Chronic Pain Patients Report Improvement from Cannabis Oil

By Pat Anson, PNN Editor

Patients with chronic pain and other illnesses who did not respond to conventional treatment reported improvements in pain, anxiety, depression, fatigue and quality of life after being prescribed cannabis oil for three months, according to a large new Australian study. There were no improvements in patients with insomnia.

Researchers at the University of Sydney surveyed 2,327 patients with chronic health issues who were prescribed cannabis oil products containing cannabinoids, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The oils are made by Little Green Pharma , a company that specializes in cannabis-based medicine and provided funding for the Quality of Life Evaluation Study (QUEST Initiative).

Over two-thirds of the participants (69%) suffered from chronic pain. Half were being treated for more than one health condition; and one in four were unemployed, on leave, or had limited work duties due to illness.   

Medical cannabis was legalized in Australia in 2016. Cannabis is only available by prescription in Australia to patients with health conditions that are unresponsive to conventional treatment.

“Short-term findings over 3-months indicate that patients prescribed MC (medical cannabis) in practice have improved HRQL (health-related quality of life) and reduced fatigue. Patients experiencing anxiety, depression, or chronic pain also improved in those outcomes over 3-months, but no changes in sleep disturbance were observed in patients with sleep disorders,” researchers reported in PLOS ONE.  

“The study continues to follow patients over 12-months to determine whether improvements in PROs (patient reported outcomes) are maintained long-term. In addition, further subgroup analyses will be undertaken to determine whether patients with specific health conditions have better outcomes compared with others when using validated condition-specific questionnaires.”

The researchers did not measure adverse effects in the QUEST Initiative, but 30 participants withdrew from the study due to “unwanted side effects.” The authors noted that more research on cannabis oil products used in the study is needed in order to successfully treat patients with insomnia and sleep disorders.

Another recent survey in Australia of patients with chronic illness found significant improvements in their physical and mental health after they started using medical cannabis. Most of the cannabis products in that study were oils containing CBD and/or THC.   

'Growing Pains' in Childhood Linked to Migraine

By Pat Anson, PNN Editor

Did you experience “growing pains” as a child? An unusual ache or throbbing in your legs that occurred late in the day and kept you awake at night?

The Mayo Clinic says there’s no evidence that a growth spell actually causes physical pain, and that any discomfort may be caused by a low pain threshold or even psychological issues.

But a small new study suggests something else may be going on: Brazilian researchers say children who have growing pains are significantly more likely to develop migraines – just as their parents did.  Migraine can be hereditary, and if one or both parents have migraine, there’s a 50-75% chance that their children will also.

“In families of children with growing pains, there is an increased prevalence of other pain syndromes, especially migraine among parents,” wrote lead author Raimundo Pereira Silva-Néto. PhD, a neurology professor at Federal University of Delta do Parnaibal. “Children with migraine have a higher prevalence of growing pains, suggesting a common pathogenesis; therefore, we hypothesized that growing pains in children are a precursor or comorbidity with migraine.”

With parental authorization, Silva-Néto and his colleagues followed 78 children between 5 and 10 years of age, who were born to mothers being treated for migraine at a headache clinic. Their findings were published in the journal Headache.

After five years, about half of the children reported growing pains in their lower limbs. Headaches occurred in 76% of those children, with many meeting the criteria for migraine without aura. By comparison, only 22% of the children who did not have growing pains had headaches.

Lower limb pain was reported most often in the calf muscles (70%), usually lasted more than 30 minutes, and occurred more frequently at night.

That nocturnal connection intrigued the researchers, who noted that previous studies have found that sleepwalking, nightmares, and restless leg syndrome also occur more frequently in children who have migraines.   

“There is no definitive explanation for the nocturnal patterns of growing pains, nor for the overlap with sleep disturbances; however, the authors believe the hypothesis of a common pathogenesis with migraine,” researchers concluded. “Pain in the lower limbs of children and adolescents, commonly referred to as GP (growing pains) by pediatricians and orthopedists, may reflect a precursor/comorbidity with migraine.”

Migraine affects about 39 million people in the United States and is the second leading cause of disability worldwide, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. About one in five teens suffer from migraine.

Rx Opioid Shortages Persist With No Federal Action

By Pat Anson, PNN Editor

There is no end in sight to shortages of opioid pain medication in the US, with the federal government taking no apparent action to increase opioid production and several drug makers unable to estimate when full supplies will be restored.

In a recent update, the American Society of Health-System Pharmacists (ASHP) said five generic drug makers were running low or have exhausted their supply of oxycodone/acetaminophen tablets, which are better known as the brand names Percocet and Endocet. The medication is usually prescribed for moderate to severe pain.   

ASHP asked drug makers about their current supplies and received these responses:

• Camber has no doses of oxycodone/acetaminophen available. The tablets are on back order and “the company cannot estimate a release date.” Camber said it was still awaiting DEA approval for additional supplies.

• Amneal and KVK-Tech said they had limited supplies of 5 and 7.5 mg oxycodone/acetaminophen tablets, and that 10 mg tablets were on back order with no estimated resupply date.

• Major anticipates getting 7.5 mg tablets in late September and 10 mg tablets in late October.

• Rhodes said it had 7.5 and 5 mg tablets on “intermittent back order” and would only be releasing supplies as they become available.

Percocet and Endocet tablets in various doses are still available from Endo and Par Pharmaceuticals, according to the ASHP.

Shortages of oxycodone/acetaminophen tablets, as well as immediate release oxycodone and hydrocodone/acetaminophen tablets, were first reported by ASHP several months ago. But they have yet to appear on the FDA’s drug shortage list or even be publicly acknowledged by the agency.

In a recent joint letter, FDA Commissioner Robert Califf, MD, and DEA administrator Anne Milgram said they were working “as quickly as possible” to resolve persistent drug shortages. But the letter only addressed shortages of prescription stimulants used to treat ADHD, and makes no mention of opioids.

When asked by PNN, one federal health official did acknowledge shortages of opioid medication, but was vague about possible solutions.

“This is an important issue that CDC and other federal partners are aware of and working to find solutions to,” said Stephanie Rubel, who heads the CDC’s Overdose Preparedness and Response Team (ORRP). Rubel’s office works with other federal and state agencies to reduce the serious risks posed to patients who suddenly lose access to prescription opioids. 

“As part of ORRP’s work, we strongly encourage state health officials to proactively partner with pharmacists and pharmacies to ensure that impacted patients are able to continue receiving appropriate pain management care after a disruption,” said Rubel in a statement to PNN. “Because ORRP cannot provide medical care or make referrals to healthcare providers, advanced preparation and partnerships with pharmacists is essential to ensure continuity of care.” 

But many pharmacists have their hands tied due to opioid litigation. Last year, three large drug wholesalers reached a $21 billion settlement with 46 states, requiring them to impose strict limits on the pharmacies they do business with. Most pharmacies are capped on the amount of opioids they can dispense in any given month, regardless of patient needs. An unusually large order for opioids could get a pharmacy red-flagged by its wholesale supplier and the order cancelled.  

