White House Pharmacy Violated DEA Policy

By Pat Anson, PNN Editor

A pharmacy operated by the White House Medical Unit dispensed hundreds of prescriptions for opioids and other controlled substances without keeping proper records, according to a scathing audit released this month by the Office of the Inspector General (OIG) at the Department of Defense.

In many cases, drugs, surgeries and other medical services were provided to ineligible White House staff members at no cost. Over-the-counter medications were also free to be taken from open bins to anyone who wanted them.

The OIG launched an audit of the medical unit in 2018, after receiving complaints that an unnamed senior military medical officer assigned to the White House was acting improperly. Additional complaints received over a hotline questioned procedures at the pharmacy and the eligibility of patients that were being treated.

The resulting audit – which covered the years 2009 to 2020 – found “severe and systematic” problems at the White House pharmacy due to poor oversight that may have resulted in “prescribing errors and inadequate medication management.”

“In our analysis of the White House Medical Unit’s controlled substance records, we found that medications, such as opioids and sleep medications, were not properly accounted for, in violation of (federal law),” the OIG said. “White House Medical Unit medical providers wrote prescriptions for controlled substances that often lacked the medical provider and patient information mandated by DEA policy.”

DEA regulations require that prescriptions for all controlled substances contain the patient’s full name and address, as well as the name, address, and DEA registration number of the prescriber. But when reviewing 11 examples of prescriptions for controlled substances provided by the medical unit, investigators found much of that information was missing.       

The OIG was only able to obtain pharmaceutical records from 2017 to 2019, because the pharmacy kept records for just two years. Investigators found that the pharmacy still used handwritten ledgers to track the inventory of controlled substances. The ledgers frequently contained errors, illegible text, or text was that was crossed out.

A pharmacy ledger from 2019, seen below, shows that prescriptions were dispensed for the opioids morphine, hydrocodone, fentanyl and tramadol, as well as ketamine and diazepam – all controlled substances. Some medications were dispensed in unusually large quantities, such as 2,000 tablets of the sleep aid Ambien.

Names of the prescribers and patients on the ledger were redacted. In some cases, the ledger shows no record of who picked up the medications or if anyone signed a receipt for them.     

WHITE HOUSE MEDICAL UNIT CONTROLLED SUBSTANCE TRACKING FORM

In interviews with 70 former military service members who worked at the White House between 2009 and 2018, the OIG found there was a culture of entitlement. Administration officials and staff members who sought medical treatment were “not normal patients,” as one medical unit member put it.

“We bent knees and we bent the rules to meet this very weird, strange culture that was there, and I think it was really to just impress people,” the service member said. “And so I understand it’s almost like the culture of D.C. and politics, and somehow the Medical Unit got sucked up into that culture as well.”

Another service member highlighted inconsistencies in the medical unit’s practices.

“[There] were several concerns about we’re not accomplishing the mission the right way. Is stuff getting done? Yeah. Is it being done appropriately or legally all the time? No. But, are they going to get to that end result that the bosses want? Yeah.”

Other service members said the medical unit used alias accounts to provide free specialty care and surgery to ineligible White House staff. The alias accounts did not use the patient’s real name or address. When a medical unit staff member expressed alarm about that practice, they were instructed to provide care to the ineligible individual.

“Several former White House Medical Unit staff members stated that they felt unable to act outside of the will of the Physician to the President or the White House Medical Unit Director. One former White House Medical Unit medical provider stated that White House Medical Unit staff members were fearful of ‘making independent decisions’ without the approval of the Physician to the President or the Director of the White House Medical Unit,” the report said.

Dr. Ronny Jackson

The OIG report takes pains not to identify anyone by name or associate them with either the Obama or Trump administrations. But for many of the years covered by the audit, Dr. Ronny Jackson played key roles in the White House medical unit.

A U.S. Navy officer, Jackson joined the medical unit in 2006, and became its director in 2010. In 2013, Jackson was given the additional title of Physician to the President under Obama. In December 2014, Jackson ceased being Director of the White House Medical Unit, but remained as personal physician to Obama and then Trump until 2018. President Trump appointed Jackson as Chief Medical Advisor and Assistant to the President in January 2019.

In an email to PNN, a spokesperson for Jackson said that he only had a policy role in the medical unit after 2014, and had no association or involvement with the unit’s delivery of care.

In 2018, allegations of drunkenness, misconduct and mismanagement arose about Jackson’s service. Jackson called the allegations a “political hit job.” In December 2019, he retired from the Navy as a Rear Admiral, left the White House, and was elected a Republican congressman in Texas, a position Jackson still holds.   

In 2021, a seperate OIG investigation of Jackson found that he disparaged and bullied subordinates, created a hostile work environment, and engaged in “inappropriate conduct” involving his use of alcohol. Jackson was also found to have used Ambien to help him sleep on long overseas flights on Air Force One, “raising concerns about his potential incapacity to provide proper medical care during this travel.”  

(3/7/24 Update: The Washington Post reported that Jackson was demoted to the rank of captain in 2022 after the OIG report on his conduct. The demotion had not previously been reported and has not been acknowledged by Jackson.)

Gabapentinoids Still Overprescribed Despite Warnings

By Pat Anson, PNN Editor

Despite warnings that they are overprescribed for conditions they were never intended to treat, the use of gabapentinoids continues to grow in the United States.

Pregabalin (Lyrica) and gabapentin (Neurontin) are both gabapentinoids, a class of nerve medication initially developed to treat epileptic seizures. Sales of Lyrica and Neurontin tripled a decade ago, when they were touted as safer alternatives to opioids and prescribed off-label for a variety of pain conditions.

In 2018, Michael Johansen, MD, a researcher and family medicine physician, was one of the first to warn that gabapentinoids were being overprescribed, despite little of evidence of their safety and efficacy for pain conditions. Johansen was particularly concerned the drugs were being given to older adults who were long-time users of opioids and benzodiazepines, a class of anti-anxiety medication.

Not much has changed, according to a new research study by Johansen. Using data from a large national survey, Johansen found that 4.7% of U.S. adults were prescribed a gabapentinoid in 2021, up from 4% in 2015 – a statistically significant increase of 17.5% in six years. The growth was primarily driven by gabapentin, as there was little change in pregabalin’s use.

As Johansen found in his earlier study, gabapetinoid use was much more likely in patients who were co-prescribed opioids, muscle relaxants, benzodiazepines or anti-depressants for chronic pain or mental health conditions. The likelihood of a patient being prescribed a gabapentinoid also rises sharply after age 50.

“Gabapentinoids continue to be commonly used in conjunction with other sedating medications, which is concerning in light of the US Food and Drug Administration’s 2019 warning about co-prescribing of gabapentinoids with other central nervous system depressants,” Johansen reported in the Annals of Family Medicine. “Gabapentinoids are likely used for an array of conditions, with the majority being off-label uses for chronic pain with minimal evidence supporting use.”

Despite those warnings, gabapentinoids — gabapentin in particular — are still being promoted as a treatment for all sorts of things, from dental pain to alcoholism to improving your sex life. Gabapentin has been pitched for so many different conditions that a drug company executive infamously called it “snake oil.”

Gabapentin is FDA-approved for epilepsy and neuropathic pain caused by shingles, but is often prescribed off-label for depression, ADHD, migraine, fibromyalgia, bipolar disorder and postoperative pain.  Pregabalin is approved for diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries, but is also prescribed off-label for other types of pain.

Many patients report side-effects from gabapentinoids, such as weight gain, blurred vision, dizziness, sedation and cognitive issues. There are also an increasing number of reports that the drugs are being abused and sold on the street to boost the potency of illicit drugs.

