths.

In 2021, the AMA reported that opioid prescriptions had fallen by over 44%, yet drug overdoses and deaths were still rising. “The nation’s drug overdose and death epidemic has never just been about prescription opioids,” said then-AMA President Gerald Harmon, MD.

In a 2023 report, the AMA warned again that “reductions in opioid prescribing have not led to reductions in drug-related mortality.”

Why is that not worth including in AARP’s latest sensational reporting on the opioid crisis?

I read this line the other day: “There is no word for infinite pain.” That rings very true for me, probably for many of us. Chronic pain often does not end. We may have a diagnosis, some condition or disorder that causes pain, but there is no good word for pain that is unending and unrelenting.

AARP’s continuing portrayal of many seniors as addicts or drug dealers pushing “narcotic pain pills” is not helpful. Repeatedly labeling us like that has had devastating consequences on pain patients around the country. 

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here. 

It’s All In Your Head: How Brain Circuitry Causes Placebo Effect

By Crystal Lindell

The placebo effect is very real. But how and why it happens has mostly remained a mystery. 

However, new research may shed light on what exactly is happening in our brains when just the expectation of pain relief is sufficient for people to feel better, even when the pill or treatment they’re taking has no therapeutic value.

The discovery may even lead to new treatment options. 

In studies on laboratory mice, researchers at the University of North Carolina School of Medicine discovered a pain control pathway that links the front of the brain, through the middle region of the brainstem, to the cerebellum in the back of the brain.

They then showed that certain parts of this pathway are activided in mice when they anticipate pain relief. 

“Our results do open the possibility of activating this pathway through other therapeutic means, such as drugs or neurostimulation methods to treat pain,” says lead researcher Greg Scherrer, PharmD, associate professor in the UNC Department of Cell Biology and Physiology, who conducted the study along with colleagues at Stanford, the Howard Hughes Medical Institute, and the Allen Institute for Brain Science. 

The research, recently published in the journal Nature, provides a new framework for investigating the brain pathways underlying other mind-body interactions beyond the ones involved in pain.

“We all know we need better ways to treat chronic pain, particularly treatments without harmful side effects and addictive properties,” Scherrer said. “We think our findings open the door to targeting this novel neural pain pathway to treat people in a different but potentially more effective way.”

How Scientists Studied Placebo Effect

The placebo effect is basically the brain’s way of trying to help us feel better. As such, just the expectation of pain relief is often enough to make our brains release hormones and natural chemicals that provide relief. Positive thinking and even prayer have been shown to provide similar benefits to patients, without the use of medication. 

The scientific community’s understanding of the placebo effect primarily came from human brain imaging studies, which showed increased activity in certain brain regions. However, those studies did not have enough precision to show what was actually happening in those brain regions. 

So Scherrer’s team designed a set of complex experiments to learn in more detail what was happening in the brain.

First, they created a method to generate in mice the expectation of pain relief. Then they used a series of experiments to study the anterior cingulate cortex (ACC) of their brains, which had previously been associated with the placebo effect. 

The experiments helped them see the intricate neurobiology of the placebo effect on the receptors, neurons, and synapses of the brain. When mice expected pain relief, it boosted signaling along the pain pathway.

“There is an extraordinary abundance of opioid receptors here, supporting a role in pain modulation,” Scherrer said. “When we inhibited activity in this pathway, we realized we were disrupting placebo analgesia and decreasing pain thresholds. And then, in the absence of placebo conditioning, when we activated this pathway, we caused pain relief.”

In a 2021 study, researchers had a similar breakthrough when studying the placebo effect. Researchers at Dartmouth University conducted an analysis of neuroimaging studies involving over 600 healthy people who participated in placebo studies. Their findings showed that placebo treatments reduced pain-related activity in multiple areas of the human brain.

FDA Approves Stem Cell Study for Degenerative Disc Disease

By Pat Anson

The Food and Drug Administration has given the go-ahead for a late-stage clinical trial of an injectable stem cell product that could give new hope to millions of patients suffering from lower back pain caused by degenerative disc disease (DDD).  Up to 400 patients with mild to moderate DDD are expected to enroll in the Phase 3 study later this year.