Another reason for the shortages are persistent problems in the drug supply chain and the heavy US reliance on foreign suppliers for many drugs, especially low-cost generic ones.  A third factor is aggressive cuts in the opioid supply by the DEA, which sets annual production quotas for controlled substances that drug manufacturers must follow.

Whatever the cause, it’s leaving many patients with uncontrolled pain and little faith in their government.

“I've been on hydrocodone for 10 years. With the shortage that is going on in Las Vegas, I've been out for 4 weeks,” one patient told PNN. “Unfortunately, the pain has made it too difficult to take care of myself. I cannot clean, cook or sleep without my pain levels increasing. I've been living on frozen foods and Alka Seltzer.”

“I live with 200 other seniors in a low-income complex.  I’ve seen three older veteran residents commit suicide because they couldn’t get pain medication.  I know several other seniors who live with horrible pain and are not able to get medication,” another patient told us.

“The US Government is just screwing us over by limiting what the pharmacies can get and what their suppliers can make. This is driving people to buy pain meds off the street and that's like playing Russian roulette,” said another patient who has trouble getting Norco prescriptions filled by his pharmacy. “Our government is supposed to help us, not hurt us.”

Drug makers are required to report shortages and supply interruptions to the FDA, but prescribers, pharmacies and consumers can also report them by email to drugshortages@fda.hhs.gov.  

To report a drug shortage to the ASHP, click here.

Rescheduling Won’t End Conflict Between Federal and State Marijuana Laws

By Paul Armentano, Guest Columnist 

Ten months after the Biden administration requested the Department of Health and Human Services (HHS) “to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law,” Secretary Xavier Becerra confirmed that the agency has recommended cannabis be removed from its Schedule I classification and placed in a lower schedule.

While the explicit details of HHS’ recommendation are not public, Bloomberg reports that the agency seeks to have cannabis moved to the less restrictive Schedule III of the federal Controlled Substances Act. 

The HHS recommendation now goes to the Drug Enforcement Administration, which will conduct its own scientific review. In the past, the DEA has employed its own five-factor test (which differs from HHS’ criteria) to determine whether or not cannabis ought to be rescheduled. On four prior occasions, most recently in 2016, the agency determined that cannabis failed to meet any of its five criteria.  

While it remains unknown at this time how the DEA will ultimately respond to HHS’ request, many are already speculating about the potential implications of such a policy change. And while some entities, particularly those involved in the commercial cannabis industry, have lauded the proposed change as a “giant” step forward, others – like myself – have been far more restrained.

That’s because reclassifying cannabis from Schedule I to Schedule III is neither intellectually honest, nor does it sufficiently address the widening chasm between state and federal marijuana laws. 

Specifically, reclassifying cannabis to a lower schedule within the CSA continues to misrepresent the plant’s safety relative to other controlled substances such as oxycodone and hydrocodone (Schedule II), codeine and ketamine (Schedule III), benzodiazepines (Schedule IV), or alcohol (unscheduled). More importantly, rescheduling marijuana fails to provide states with the explicit legal authority to regulate it within their borders as best they see fit, free from federal interference.  

To date, 38 states regulate the production and distribution of cannabis products for medical purposes. Twenty-three of these states regulate the possession and use of marijuana for adults. All of the state laws are currently in conflict with federal marijuana laws. Rescheduling cannabis to Schedule III will not change this reality. 

That’s because Schedule III substances are regulated only for prescription use by the federal government. That means legal access to these substances is limited to patients who possess a prescription from a licensed physician and who have obtained the product from a licensed pharmacy.

Currently, no state government regulates cannabis in such a manner – nor is it likely that any state will reconstruct their existing laws and regulations to do so in the future. 

Simply put, if marijuana is rescheduled, state laws authorizing citizens to possess cannabis for either medical or social purposes will continue be in violation of the federal law, as would the thousands of state-licensed dispensaries that currently serve these markets. And the DEA would still possess the same authority it has now under federal law to crack down on these state-regulated markets should it elect to do so. 

Some have suggested that rescheduling the cannabis plant may provide greater opportunities for investigators to conduct clinical research into its eventual drug development, but this result is also unlikely. That is because many of the existing hurdles to clinical cannabis research, such as the limits placed upon scientists’ access to source materials, are marijuana-specific regulations and predate cannabis’ Schedule I classification.

Other impediments, such as requiring the US Attorney General to approve marijuana-specific research protocols are statutory and are not specific to marijuana’s scheduling in the CSA. 

For these reasons, the National Organization for the Reform of Marijuana Laws (NORML) holds the position that the only productive outcome of the current scheduling review would be a recommendation to deschedule cannabis – thereby removing it from the Controlled Substances Act altogether and providing states with greater discretion to establish their own distinct marijuana policies. (A case in point: In 2018 Congress removed from the CSA hemp plants containing no more than 0.3 percent THC, as well as certain cannabinoids derived from them.)

Descheduling would remove the threat of undue federal intrusion in existing state marijuana programs and would respect America’s longstanding federalist principles allowing states to serve as “laboratories of democracy.”

By contrast, rescheduling simply perpetuates the existing contradictions between state and federal cannabis laws, and it fails to provide any necessary legal recognition from the federal government to either the state-licensed cannabis industry or those adults who use the plant responsibly in compliance with state laws.

Paul Armentano is the Deputy Director for NORML, the National Organization for the Reform of Marijuana Laws.

CDC Report ‘Likely Underestimated’ Deaths Linked to Counterfeit Drugs

By Pat Anson, PNN Editor

A new report from the Centers for Disease Control and Prevention found that fatal overdoses in the U.S. from counterfeit medication more than doubled in recent years, with 93% of those deaths involving illicit fentanyl.

Deaths from counterfeit pills rose from 2% of all overdoses in the third quarter of 2019 to 4.7% of drug deaths in the last quarter of 2021, according to the CDC’s Morbidity and Mortality Weekly Report (MMWR). The overdose rate from fake medication was three times higher in western U.S. states (14.7%). 

However, due the unreliability of death certificates, witnesses and coroner investigations, as well as other flaws in the study’s methodology, the MMWR report acknowledges that the number of deaths involving counterfeit medication is “likely underestimated.”

CDC researchers only looked at overdose data from 34 states and the District of Columbia, identifying 2,437 deaths linked to counterfeit pills during the 30-month study period.

Nearly 106,700 people in the U.S. died from drug overdoses in 2021, so if the 4.7% death rate was applied to that year alone, that would suggest there were over 5,000 deaths nationwide involving counterfeit medication.

Even that estimate is probably on the low end, because CDC researchers focused on counterfeit pills made to look like oxycodone and the anti-anxiety drug alprazolam (Xanax).

While “Mexican Oxy” – blue tablets that look like 30mg oxycodone – are favored by counterfeiters, fake pills are also designed to look like Vicodin, Norco, Adderall, and many other medications. Deaths from those pills were not counted.  

Importantly, whether a death was even linked to fake medication “depended largely on scene or witness evidence of pill use” and other anecdotal evidence, rather than toxicology tests on the pills or the actual people who died.

And while pills are obviously designed to be taken orally, the MMWR report only includes “noningestion routes of drug use,” such as smoking, snorting or injection, which require the pills to be ground into powder or liquefied. CDC researchers considered data on the oral ingestion of counterfeit pills so unreliable, “that information is not presented” in the report.