“Reports of gabapentinoid abuse alone, and with opioids, have emerged and there are serious consequences of this co-use, including respiratory depression and increased risk of opioid overdose death,” Douglas Throckmorton, MD, a top FDA official said when the agency released  its 2019 warning.  

A 2019 study found little evidence that gabapentinoids should be used off-label to treat pain and said their effectiveness was often exaggerated by prescribing guidelines. The CDC’s 2016 opioid guideline recommended gabapentin and pregabalin dozens of times as alternatives to opioids, without saying a word about their abuse or side effects.

The CDC’s 2022 revised opioid guideline takes a more cautious approach, saying gabapentin and pregabalin can have “small to moderate improvements” on pain, but were associated with a moderate risk of adverse events. Evidence on their long-term use was also lacking, according to the CDC.  

U.S. Healthcare System Isn’t Ready for Surge of Disabled Seniors

By Judith Graham, KFF Health News

The number of older adults with disabilities — difficulty with walking, seeing, hearing, memory, cognition, or performing daily tasks such as bathing or using the bathroom — will soar in the decades ahead, as baby boomers enter their 70s, 80s, and 90s.

But the health care system isn’t ready to address their needs.

That became painfully obvious during the covid-19 pandemic, when older adults with disabilities had trouble getting treatments and hundreds of thousands died. Now, the Department of Health and Human Services and the National Institutes of Health are targeting some failures that led to those problems.

One initiative strengthens access to medical treatments, equipment, and web-based programs for people with disabilities. The other recognizes that people with disabilities, including older adults, are a separate population with special health concerns that need more research and attention.

Lisa Iezzoni, 69, a professor at Harvard Medical School who has lived with multiple sclerosis since her early 20s and is widely considered the godmother of research on disability, called the developments “an important attempt to make health care more equitable for people with disabilities.”

“For too long, medical providers have failed to address change in society, changes in technology, and changes in the kind of assistance that people need,” she said.

Among Iezzoni’s notable findings published in recent years:

Most doctors are biased: In survey results published in 2021, 82% of physicians admitted they believed people with significant disabilities have a worse quality of life than those without impairments. Only 57% said they welcomed disabled patients.

“It’s shocking that so many physicians say they don’t want to care for these patients,” said Eric Campbell, a co-author of the study and professor of medicine at the University of Colorado.

While the findings apply to disabled people of all ages, a larger proportion of older adults live with disabilities than younger age groups. About one-third of people 65 and older — nearly 19 million seniors — have a disability, according to the Institute on Disability at the University of New Hampshire.

Doctors don’t understand their responsibilities: In 2022, Iezzoni, Campbell, and colleagues reported that 36% of physicians had little to no knowledge of their responsibilities under the 1990 Americans With Disabilities Act, indicating a concerning lack of training. The ADA requires medical practices to provide equal access to people with disabilities and accommodate disability-related needs.

Among the practical consequences: Few clinics have height-adjustable tables or mechanical lifts that enable people who are frail or use wheelchairs to receive thorough medical examinations. Only a small number have scales to weigh patients in wheelchairs. And most diagnostic imaging equipment can’t be used by people with serious mobility limitations.

Iezzoni has experienced these issues directly. She relies on a wheelchair and can’t transfer to a fixed-height exam table. She told me she hasn’t been weighed in years.

Among the medical consequences: People with disabilities receive less preventive care and suffer from poorer health than other people, as well as more coexisting medical conditions. Physicians too often rely on incomplete information in making recommendations. There are more barriers to treatment and patients are less satisfied with the care they do get.

Discrimination in Healthcare

Egregiously, during the pandemic, when crisis standards of care were developed, people with disabilities and older adults were deemed low priorities. These standards were meant to ration care, when necessary, given shortages of respirators and other potentially lifesaving interventions.

There’s no starker example of the deleterious confluence of bias against seniors and people with disabilities. Unfortunately, older adults with disabilities routinely encounter these twinned types of discrimination when seeking medical care.

Such discrimination would be explicitly banned under a rule proposed by HHS in September. For the first time in 50 years, it would update Section 504 of the Rehabilitation Act of 1973, a landmark statute that helped establish civil rights for people with disabilities.

The new rule sets specific, enforceable standards for accessible equipment, including exam tables, scales, and diagnostic equipment. And it requires that electronic medical records, medical apps, and websites be made usable for people with various impairments and prohibits treatment policies based on stereotypes about people with disabilities, such as covid-era crisis standards of care.

“This will make a really big difference to disabled people of all ages, especially older adults,” said Alison Barkoff, who heads the HHS Administration for Community Living. She expects the rule to be finalized this year, with provisions related to medical equipment going into effect in 2026. Medical providers will bear extra costs associated with compliance.

Also in September, NIH designated people with disabilities as a population with health disparities that deserves further attention. This makes a new funding stream available and “should spur data collection that allows us to look with greater precision at the barriers and structural issues that have held people with disabilities back,” said Bonnielin Swenor, director of the Johns Hopkins University Disability Health Research Center.

One important barrier for older adults: Unlike younger adults with disabilities, many seniors with impairments don’t identify themselves as disabled.

“Before my mom died in October 2019, she became blind from macular degeneration and deaf from hereditary hearing loss. But she would never say she was disabled,” Iezzoni said.

Similarly, older adults who can’t walk after a stroke or because of severe osteoarthritis generally think of themselves as having a medical condition, not a disability.

Meanwhile, seniors haven’t been well integrated into the disability rights movement, which has been led by young and middle-aged adults. They typically don’t join disability-oriented communities that offer support from people with similar experiences. And they don’t ask for accommodations they might be entitled to under the ADA or the 1973 Rehabilitation Act.

Many seniors don’t even realize they have rights under these laws, Swenor said. “We need to think more inclusively about people with disabilities and ensure that older adults are fully included at this really important moment of change.”

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

Study Finds Low-Dose Naltrexone Works No Better than Placebo

By Pat Anson, PNN Editor

In recent years, low-dose naltrexone (LDN) has grown in popularity as a treatment for fibromyalgia and other chronic pain conditions. Although naltrexone is only FDA-approved for the treatment of substance use disorders, a growing number of patients and providers say low doses of naltrexone prescribed off-label can be effective in relieving pain.

A new study by Danish researchers is casting doubt on the some of those claims, finding that LDN works no better than a placebo in reducing pain for women with fibromyalgia. In their double-blind, placebo-controlled study, 99 adult women with fibromyalgia were randomly assigned to receive either an LDN pill or an identical-looking placebo daily for 12 weeks.

The study findings, recently published The Lancet Rheumatology, found a minor improvement in pain intensity for the LDN group, with a similar pain reduction in the placebo group. There were no serious adverse events in either group.

“This study did not show that treatment with low-dose naltrexone was superior to placebo in relieving pain. Our results indicate that low-dose naltrexone might improve memory problems associated with fibromyalgia, and we suggest that future trials investigate this further,” wrote lead author Karin Due Bruun, MD, a researcher in the Pain Center at Odense University Hospital in Denmark.

The Danish study is notable, because placebo-controlled, double-blind studies are considered the gold standard in medical research. Until now, much of the evidence about LDN has been anecdotal or low quality.

In a 2020 review of nearly 800 LDN studies, another research team could find only eight that were high quality enough to meet their criteria for evaluation. Nevertheless, they found that LDN “provides an alternative in medical management of chronic pain disorders.”

A 2019 review by British researchers also found that LDN is safe to use, but recommended that more clinical studies be conducted.

How naltrexone works is not exactly clear. LDN supporters believe the drug modulates the immune system, reduces inflammation and stimulates the production of endorphins, the body's natural painkiller.