The trial is being conducted by DiscGenics, a Utah-based biopharmaceutical company that is developing new cell-based therapies for musculoskeletal conditions. It’s one of the first late-stage studies of a stem cell product to win approval from the FDA, which has been openly skeptical of cell-based therapies due to lack of evidence proving their safety and efficacy in clinical trials.

The only stem cell therapies currently approved by the FDA are used to treat sickle cell disease and some cancers. Approval of a stem cell product to treat degenerative discs would be a big step forward for regenerative medicine, and give patients an alternative to fusions and other more invasive spinal procedures.

“The FDA has been very familiar with our process, our product, and the chemistry, manufacturing and controls for quite some time,” says Flagg Flanagan, CEO and Chairman of DiscGenics. “We feel really good about where we are in terms of the patient reported outcomes. But most importantly about the safety. We feel like this cell is extremely safe to be used on human patients and we're feeling really, really good that we can help a lot of people.”

Discgenics’ injectable disc cell therapy (IDCT) is a single-injection biologic treatment designed to halt the progression of lumbar DDD by regenerating the disc “from the inside out.” The active ingredients in IDCT are enriched stem cells known as discogenic cells, which are derived from donated adult human disc tissue.

IDCT has been granted regenerative medicine advanced therapy and Fast Track designations by the FDA. Approval of the Phase 3 study came just weeks after Discgenics released positive results from a combined Phase 1/Phase 2 human trial of IDCT, published in the International Journal of Spine Surgery.

In that study, 60 patients with mild to moderate DDD were randomly assigned to receive an injection of either low-dose discogenic cells, high-dose cells, or a placebo. After one year, patients in the high-dose group had an average reduction in pain intensity of nearly 63 percent, along with significant improvements in their disability and quality of life. The regeneration of discs, which was monitored through MRIs and other imaging tests, was sustained two years after the injection.

“Things even came out a little better than we even expected,” Flanagan told PNN. “We showed very good durability, out to two years with the high dose patients. Anecdotally, we continue to follow some of those high dose patients and we have data in a pretty good cohort out to three years. We have a couple (patients) out to four years and the durability still seems to hold pretty well.”

The Phase 3 trial will consist of two parallel studies of IDCT that will also be randomized and placebo-controlled. Like the two earlier trials, each study will last for two years to assess the long-term safety and efficacy of IDCT. The first participants are expected to be enrolled in the final quarter of 2024.

“We'll start looking for patients and reviewing patient profiles that want to apply for the study shortly,” Flanagan said. “I think this is something where we can help many, many patients hopefully avoid a surgical intervention with an injection in a treatment room.”

People interested in getting updates on the Phase 3 IDCT trial or volunteering for it can submit their contact information to DiscGenics here.

Mesoblast, an Australian company specializing in regenerative medicine, recently began enrolling U.S. patients with chronic low back pain in a Phase 3 study of its proprietary mesenchymal stem cells, which are derived from young and healthy adult donors.

Long COVID Risk Declining, Mostly Due to Vaccinations

By Crystal Lindell

Rates of Long Covid appear to have declined over the course of the pandemic, according to new research from the Washington University School of Medicine. One reason is that people who are vaccinated against COVID-19 and its variants have about half the risk of developing Long Covid than those who are unvaccinated.

Long Covid refers to a wide range of symptoms that some people experience four or more weeks after an initial infection with COVID-19. Symptoms such as fatigue, body pain and shortness of breath may last for weeks, months or years, and can be mild or severe.  

While the new research only looked at COVID cases through 2022 – making it unclear how newer COVID strains and vaccines in 2023 and 2024 may be impacting Long COVID cases  – it does provide a ray of hope.

Specifically, researchers attributed about 70% of the risk reduction to vaccination against COVID-19 and 30% to changes over time, such as the evolving characteristics of SARS-CoV-2 and improved detection and management of COVID-19. The research was published in The New England Journal of Medicine.