Many of these details on the study’s strange methodology are buried in the footnotes of the MMWR report, which a casual reader could easily miss. 

Not surprisingly, given the limitations on data, smoking was found to have an outsized role in overdose deaths. According to the MMWR, nearly 40% of the deaths linked to counterfeit medication involved smoking – a misleading statistic, given the study’s flaws. But that didn’t stop researchers from drawing conclusions or recommending “safer smoking practices.”

“The higher percentage of deaths with evidence of drug use by smoking might reflect recent general shifts from injecting drugs to smoking them in western states or could be specific to counterfeit pill use methods,” wrote lead author Julie O’Donnell, PhD, an epidemiologist at the CDC’s National Center for Injury Prevention and Control.

“Harm reduction services that expand outreach to persons using drugs by methods other than injection, such as smoking, and provide education about safer smoking practices and risks related to smoking, might be most successful at addressing diverse drug use patterns.”

There’s a safer way to smoke illicit fentanyl?

This is the CDC’s first MMWR report to look exclusively at deaths caused by fake pills, a public health crisis that the agency has been slow to acknowledge. The DEA started warning about a “fentanyl crisis” as far back as 2016, a time when the CDC was preoccupied with its guideline to reduce opioid prescribing.

There were major flaws in CDC research even back then. The agency eventually admitted that thousands of overdose deaths linked to illicit fentanyl and other street drugs were misclassified as deaths caused by prescription opioids. Some deaths that involved more than one drug were counted multiple times.

HHS to DEA: Marijuana Is Not Heroin

By Pat Anson, PNN Editor

The top U.S. health agency is asking the Drug Enforcement Administration to reclassify marijuana as a Schedule III drug under the Controlled Substances Act, putting cannabis in the same risk category as codeine, ketamine and steroids. Marijuana is currently classified as a Schedule I substance, the same as heroin and LSD.  

Bloomberg News was first to report that a top administrator in the Department of Health and Human Services (HHS) wrote a letter to DEA Administrator Anne Milgram asking for the change. Although 38 states and the District of Columbia have legalized recreational or medical marijuana, it remains illegal under federal law.

President Biden asked HHS Secretary Xavier Becerra nearly a year ago to review marijuana’s legal status, saying the classification of marijuana on the same level as heroin “makes no sense” and that people shouldn’t go to jail for marijuana possession.

“I can now share that, following the data and science, @HHSGov has responded to @POTUS’ directive to me for the Department to provide a scheduling recommendation for marijuana to the DEA. We’ve worked to ensure that a scientific evaluation be completed and shared expeditiously,” Becerra posted on Twitter Wednesday.

Although the Biden administration favors the move, rescheduling will not be a slam dunk. Marijuana falls under the jurisdiction of the Department of Justice, not HHS, and Milgram reports to Attorney General Merrick Garland, not Becerra. Conservative states where marijuana remains illegal are also likely to oppose the move.

Rescheduling has long been the goal of marijuana advocates, but some are disappointed that HHS is recommending it be moved to Schedule III, where it will still be regulated as a controlled substance.

“The goal of any federal cannabis policy reform ought to be to address the existing, untenable chasm between federal marijuana policy and the cannabis laws of the majority of US states. Rescheduling the cannabis plant to Schedule III of the US Controlled Substances Act fails to adequately address this conflict,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“Just as it is intellectually dishonest to categorize cannabis in the same placement as heroin, it is equally disingenuous to treat cannabis in the same manner as anabolic steroids. The majority of Americans believe that cannabis ought to be legal and that its hazards to health are less significant than those associated with federally descheduled substances like alcohol and tobacco. Like those latter substances, we have long argued the cannabis plant should be removed from the Controlled Substances Act altogether.”

The DEA will now conduct its own scientific review of marijuana. On at least four previous occasions, the DEA has refused to reschedule marijuana because there were inadequate safety studies and little scientific evidence supporting its use.

Another major hurdle under federal regulations is that before a substance can be used for a medical purpose, its “chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized.” That would imply that cannabis or pharmaceutical companies would need to produce marijuana medication in measured doses that are FDA approved and only available by prescription.

There is little consistency in labeling, regulating or testing of cannabis.products sold in states where it is legal. Many products are mislabeled, with concentrations of CBD (cannabinoids) and THC (tetrahydrocannabinol) that are well above or below their label claims.

“It will be very interesting to see how DEA responds to this (HHS) recommendation, given the agency’s historic opposition to any potential change in cannabis’ categorization under federal law,” said Armentano. “Since the agency has final say over any rescheduling decision, it is safe to say that this process still remains far from over.”

Although nearly a third of U.S. adults with chronic pain have used cannabis as a pain reliever, professional medical associations have been reluctant to endorse its use. In 2021, the International Association for the Study of Pain (IASP) released a position statement saying it could not endorse the use of cannabinoids to treat pain, citing too many “uncertainties” about the clinical evidence.

Artificial Intelligence May Decide Whether You Get Rx Opioids

By Andy Miller and Sam Whitehead, KFF Health News

Elizabeth Amirault never heard of NarxCare until last year, when she learned its software was tracking her medication use. During a visit to a hospital in Fort Wayne, Indiana, Amirault told a nurse practitioner she was in severe pain and received a puzzling response.

“Your Narx Score is so high, I can’t give you any narcotics,” she recalled the man saying, as she waited for an MRI before a hip replacement.

Tools like NarxCare are used to help medical providers review controlled substance prescriptions. They influence, and can limit, the prescribing of painkillers, similar to a credit score influencing the terms of a loan. NarxCare’s overdose risk ratings – known Narx Scores -- are produced by health care technology company Bamboo Health (formerly Appriss Health).

NarxCare’s software uses artificial intelligence to analyze data about prescriptions for controlled substances to identify patterns of potential problems involving patients and physicians. State and federal health agencies, law enforcement officials, and health care providers have enlisted these tools, but the mechanics behind their algorithm formulas are generally not shared with the public.

Artificial intelligence is working its way into more parts of American life. As AI spreads within the health care landscape, it brings familiar concerns of bias and accuracy and whether government regulation can keep up with rapidly advancing technology.

The use of systems to analyze opioid-prescribing data has sparked questions over whether they have undergone enough independent testing outside of the companies that developed them, making it hard to know how they work. Lacking the ability to see inside these systems leaves only clues to their potential impact.

Some patients say they have been cut off from needed care. Some doctors say their ability to practice medicine has been unfairly threatened.

Researchers warn that such technology — despite its benefits — can have unforeseen consequences if it improperly flags patients or doctors.

“We’re concerned that it’s not working as intended, and it’s harming patients.”

— Jason Gibbons, Health Economist

“We need to see what’s going on to make sure we’re not doing more harm than good,” said Jason Gibbons, a health economist at the Colorado School of Public Health at the University of Colorado’s Anschutz Medical Campus. “We’re concerned that it’s not working as intended, and it’s harming patients.”

Amirault, 34, said she has dealt for years with chronic pain from health conditions such as sciatica, degenerative disc disease, and avascular necrosis, which results from restricted blood supply to the bones.