In 50mg doses, naltrexone blocks opioid receptors in the brain and decreases the desire to take opiates or alcohol. But in smaller doses of 5mg or less, patients have found LDN to be an effective pain reliever. PNN columnists have shared their positive experiences using LDN to treat everything from interstitial cystitis to Ehlers-Danlos syndrome to fibromyalgia.  

A woman with fibromyalgia tried all sorts of FDA-approved medications to relieve her leg pain, brain fog and depression. None worked, until she tried LDN.   

“After about seven days, my pain lessened,” said Janice Hollander. “[LDN] has completely changed my life. I don’t know that I would be here today if it wasn’t for it. I don’t think I could go for another year in the misery I was in.” 

Naltrexone does cause minor side effects, such as nausea and dizziness, and because it is an opioid antagonist it should not be taken with opioid medication.

Patients interested in trying LDN often encounter doctors who won’t prescribe it off-label. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

Checking the Boxes: Why Therapy Was Not Helpful

By Mia Maysack, PNN Columnist

Living with persistent pain or chronic illness is enough to push anyone to the brink of insanity. I’ve reached out for mental health assistance in the past, and either regretted it or didn’t feel it was much help at all.

I later came to the realization that therapy could only ever be what we make of it, so I decided to release the disappointment from the past and give it another wholehearted try.

I learned that the therapy process, particularly since COVID-19, is a nightmare. The isolation of the pandemic helped us recognize the importance of mental health, along with the fact that there’s a shortage of providers. It’s now nearly impossible to find a therapist.

It’s even more difficult to come across one that is accepting new patients and whatever insurance you might or might not have. I spent the better part of a year researching, making phone calls and being told no, before I finally came across a situation that seemed promising.

After providing extensive documentation exploring every aspect of my life and then playing the waiting game to get the green light from insurance, I was finally able to move forward with scheduling an appointment at a clinic. It would have been many more months before I could be seen in-person, so I settled for a virtual appointment.

I was happy to connect with a provider, who initially seemed warm and caring. Little did I realize how short lived this would be.

During our conversation, we covered the basics. I attempted to explain how anyone who lives the way that I do must experience some form of depression or sadness, but that doesn’t necessarily mean that I always feel that way. I don’t feel a need to label people as “sad” or “depressed,” for I believe there’s a wide spectrum we all exist on. We can allow ourselves to feel sad or anxious in any given moment, without necessarily committing to that experience permanently.

Prior to this therapy session, I’d been participating in a behavioral health program where a provider would call once every few weeks for a momentary check-in. Being that I had no other support at that time, I was thankful for the resource and couldn’t help but imagine what different points in my life would’ve been like had something like that been available then.

I’m under the impression this check-in option was cultivated during the pandemic in an attempt to alleviate the mental health stress that so many of us were having.  It’s more of a band-aid than anything else, but slowing the emotional bleeding can be the difference between life or death for many.

I remember having a pleasant conversation with someone who reached out. We chatted for about a half hour as they listened to some of my health-related goals, then advised me they’d have someone follow up to ensure the plan was proceeding smoothly.  

At the very last second, they requested I complete a survey -- one that I’d done countless times already: the PHQ-9 questionnaire.  It asks how you were feeling in the last two weeks and to rate your experiences on a numeric scale.  Was I tired? Feeling hopeless? Eating enough? Eating too much? Was I thinking of hurting myself?

Ending the phone call on such a note turned an otherwise enjoyable and productive conversation into a traumatic reminder of the ways I’d been struggling. Then the session was over and I was on my own again.

On the next call, I offered feedback -- mentioning the survey should come sooner in the conversation and empower the patient to choose when they’d complete it or even not take it. That should be my right and my choice.

I was advised that the survey was part of the process of getting a diagnosis. The therapist said this wasn’t so much the clinic’s way of doing things, but rather “served insurance purposes.” That rubbed me the wrong way.

Here I was, absolutely desperate for therapy, but instead of receiving actual help, I was reminded once again that the most important thing for a provider is to collect patient data. With a heavy heart, I chose to end my pursuit of counseling. It feels harmful and unsafe to be reminded that “checking the boxes” is prioritized over the quality of human life.

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is a healthcare reform advocate and founder of Keepin’ Our Heads Up, a support network; Peace & Love, a life coaching practice; and Still We Rise, an organization that seeks to alleviate pain of all kinds.

Lack of Awareness Is Harming People with Scoliosis

By Drs. Sanja Schreiber and Emily Somers

Cael was a typical 15-year-old — until the discovery of an already advanced abnormal curvature of his spine.

“I felt like the Hunchback of Notre Dame,” Cael told CBC News, recalling the emotionally draining and gruesome two-year wait for spinal surgery during which his curve progressed to a whopping 108 degrees.

Scoliosis is an abnormal twisting and curving of the spine that can develop at any age, but mostly occurs during rapid growth spurts in children, and as part of spine aging in adults over the age of 60.

Of all types of scoliosis in children, adolescent idiopathic scoliosis is the most prevalent, accounting for as many as nine in 10 cases and impacting up to one in 20 adolescents globally. On the other end of the age spectrum, a staggering two-thirds of older adults are also affected.

In clinical care, research and education related to scoliosis, disparities persist worldwide. Despite its widespread prevalence, scoliosis often goes undiagnosed, or has delayed diagnosis as in Cael’s case. It also receives limited attention in clinical and public health education, leading to significant gaps in health care.

This general lack of awareness has serious implications for thousands of people like Cael.

Gaps in Scoliosis Care

In the United States, fewer than half of states legislate school-based scoliosis screening in children. Even worse, Canada discontinued screening back in 1979 because it was not considered cost-effective.

Pediatricians’ screening practices vary, and some cases of scoliosis in children are only discovered when an unrelated chest X-ray reveals a curved spine. With about 30 per cent of cases being hereditary, parents may not recognize the signs early on.

The recommended care in North America involves bracing for mild to moderate curves (25° to 45°) and surgery for curves exceeding 45°. Shockingly, 32 per cent of Canadian children, like Cael, face delayed referrals, discovering significant curves when they finally see specialists.

Despite documented success in managing scoliosis through early screening, exercise rehabilitation and brace treatment, global health-care education often neglects this condition.

The general lack of global awareness leaves physicians, nurses and other practitioners unaware of effective treatments and referral processes, contributing to the misunderstanding and under-treatment of patients. Consequently, when children with scoliosis eventually reach specialists for care, they may encounter challenges navigating the health-care system as they transition into adulthood.

Sex Disparities

It is unclear why adolescent idiopathic scoliosis affects mainly girls. The more severe the curve, the more likely the patient is female.

Due to their specific biology, females also face a five-fold higher risk of progressive deformities and are 10 times more likely, compared to males, to require surgery.

Despite generally uncomplicated pregnancies and deliveries, women with scoliosis often face difficulties receiving pain control during labour, with higher epidural failure rates.

Moreover, they often suffer pregnancy-related back pain, and their spine curvature may worsen after pregnancy.

Healthcare Barriers

Healthcare access in the U.S. is influenced by a range of factors including race, income and health insurance coverage.

Patients with better insurance plans tend to seek pediatric orthopedic care at a younger age. Those with public insurance tend to have worse spine curvatures by the time they reach a scoliosis specialist; this is particularly striking among Black patients with public insurance, who are 67 per cent less likely to be diagnosed at a stage early enough for effective brace treatment compared to Black patients with private insurance.

While Canada’s health-care system covers spinal fusion for severe scoliosis, the lack of a national insurance program in the U.S. leads to varying out-of-pocket expenses for patients.

Those without insurance often cannot afford surgery at all.