“The research on declining rates of long COVID marks the rare occasion when I have good news to report regarding this virus,” said the study’s senior author, Ziyad Al-Aly, MD, a Washington University clinical epidemiologist and global leader in COVID-19 research. “The findings also show the positive effects of getting vaccinated.”

Although the latest findings sound more reassuring than previous studies, Al-Aly tempered the good news. 

“Long COVID is not over,” said the nephrologist, who treats patients at the John J. Cochran Veterans Hospital in St. Louis. “We cannot let our guard down. This includes getting annual COVID vaccinations, because they are the key to suppressing long COVID risk. If we abandon vaccinations, the risk is likely to increase.”

For the research, Al-Aly and his team analyzed millions of de-identified medical records in a database maintained by the Department of Veterans Affairs, the nation’s largest integrated health-care system. 

The study included over 440,000 veterans with SARS-CoV-2 infections and more than 4.7 million uninfected veterans. Patients included those who were infected by the original strain, as well as those infected by the delta and omicron variants. Some were vaccinated, while others were unvaccinated. 

The Long COVID rate was highest among those with the original strain, about one in every ten (10.4%). No vaccines existed while the original strain circulated.

The rate declined to 9.5% among those in the unvaccinated groups during the delta era and 7.7% during omicron. Among the vaccinated, the rate of Long COVID during delta was 5.3% and 3.5% during omicron.

“You can see a clear and significant difference in risk during the delta and omicron eras between the vaccinated and unvaccinated,” said Al-Aly. “So, if people think COVID is no big deal and decide to forgo vaccinations, they’re essentially doubling their risk of developing long COVID.”

Al-Aly also emphasized that even with the overall decline, the lowest rate — 3.5% — remains a substantial risk. 

“That’s three to four vaccinated individuals out of 100 getting long COVID,” he said. “Multiplied by the large numbers of people who continue to get infected and reinfected, it’s a lot of people. This remaining risk is not trivial. It will continue to add to an already staggering health problem facing people across the world.”

The World Health Organization has documented more than 775 million cases of COVID-19.

Disabled at Higher Risk of Long COVID  

The CDC recently found that Long COVID symptoms were more prevalent among people with disabilities (10.8%) than among those without disabilities (6.6%).

The new data was released as part of the CDC’s annual update to its Disability and Health Data System, which provides quick and easy online access to state-level health data on adults with disabilities.

The report found data that over 70 million adults in the U.S. reported having a disability in 2022.

Older adults reported a higher disability rate (43.9% for those aged 65 and older) compared to younger age groups. The race/ethnic groups with the highest rate of disability, regardless of age, identified as American Indian or Alaska Natives.

The CDC has fact sheets that provide an overview of disability in each state, including the percentages and characteristics of adults with and without disabilities. Click on any state listed here to view that state’s profile.

The findings underscore the fact that people with disabilities are a large part of every community and population.

Selling Us Short With Long COVID

By Cynthia Toussaint, PNN Columnist

After four years of diligently following CDC guidelines to avoid COVID-19 like the plague, it finally caught up with me. And, like my doctors presumed, I now have Long COVID.

That being said, two months into what I was assured would be worse than a living death, I have to shake my head at how colossally the powers that be underestimate the toughness of women in pain.

After my partner John and I had to cancel a 2020 dream trip to Iceland due to my cancer and the COVID shutdown, we bunkered down because my doctors said I had no wiggle room with chemotherapy – and that likely saved my life.

When I had remission from cancer a second time in 2022, those same doctors shared that while the COVID virus might no longer end me, I’d surely get Long COVID, which would leave me barely able to breathe or move for the rest of my life. This was backed up by many articles and programs that I devoured. I felt doomed.

These were some of my darkest, most dire years – which says a hell of a lot. Already isolated for 44 years from profound disability caused by Complex Regional Pain Syndrome, I felt ever more the odd one out, still wearing a mask and saying no to virtually every invitation.