The opioid Percocet offers her some relief. Amirault had been denied the medication before, but never had been told anything about a Narx Score, she said.

In a chronic pain support group on Facebook, she found others posting about NarxCare, which scores patients based on their supposed risk of prescription drug misuse. She’s convinced her ratings negatively influenced her care.

“Apparently being sick and having a bunch of surgeries and different doctors, all of that goes against me,” Amirault said.

Database-driven tracking has been linked to a decline in opioid prescriptions, but evidence is mixed on its impact on curbing the epidemic. Overdose deaths continue to plague the country, and patients like Amirault have said the monitoring systems leave them feeling stigmatized as well as cut off from pain relief.

The Centers for Disease Control and Prevention estimated that in 2021 about 52 million American adults suffered from chronic pain, and about 17 million people lived with pain so severe it limited their daily activities. To manage the pain, many use prescription opioids, which are tracked in nearly every state through electronic databases known as prescription drug monitoring programs (PDMPs).

The last state to adopt a program, Missouri, is still getting it up and running.

More than 40 states and territories use the technology from Bamboo Health to run PDMPs. That data can be fed into NarxCare, a separate suite of tools to help medical professionals make decisions. Hundreds of health care facilities and five of the top six major pharmacy retailers also use NarxCare, the company said.

The platform generates three Narx Scores based on a patient’s prescription activity involving narcotics, sedatives, and stimulants. A peer-reviewed study showed the “Narx Score metric could serve as a useful initial universal prescription opioid-risk screener.”

NarxCare’s algorithm-generated “Overdose Risk Score” draws on a patient’s medication information from PDMPs — such as the number of doctors writing prescriptions, the number of pharmacies used, and drug dosage — to help medical providers assess a patient’s risk of opioid overdose.

Bamboo Health did not share the specific formula behind the algorithm or address questions about the accuracy of its Overdose Risk Score but said it continues to review and validate the algorithm behind it, based on current overdose trends.

Guidance from the CDC advised clinicians to consult PDMP data before prescribing pain medications. But the agency warned that “special attention should be paid to ensure that PDMP information is not used in a way that is harmful to patients.”

This prescription-drug data has led patients to be dismissed from clinician practices, the CDC said, which could leave patients at risk of being untreated or undertreated for pain. The agency further warned that risk scores may be generated by “proprietary algorithms that are not publicly available” and could lead to biased results.

(Editor’s note: A citizen’s petition filed with FDA earlier this year alleged that NarxCare software “altered the practice of medicine in the U.S. to the detriment of patients,” and sought to have the software declared a misbranded medical device and recalled. The petition by the Center for U.S. Policy was rejected by FDA on technical grounds because it was “not within the scope” of the agency’s petition process.)

Impact on Patients

Bamboo Health says NarxCare’s rating system should never replace decisions made by physicians. But some patients say the risk scores have had an outsize impact on their treatment.

Bev Schechtman, 47, who lives in North Carolina, said she has occasionally used opioids to manage pain flare-ups from Crohn’s disease. As vice president of the Doctor Patient Forum, a chronic pain patient advocacy group, she said she has heard from others reporting medication access problems, many of which she worries are caused by red flags from databases.

“There’s a lot of patients cut off without medication,” according to Schechtman, who said some have turned to illicit sources when they can’t get their prescriptions. “Some patients say to us, ‘It’s either suicide or the streets.’”

The stakes are high for pain patients. Research shows rapid dose changes can increase the risk of withdrawal, depression, anxiety, and even suicide.

Some doctors who treat chronic pain patients say they, too, have been flagged by data systems and then lost their license to practice and were prosecuted.

Lesly Pompy, a pain medicine and addiction specialist in Monroe, Michigan, believes such systems were involved in a legal case against him.

His medical office was raided by a mix of local and federal law enforcement agencies in 2016 because of his patterns in prescribing pain medicine. A year after the raid, Pompy’s medical license was suspended. In 2018, he was indicted on charges of illegally distributing opioid pain medication and health care fraud.

“I knew I was taking care of patients in good faith,” he said. A federal jury in January acquitted him of all charges. He said he’s working to have his license restored.

One firm, Qlarant, a Maryland-based technology company, said it has developed algorithms “to identify questionable behavior patterns and interactions for controlled substances, and for opioids in particular,” involving medical providers.

The company, in an online brochure, said its “extensive government work” includes partnerships with state and federal enforcement entities such as the Department of Health and Human Services’ Office of Inspector General, the FBI, and the Drug Enforcement Administration.

In a promotional video, the company said its algorithms can “analyze a wide variety of data sources,” including court records, insurance claims, drug monitoring data, property records, and incarceration data to flag providers.

William Mapp, the company’s chief technology officer, stressed the final decision about what to do with that information is left up to people — not the algorithms.

Mapp said that “Qlarant’s algorithms are considered proprietary and our intellectual property” and that they have not been independently peer-reviewed.

“We do know that there’s going to be some percentage of error, and we try to let our customers know,” Mapp said. “It sucks when we get it wrong. But we’re constantly trying to get to that point where there are fewer things that are wrong.”

Prosecutions against doctors through the use of prescribing data have attracted the attention of the American Medical Association.

“These unknown and unreviewed algorithms have resulted in physicians having their prescribing privileges immediately suspended without due process or review by a state licensing board — often harming patients in pain because of delays and denials of care,” said Bobby Mukkamala, chair of the AMA’s Substance Use and Pain Care Task Force.

Even critics of drug-tracking systems and algorithms say there is a place for data and artificial intelligence systems in reducing the harms of the opioid crisis.

“It’s just a matter of making sure that the technology is working as intended,” said health economist Gibbons.

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

New DEA Rule Allows Pharmacies to Transfer Opioid Prescriptions

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has adopted a new rule that allows patients, doctors and pharmacists to transfer initial prescriptions for opioids and other controlled substances from one pharmacy to another.  

The rule became effective August 28, but has been in the works for several years. It revises DEA regulations to allow prescribers, hospitals and pharmacists the ability to write, dispense and transfer electronic prescriptions for controlled substances “upon request of the patient.” Under the old rule, prescriptions could not be transferred if a pharmacy is unwilling or unable to fill them – forcing doctors to write a second prescription for another pharmacy and creating delays for patients in need of treatment.

“The final rule amends DEA regulations to explicitly state that an electronic prescription for a controlled substance in schedule II–V may be transferred between retail pharmacies for initial filling on a one-time basis only, upon request from the patient, and clarifies that any authorized refills included on a prescription for a schedule III, IV, or V controlled substance are transferred with the original prescription,” DEA said in a lengthy notice published in the Federal Register.

In recent years, many patients have experienced delays or outright refusals getting prescriptions filled for opioids, stimulants, sedatives, steroids and other medications classified as controlled substances.  The problem has grown worse in recent months, due to chronic shortages of oxycodone, hydrocodone and stimulants.

It would be nice to say the DEA changed the rule to make it easier for patients to get their prescriptions filled, but the agency’s primary goal is to reduce drug diversion. Having doctors write duplicate prescriptions for the same patient is not only a waste of time, in the eyes of the DEA it raises the risk of the original prescription being misused.

“DEA realizes that this scenario creates the potential for duplication of prescriptions, if the practitioner transmits a new prescription to a different pharmacy and does not cancel or void the original prescription that was sent to the first pharmacy. It also recognizes that this scenario creates additional burden for patients, who have to get back in touch with the prescribing practitioner to request a new prescription,” the agency said.

“DEA believes that allowing the electronic transfer of controlled substance prescriptions will decrease the potential for duplicate prescriptions and thus reduce the opportunity for diversion or misuse.”

The diversion of prescription opioids is actually rare. According to the DEA, less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) is lost, stolen or diverted to someone they were not prescribed to.

The DEA estimates the new prescription transfer rule will cost pharmacies over $91 million annually due to additional record-keeping and time spent transferring prescriptions, but will reduce overall costs to the healthcare system by $22 million a year.  

FDA Approves First Biosimilar for Multiple Sclerosis

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved Tyruko (natalizumab-sztn) as the first biosimilar for adults with relapsing forms of multiple sclerosis (MS), a move that could substantially reduce treatment costs for MS patients. Biosimilars are “highly similar” to brand-name biologic medicines, but about 30% cheaper.

"Approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA's longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost," said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars.

Like Tysabri (natalizumab), the biologic it is modeled after, Tyruko is administered by infusion every four weeks to patients with MS, a chronic disease that attacks the body’s central nervous system, causing numbness, paralysis, loss of vision, fatigue and pain. Many MS patients experience periods of remission, followed by relapses.  

The listed cash price for a single vial of Tysabri is over $17,000, although the discounted price for insured patients is about $8,500 or $102,000 a year. Sandoz, a pharmaceutical company that specializes in biosimilars and generics, has not revealed its pricing plans for Tyruko or said when it will become available. Sandoz is a division of Novartis.

“Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market,” Keren Haruvi, President North America, Sandoz Inc., said in a news release.

Like Tysabri, Tyruko may also be used to treat adults with moderate to severe symptoms from Crohn's disease who have not responded well to other treatments. Crohn’s causes chronic inflammation in the digestive tract.

The FDA says patients using natalizumab products (including Tyruko and Tysabri) are at higher risk of developing progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that can lead to death or severe disability. Because of that risk, prescribers must evaluate patients three and six months after their first infusion, every six months thereafter, and even after they discontinue treatment.

Growing Market for Biosimilars

Patients have long complained about the high price of MS drugs in the US, which cost two to three times more than the same drugs in Canada, Australia or the UK. One reason biologics are so expensive is that they derived from living organisms such as animal cells or bacteria, making them costly to develop.

Drug patents also last a long time – usually five years – before a “copycat” version can be introduced. Patent holders often take their competitors to court to further delay the introduction of generics or biosimilars, as was the case with AbbVie’s Humira, a biologic widely used to treat rheumatoid arthritis and other chronic inflammatory diseases. At least 9 new Humira biosimilars are finally entering the U.S. market this year.

Last week, CVS Health announced that it was launching a wholly owned subsidiary called Cordavis, which will work with drug manufacturers to commercialize biosimilars. The first biosimilar CVS plans to market in early 2024 is Hyrimoz (adalimumab-adaz), a biosimilar for Humira produced by Sandoz. CVS says the list price of the Hyrimoz will be over 80% lower than the current list price of Humira.

"Biosimilars are crucial to creating competition and reducing costs for specialty pharmaceuticals where drug prices are rising the fastest," said Prem Shah, PharmD, Executive Vice President and Chief Pharmacy Officer for CVS. "Through our direct involvement, we will expand the supply chain and ensure biosimilar availability in the market.”

As more patents expire, the biosimilars market in the U.S. is projected to grow from $6.7 billion in 2021 to more than $100 billion in 2029, according to one market forecast..

What Is End-of-Life Care?

By Dr. Forest Tennant and Kristen Ogden

The Medical Board of California’s new Guidelines for Prescribing Controlled Substances for Pain are futuristic and practical.  They recognize that persons who need intractable pain or “end-of-life” care may often require a non-standard medical program, so the board made these two conditions exempt from any limitations on dosage or treatment.

In our recent column on the guidelines, we clarified the meaning of intractable pain and suggested criteria for identification of the intractable pain patient who requires non-standard drugs and dosages. This column does the same for “end-of-life” care. 

The California guidelines define end-of-life care as “for persons with a terminal illness or at risk of dying in the near future whether in hospice care, hospitals, long-term care or at home.”  Note that this definition does not include palliative care, whose definition is frankly now in limbo, because medical textbooks define it as “symptomatic rather than curative care.” Third party payers only recognize palliative care as being in the last few months of life.

How does one identify a person who needs “end-of-life” care?  California actually has a law which helps identify the person who needs end-of-life care.  Such a person “is suffering from an incurable and irreversible illness that will bring about death within one year if the illness takes its normal course and the treatment is for pain control and/or symptom management rather than to cure the illness.” 

In effect, this definition includes intractable pain patients who are not expected to live more than a year without treatment.  Severe intractable pain, regardless of cause, if left untreated will result in malnutrition, immune deficiency, cardiac or adrenal failure, and a shorter life. 

To our knowledge there are no formal criteria published for clinicians to determine when there exists high risk of death within a year.  Here are criteria used and suggested by us: 

1. Patient has a known disease that may shorten life, such as cancer, adhesive arachnoiditis, head trauma, and Ehlers-Danlos syndromes.

2. Pain is constant and interferes with activities of daily living as reported by a close family member.  Examples are inability to eat, toileting, mobility, hygiene, and dressing.

3. Bed bound and immobile for many hours of each day.

4. Malnutrition, evidence of tissue loss, poor skin turgor (rigidity), and/or weight loss.

5. Family reports inability to normally read, answer questions, or socially respond.

6. Some alterations in normal physiologic functions such as blood pressure, pulse, and hormone levels.

We encourage clinicians to use our criteria for “end-of-life” care or develop some specific alternative criteria.  Too many seriously ill intractable pain patients have been denied care until it was too late.  An “end-of-life” case may begin at any age, be it 14, 40 or 80 years old. 

Many, if not most “end-of-life” patients meet terminus within a year. But some persons turn things around with adequate intractable pain care and live much longer.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain. The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Kristen Ogden is a patient advocate from Virginia. Kristen and her husband Louis travel regularly to California for his intractable pain treatment and prescriptions, which are not available in their home state.

Tramadol Banned by Anti-Doping Agency

By Pat Anson, PNN Editor

When it comes to treating pain, tramadol (Ultram) is widely seen as a weak synthetic opioid that provides little relief to patients with severe or chronic pain.

“I get a lot more relief from aspirin” and “this stuff does nothing but make you dizzy and sleep,” are some of the comments PNN readers have made about tramadol.  

But some professional athletes, particularly those in cycling, have a completely different take on tramadol. They use it as a performance enhancing drug that can help them run, skate or peddle faster, and for longer periods of time. That’s why the World Anti-Doping Agency (WADA) is adding tramadol to its list of prohibited drugs, starting in 2024.

“Tramadol has been on the WADA Monitoring Program for some years. Monitoring data has indicated significant use in sports including cycling, rugby and football,” WADA said in a statement. “Research studies funded by WADA have confirmed the potential for tramadol to enhance physical performance in sports.”

Results from one of those studies, recently published in the Journal of Applied Physiology, confirm many of WADA’s concerns. UK researchers enrolled 27 cyclists in a double-blind randomized study, in which they were given either 100mg tramadol or a placebo before engaging in 30 minutes of high intensity cycling, followed by a 25-mile time trial.

On average, the cyclists who took tramadol were 1.3% faster in the time trial (TT) than those given a placebo. That doesn’t sound like much, but in the highly competitive world of professional cycling, even a few seconds can be the difference between finishing first or second.

Interestingly, the researchers found there were “no differences in pain intensity” between the cyclists on tramadol and those who took the placebo.

“This study demonstrates that highly trained cyclists can maintain a significantly higher power output and complete a competitive TT in a significantly faster time following acute ingestion of 100 mg of fast-acting soluble tramadol. Tramadol reduced the perception of effort for a given power output but had no discernible impact on pain intensity whilst cycling,” wrote lead author Alexis Mauger, PhD, a professor in the School of Sport and Exercise Sciences at the University of Kent.

“The findings from this study suggest that tramadol elicits a significant performance-enhancing effect in highly trained cyclists, such that it can change the outcomes of a race. Given the evidence of the historical prevalence of use of tramadol in sport with the intention of improving performance, and the risks pertaining its use, this study provides strong evidence to justify its inclusion on the 2024 Prohibited Substance List.”

To be clear, no one is taking tramadol away from pain patients. But professional athletes who test positive for tramadol — without a medical reason for taking it — run the risk of suspension or disqualification if their sport follows the WADA guidelines..

Previous studies by Mauger found that acetaminophen (Tylenol) gave a 2% boost in performance for cyclists, suggesting that even a mild analgesic can be helpful in making endurance exercise seem easier. Conversely, it also lends weight to pain sufferers who say tramadol works no better than Tylenol or aspirin.      

“Now we have a conundrum. Tramadol, an opioid painkiller, appears to have had no effect whatsoever on the pain experienced during cycling. On the other hand, it significantly lowered the perception of effort, which in turn…  improved performance,” journalist Alex Hutchinson wrote in Outside. “I’m not sure what to make of this finding, but it reaffirms my sense that we still have a lot to learn about how pain and effort and other related constructs like mental fatigue influence our performance.”

The U.S. Food and Drug Administration classifies tramadol as a Schedule IV controlled substance, meaning it has less potential for abuse and addiction compared to opioids like oxycodone or hydrocodone, which are Schedule II drugs.

In recent years, prescriptions for tramadol have soared in the U.S. because it is considered “safer” than other opioids. In many third world countries, however, tramadol is widely misused. In 2019, Public Citizen filed an unsuccessful petition with the FDA to have tramadol reclassified as a Schedule II drug, saying there was “overwhelming evidence” that tramadol was a public health risk.

Doctors and Patients Shame Insurers to Reverse Treatment Denials

By Lauren Sausser, KFF Health News

Sally Nix was furious when her health insurance company refused to pay for the infusions she needs to ease her chronic pain and fatigue.

Nix has struggled with a combination of autoimmune diseases since 2011. Brain and spinal surgeries didn’t ease her symptoms. Nothing worked, she said, until she started intravenous immunoglobulin infusions late last year. Commonly called IVIG, the treatment bolsters her compromised immune system with healthy antibodies from other people’s blood plasma.

“IVIG turned out to be my great hope,” she said.

That’s why, when Nix’s health insurer started denying payment for the treatment, she turned to Facebook and Instagram to vent her outrage.

“I was raising Cain about it,” said Nix, 53, of Statesville, North Carolina, who said she was forced to pause treatment because she couldn’t afford to pay more than $13,000 out of pocket every four weeks.

“There are times when you simply must call out wrongdoings,” she wrote on Instagram. “This is one of those times.”

Prior authorization is a common cost-cutting tool used by health insurers that requires patients and doctors to secure approval before moving forward with many tests, procedures, and prescription medications.

SALLY NIX

Insurers say the process helps them control costs by preventing medically unnecessary care. But patients say the often time-consuming and frustrating rules create hurdles that delay or deny access to the treatments they need. In some cases, delays and denials equal death, doctors say.

That’s why desperate patients like Nix — and even some physicians — say they have turned to publicly shaming insurance companies on social media to get tests, drugs, and treatments approved.

“Unfortunately, this has become a routine practice for us to resort to if we don’t get any headway,” said Shehzad Saeed, a pediatric gastroenterologist at Dayton’s Children’s Hospital in Ohio. In March, he tweeted a photo of an oozing skin rash, blaming Anthem for denying the biologic treatment his patient needed to ease her Crohn’s disease symptoms.

In July, Eunice Stallman, a psychiatrist based in Idaho, joined X, formerly known as Twitter, for the first time to share how her 9-month-old daughter, Zoey, had been denied prior authorization for a $225 pill she needs to take twice a day to shrink a large brain tumor. “This should not be how it’s done,” Stallman said.

Prior Authorization Reform

The federal government has proposed ways to reform prior authorization that would require insurance companies to provide more transparency about denials and to speed up their response times. If finalized, those federal changes would be implemented in 2026.

But even then, the rules would apply only to some categories of health insurance, including Medicare, Medicare Advantage, and Medicaid plans, but not employer-sponsored health plans. That means roughly half of all Americans wouldn’t benefit from the changes.

The 2010 Patient Protection and Affordable Care Act prohibits health insurance plans from denying or canceling coverage to patients due to their preexisting conditions.

AHIP, an industry trade group formerly called America’s Health Insurance Plans, did not respond to a request for comment.

“They just delay and delay and delay until you die. And you’re absolutely helpless as a patient.”

— Linda Peeno, Healthcare Consultant

But some patient advocates and health policy experts question whether insurers are using prior authorization as “a possible loophole” to this prohibition, as a way of denying care to patients with the highest health care costs, explained Kaye Pestaina, a KFF vice president and the co-director of its Program on Patient and Consumer Protections.

“They take in premiums and don’t pay claims. That’s how they make money,” said Linda Peeno, a health care consultant and retired Kentucky physician who was employed as a medical reviewer by Humana in the 1980s and later became a whistleblower. “They just delay and delay and delay until you die. And you’re absolutely helpless as a patient.”

But there’s reason to hope things may get marginally better. Some major insurers are voluntarily revamping their prior authorization rules to ease preapproval mandates for doctors and patients. And many states are passing laws to rein in the use of prior authorization.

“Nobody is saying we should get rid of it entirely,” said Todd Askew, senior vice president for advocacy at the American Medical Association, in advance of the group’s annual meeting in June. “But it needs to be right-sized, it needs to be simplified, it needs to be less friction between the patient and accessing their benefits.”

Online Venting

Customers are increasingly using social media to air their complaints across all industries, and companies are paying attention. Nearly two-thirds of complainants reported receiving some sort of response to their online post, according to the 2023 “National Consumer Rage Survey,” conducted by Customer Care Measurement & Consulting in collaboration with Arizona State University.

Some research suggests companies are better off engaging with unhappy customers offline, rather than responding to public social media posts. But many patients and doctors believe venting online is an effective strategy, though it remains unclear how often this tactic works in reversing prior authorization denials.

“It’s not even a joke. The fact that that’s how we’re trying to get these medications is just sad,” said Brad Constant, an inflammatory bowel disease specialist who has published research on prior authorization. His work found that prior authorizations are associated with an increased likelihood that children with inflammatory bowel disease will be hospitalized.

Saeed said the day after he posted the picture of the skin rash, the case was marked for a peer-to-peer review, meaning the prior authorization denial would get a closer look by someone at the insurance company with a medical background. Eventually, the biologic medicine Saeed’s patient needed was approved.

Stallman, who is insured through her employer, said she and her husband were prepared to pay out of pocket if Blue Cross of Idaho didn’t reverse the denial for the drug Zoey needed.

Bret Rumbeck, a spokesperson for the insurer, said Zoey’s medication was approved on July 14 after the company consulted an outside specialist and obtained more information from Zoey’s doctor.

Stallman posted details about the ordeal online only after the insurer approved the drug, in part, she said, to prevent them from denying the treatment again when it comes up for a 90-day insurance review in October. “The power of the social media has been huge,” she said.

Nix had been insured by Blue Cross Blue Shield of Illinois through her husband’s employer for almost two decades. Dave Van de Walle, a spokesperson for the company, did not specifically address Nix’s case. But in a prepared statement, the company said it provides administrative services for many large employers who design and fund their own health insurance plans.

Nix said an “escalation specialist” from the insurance company reached out after she posted her complaints on social media, but the specialist couldn’t help.

Then, in July, after KFF Health News contacted Blue Cross Blue Shield of Illinois, Nix logged in to the insurer’s online portal and found that $36,000 of her outstanding claims had been marked “paid.” No one from the company had contacted her to explain why or what had changed. She also said she was informed by her hospital that the insurer will no longer require her to obtain prior authorization before her infusions, which she restarted in late July.

“I’m thrilled,” she said. But “it just should never have happened this way.”

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

The Way Forward: California’s New Opioid Guidelines

By Dr. Forest Tennant and Kristen Ogden

The Medical Board of California recently published new guidelines for prescribing opioids and other controlled substances for pain, which emphasize “individualized care” that is customized for each patient. 

The guidelines are a remarkable, positive and practical way forward in pain care. All persons concerned about chronic pain treatment with opioids, benzodiazepines and other controlled drugs need to know the basic concepts embedded in them.    

As the medical board was updating its guidelines, we had great concern that they would bury California’s Pain Patient's Bill of Rights and Intractable Pain Treatment Act. When these laws were passed in the 1990’s, they were a godsend to patients with chronic intractable pain, who were given the right to “request or reject the use of any or all modalities in order to relieve his or her pain.”

That means patients, with the support of their doctors, could get opiate medication without first having to submit to surgery, medical devices and other forms of pain treatment.  

To our great pleasure, the medical board’s new guidelines recognize, define and support these worthy laws.  Importantly, the guidelines also state that they are “not in any way intended to limit treatment” of patients in hospice or palliative care. And they allow for doctors to prescribe high dose opioids, provided they keep good medical records that document a need for them.

Defining Intractable Pain

The California guidelines provide a classic definition of intractable pain as “a state in which the cause cannot be removed or otherwise treated and no relief or cure has been found after reasonable efforts.” 

The problem with this definition is that intractable pain may be mild or intermittent and not curable, but may still be treated with non-opioid modalities. To require and receive treatment with opioids and other controlled drugs, one really needs a specific causative diagnosis of the unremitting “high impact” pain that produces physiologic complications such as hypertension, tachycardia, and endocrine deficiencies. 

Put another way, is intractable pain an incurable but treatable problem? Or is it constant and incurable with potentially life-threatening complications? 

Physicians, as a group, are often mystified, confused and unaware of how to determine which patients have an incurable, but readily treatable problem, and which patients have the constant and incurable pain that causes complications and require opioid therapy.

Physicians need help to make sound, defensible treatment decisions in the face of this quandary.  Some patients with complex intractable pain are greatly impacted and require non-standard treatment, which may include high-dose opioids, benzodiazepines and stimulant drugs. 

Here are the recommended criteria to identify such patients and support non-standard treatment plans.

1. A specific medical cause of intractable pain has been identified.

2. Constant pain has impacted some physiological and/or mental functions such as sleep, eating, hygiene, reading, concentration, and mobility.

3. Trials of standard medications and dosages with such agents as anti-depressants, muscle relaxants, anti-inflammatories, stimulants, anti-seizure medications, and low-dose opioids have not controlled pain or normalized functions.

4. There is objective physical evidence of the causative disease or complications of the pain, such as hypertension, tachycardia, neurologic deficits, or anatomic structural abnormalities.

5. There is an objective, diagnostic test result that documents an abnormality of the cause of pain or its complications, such as a magnetic resonance imaging (MRI), hormone deficiency, elevated autoimmune or inflammatory marker, or an abnormal electrodiagnostic test.

It is the lack of adequate treatment of complex intractable pain that is really the crux of the suffering and deaths that have emerged due to overzealous and misinformed opioid regulations and guidelines.  These legitimate, complex patients comprise about 3 to 5% of chronic pain patients.

The California medical board’s new guidelines provide clinicians the opportunity to implement individualized and effective treatments for these unfortunate and deserving intractable pain patients. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain. Dr. Tennant was the lead physician in crafting California’s Intractable Pain Law and Pain Patient Bill of Rights, and worked with the legislature to get them passed. 

Kristen Ogden is a patient advocate from Virginia. Kristen and her husband Louis travel regularly to California for his intractable pain treatment and prescriptions, which are not available in their home state. Kristen testified during public hearings on the California guidelines and closely followed their development. 

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

A Pained Life: Let the Words Flow

By Carol Levy, PNN Columnist

I ended my last column with my favorite saying: “You don't know what you don't know. And if you don't know what you don't know, you don't know what to ask. Our doctors need to ask.”

A couple of days later, I thought about the column and my second appointment with a neuro ophthalmologist, a specialist in nerve disorders that affect the eye.

I didn’t know that my parents were still carrying insurance on me, so I was going to a low-fee clinic in New York City, where I lived at the time.  It took almost a year, but finally one of the residents there decided I had trigeminal neuralgia. Even with a name for my condition, they still didn't have a clue what to do for it. Or with me.

When I realized that I could afford to see a private doctor, I returned to one I had seen years ago.  He referred me to the specialist.

The first appointment did not go well. He told me the disabling, horrendous facial and eye pain I had were caused by anxiety. At the end of the appointment, he patted me on the head, handed me a prescription for an anti-anxiety drug, and sent me home.

I was mad. Another "I dunno" exam that ends with a doctor saying, "It's psychosomatic." I debated if I even wanted to keep the second appointment, but what else could I do?  A feeling I think many of us have.

At the next appointment, I repeated my story of how the pain started, what it felt like, and what it was doing to me.  Again, he was unimpressed. He turned away from me, saying nothing.

Then, just to fill the silence, I said "You know, the other day, for a few seconds, I thought the pain was done and gone."

He abruptly turned back towards me. “What made you think that?” he said, the vehemence in his voice surprising me.

“Well, a lady on the bus inadvertently touched the left side of my face, where the pain is,” I explained. “And the pain didn't start. I was so, so happy. Until about 20 seconds later, when the lightning bolts came.”

The doctor walked over to me, and without missing a beat said, “I think it's time we brought you into the hospital.” I was startled and dumbfounded. In the span of a minute, he went from nonchalant to alarmed. I didn't think to ask why.

I was in the hospital for 52 days. After many tests and workups, they decided I should have brain surgery. The surgeon would cut away the numerous tiny little blood vessels that were wrapped around the part of my trigeminal nerve that gives sensation. The surgery only worked for three months, but it was a glorious three months.

Sometimes, it's the minor things: a change in the way pain feels, a new area of pain, or a change in how and when it happens. We may think, why bother the doctor with this? He won't care anyway. It's unimportant. If I tell him, he may think I'm a dolt or making things up. I’ll keep it to myself.

Which brings me to my second favorite saying: “You don't know what you don't know. And if you don't know what you don't know, how will you know if it matters?” 

Sometimes our deciding what a doctor doesn't need to know may be the one thing he needs to know the most. It may really matter. So let the words flow.

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.

Medicare May Cover Training for Family Caregivers

By Judith Graham, KFF Health News

Even with extensive caregiving experience, Patti LaFleur was unprepared for the crisis that hit in April 2021, when her mother, Linda LaTurner, fell out of a chair and broke her hip.

LaTurner, 71, had been diagnosed with early-onset dementia seven years before. For two years, she’d been living with LaFleur, who managed insulin injections for her mother’s Type 1 diabetes, helped her shower and dress, dealt with her incontinence, and made sure she was eating well.

In the hospital after her mother’s hip replacement, LaFleur was told her mother would never walk again. When LaTurner came home, two emergency medical technicians brought her on a stretcher into the living room, put her on the bed LaFleur had set up, and wished LaFleur well.

That was the extent of help LaFleur received upon her mother’s discharge.

She didn’t know how to change her mother’s diapers or dress her since at that point LaTurner could barely move. She didn’t know how to turn her mother, who was spending all day in bed, to avoid bedsores.

Even after an occupational therapist visited several days later, LaFleur continued to face caretaking tasks she wasn’t sure how to handle.

“It’s already extremely challenging to be a caregiver for someone living with dementia. The lack of training in how to care for my mother just made an impossible job even more impossible,” said LaFleur, who lives in Auburn, Washington, a Seattle suburb. Her mother passed away in March 2022.

LINDA AND PATTI LAFLEUR

A new proposal from the Centers for Medicare & Medicaid Services addresses this often-lamented failure to support family, friends, and neighbors who care for frail, ill, and disabled older adults. For the first time, it would authorize Medicare payments to health care professionals to train informal caregivers who manage medications, assist loved ones with activities such as toileting and dressing, and oversee the use of medical equipment.

The proposal, which covers both individual and group training, is a long-overdue recognition of the role informal caregivers — also known as family caregivers — play in protecting the health and well-being of older adults. About 42 million Americans provided unpaid care to people 50 and older in 2020, according to a much-cited report.

“We know from our research that nearly 6 in 10 family caregivers assist with medical and nursing tasks such as injections, tube feedings, and changing catheters,” said Jason Resendez, president and CEO of the National Alliance for Caregiving. But fewer than 30% of caregivers have conversations with health professionals about how to help loved ones, he said.

Even fewer caregivers for older adults — only 7% — report receiving training related to tasks they perform, according to a June 2019 report in JAMA Internal Medicine.

Nancy LeaMond, chief advocacy and engagement officer for AARP, experienced this gap firsthand when she spent six years at home caring for her husband, who had amyotrophic lateral sclerosis, a neurological condition also known as Lou Gehrig’s disease. Although she hired health aides, they weren’t certified to operate the feeding tube her husband needed at the end of his life and couldn’t show LeaMond how to use it. Instead, she and her sons turned to the internet and trained themselves by watching videos.

“Until very recently, there’s been very little attention to the role of family caregivers and the need to support caregivers so they can be an effective part of the health delivery system,” she told me.

Training Coverage Could Begin Next Year

Several details of CMS’ proposal have yet to be finalized. Notably, CMS has asked for public comments on who should be considered a family caregiver for the purposes of training and how often training should be delivered.

If you’d like to let CMS know what you think about its caregiving training proposal, you can comment on the CMS site until 5 p.m. ET on Sept. 11. The expectation is that Medicare will start paying for caregiver training next year, and caregivers should start asking for it then.

Advocates said they favor a broad definition of caregiver. Since often several people perform these tasks, training should be available to more than one person, Resendez suggested. And since people are sometimes reimbursed by family members for their assistance, being unpaid shouldn’t be a requirement, suggested Anne Tumlinson, founder and chief executive officer of ATI Advisory, a consulting firm in aging and disability policy.

As for the frequency of training, a one-size-fits-all approach isn’t appropriate given the varied needs of older adults and the varied skills of people who assist them, said Sharmila Sandhu, vice president of regulatory affairs at the American Occupational Therapy Association.

Some caregivers may need a single session when a loved one is discharged from a hospital or a rehabilitation facility. Others may need ongoing training as conditions such as heart failure or dementia progress and new complications occur, said Kim Karr, who manages payment policy for AOTA.

When possible, training should be delivered in a person’s home rather than at a health care institution, suggested Donna Benton, director of the University of Southern California’s Family Caregiver Support Center and the Los Angeles Caregiver Resource Center. All too often, recommendations that caregivers get from health professionals aren’t easy to implement at home and need to be adjusted, she noted.

Nancy Gross, 72, of Mendham, New Jersey, experienced this when her husband, Jim Kotcho, 77, received a stem cell transplant for leukemia in May 2015.

Once Kotcho came home, Gross was responsible for flushing the port that had been implanted in his chest, administering medications through that site, and making sure all the equipment she was using was sterile.

Although a visiting nurse came out and offered education, it wasn’t adequate for the challenges Gross confronted.

“I’m not prone to crying, but when you think your loved one’s life is in your hands and you don’t know what to do, that’s unbelievably stressful,” she told me.

NANCY AND JIM KOTCHO

For her part, Cheryl Brown, 79, of San Bernardino, California — a caregiver for her husband, Hardy Brown Sr., 80, since he was diagnosed with ALS in 2002 — is skeptical about paying professionals for training. At the time of his diagnosis, doctors gave Hardy five years, at most, to live. But he didn’t accept that prognosis and ended up defying expectations.

HARDY AND CHERYL BROWN

Today, Hardy’s mind is fully intact, and he can move his hands and his arms but not the rest of his body. Looking after him is a full-time job for Cheryl, who is also chair of the executive committee of California’s Commission on Aging and a former member of the California State Assembly.

She said hiring paid help isn’t an option, given the expense. And that’s what irritates Cheryl about Medicare’s training proposal.

“What I need is someone who can come into my home and help me,” she told me. “I don’t see how someone like me, who’s been doing this a very long time, would benefit from this. We caregivers do all the work, and the professionals get the money? That makes no sense to me.”

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