But even with Canada’s universal coverage, patients typically wait an entire year for surgery due to a shortage of providers. Because of regional variability in resources such as access to spinal surgeons, funding and specialized facilities, some kids, like Cael, wait even longer, experiencing physical, emotional and psychological burdens, while their curves get progressively worse.

Delayed surgery in Canada cost the health-care system $44.6 million due to more complex surgeries, extended hospital stays, readmission and re-operation rates.

Lack of Research

Ongoing gender disparities in the healthcare workforce and lack of research funding for this female-predominant condition continue to hamper effective action.

Fewer than five per cent of spinal surgeons identify as women. Glass-ceiling effects surround women surgeons in this male-dominated culture, perpetuating gendered training environments, being held to higher standards and earning lower wages. The dearth of senior women role models and mentors is a further barrier for career advancement and retention.

Furthermore, research funding for diseases, such as scoliosis, that mainly affect females has historically lagged far behind funding for male-predominant diseases. Improving workforce diversity is an important facet of addressing health disparities and shaping research agendas.

Inequities abound in scoliosis care and research. The impact of lack of awareness and delayed care extends beyond physical challenges. The patient and their family suffer emotionally, incurring significant financial burden while fearing the future.

The message is clear, we must do better for this underserved population.

Sanja Schreiber, PhD, is an Adjunct Professor of Physical Therapy at the University of Alberta and the Owner/Director of Curvy Spine, a specialized clinic for treating structural spinal disorders and training physiotherapists in scoliosis rehabilitation.

Emily Somers, PhD, is an epidemiologist specializing in immune-mediated and musculoskeletal diseases. She also directs the Interdisciplinary Research & Team Science Program at the Michigan Institute for Clinical and Health Research.

This article originally appeared in The Conversation and is republished with permission.

‘Safe Supply’ of Rx Opioids Saved Lives in British Columbia

By Pat Anson, PNN Editor

Prescribing opioids and other medications to people with substance use disorders significantly reduces their risk of dying, according to a large new study in British Columbia. The findings add weight to efforts to create a “safe supply” of legal medications for patients at risk of an overdose from increasingly toxic street drugs.

Vancouver, British Columbia was the first major North American city to be hit by a wave of overdoses involving illicit fentanyl, a potent synthetic opioid. That led Vancouver to become a laboratory for harm reduction programs and safe supply sites offering prescription opioids and injectable heroin to drug users.  

How effective have those programs been?

A study by the B.C. Centre for Disease Control, recently published in the British Medical Journal, found that prescribing opioids, stimulants and anti-anxiety medication to nearly 6,000 drug users dramatically reduced their risk of death.

The Risk Mitigation Guide (RMG) program was initially launched in early 2020 to help drug users going through withdrawal while isolated by the COVID-19 quarantine. A year later, the program was extended, allowing doctors and nurse practitioners to prescribe hydromorphone, morphine, oxycodone, fentanyl, benzodiazepines and stimulants to drug users.

People who were given an initial dose of prescription opioids had a 61% lower risk of death from any cause the following week, and were 55% less likely to die of a drug overdose.

The protective effect of a safe supply increased as more doses were provided. Drug users who received four or more days of opioids were 91% less likely to die from any cause and 89% less likely to die from an overdose.

"We saw a profound impact on reduction in somebody's overdose death risk the week after they picked up these drugs, to a degree that is really surprising and has enormous potential," co-author Paxton Bach, MD, an addiction medicine specialist, told CBC News. "This paper is the strongest evidence we have so far, by a large margin, supporting the idea that this can be an effective strategy for reducing overdose death risk."

But critics of safe supply programs say they don’t really reduce drug abuse. An investigation last year by the National Post found that hydromorphone pills given to drug users in Vancouver were being sold to other addicts, with the sellers then using the money to buy more potent street drugs that were often laced with fentanyl.

A new study in JAMA Internal Medicine also found that opioid-related hospitalizations rose sharply in British Columbia after safe supply programs were launched there, although there was no significant change in overdose deaths. The spike in hospitalizations may have been due to more potent street drugs and counterfeit pills on the black market.

Since a public health emergency was declared in British Columbia in 2016, over 13,000 people have died from drug overdoses. A 2020 analysis found that only about 2% of the B.C. opioid-related deaths were caused by prescription opioids alone. The other overdoses mainly involved illicit fentanyl and other street drugs.  

FDA Finds ‘Credible Scientific Support’ for Marijuana as Pain Reliever

By Pat Anson, PNN Editor

It took a lawsuit to prompt its release, but the U.S. Department of Health and Human Services (HHS) has finally made public a lengthy FDA review explaining why it thinks marijuana should be rescheduled as a Schedule III controlled substance. Such a move would make it legal under federal law for marijuana to be used for medically approved purposes, such as pain relief.

The FDA review was completed last August, nearly a year after it was requested by President Biden. But the 252-page review was not released until Friday, after a lawsuit was filed by two pro-cannabis lawyers when HHS didn’t respond to Freedom of Information Act (FOIA) requests.

Medical marijuana is already legal in 38 states, but cannabis remains classified as a Schedule I substance by the Drug Enforcement Administration, making its sale or use illegal under federal law. The DEA is expected to make its decision on rescheduling soon.

The FDA looked at seven potential medical uses of cannabis: pain, anorexia, anxiety, epilepsy, inflammatory bowel disease (IBD), nausea, and post-traumatic stress disorder (PTSD).

After reviewing clinical studies of cannabis, and the views of academic and professional medical societies, the FDA said they found “mixed findings of effectiveness.” The strongest evidence was for pain relief, anorexia and nausea.

“The available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain.”

— FDA review

“The largest evidence base for effectiveness exists for marijuana use within the pain indication (in particular, neuropathic pain),” the FDA said. “On balance, the available data indicate that there is some credible scientific support for the use of marijuana in the treatment of pain, anorexia related to a medical condition, and nausea and vomiting, with varying degrees of support and consistency of findings.”

Perhaps just as importantly, the FDA found no evidence of “unacceptably high safety risks” when marijuana was used therapeutically. That is a key finding for marijuana to be rescheduled by the DEA. The risk of marijuana being used nonmedically was also low, compared to substances like alcohol, heroin, cocaine, prescription opioids and anti-anxiety drugs.

“The rank order of the comparators in terms of greatest adverse consequences typically places heroin, benzodiazepines and/or cocaine in the first or immediately subsequent positions, with marijuana in a lower place in the ranking, especially when a utilization adjustment is calculated. For overdose deaths, marijuana is always in the lowest ranking among comparator drugs,” FDA said.

“These evaluations demonstrate that there is consistency across databases, across substances, and over time that although abuse of marijuana produces clear evidence of a risk to public health, that risk is relatively lower than that posed by most other comparator drugs.”

The FDA said the “vast majority” of professional medical organizations do not recommend marijuana, but they don’t specifically recommend against it either. The lone exception is the American Psychiatric Association, which warns that long-term use of marijuana can worsen psychiatric conditions, such as paranoia and hallucinations.

Reclassifying marijuana as a Schedule III substance – in the same category as codeine and ketamine – would certainly be historic, but it won’t resolve the many differences between federal and state regulation of cannabis.

Under federal law, legal access to Schedule III substances requires a prescription from a licensed doctor that is dispensed from a licensed pharmacy. Medical marijuana products would also have to go through the FDA’s lengthy and costly clinical trial process to assess their safety and effectiveness. Even if they pass that test, they would only be approved by FDA for certain conditions.  

Pain Patients Feel Abandoned by U.S. Healthcare System

By Pat Anson, PNN Editor

Many pain patients feel abandoned by the U.S. healthcare system and say it’s increasingly difficult to find a doctor or obtain opioid analgesics, according to a large new survey by Pain News Network. Some patients have turned to other substances – both legal and illegal -- for pain relief, and almost a third have contemplated suicide.

Nearly 3,000 pain patients or their caregivers participated in PNN’s online survey in the final weeks of 2023.

Over 90% of those with opioid prescriptions said they faced delays or problems last year getting their prescriptions filled at a pharmacy. Nearly a third were hoarding opioids because of fear they’ll not be able to get them in the future. And over 40% rated the quality of their pain care as “bad” or “very bad.”

“I’ve given up hope of getting help for chronic, severe pain in this country. I’m planning to move to where I can receive humane treatment,” one patient told us.

“The hoops in which I have had to jump through to get the minimal help that I have gotten throughout the years is ridiculous,” said another. “I have a very extensive and very well documented history of mental and physical trauma, but I am still treated as a drug seeker. I am currently unable to get any form of medication.”

“Every pain patient worries, from one month to the next, if their doctor will cut them off opioids or force taper them to such low levels that there is NO pain relief,” another patient wrote.

HOW WOULD YOU RATE THE CURRENT QUALITY OF YOUR PAIN CARE?

“I’ve spent the last 8 years explaining my inadequate pain control and lack of sleep that has fallen on deaf ears. I’ve tried so many different doctors and now feel like no one cares at all. Honestly feel as though they would rather see me die and be rid of me,” said another.

‘Impossible to Find Help’

About one in every four patients said they were tapered to a lower dose or taken off opioids — but only a small number were referred to addiction treatment. Less than one percent of those who stopped opioid treatment said it improved their pain and quality of life.

One in five patients couldn’t find a doctor to treat their pain. Many were abandoned by a physician or had a doctor who retired from clinical practice.   

• 20% Unable to find doctor willing to treat pain

• 14% Doctor retired or left their practice  

• 12% Abandoned or discharged by a doctor

• 27% Tapered to a lower dose or taken off opioids

• 3%   Received a referral for addiction treatment

• 0.6% Stopped opioids & pain and quality of life improved

“My primary retired. Then my rheumatologist moved to another state. Now most doctors don't prescribe and it's impossible to find help,” a patient wrote.

“Every pain management office in my area were nothing but nightmares waiting to happen. And every person I talked to… were solely concerned with either getting people off of pain medication or reducing the amount of medicine by over half,” said another.

“Doctors I talked to said they felt like they had a gun to their head and that they are being watched, so they won't prescribe or prescribe very little,” a patient wrote.

“My insurance just capped opioids to 7 days a month, so I have to choose whether to buy the other 3 weeks and cut back on my food budget, or take to my bed for 3 weeks a month,” said another.

“I am unable to find a new doctor to treat pain. A couple of years ago I was tapered from a previously working amount of pain med, so now I have daily severe pain and too many sleepless nights from pain. But the doc doesn't care. It seems my clinic system only sees me as an addict,” wrote another pain patient.

Risky Choices

With pain care increasingly difficult to find, nearly a third of patients said they considered suicide in the past year because their pain was so severe. Others adopted risky behaviors, such as hoarding opioid medication, obtaining opioids from another person, buying illicit substances off the black market, or using alcohol, cannabis and other substances for pain relief.    

• 29% Considered suicide

• 32% Hoarded opioid medication

• 30% Used cannabis for pain relief

• 14% Used alcohol for pain relief

• 11% Used kratom for pain relief

• 11% Obtained prescription opioids from friend, family or black market

•  4%  Used heroin, illicit fentanyl or illegal substance for pain relief

“I was taken off my prescription opioid twice and attempted suicide twice because the other prescriptions were not effective,” one patient told us.

“I have a therapist that has been helpful, because I have considered taking my life. He is concerned that I'm not getting adequate pain relief,” said another.

“Since suicide is against my faith, I prayed for death,” one patient wrote. 

“I know so many people that have stopped going to doctors and started buying heroin off the street. They say it’s easier and cheaper,” another patient said.

“The obscenely high cost of medical marijuana made me suffer so much financially that I have been unable to make use of the compassion center’s offerings,” wrote another patient. “Why on earth do we let plants be illegal in the first place, then let them be sold for so much money that they are almost impossible to afford on a disability income?”

“We desperately need to get away from the denial of opioids as a way to deal with this crisis. So far, the results of these laws on opioids have been an abject failure. Deaths have not been reduced, but actually increased due to chronic pain patients having to resort to suicide,” said another.

“I hope that all the people who are in charge of this will one day feel what I do and have some grasp of the pain situation people are forced to live through. They take care of their dogs and cats better than human beings,” a patient said.

“I have considered suicide multiple times over the past few years. These laws, while meant to curb illicit abuse of these medications, are harming legitimate patients like myself,” another patient wrote. “The worst part is that, for the time being, it looks like things are going to get much, much worse for me and the millions of others like me.” 

PNN’s online survey was conducted from November 13 to December 31, 2023. A total of 2,961 U.S. pain patients or caregivers participated. We’ll be releasing more results in the coming days.  

90% of Pain Patients Have Trouble Filling Opioid Prescriptions

By Pat Anson, PNN Editor

Nine out of ten pain patients with an opioid prescription in the United States experienced delays or problems in the past year getting their prescription filled at a pharmacy, according to a large new survey by Pain News Network.  Nearly 20% of patients were not able to get their opioid medication, even after contacting multiple pharmacies.

Over 2,800 pain patients participated in PNN’s online survey. Many were so frustrated with pharmacists being unable or unwilling to fill their opioid prescriptions that they turned to other substances for pain relief or contemplated suicide.

“My medication helps my pain be at a level I can tolerate. When I can't get it, I honestly feel like ending my life due to the pain. I wish they'd stop to realize there are those of us with a legitimate need,” one patient told us.

“The discrimination we receive, not to mention all the hurdles we are put through just being a chronic pain patient, is absolutely affecting my physical, mental, and emotional health. It’s only gotten worse, leaving myself and family to scramble looking for medication,” another patient said.

“The problem I've had this year is my pharmacy running out of my pain meds. Then it's a frantic and anxiety filled race to find one that will,” another patient wrote. “My regular medication has been Percocet for years and I haven't received that in almost a year. No pharmacies in this area have been able to get it.”

DID YOU EXPERIENCE DELAYS OR PROBLEMS GETTING YOUR OPIOID PRESCRIPTION FILLED AT A PHARMACY?

The U.S. is currently experiencing its worst drug shortages in a decade, with supplies running low for medications used to treat cancer, ADHD and diabetes. Less publicized are chronic shortages of oxycodone, hydrocodone and other opioids used to treat pain – shortages that that have gotten little, if any, attention from the White House, Congress, or federal health agencies like the CDC and FDA.  

While supply chain issues and low profit margins for generic medication are driving many of the drug shortages, the low supply of opioids is largely the result of policy and political decisions. Egged on by Congress, the DEA for eight straight years has cut opioid production quotas, reducing the supply of many opioids by over two-thirds in a failed attempt to bring the overdose crisis under control.

Opioid litigation has also played a major role in the shortages, with drug wholesalers and big pharmacy chains agreeing to limit the supply of opioids at each individual pharmacy as part of the $21 billion national opioid settlement.

Whatever the cause, American pain patients routinely run into problems when they try to get an opioid prescription filled. Nearly 85% said they were told by a pharmacist that their medication is temporarily out of stock, while 6% were told there is only enough to partially fill the prescription.

What was primary reason the pharmacist gave for not filling the prescription?

• 85% Opioid medication not in stock

• 6% Can only make partial fills

• 4% Insurance issue

• 3% Did not explain why

• 2% Might get in trouble or lose their job

• 1% Prescription too risky or inappropriate

Some pharmacists said they might get in trouble or lose their job if they filled the prescription, while others claimed the medication was inappropriate, too risky, or that there was an insurance issue. Many gave multiple excuses to patients.

“First it was that they didn’t have the full quantity in stock. They then tried to get me to take a partial fill, then they told me they needed a prescription for Narcan from the prescribing doctor, and then out of nowhere it’s not covered by my insurance,” one patient wrote.

“Pharmacy said that there were shortages everywhere and had no idea when they would have the oxycodone that I need daily for my lower back pain,” said another.

“Pharmacist stated that the medication was on back order. They also said that they don't know if they will ever get them back again,” a patient wrote.

“At first the pharmacist said both scripts were out of stock, then he said he could only do a partial fill. Then told me he couldn't fill my scripts anymore and to find a new pharmacy,” another frustrated patient explained.

Over 60% of patients did just that, by visiting or calling another pharmacy. That’s not as easy as it may sound. Over half said they contacted three or more pharmacies while trying to get their prescription filled.

Many were turned away, as pharmacies are often reluctant to take on new pain patients because that would make their rationed supply of opioids even tighter.  

“They had it in stock one month but the next month she told me she had to save them for her regular customers. Then she went on to say that Walgreens will no longer accept people with no insurance,” a patient wrote.

DID YOU HAVE TO FIND ANOTHER PHARMACY TO FILL THE PRESCRIPTION?

“Getting my monthly pain pills is a 3 ring circus joke. It takes 10 to 15 days of making calls covering 175 miles to make sure I can pick them up!” said another.

“CVS is only allowed so many hydrocodone a month and if my prescription doesn't get in ahead of somebody else's I'm screwed,” said a patient who lives with pain from fibromyalgia and osteoporosis. “Without it I am bed-bound and have to basically cry and crawl to the bathroom and back to bed.”

“The pharmacies try their best to fill your prescription, but if they don't have it in stock, they don't have it in stock,” another patient wrote. “It definitely affects the quality of life. You live in fear every month that this is going to be it.”

WERE YOU EVENTUALLY ABLE TO GET THE PRESCRIPTION FILLED?

PNN’s online survey was conducted from November 13 to December 31, 2023. A total of 2,826 U.S. pain patients or caregivers with an opioid prescription participated. We’ll be releasing more results in the coming days.  

Patients With Irritable Bowel Syndrome Have High Rates of Fibromyalgia

By Pat Anson, PNN Editor

A large new study has found high rates of fibromyalgia in patients with irritable bowel syndrome (IBS), adding to a growing body of evidence linking gut bacteria to chronic pain disorders. IBS patients were also more likely to have chronic fatigue syndrome (CFS).

The study, recently published in the journal Biomedicines, looked at more than 1.2 million IBS patients hospitalized in the U.S. over a three-year period. They found that the prevalence rate of fibromyalgia in the IBS patients was 10.7 percent, about five times higher than the fibromyalgia rate (1.4%) in the general adult population.

Fibromyalgia is a poorly understood condition characterized by widespread body pain, headaches, fatigue, insomnia and mood disorders; while IBS causes abdominal pain, cramps, bloating, gas and diarrhea. Gut bacteria has been associated with both IBS and fibromyalgia, but the exact mechanism of action remains unclear.

“This is yet another example where ailments in the gut are linked to ailments elsewhere in the body and mind,” said senior author Yezaz Ghouri, MD, an assistant professor of clinical medicine and gastroenterology at the University of Missouri School of Medicine. “As we continue to learn more about how gut health effects health elsewhere it is important that clinicians look for and manage somatic comorbidities in IBS patients.”

Fibromyalgia and CFS are known as “somatic” disorders because patients who have them often experience anxiety and depression – a tendency perhaps explained about the lack of effective treatments for their physical symptoms.

“Because IBS patients have higher prevalence of somatic comorbidities such as fibromyalgia and chronic fatigue syndrome, identifying and treating these disorders can improve their quality of life,” said lead researcher Zahid Ijaz Tarar, MD, a fellow in the division of gastroenterology and hepatology at the University of Missouri School of Medicine.

“Earlier identification of comorbidities is valuable to inform treatment strategies, including consulting other specialties such as rheumatology and psychiatry to improve the overall health outcomes in IBS patients.”

In addition to fibromyalgia, the research team found that hospitalized IBS patients were also significantly more likely to be white and female.  Less than one percent (0.42%) had a CFS diagnosis – a small percentage to be sure, but still higher than CFS rates in the general population (0.06%).

The high rates of fibromyalgia and CFS in IBS patients has led to speculation that poor diets or antibiotics may cause an imbalance of “bad” bacteria in the gastrointestinal system, allowing toxins to leak into the bloodstream and cause other health problems.

A recent study found that Klebsiella aerogenes, a bacterium that causes white blood cells to produce excess amounts of histamine, can trigger a painful immune system response.

Another study found that women with fibromyalgia have strikingly different types and amounts of bacteria than those without fibromyalgia. Faecalibacterium prausnitzii, a “good” bacterium that is normally abundant in the human gut, was found to be depleted in fibromyalgia patients. Other bacteria associated with IBS, CFS and interstitial cystitis were found to be abundant in fibromyalgia patients, but not in the healthy control group.  

New Covid Variant Leading Surge in Respiratory Illness

By Julie Appleby, KFF Health News

It’s winter, that cozy season that brings crackling fireplaces, indoor gatherings — and a wave of respiratory illness. Nearly four years since the pandemic emerged, people are growing weary of dealing with it, but the virus is not done with us.

Nationally, a sharp uptick in emergency room visits and hospitalizations for covid-19, influenza, and respiratory syncytial virus, or RSV, began in mid-December and appears to be gaining momentum.

Here are a few things to know this time around:

What’s Circulating Now?

The covid virus is continually changing, and a recent version is rapidly climbing the charts. Even though it appeared only in September, the variant known as JN.1, a descendant of omicron, is rapidly spreading, representing between 39% to half of the cases, according to pre-holiday stats from the Centers for Disease Control and Prevention.

Lab data indicates that the updated vaccines, as well as existing covid rapid tests and medical treatments, are effective with this latest iteration. More good news is that it “does not appear to pose additional risks to public health beyond that of other recent variants,” according to the CDC.

Even so, new covid hospitalizations — 34,798 for the week that ended Dec. 30 — are trending upward, although rates are still substantially lower than last December’s tally. It’s early in the season, though. Levels of virus in wastewater — one indicator of how infections are spreading — are “very high,” exceeding the levels seen this time last year.

And don’t forget, other nasty bugs are going around. More than 20,000 people were hospitalized for influenza the week ending Dec. 30, and the CDC reports that RSV remains elevated in many areas.

“The numbers so far are definitely going in the not-so-good direction,” said Ziyad Al-Aly, the chief of the research and development service at the Veterans Affairs St. Louis Healthcare System and a clinical epidemiologist at Washington University in St. Louis. “We’re likely to see a big uptick in January now that everyone is back home from the holidays.”

Milder Cases and Fewer Deaths

Certainly, compared with the first covid winter, things are better now. Far fewer people are dying or becoming seriously ill, with vaccines and prior infections providing some immunity and reducing severity of illness.

Even compared with last winter, when omicron was surging, the situation is better. New hospitalizations, for example, are about one-third of what they were around the 2022 holidays. Weekly deaths dropped slightly the last week of December to 839 and are also substantially below levels from a year ago.

“The ratio of mild disease to serious clearly has changed,” said William Schaffner, a professor of medicine in the division of infectious diseases at Vanderbilt University School of Medicine in Nashville, Tennessee.

Even so, the definition of “mild” is broad, basically referring to anything short of being sick enough to be hospitalized.

While some patients may have no more than the sniffles, others experiencing “mild” covid can be “miserable for three to five days,” Schaffner said.

How Will This Affect My Day-to-Day Life?

“Am I going to be really sick? Do I have to mask up again?” It is important to know the basics.

For starters, symptoms of the covid variants currently circulating will likely be familiar — such as a runny nose, sore throat, cough, fatigue, fever, and muscle aches.

So if you feel ill, stay home, said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. “It can make a big difference.”

Dust off those at-home covid test kits, check the extended expiration dates on the FDA website, and throw away the ones that have aged out. Tests can be bought at most pharmacies and, if you haven’t ordered yours yet, free test kits are still available through a federal program at covid.gov.

Test more than once, especially if your symptoms are mild. The at-home rapid tests may not detect covid infection in the first couple of days, according to the FDA, which recommends using “multiple tests over a certain time period, such as two to three days.”

With all three viruses, those most at risk include the very young, older adults, pregnant people, and those with compromised immune systems or underlying diseases, including cancer or heart problems. But those without high-risk factors can also be adversely affected.

While mask-wearing has dropped in most places, you may start to see more people wearing them in public spaces, including stores, public transit or entertainment venues.

Although a federal mask mandate is unlikely, health officials and hospitals in at least four states — California, Illinois, Massachusetts, and New York — have again told staff and patients to don masks. Such requirements were loosened last year when the public health emergency officially ended.

Such policies are advanced through county-level directives. The CDC data indicates that, nationally, about 46.7% of counties are seeing moderate to high hospital admission rates of covid.

“We are not going to see widespread mask mandates as our population will not find that acceptable,” Schaffner noted. “That said, on an individual basis, mask-wearing is a very intelligent and reasonable thing to do as an additional layer of protection.”

The N95, KN95, and KF94 masks are the most protective. Cloth and paper are not as effective.

And, finally, if you haven’t yet been vaccinated with an updated covid vaccine or gotten a flu shot, it’s not too late. There are also new vaccines and monoclonal antibodies to protect against RSV recommended for certain populations, which include older adults, pregnant people, and young children.

Generally, flu peaks in midwinter and runs into spring. Covid, while not technically seasonal, has higher rates in winter as people crowd together indoors.

“If you haven’t received vaccines,” Schaffner said, “we urge you to get them and don’t linger.”

Repeat Infections

People who have dodged covid entirely are in the minority.

At the same time, repeat infections are common. Fifteen percent of respondents to a recent Yahoo News/YouGov poll said they’d had covid two or three times. A Canadian survey released in December found 1 in 5 residents said they had gotten covid more than once as of last June.

Aside from the drag of being sick and missing work or school for days, debate continues over whether repeat infections pose smaller or larger risks of serious health effects. There are no definitive answers, although experts continue to study the issue.

Two research efforts suggest repeat infections may increase a person’s chances of developing serious illness or even long covid — which is defined various ways but generally means having one or more effects lingering for a month or more following infection. The precise percentage of cases — and underlying factors — of long covid and why people get it are among the many unanswered questions about the condition. However, there is a growing consensus among researchers that vaccination is protective.

Still, the VA’s Al-Aly said a study he co-authored that was published in November 2022 found that getting covid more than once raises an “additional risk of problems in the acute phase, be it hospitalization or even dying,” and makes a person two times as likely to experience long covid symptoms.

The Canadian survey also found a higher risk of long covid among those who self-reported two or more infections. Both studies have their limitations: Most of the 6 million in the VA database were male and older, and the data studied came from the first two years of the pandemic, so some of it reflected illnesses from before vaccines became available. The Canadian survey, although more recent, relied on self-reporting of infections and conditions, which may not be accurate.

Still, Al-Aly and other experts say taking preventive steps, such as getting vaccinated and wearing a mask in higher-risk situations, can hedge your bets.

“Even if in a prior infection you dodged the bullet of long covid,” Al-Aly said, “it doesn’t’ mean you will dodge the bullet every single time.”

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

Stopping Long-Term Use of Benzodiazepines Increases Risk of Death

By Pat Anson, PNN Editor

Abruptly stopping long-term treatment with benzodiazepines nearly doubles the risk of a patient dying within a year, according to a large new study.

Benzodiazepines such as Valium and Xanax have long been used to treat anxiety, insomnia and seizures, but their coprescribing with opioids is controversial because both drugs cause respiratory depression, increasing the risk of an overdose.

In 2016, the CDC warned doctors to avoid coprescribing opioids and benzodiazepines “whenever possible.” That same year, the FDA warned that taking the drugs concurrently has serious risks, including “profound sedation, respiratory depression, coma and death.”

Those warnings led many prescribers to abruptly take their patients off benzodiazepines, which many used safely for years. Some patients took opioids and benzodiazepines with a muscle relaxant, a combination known as the “Holy Trinity.”  

Researchers at the University of Michigan analyzed the insurance claims of over 350,000 adults prescribed benzodiazepines long-term from 2013 to 2019, expecting to find the FDA and CDC warnings validated. To their surprise, the risk of death from suicide, accidents and other causes rose for patients in the 12 months after benzodiazepines were discontinued.

“These results were unexpected,” researchers reported in JAMA Network Open. “Given the increased OD (overdose) risk and mortality associated with benzodiazepine prescribing, particularly when coprescribed with opioids, we anticipated that discontinuing benzodiazepine prescriptions would be associated with a lower mortality risk.

“However, for every outcome examined in this analysis, discontinuation was associated with some degree of increased risk — at odds with the assumption underlying ongoing policy efforts that reducing benzodiazepine prescribing to long-term users will decrease harms.”

Researchers found that patients on opioids who stopped taking benzodiazepines had a 6.3% risk of dying over the next year, compared to 3.9% of those who continued taking both drugs. Patients who were discontinued also had a slightly higher risk of a nonfatal overdose, suicidal thoughts, and emergency department visits.

Risk of Death for Opioid Patients Taken Off Benzodiazepines

JAMA NETWORK OPEN

"I think it is important to revisit the assumption that tapering stable long-term users should be the default and instead, perhaps, focus on those with clearly elevated risk of harms," lead author Donovan Maust, MD, a geriatric psychiatrist at UM Health, told MedPage Today.

Maust and his colleagues say patients discontinued from benzodiazepines could be suffering the effects of withdrawal or may be turning to other substances such as cannabis or alcohol. Given the risks involved, they urge prescribers to be “judicious” when prescribing benzodiazepines for the first time and to carefully limit their long-term use.

Older Americans Feel Trapped in Medicare Advantage Plans

By Sarah Jane Tribble, KFF Health News  

In 2016, Richard Timmins went to a free informational seminar to learn more about Medicare coverage.

“I listened to the insurance agent and, basically, he really promoted Medicare Advantage,” Timmins said. The agent described less expensive and broader coverage offered by the plans, which are funded largely by the government but administered by private insurance companies.

For Timmins, who is now 76, it made economic sense then to sign up. And his decision was great, for a while.

Then, three years ago, he noticed a lesion on his right earlobe.

“I have a family history of melanoma. And so, I was kind of tuned in to that and thinking about that,” Timmins said of the growth, which doctors later diagnosed as malignant melanoma. “It started to grow and started to become rather painful.”

Timmins, though, discovered that his enrollment in a Premera Blue Cross Medicare Advantage plan would mean a limited network of doctors and the potential need for preapproval, or prior authorization, from the insurer before getting care. The experience, he said, made getting care more difficult, and now he wants to switch back to traditional, government-administered Medicare.

But he can’t. And he’s not alone.

RICHARD TIMMINS

“I have very little control over my actual medical care,” he said, adding that he now advises friends not to sign up for the private plans. “I think that people are not understanding what Medicare Advantage is all about.”

Low Premiums and Extra Benefits

Enrollment in Medicare Advantage plans has grown substantially in the past few decades, enticing more than half of all eligible people, primarily those 65 or older, with low premium costs and perks like dental and vision insurance. And as the private plans’ share of the Medicare patient pie has ballooned to 30.8 million people, so too have concerns about the insurers’ aggressive sales tactics and misleading coverage claims.

Enrollees, like Timmins, who sign on when they are healthy can find themselves trapped as they grow older and sicker.

“It’s one of those things that people might like them on the front end because of their low to zero premiums and if they are getting a couple of these extra benefits — the vision, dental, that kind of thing,” said Christine Huberty, a lead benefit specialist supervising attorney for the Greater Wisconsin Agency on Aging Resources.

“But it’s when they actually need to use it for these bigger issues,” Huberty said, “that’s when people realize, ‘Oh no, this isn’t going to help me at all.’”

Medicare pays private insurers a fixed amount per Medicare Advantage enrollee and in many cases also pays out bonuses, which the insurers can use to provide supplemental benefits. Huberty said those extra benefits work as an incentive to “get people to join the plan” but that the plans then “restrict the access to so many services and coverage for the bigger stuff.”

Switching Plans

David Meyers, assistant professor of health services, policy, and practice at the Brown University School of Public Health, analyzed a decade of Medicare Advantage enrollment and found that about 50% of beneficiaries — rural and urban — left their contract by the end of five years. Most of those enrollees switched to another Medicare Advantage plan rather than traditional Medicare.

In the study, Meyers and his co-authors muse that switching plans could be a positive sign of a free marketplace but that it could also signal “unmeasured discontent” with Medicare Advantage.

“The problem is that once you get into Medicare Advantage, if you have a couple of chronic conditions and you want to leave Medicare Advantage, even if Medicare Advantage isn’t meeting your needs, you might not have any ability to switch back to traditional Medicare,” Meyers said.

Traditional Medicare can be too expensive for beneficiaries switching back from Medicare Advantage, he said. In traditional Medicare, enrollees pay a monthly premium and, after reaching a deductible, in most cases are expected to pay 20% of the cost of each nonhospital service or item they use. And there is no limit on how much an enrollee may have to pay as part of that 20% coinsurance if they end up using a lot of care, Meyers said.

To limit what they spend out-of-pocket, traditional Medicare enrollees typically sign up for supplemental insurance, such as employer coverage or a private Medigap policy. If they are low-income, Medicaid may provide that supplemental coverage.

But, Meyers said, there’s a catch: While beneficiaries who enrolled first in traditional Medicare are guaranteed to qualify for a Medigap policy without pricing based on their medical history, Medigap insurers can deny coverage to beneficiaries transferring from Medicare Advantage plans or base their prices on medical underwriting.

Only four states — Connecticut, Maine, Massachusetts, and New York — prohibit insurers from denying a Medigap policy if the enrollee has preexisting conditions such as diabetes or heart disease.

Paul Ginsburg is a former commissioner on the Medicare Payment Advisory Commission, also known as MedPAC. It’s a legislative branch agency that advises Congress on the Medicare program. He said the inability of enrollees to easily switch between Medicare Advantage and traditional Medicare during open enrollment periods is “a real concern in our system; it shouldn’t be that way.”

The federal government offers specific enrollment periods every year for switching plans. During Medicare’s open enrollment period, from Oct. 15 to Dec. 7, enrollees can switch out of their private plans to traditional, government-administered Medicare.

Medicare Advantage enrollees can also switch plans or transfer to traditional Medicare during another open enrollment period, from Jan. 1 to March 31.

“There are a lot of people that say, ‘Hey, I’d love to come back, but I can’t get Medigap anymore, or I’ll have to just pay a lot more,’” said Ginsburg, who is now a professor of health policy at the University of Southern California.

Timmins is one of those people. The retired veterinarian lives in a rural community on Whidbey Island just north of Seattle. It’s a rugged, idyllic landscape and a popular place for second homes, hiking, and the arts. But it’s also a bit remote.

While it’s typically harder to find doctors in rural areas, Timmins said he believes his Premera Blue Cross plan made it more challenging to get care for a variety of reasons, including the difficulty of finding and getting in to see specialists.

Nearly half of Medicare Advantage plan directories contained inaccurate information on what providers were available, according to the most recent federal review. Beginning in 2024, new or expanding Medicare Advantage plans must demonstrate compliance with federal network expectations or their applications could be denied.

Amanda Lansford, a Premera Blue Cross spokesperson, declined to comment on Timmins’ case. She said the plan meets federal network adequacy requirements as well as travel time and distance standards “to ensure members are not experiencing undue burdens when seeking care.”

Traditional Medicare allows beneficiaries to go to nearly any doctor or hospital in the U.S., and in most cases enrollees do not need approval to get services.

Timmins, who recently finished immunotherapy, said he doesn’t think he would be approved for a Medigap policy, “because of my health issue.” And if he were to get into one, Timmins said, it would likely be too expensive. For now, Timmins said, he is staying with his Medicare Advantage plan.

“I’m getting older. More stuff is going to happen.”

There is also a chance, Timmins said, that his cancer could resurface: “I’m very aware of my mortality.”

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

New Physical Therapy Helps Older Adults with Chronic Low Back Pain

By Pat Anson, PNN Editor

Older adults suffering from chronic low back pain experienced faster pain relief after getting a new type of physical therapy focused on strengthening their hip muscles, according to a new study.

The study findings, recently reported in The Lancet Rheumatology, are notable given the limited research on back pain therapies for older adults.

“Unfortunately, the societal attitude is that older people don’t warrant the same level of care that younger people do when it comes to musculoskeletal problems,” lead author Gregory Hicks, PhD, Distinguished Professor of Health Sciences at the University of Delaware, said in a press release.

“When I started this work, there were a lot of naysayers. I’d tell them, ‘Read the literature — why are we excluding older adults from low back pain research?’ We all hope to get older. Why ignore a place in time where we all hope to end up?”

Hicks and his colleagues enrolled 184 people aged 60 or older who reported moderate low back pain, hip pain, and muscle weakness for at least 6 months. Patients were randomly assigned to a hip-focused physical therapy known as Manual Therapy and Strengthening the Hip (MASH) or a more traditional physical therapy for back pain that focused on the spine. Both groups received therapy for eight weeks at the University of Delaware, Duke University or the University of Pittsburgh.

Researchers found that participants who received the MASH therapy had more pain relief after eight weeks than those who had spine-focused therapy. They also showed more improvement in walking endurance and in their ability to rise from a seated position. However, after six months, both groups showed similar levels of improvement.

Previous research by Hicks, funded by the National Institutes of Health, has studied the impact of hip impairment, vitamin D deficiency, and trunk muscle composition in older patients with low back pain. He learned that there were distinct sub-groups of patients with back pain who had unique characteristics and treatment needs.

“It’s becoming quite clear, if you make the assumption that all low back pain is the same, you’re wrong,” said Hicks. “If you can identify sub-groups of low back pain patients with similar traits, you can develop matched treatments, which hopefully lead to better outcomes.”

Low back pain is the leading cause of disability worldwide. According to a recent Harris Poll, nearly 3 out of 10 U.S. adults currently suffer from chronic low back pain, surpassing the number of Americans who have arthritis, diabetes or heart disease. On average, the typical back pain sufferer has sought relief from at least three healthcare providers, with many treatments such as epidural steroid injections proving ineffective.