But with time, the expert prognosis wasn’t adding up – as I watched most of my friends with pain and other chronic illnesses get COVID, only to recover and return to their baseline of “normal.”

Iceland was still beckoning – it’s glaciers, waterfalls, active volcanoes, charming capital city, unique horses and white nights. Come spring this year, my desire trumped all else. I yearned to be amongst the living again, so John and I booked a trip for early June.

We followed the recommended CDC guidelines for travelers, only to land in Iceland sick as dogs. So much for playing by the rules!

Being out of country, we didn’t have any COVID tests, and because we weren’t on our deathbeds as promised, we assumed we’d picked up a run-of-the-mill flu bug.

Flinging off our high temps, chills and fatigue (to name just a few of our symptoms), there was no staying in bed slurping chicken broth and taking Tylenol for us. We muscled on through our trip – and fell in love with this other-worldly land.

Testing Positive

A couple days after our return, John took what I considered a pointless COVID test – and I was floored when he shouted that we’d joined the ranks of the infected by testing positive. More surprising, on day ten of what was supposed to be a worse-than-death sentence, I was functioning fairly well. I could breathe fine and was swimming most of my laps. No hospital, no ventilator, no ICU, no death certificate.

Yes, I’ll give the docs a point or two, if you’re keeping score at home. Eight weeks post-infection, I’ve developed the aforementioned Long COVID, which has triggered my chronic fatigue syndrome, accompanied by a litany of life-compromising symptoms that ebb and flow.

Sometimes I feel fine and other times I uncharacteristically fall asleep from post-exertion malaise. I’m burdened by debilitating migraines and dizziness, and am still hoarse and wonder when I’ll be able to sing clearly again. Still, unless something changes drastically, long-hauling didn’t come as advertised.   

So now I’ve moved from fear of the worst to hope for better days ahead. But with that hope, I’m still mightily pissed off.

I’m livid that doctors and researchers put me into a catastrophic, doomsday mindset during the pandemic. The picture they painted for people like me -- with high-impact chronic illness and a cancer diagnosis -- was black as ink, with no exceptions.

I lived accordingly with terror, dread, fear, high-anxiety and isolation-induced depression. Missed holiday events, get-togethers and no traveling rounded out the experience.

Not being around people, while going through cancer twice, was the apex of these dark years. That inhumanity strained my ability to heal when I needed it most.

Humans are social creatures and inclusion is how we’ve evolved so that we can feel safe, contented and well. Without connection, our mental health suffers, which is just as important as our physical health.

I’m now critically reassessing the necessity of my “bunkering years.” Were they needed? Or did I spend four and a half years of my hard-fought-for life alone for no damn good reason?

CYNTHIA GREETS A FRIEND IN ICELAND

I recently met two lovely women, both with pain and autoimmune issues, who recovered from Long COVID in less than a year, no worse for the wear. I wonder why none of the experts told me that recovery was a possibility, even a likely one. Why was I only given the worst-case scenario? Safe to say if I’d had the facts, I would have poked my head out of the hole far sooner than I did. And when you’re still in the red zone with cancer, every day, every outing COUNTS.

While it’s super hard to watch friends and family recover quickly from COVID, while I trudge on sick and with no end in sight, we with high-impact pain know our lot is always a ton more challenging than normies. That’s money in the bank, a sure bet. Luckily, we’re experts at suffering and coming out the other side.  

But let’s not bury the lead. I’m freer than I’ve been in years. These days I’m doing less mask wearing, so bring on the intimate get-togethers in a cramped, under-ventilated house (ok, ok, maybe after the summer surge next to an open window.) Hugging, kissing and touching those near and dear are back on my to-do list.

Before COVID, John would joke: “I always know when Cynth’s worked a room – because everyone’s got lipstick on their face.” Going forward, look out for the high-gloss and ruby red.       

Whoa, Nelly! Let me be clear. How one takes on COVID is an individual experience – and I respect everyone’s choice. I know women in pain who’ve never put a mask on or vaccinated, and others who plan to mask-up for the rest of their lives while counting the days till the next booster.

We all need to do what makes us feel safe. And, like me, sometimes our choices change with time and information.       

My smile has a deeper meaning these days. Exiting my Y just after our return from Iceland, a friend I adore at the front desk, Solange, excitedly commented, “You look much better, Cynthia!”

I had to laugh, while sharing that I was still getting over COVID. When she quizzically stared, it then hit me. I wasn’t wearing a mask!

A moment of wow struck us both. I’ve known this woman for two years and we’ve shared countless conversations, but that was the first time she’d ever seen my face.              

Women in pain, we’re tougher than the rest. The doctors, the researchers, the experts, the “know-it-alls” always seem to sell us short, either under-protecting because they think we make a mountain out of molehill – or over-protecting because they don’t think we know what’s in our own best interest.

Screw ‘em. They don’t get us, never will. And a once-in-a-century pandemic isn’t going to knock us out. That’s something to smile about.   

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and multiple co-morbidities for over four decades, and has been battling cancer since 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.” 

Genes May Explain Why Gabapentin Works for Some Pain Patients

By Pat Anson

Over the years, gabapentin (Neurontin) has been prescribed for dozens of health conditions, from epilepsy and fibromyalgia to depression and post-operative pain. It’s even been used to treat bipolar disorder. Gabapentin has been marketed for so many different conditions – at times illegally -- that a pharmaceutical company executive infamously referred to the drug as “snake oil.”

Even though it’s been approved for medical use for over 30 years, the UK’s National Health Service admits it’s still “not clear exactly how gabapentin works.”

A new study may finally help explain why gabapentin is an effective pain medication for some patients and an addictive drug with unwelcome side effects for many others.

It could be all in the genes.

Researchers at the University of Edinburgh took another look at a previous study of women with chronic pelvic pain to see why gabapentin worked no better than a placebo for most, but was a moderately effective pain reliever for about 40% of them.

Researchers took saliva samples from 71 women who participated in the study -- 29 who responded to gabapentin and 42 who had no improvement -- and found that the responders were more likely to have a variation of the gene Neuregulin 3 (NRG3). The gene is primarily expressed in the brain, spinal cord and central nervous system, and helps regulate pain sensation and transmission.

The findings, recently published in the journal iScience, may explain why gabapentin works for some women with chronic pelvic pain.

"A genetic factor that can predict how well gabapentin will work in patients offers the prospect of tailored treatment, and provides invaluable insights into understanding chronic pain. We hope eventually to use this genetic marker to optimize personalized treatment decisions and minimize adverse effects for women with chronic pelvic pain," wrote lead author Scott Mackenzie, MD, from the University of Edinburgh's Centre for Reproductive Health.

The study also has implications for other chronic pain conditions. Further research is needed to confirm the findings, but researchers say a genetic test for NRG3 could help limit the use of gabapentin to people who actually benefit from the drug.

"Isolating this single genetic marker is an important discovery that could ultimately help refine treatments for millions of women worldwide who suffer from chronic pelvic pain, as well as increasing our understanding of its role in other pain conditions. We believe this is an exciting opportunity for collaboration with a commercial partner who can help translate the research into a clinical setting," said Susan Bodie, PhD, Head of Business Development for the College of Medicine and Veterinary Medicine at the University of Edinburgh.

Gabapentin and other nerve drugs like pregabalin (Lyrica) have come under increased scrutiny in the UK because they are increasingly involved in overdose deaths.  

A recent analysis of drug tests suggests that gabapentin is also being misused in the U.S. Gabapentin was found in in over 13% of urine samples that tested positive for fentanyl -- about twice the number of drug tests in which prescription opioids were found.

Despite the risks of side effects and addiction, gabapentin is increasingly prescribed “off-label” for conditions it is not approved to treat, such as dental pain. A 2019 study found little evidence that gabapentin and pregabalin should be used for pain and said their effectiveness was often exaggerated by prescribing guidelines.

The CDC’s revised opioid guideline says gabapentin and pregabalin can have “small to moderate improvements” on pain, but with a moderate risk of side effects.

Feds Warn About Copycat Packaging of Delta-8 THC Edibles

By Crystal Lindell

The U.S. government is once again going after companies that sell Delta-8 THC edibles in packaging that looks like popular brand name candy and snacks. 

The Food and Drug Administration and the Federal Trade Commission sent warning letters to five companies for selling copycat food products containing delta-8 THC derived from hemp.

For example, one company was selling a package of “Slizzles” edibles that looks strikingly similar to “Skittles” candy. Another company sold a “Double Stuff Stoneo” product in packaging that looks like “Oreo” cookies. 

The cease and desist warning letters were issued to Hippy Mood, Earthly Hemps, Shamrockshrooms, Mary Janes Bakery and Life Leaf Medical CBD Center. 

“Inadequate or confusing labeling can result in children or unsuspecting adults consuming products with strong resemblance to popular snacks and candies that contain delta-8 THC without realizing it,” FDA Principal Deputy Commissioner Namandjé Bumpus, PhD, said in a statement. 

“As accidental ingestion and/or overconsumption of Delta-8 THC containing products could pose considerable health risks, the companies who sell these illegal products are demonstrating complete neglect for consumer safety.”

Delta-8 THC is derived from hemp, which Congress legalized in the 2018 Farm Bill. Hemp contains only trace amounts of THC, the psychoactive ingredient in cannabis, so the thinking was that hemp would only be used to make cash products such as rope, clothing and horse feed. It didn’t take long, however, for cannabis companies to develop a synthetic form of hemp-derived THC that is just as potent as regular THC. 

Efforts are underway to close that loophole in the next Farm Bill, but in the meantime delta-8 THC products remain legal under federal law, although some individual states have banned them. 

In 2022 and 2023, the feds issued similar warnings against other companies marketing Delta-8 THC edibles. Although those products were withdrawn from the market, other companies have stepped into the void and began selling similar ones. 

The FDA and FTC say the copycat branding of delta-8 edibles violates federal laws against unfair or deceptive marketing, including practices that present health or safety risks. The agencies say children are particularly vulnerable, because they might not realize the edibles contain THC. 

“Companies that market and sell edible THC products that are easily mistaken for snacks and candy are not only acting illegally, but they are also putting the health of young children at risk,” said Samuel Levine, director of the FTC’s Bureau of Consumer Protection. “Those that prioritize profits in front of children's safety are at serious risk of legal action.”

Industry groups that represent companies that have seen their branded products mimicked have come out against this type of copycat packaging.  The Consumer Brands Association (CBA) has a position paper on its website specifically addressing THC edibles that mimic popular brands. 

“Companies are unequivocally opposed to their brands being illegally used in products containing THC,” the CBA writes. “But rooting out these bad actors is like a game of whack-a-mole. By the time a company or government entity goes after them, their local storefront or online presence disappears and they pop up with a new name and new site.”

The issue goes beyond simple copyright infringement. The CBA cites recent data showing that national poison control centers handled nearly 10,500 incidents involving products laced with THC. Of those cases, 77% involved consumers 19 years old or younger.

“The urgency of this issue is not about intellectual property infringement, but about how that infringing use of trusted food brands creates a direct threat to consumer safety — particularly that of children,” the CBA says. “As incidents of children being hurt by lookalike products that endanger them increase, greater enforcement is necessary.”

The National Confectioners Association (NCA) has also warned about cannabis companies using packages that looks like popular candy and snacks.

Edibles may deliberately mimic the trade dress of beloved consumer brands,” the NCA said. “It is often very difficult to distinguish these edibles from conventional foods and beverages, resulting in confusion and injury to consumers, including children, and reputational damage to food companies.”

The NCA says it is difficult and costly for companies to try to protect their brands in this situation, because it requires “state-by-state surveillance” and “burdensome legal action.”

The FDA is also concerned about the processes used to synthesize delta-8 THC, as impurities or variations in the processing can result in products that may be harmful or have unpredictable effects. The agency has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence.