Large Study Debunks Myths About Rx Opioid Addiction

By Pat Anson, PNN Editor

A large new study in Australia is debunking myths about the addictive nature of opioid pain medication and how a single prescription can lead to long term use.

In an analysis of nearly 3.5 million Australians who were prescribed opioids for the first time, researchers found that 92% never progressed beyond low opioid use and only 3% became persistent users or needed higher doses. The “sustained use” of opioids occurred mostly in seniors (65 and older) suffering from cancer, depression, anxiety and other chronic health problems.

“Results of this cohort study suggest that most individuals commencing treatment with prescription opioids had relatively low and time-limited exposure to opioids over a 5-year period,” wrote lead author Natasa Gisev, PhD, a clinical pharmacist at National Drug and Alcohol Research Centre, UNSW Sydney.

“The small proportion of individuals with sustained or increasing use was older with more comorbidities and use of psychotropic and other analgesic drugs, likely reflecting a higher prevalence of pain and treatment needs in these individuals.”

Previous research estimated the risk of long-term opioid use as high as 57 percent, but Gisev and her colleagues say those studies are flawed because they excluded people with cancer and opioid use disorder, or used various definitions of long-term use. The Australian researchers took a different approach in tracking opioid prescriptions, developing five “trajectories of opioid use.”

The vast majority of patients had very low (75%) or low use (17%) of opioids. Others started with moderate opioid use and decreased to low use (3%), or began with low use and increased to moderate use (3%). Only 3% became sustained users or took higher doses.

Five-Year Trajectories of Opioid Use

JAMA NETWORK OPEN

“Overall, these findings suggest that most people who initiate an opioid prescription are likely to have low, time-limited exposure to opioids with little indication of ongoing use. This possibility is an important consideration for policymakers and stakeholders considering population-level prescribing of high-risk drugs,” researchers reported in JAMA Network Open.

“Opioids are essential drugs for acute and cancer pain, and many people with CNCP (chronic non-cancer pain) benefit from opioids. Continued focus and policy responses based on findings from a small group of people with increased risk of harms run the risk of limiting access to people who safely derive objective benefits from opioids.”  

That’s exactly what happened to millions of pain patients in the US, who lost access to opioids due to steep cuts in prescribing, chronic shortages of opioid medication, and a relentless drumbeat in the media about people becoming addicted or overdosing after one pill.  

“One prescription can be all it takes to lose everything,” the CDC said in a 2017 advertising campaign that emphasized the risks of prescription opioids, while ignoring the far more serious problem of illicit fentanyl and other street drugs.

Just how common is opioid addiction? Estimates are all over the map, ranging as low as 1% to as high as 40% for long-term opioid users.

“The problem with all of these studies is that they are retrospective in nature, limited to a particular patient population, and constrained by the diagnostic criteria in use at the time,” my late colleague Roger Chriss pointed out in a 2019 column on opioid addiction.  

Roger was prescient about the imprecision of diagnostic criteria. A little known 2021 study of U.S. veterans who were diagnosed with opioid use disorder (OUD) challenged how many actually had it. Researchers found that nearly 20% of veterans with OUD used prescription opioids without any signs of abuse and evidence was lacking in another 7% of cases. Less than 60% of the veterans had a “high likelihood” of being correctly diagnosed with OUD.

DEA Considering More Changes to Telehealth Prescribing Rules

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration will hold two public hearings next month – what it calls “listening sessions” – to consider if providers should continue prescribing controlled substances through telehealth without first requiring patients to have an in-person medical evaluation.

Patients are currently allowed to get a controlled medications without visiting their doctor under emergency telehealth rules adopted three years ago at the start of the Covid-19 pandemic. Controlled substances include many opioids, stimulants, sedatives, steroids, and addiction treatment medications such as methadone and buprenorphine (Suboxone).

“DEA recognizes the importance of telemedicine in providing Americans with access to needed medications, and DEA has been, and remains, committed to expanding access to telemedicine in a way that puts patients — and their safety — first, is simple to understand and apply, reflects technological advancements, and is consistent with lessons learned during the COVID–19 PHE and the ongoing opioid epidemic,” the agency said in a statement.

Rules that are “simple to understand and apply” may be the key issue. In March, the DEA proposed changing the telehealth rules to reimpose “guardrails” on Schedule II opioids such as oxycodone and hydrocodone. For those medications, a patient would first be required to have an in-person meeting with a doctor, with refills then allowed via telehealth. Other drugs that are classified as Schedule III, IV or V substances could initially be prescribed for 30 days via telehealth, but any refills would require an in-person meeting.

The proposed rule changes are so confusing and drew so much opposition that the DEA delayed implementing them until this November. Next month’s public hearings are another sign the agency is still uncertain what to do.

In a notice published in the Federal Register, the DEA said it was open to creating a special registration process that would allow providers to continue prescribing “some controlled substances” without seeing patients in-person. The agency didn’t specific which controlled substances it is referring to.

“DEA is open to considering — for some controlled substances — implementation of a separate Special Registration for telemedicine prescribing for patients without requiring the patient to ever have had an in-person medical evaluation at all,” the DEA notice said.

“DEA also observes that making permanent some telemedicine flexibilities on a routine and large-scale basis would potentially create a new framework for medicine that fundamentally expands access to controlled substances in a way that warrants a new framework for accountability based, in part, on increased data collection and visibility into prescription practices in order to ensure patient safety and prevent diversion in near-real-time.”

Opioid Diversion Rare

Contrary to popular belief, opioid diversion is rare. Using data gathered from prescription drug monitoring programs (PDMPs), pharmacies, hospitals and others in the drug supply chain, the DEA’s most recent estimate is that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) is lost, stolen or diverted to someone they were not prescribed to.

Opioid prescriptions are also harder to obtain and there are chronic opioid shortages around the country, so few pain patients are willing to part with their legally prescribed medications. Counterfeit medications and other street drugs made with illicit fentanyl are the real problem, which the DEA “listening sessions” won’t address.

The public hearings will be held on September 12 and 13 at DEA headquarters in Arlington, Virginia. Medical practitioners, patients, pharmacists, drug makers, distributors, law enforcement, and other interested parties can express their views either in-person or by video teleconference. The public hearings will also be streamed live online.

The DEA is seeking input on these key questions:

• Should telemedicine prescribing of Schedule II medications be permitted without an in-person medical evaluation?  If it is permitted, what safeguards would you recommend to ensure patient safety and prevent diversion?

• If telemedicine prescribing of Schedule III–V medications is permitted without an in-person medical evaluation, what safeguards and data should be collected for those substances? 

To register as a speaker, click here. The deadline for registering is August 21.

Can Peppermint Oil Help With Postoperative Pain?

By Pat Anson, PNN Editor

In recent years, hospitals around the world have resorted to unconventional and novel methods to reduce the use of opioids by patients recovering from surgery. 

Some use “harp therapy” to help patients relax and forget about their postoperative pain while listening to live music played on a harp.  Others use virtual reality games to help distract patients.  And some German hospitals even played a recording of “positive suggestions” to surgery patients while they were under general anesthesia.

Aromatherapy may soon be added to the growing list of alternative treatments for postoperative pain. A small study in Iran suggests that aromatherapy with peppermint oil can reduce pain and improve sleep in patients recovering from surgery.    

Aromatherapy with concentrated extracts from plants – known as essential oils -- has been used for thousands of years to help reduce stress and treat infections. Peppermint essential oil is particularly useful because it has a pleasant smell, binds easily to nasal mucous, and enters the bloodstream quickly, where it promotes the release of endorphins that ease pain and improve mood.

Iranian researchers wanted to know if peppermint oil could also help patients recovering from open heart surgery, a major invasive procedure that requires breaking through the breastbone (sternum), as well as mechanical ventilation to help breathing. Patients waking up in intensive care following heart surgery often have high levels of pain, stress and difficulty sleeping.

“Among complementary medicine treatments, particular attention should be given to essential oils, which are both pleasant and inexpensive and can be quite useful,” wrote lead author Dr. Ismail Azizi-Fini, MD, Kashan University of Medical Sciences. “There is some clinical scientific evidence in favour of using aromatherapy with essential oils in various phases of preoperative and postoperative treatment.”

For the study, 59 adults undergoing cardiac surgery were randomly divided into two groups. One group received a diluted solution of essential peppermint oil for 30 minutes before their breathing tube was removed, and six times afterward through a nebulizer, a small machine that turns liquids into a mist than can be easily inhaled. The control group breathed a placebo mist of distilled water.  

After 2 days of treatment, the average on a zero-to10 pain score was 3.22 in the aromatherapy group and 4.56 in the control group, a statistically significant difference. Average sleep scores were also better in the aromatherapy group, which used fewer opioid analgesics (morphine and fentanyl) than the control group.  

“The results show that inhalation of peppermint essential oil can reduce the pain intensity of patients after open heart surgery and consequently reduce the use of pain relievers by patients,” researchers reported in the journal BMJ Supportive & Palliative Care.

“Also, the use of this herbal product can improve the sleep quality of patients in the first nights after surgery and bring them more comfort. Considering the effect of peppermint essential oil inhalation on pain and sleep quality of patients after open-heart surgery, it can be concluded that this herbal product can be safely used as a complementary treatment in relieving pain and making patients comfortable after heart surgery.” 

It’s rare for a patient to become addicted or develop a dependence on opioids after surgery. One study finding that less than one percent of seniors were still taking opioids a year after major elective surgery.

A 2021 survey found that nearly 8 out of 10 U.S. adults believe opioids are sometimes necessary to manage postoperative pain. Most people are more worried about treating surgical pain than they are about becoming addicted.

My Story: A Bone Cancer Survivor’s Search for Pain Relief

By Kristen Hernandez

The past three weeks have been the most challenging since my cancer diagnosis 20 years ago. Shortages of opioid pain medication have taken their toll, costing me weeks of productivity, mental and physical anguish, and a negative bank account.

When I was 25, I had a different life -- a career as a corporate travel consultant for RCA Records in New York City. I clawed my way out the ghettos of the Bronx and into corporate America, and purchased my first home in the suburbs of Long Island.

But everything changed when I was diagnosed with an insidious and rare form of bone cancer called Chordoma. It’s a literal one-in-a-million disease, with just one in every million individuals diagnosed with it each year.

The type of Chordoma that chose me is extremely rare, due to the tumor’s location: it was housed inside the L3 vertebra of my lumbar spine. And it was extraordinarily painful.

KRISTEN HERNANDEZ

Because Chordoma doesn't respond to chemotherapy or radiation, surgery is the only treatment. To save my life, surgeons reconstructed my spine, replacing a vertebra with a titanium cage and filling it with bone graft from my hip.

They also replaced a spinal disc with two more titanium cages, adding 16 rods and 20 screws for reinforcement.

My spine today resembles a nightmarish ladder that Tim Burton might have created.

After eight reconstructive spinal surgeries, I was given a miraculous drug called OxyContin. Doctors did not think I’d ever walk again because they needed to sever the nerves to my legs so that they could remove the cancer-infected bone.

Because of OxyContin, I was able to take my first step and eventually walk. This was in 2005, at the beginning of the so-called opioid crisis.

Once I relocated to Florida, pain management doctors refused to prescribe OxyContin to me, fearing lawsuits and scrutiny from law enforcement. Regardless of how much I protested, I was dismissed as if I was the problem, instead of having a problem.

At the time, pill mills were everywhere in Florida. They were places where if you had cash, you could get any medication. It’s also why there’s a such stigma today against chronic pain sufferers.

Eventually, I found a legitimate pain management doctor in Fort Lauderdale. Instead of OxyContin, he changed my regimen to a fentanyl patch, along with oxycodone/acetaminophen tablets (Percocet) for breakthrough pain, essentially replacing one opioid with two. That was my pain management routine for the past twelve years, until recently.

When I went to a Walgreens pharmacy this past June, I was shocked to hear, “Sorry, oxycodone is on back order, and we have no idea if or when it’s coming back.”

Opioid Shortages

Shortages of oxcodone, hydrocodone and other opioids are increasing around the country. And there is zero advance notice from pharmacies about when a prescribed medication will be available. Patients like me who suffer from severe pain are forced to go through withdrawal until the pharmacy restocks.

It’s a nightmare to deal with. Pain patients are usually not prepared for the sudden halt in medical care. Even the smallest disruption can have devastating effects, such as loss of productivity, reduced quality of life, and a diminished social life. Even smiling takes an effort.

Patients are always the last to know when there’s a problem with a prescription. Like thousands of others, I made frantic phone calls to my doctor, who scrambled to find an alternative medication. Without consulting me, he wrote a script for hydrocodone/acetaminophen (Vicodin), a medication I had never taken before. That’s when my three-week nightmare began. Because I wasn’t prepared to handle the ineffectiveness of hydrocodone for bone pain, my condition quickly began to decline.

Each morning, the first sensation I get feels like someone dug their elbow into my lower back all night long. It’s so fierce, it takes my breath away. Then, when I stand and all the titanium in my spine settles, the nerves hum in my legs and a crawling sensation shoots up and down, vibrating constantly.

As the morning coffee brews, I get the “poke” sensation. Due to a 200-pound weight loss, there’s a rod that sticks out of my thoracic spine area that rubs up against everything -- the bed, couch, office chair, car seat, everything. It’s miserable because it’s there forever.

Hydrocodone/acetaminophen tablets seem to exacerbate those symptoms, causing my body to swell and tighten into a ball of pressure, while the pain intensified. My productivity stopped and the bills began to pile up. Working while experiencing severe spinal and bone pain is nearly impossible.

After a recent candid discussion with my pain management doctor, we formed a “Plan B.” We’re trying oxycodone without acetaminophen to see if that works better. Having a backup plan with an alternate list of medications is essential with the shortages and fear-based drug culture we’ve found ourselves dumped into.

Government regulators and health policies have failed the people who suffer the most in this country, who often live with medical conditions they cannot control, like cancer. They’ve failed us time after time, filing lawsuits and adopting guidelines that make it harder for us to get prescription opioids – even though over 82% of opioid overdoses are caused by illicit fentanyl and other street drugs.

Patients who suffer from chronic pain all have one common goal: relief. When that relief is interrupted, and access to crucial therapies and drugs is denied, you leave us with few choices. We can either live our lives without pain relief or seek out riskier alternatives. Those are not good choices.

Kristen Hernandez is a freelance journalist and creative nonfiction writer living in South Florida. 

Do you have a “My Story” to share? Pain News Network invites other readers to share their experiences about living with pain and treating it.

Send your stories to editor@painnewsnetwork.org.

FDA and DEA Leaders Call for More ADHD Meds, But Ignore Rx Opioid Shortages

By Pat Anson, PNN Editor

Leaders of the Food and Drug Administration and the Drug Enforcement Administration say they’re working to end one of the worst drug shortages in decades.

“The lack of availability of certain medications in recent months has been understandably frustrating for patients and their families,” FDA commissioner Robert Califf, MD, and DEA Administrator Anne Milgram said in an unusual joint letter. “We are calling on key stakeholders, including manufacturers, distributors, pharmacies, and payors, to do all they can to ensure access for patients when a medication is appropriately prescribed.”

Those should be welcome words for pain patients across the U.S. who have trouble getting their prescriptions filled for opioid medication. Unfortunately, the letter has nothing to do with opioids. It’s only about shortages of Adderall and other prescription stimulants, which are used primarily to treat attention-deficit/hyperactivity disorder (ADHD).

The letter is the latest example of how the FDA and DEA have turned a blind eye to opioid shortages, which both agencies have played prominent roles in creating. Two widely used painkillers, oxycodone and hydrocodone, have been difficult to get for months, leaving thousands of patients in uncontrolled pain or going into withdrawal. Even big chain pharmacies like CVS are out of opioids or have a limited supply.   

“I had to once again follow up with CVS, just to be told they received absolutely nothing! Pain management provider in response sent another prescription to the outpatient pharmacy,” says Christine Kucera, a pain patient who recently wrote a column for PNN about her problems getting prescriptions filled for oxycodone.

“I'm currently sitting in the waiting area at the outpatient pharmacy, stressing, waiting for another bomb to drop.”

The American Society of Health-System Pharmacists (ASHP) first warned about a shortage of immediate release oxycodone in March. Over the next few months, hydrocodone/acetaminophen tablets (Vicodin) and oxycodone/acetaminophen tablets (Percocet) were added to the ASHP’s shortage list. Those shortages could soon grow even worse, because one of the largest generic drug makers in the world, Teva Pharmaceutical, is discontinuing production of immediate release oxycodone. 

Despite these warning signs, the FDA and DEA have yet to acknowledge shortages of either oxycodone or hydrocodone, and appear to be doing nothing about them. But they are moving to boost production of stimulants used to treat ADHD. The agencies say drug makers have sold only 70% of the stimulants they were authorized to produce.   

“We want to make sure those who need stimulant medications have access,” Califf and Milgram said in their letter. “We have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount.” 

“What this latest notice shows is that the FDA and DEA could get involved with the opioid shortage if they wanted to,” says Rick Martin, a retired pharmacist disabled by back pain. Martin recently had to switch to a weaker opioid for pain relief because he can’t find a pharmacy with hydrocodone in stock.

“Teva said they were going to stop making oxycodone. The DEA/FDA could be proactive and ask Teva to relinquish their remaining 2023 quota allotment, then redistribute to other manufacturers,” Martin told PNN. 

Lower Production Quotas

The DEA sets annual production quotas for opioids, stimulants and other controlled substances, working closely with the FDA in assessing demand. Last year, the FDA advised the DEA that demand for hydrocodone, oxycodone and other Schedule II opioids would fall by 5.3% in 2023, which resulted in another year of cuts by the DEA in opioid production. Since 2013, the supply of oxycodone has fallen by 65 percent and hydrocodone by 73 percent. 

The FDA also advised the DEA that domestic medical use of stimulants would fall by 0.1% in 2023, even while warning that shortages were developing. The DEA’s response last December was that amphetamine and other stimulants were overprescribed to patients who didn’t really need them, and that its proposed production quotas (APQ) for the drugs in 2023 would be adequate.

“The majority of the manufacturers contacted by DEA and/or FDA have responded that they currently have sufficient quota to meet their contracted production quantities for legitimate patient medical needs,” the DEA said in the Federal Register. “Based on this trend, DEA has not implemented an increase to the APQ for amphetamine at this time.”

That kind of background detail is missing from Califf’s and Milgram’s letter, which disingenuously claims that there is little that the DEA and FDA can do to ensure that there are adequate supplies of medication. 

“This is not a problem that the FDA and DEA can solve on our own,” Califf and Milgram wrote. “The FDA and DEA do not manufacture drugs and cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug.” 

Only briefly do Califf and Milgram acknowledge that their own production quotas are part of the problem, saying they were “committed to reviewing and improving our quota process.” 

“These (stimulant) shortages were caused by the DEA, which limited the manufacture of these medications,” says Andrea Anderson, a pain sufferer and patient advocate. “This exact problem has affected patients who require opioid analgesics to manage their severe pain. It has been affecting them for over six years, yet we see no mention of the extraordinary difficulties these patients are experiencing trying to find pain medication.  

“The DEA has no reason to be involved in deciding how many prescriptions should be written for any medical condition. This is the purview of trained medical clinicians and quantities should not be dictated by law enforcement agencies.” 

Drug manufacturers are required to report shortages and supply interruptions to the FDA. Doctors, hospitals, pharmacies and consumers can also report supply problems by sending an email to drugshortages@fda.hhs.gov.

That’s where Christine Kucera recently sent an email addressed to the FDA commissioner.

“Three different medications used in my treatment are continuously unavailable, sometimes for weeks and months. CVS IS OUT, the system is not working, and all you do is NOTHING!” Kucera wrote to Califf. 

“When will you address the unethical treatment and harms being inflicted upon millions of US citizens directly caused by government practicing medicine, limiting and denying access to essential medicines based on biased and manipulated facts, reduced quotas, faulty CDC prescription guidelines that should never have been created; and the DEA who are making up their own rules, practicing medicine, and deciding what they think appropriate medical care is?”  

Why Being ‘Strong Enough’ Isn’t Good Enough

By Mia Maysack, PNN Columnist

"It takes so much to be able to get this treatment for myself," I told the nurse, as I was being hooked up for a life-giving infusion.

After answering an inquiry about my arm preference for "a poke," we laugh about needle sticks being the least of my worries, because I am covered in tattoos -- pain I had the privilege of choosing.

A moment of comfortable silence passed and then I proceeded to express my gratitude for being there in that moment. And for still being here on this planet, period.

"You're just so positive! Wow, what amazing energy you have!" the nurse told me.

Me to Me: “I barely made it here today.”

The moments when I feel unable to go on are plentiful. I'm still unsure how to live this life, but as the saying goes, I am "strong enough" and “tough enough” to endure. 

I don't know about that…

I've decided it's perfectly okay to have moments when I'm absolutely not strong enough. Strength of will isn't measurable. Neither is the resilient fortitude that continually gets tested on a daily basis when you have unmanaged and permanent pain.

Me to Her: "Thank you. That’s very kind. There are no words to express how hard I try."

I close my eyes as I feel the tears ascending. I breathe deeply and reflect on a reason, any reason, every reason, to smile.

The first thing I'd tell anybody about “being positive” is that it’s not where strength comes from.  It sounds ideal to seek out bright sides, silver linings and rainbows, but positivity can also be inauthentic and inadequate. At least it has been in my experience.

There’s a difference between pushing through pain, as opposed to masking it. The “fake it until we make it” mentality only takes us so far, and doesn’t actually work when it comes to dealing with pain.

Pain of any kind, I’ve come to believe, is a message that something needs addressing. It’s the body’s way of communicating. Many different issues can arise as a result of this, especially when pain is untreated or its fundamental causes and symptoms are overlooked. Pain will then intensify and worsen, leading to a severely diminished or low quality of life, if not the ultimate decision to put an end to it.

I've had enough years when my ailments would throw occasional tantrums and demand my attention. But that did not change the pain’s existence or ease the constant requirements for attending to it.

I’ve learned that approaching things with a mind-frame of coexistence, as opposed to constantly battling them, works better. There’s less emotion and mental torment, if nothing else. That right there can make a major and empowering shift.

Another thing I’ve decided is that since this is the hand I’ve been dealt, I’m going to play it as absolutely best I can, with a ferocity to make the most of each moment to whatever extent that may be possible. Sometimes this means doing what would appear to be nothing, when in actuality things are healing and restoring.

This realization also means accepting that the pain is going to exist anyway. And things are going to hurt anyway. I no longer reflect upon that as a reason to be strong, but rather as an excuse for celebrating each small victory.  

It takes everything within me to continue existing from one day into another. To function in a meaningful way and contribute somehow to our world.  My life is not as painless as it looks. You may see me living, but miss what it takes for me to live.

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill. 

Pain Patients Get ‘Substantial Relief’ from Scrambler Therapy

By Pat Anson, PNN Editor

A little-known therapy for Complex Regional Pain Syndrome (CRPS) and other painful neuropathic conditions is finally getting some attention from a prominent medical journal.

“Scrambler therapy is the most exciting development I have seen in years — it’s effective, it’s noninvasive, it reduces opioid use substantially and it can be permanent,´ says Thomas Smith, MD, a professor of oncology at the Johns Hopkins University School of Medicine and co-author of a review recently published in The New England Journal of Medicine.

Scrambler therapy – also known as Calmare pain therapy -- sends mild electric signals through the skin via electrodes placed near areas where chronic nerve pain is felt. Similar to transcutaneous electrical nerve stimulation (TENS), the idea is to “scramble” pain signals being sent to the brain and reduce central sensitization.

Some patients get immediate relief after a 30-minute scrambler session, but most will have to undergo a series of treatments on successive days to have a prolonged analgesic effect. Smith says many patients “get really substantial relief.”

“The duration of relief usually increases with each day of treatment, and in contrast to TENS, analgesic effects have been reported to last for weeks, months, or even years after a treatment course,” wrote Smith, who reviewed 381 clinical trials of TENS and scrambler therapy with his co-author.

“The major limitation with respect to our understanding of electroanalgesia is the small number of well-designed, large, randomized, sham-controlled clinical trials of TENS and scrambler therapy.”

In one small study, patients getting scrambler therapy had a 91% reduction in pain and reduced their use of opioids and other pain relievers by 75 percent.

“If you can block the ascending pain impulses and enhance the inhibitory system, you can potentially reset the brain so it doesn’t feel chronic pain nearly as badly,” Smith says. “It’s like pressing Control-Alt-Delete about a billion times.”

Scrambler therapy seems to be most effective in patients with CRPS or those who develop neuropathic pain after chemotherapy. It’s also been used to treat fibromyalgia, shingles, diabetic neuropathy and post-operative pain.

Amanda Greening was bedridden by CRPS at the young age of 20, but was able to walk again after several sessions of scrambler therapy. Amanda’s father wrote a column for PNN on her recovery. So did a local TV station:

Although scrambler therapy was approved by the FDA in 2009 for patients with chronic or neuropathic pain, the procedure is still not widely available or covered by insurance. Only one company makes the scrambler device, which costs about $65,000, and practitioners have to undergo several days of training to use it. Treatments cost about $300 per session.

Like other pain treatments, scrambler therapy doesn’t work for everyone. About 10 to 20% of  patients have no analgesic response -- a risk many would be willing to take, if it means freeing themselves from a lifetime of pain.

How to Overcome Repetitive Negative Thinking

By Anna Andrianova, Laval University

Do you ever find yourself caught in a cycle of negative thoughts? Maybe you ruminate on past mistakes, worry excessively about the future, or imagine worst-case scenarios?

Do you sometimes have a great day, everything goes well, and then your brain says, “Hey, remember that time you embarrassed yourself in front of everyone? Let’s relive that moment for the next 20 minutes.” And suddenly, your good day turns into a cringe-fest.

If so, know that you’re not alone. Many people struggle with repetitive negative thinking, and this can have a serious impact on mental health and well-being.

As the coordinator of expertise in caregiving at the Centre for Research and Expertise in Social Gerontology and an associate member of the Centre for Study and Research on India, South Asia and its Diaspora, I would like to shed light on the negative impact of repetitive negative thinking on the mental and physical health of caregivers.

Repetitive negative thinking (RNT) is a cognitive process characterized by persistent and intrusive contemplation on past events, commonly known as rumination, and apprehensions about future possibilities, often referred to as worries.

RNT is a recurring, unwelcome, and difficult to dislodge pattern of thinking that has been implicated in the onset and perpetuation of diverse mental disorders, including depression, anxiety, and post-traumatic stress disorder. Furthermore, RNT has been found to be associated with physical health and has been linked to an increased likelihood of future health issues. RNT may negatively impact one’s quality of sleep, decrease efficiency, and hinder decision-making abilities.

Recent studies have revealed that the severity of RNT is connected with changes in brain morphology, leading to a decline in general cognitive abilities and increasing the risk of developing Alzheimer’s disease. Even at low levels, RNT can have detrimental effects on the cardiovascular, autonomic nervous, and endocrine systems.

The Power of Mindfulness

So, what would be the most effective strategy for managing repetitive negative thinking? Research has demonstrated a negative correlation between RNT and mindfulness, implying that a low level of mindfulness can increase one’s susceptibility to RNT.

Mindfulness can be seen as a mental faculty or skill that can be developed through regular practice. It entails cultivating a non-judgmental and non-reactive awareness of the present moment. The objective is to be fully engaged in what’s happening right now, rather than dwelling on the past or worrying about the future.

There are two main styles of mindfulness practice: focused attention meditation and open monitoring meditation. Focused attention meditation involves choosing a specific object, such as the breath, and bringing your full attention to it. Whenever the mind wanders, it is simply brought back to the object of focus.

In contrast, open monitoring meditation involves being aware of everything occurring in the present moment. Instead of trying to focus on a specific object, one simply observes whatever arises in the experience, including thoughts, emotions, and physical sensations.

But what’s happening in the brain during these practices? Recent studies have revealed that only during focused attention meditation, there is a deactivation of the “default mode network” — a network of brain areas that are typically active when we’re not focused on any particular task. This network is implicated in “resting-state” thinking, which involves repetitive negative thinking. By deactivating the “default mode network,” focused attention meditation can help reduce this harmful type of thinking.

An Intervention for Caregivers

As part of our project, we will develop and examine an intervention targeted at reducing RNT in family caregivers.

According to a recent report, over eight million Canadians aged 15 and older, or 25 per cent of the population, provide care to a family member or friend with a long-term health condition, disability, or aging-related needs.

While caregiving can be rewarding, it can also be challenging and stressful, particularly for those who provide extensive or complex care. Chronic stress is a common experience for family caregivers, and it can take a toll on their health and well-being. A survey of caregivers found that the top areas of need for caregivers were emotional health (58 per cent) and physical health (32 per cent). RNT is strongly associated with caregiver burden and predicts negative impacts on the physical and mental health of caregivers.

We will recruit 100 caregivers with high levels of RNT. The intervention will be presented to participants in the form of interactive videos that guide them through the practice of focused attention meditation. We will measure changes in RNT, stress, anxiety, depression, and quality of life before and after the intervention, as well as at a six-month follow-up.

If the intervention is effective, it could serve as the basis for the development of an innovative tool for monitoring and reducing RNT. This tool could be deployed as a mobile app or on virtual reality platforms, providing caregivers with access to an intervention that they can use at their convenience. This could significantly expand the reach of the intervention, making it more accessible and convenient for caregivers who may not have the time or resources to participate in traditional face-to-face interventions.

Overall, the potential of the focused attention meditation intervention to improve the mental and physical health of caregivers, as well as the development of new innovative tools, represents a promising avenue in the field of caregiver support services. Further research and implementation of such interventions could significantly improve the quality of life for caregivers and the people they care for.

After all, to echo the words of philosopher Marcus Aurelius, “the happiness of your life depends upon the quality of your thoughts.”

Anna Andrianova holds degrees in psychology and social work, and is currently a doctoral candidate in social work at Laval University in Quebec. As part of her doctoral thesis, she explores the impact of the practice of mindfulness on the reduction of repetitive negative thoughts on well-being and health.

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

Army Veteran Is Latest Casualty of DEA’s War on Drugs

By Pat Anson, PNN Editor

Becky Snyder and her husband Vance were soldiers when they first met in 1979 at Fort Lewis, Washington. Becky was a legal clerk for the Army, while Vance was a combat medic who later became an Army-trained physician assistant and chief warrant officer. They soon married and had a son.

After years spent defending their country, Vance and Becky could not have imagined they’d windup becoming unintended casualties of the DEA’s failed War on Drugs. Vance lost the love of his life when Becky died last month at the age of 70, after a lifetime of suffering from chronic pain.

“She had scoliosis her whole life, probably congenital. And that made it hard for her to do sit ups in the in the military and probably injured her spine trying to do that,” said Vance. “She could walk with difficulty. Usually when we went out, we used a wheelchair.”

Becky’s back pain progressively worsened and she became bedridden after developing intractable pain from two very serious complications: Complex Regional Pain Syndrome (CRPS) and arachnoiditis, a chronic inflammation of spinal nerves.

Both conditions are incurable and cause severe pain, but Becky found relief under the care of two Los Angeles-area doctors, Forest Tennant and David Bockoff. 

BECKY SNYDER AND SON

The careers of both physicians effectively ended after their offices were raided by DEA agents, Dr. Tennant in 2017 and Dr. Bockoff in 2022. They were targeted by the DEA for giving patients like Becky with complex medical conditions high doses of opioid pain medication — which, in the eyes of the DEA, has no legitimate medical use.

There is no evidence that any of Tennant’s patients were harmed or overdosed while under his care, but he retired in 2018 rather than face a costly legal battle with the DEA and Department of Justice.

Becky and other Tennant patients became “opioid refugees,” scouring the country for doctors because no one was willing to treat them locally. Several eventually found their way to Bockoff, with some traveling thousands of miles from out-of-state to see him and get their prescriptions filled in California. That made Bockoff a target for the DEA.

Last November, the DEA suspended Bockoff’s license to prescribe opioids and other controlled substances, even though he practiced medicine for over 50 years in California with no record of any disciplinary action or complaints filed with the state medical board. The DEA claimed five of Bockoff’s patients were in “imminent danger,” but then waited a year to suspend him.  

Patient Deaths

While Bockoff appeals his suspension, at least three of his former patients have died, including one who committed suicide with his wife and another who died after buying opioid medication in Mexico. Becky Snyder is the most recent death.        

“The last six years have been very difficult, because we couldn’t get the amount of medicine that Dr. Tennant gave. Dr. Bockoff, I mean to his credit he did the best he could, but he couldn’t give the amount that Forest Tennant was willing to give,” said Vance.

“But if there hadn’t been Dr. Bockoff, I think she would have died even sooner.”

Becky didn’t die from withdrawal, but from pancreatic cancer. She was diagnosed earlier this summer after complaining of stomach pain, and the cancer quickly metastasized. Becky didn’t drink, and Vance is convinced that poorly treated pain contributed to her death.

BECKY SNYDER

“I was in Army medicine. Clinically and diagnostically, pain can be an important indicator of what’s wrong with a patient. You have to take the suffering seriously,” Vance told PNN. “I believe pain kills people all the time because it just wears the person out. It leads to all kinds of conditions, whether it’s endocrine, whether it’s cancer, whether it’s depression and suicide. There’s all kind of things that pain causes.”

“Cancer follows intractable pain like night follows day,” says Tennant, who believe Becky’s death was preventable. “Because if you can’t get the pain relieved, you disturb your hormonal systems and your immune system. I can’t tell you how common cancer is in these people who can’t get care. It’s just one of the complications.

“I’m sure if I was still in practice or Dr. Bockoff was, she’d still be alive.“

Vance Snyder says intractable pain took a toll on Becky’s physical and mental health, and she aged considerably in her final years. He believes high dose opioids is what kept her alive.

“For the worst, worst cases of intractable pain, opioids have to be part of the package. The idea that nerve blocks, epidurals, aromatherapy, cognitive behavioral therapy and all those things are going to make a big difference with the worst kind of pain is ridiculous,” he said.

Snyder has joined with several other Bockoff patients in a lawsuit asking the U.S. Court of Appeals to give them legal standing as interested parties in the Bockoff case. 

In an open letter, Snyder urged the court to find a “proper balance” between appropriate pain care and the needs of law enforcement.

“Severe intractable pain does not exist in isolation, but is connected to every other aspect of the patient’s overall health,” he wrote. “Becky is gone now, but there are many thousands of agonized patients who are desperate and on the verge of suicide. Please think about them when you make your decisions.”     

Why Cheap Generic Drugs Are Harder to Find

By Dr. Geoffrey Joyce, University of Southern California

Past public ire over high drug prices has recently taken a back seat to a more insidious problem – no drugs at any price.

Patients and their providers increasingly face limited or nonexistent supplies of drugs, many of which treat essential conditions such as cancer, heart disease and bacterial infections. The American Society of Health System Pharmacists now lists over 300 active shortages, primarily of decades-old generic drugs no longer protected by patents.

While this is not a new problem, the number of drugs in short supply has increased in recent years, and the average shortage is lasting longer, with more than 15 critical drug products in short supply for over a decade. Current shortages include widely known drugs such as the antibiotic amoxicillin; the heart medicine digoxin; the anesthetic lidocaine; and the medicine albuterol, which is critical for treating asthma and other diseases affecting the lungs and airways.

What’s going on?

I’m a health economist who has studied the pharmaceutical industry for the past 15 years. I believe the drug shortage problem illustrates a major shortcoming of capitalism. While costly brand-name drugs often yield high profits to manufacturers, there’s relatively little money to be made in supplying the market with low-cost generics, no matter how vital they may be to patients’ health.

The shortage includes chemotherapy drugs, antibiotics, medications to treat ADHD and other critical drugs. Some patients are able to get their drugs, while others are not, and in some cases patients are getting ‘rationed care.’

Brand Name Drugs More Profitable

The problem boils down to the nature of the pharmaceutical industry and how differently the markets for brand and generic drugs operate. Perhaps the clearest indication of this is the fact that prices of brand drugs in the U.S. are among the highest in the developed world, while generic drug prices are among the lowest.

When a drugmaker develops a new pill, cream or solution, the government grants the company an exclusive patent for up to 20 years, although most patents are filed before clinical testing, and thus the effective patent life is closer to eight to 12 years. Nonetheless, patents allow the drugmakers to cover the cost of research and development and earn a profit without the threat of competition from a rival making an identical product.

But once the patent expires, the drug becomes generic and any company is allowed to manufacture it. Since generic manufacturers are essentially producing the same product, profits are determined by their ability to manufacture the drug at the lowest marginal cost. This often results in low profit margins and can lead to cost-cutting measures that can compromise quality and threaten supply.

Outsourced Production Creates Supply Risks

One of the consequences of generics’ meager margins is that drug companies outsource production to lower-cost countries.

As of mid-2019, 72% of the manufacturing facilities making active ingredients for drugs sold in the U.S. were located overseas, with India and China alone making up nearly half of that.

While overseas manufacturers often enjoy significant cost advantages over U.S. facilities, such as easy access to raw materials and lower labor costs, outsourcing production at such a scale raises a slew of issues that can hurt the supply. Foreign factories are more difficult for the Food and Drug Administration to inspect, tend to have more production problems and are far more likely than domestic factories to be shut down once a problem is discovered.

In testimony to a House subcommittee, Janet Woodcock, the FDA’s principal deputy commissioner, acknowledged that the agency has little information on which Chinese facilities are producing raw ingredients, how much they are producing, or where the ingredients they are producing are being distributed worldwide.

The COVID-19 pandemic underscored the country’s reliance on foreign suppliers – and the risks this poses to U.S. consumers.

India is the world’s largest producer of generic drugs but imports 70% of its raw materials from China. About one-third of factories in China shut down during the pandemic. To ensure domestic supplies, the Indian government restricted the export of medications, disrupting the global supply chain.

This led to shortages of drugs to treat COVID-19, such as for respiratory failure and sedation, as well as for a wide range of other conditions, like drugs to treat chemotherapy, heart disease and bacterial infections.

Low Profits Hurt Quality

Manufacturing drugs to consistently high-quality standards requires constant testing and evaluation. A company that sells a new, expensive, branded drug has a strong profit motive to keep quality and production high. That’s often not the case for generic drug manufacturers, and this can result in shortages.

In 2008, an adulterated version of the blood-thinning drug Heparin was recalled worldwide after being linked to 350 adverse events and 150 deaths in the U.S. alone.

In 2013, the Department of Justice fined the U.S. subsidiary of Ranbaxy Laboratories, India’s largest generic drug manufacturer, US$500 million after it pleaded guilty to civil and criminal charges related to drug safety and falsifying safety data. In response, the FDA banned products made at four of the company’s manufacturing facilities in India from entering the U.S., including generic versions of gabapentin, which treats epilepsy and nerve pain, and the antibiotic ciprofloxacin.

And while there may be multiple companies selling the same generic drug in the U.S., there may be only a single manufacturer supplying the basic ingredients. Thus, any hiccup in production or shutdown due to quality issues can affect the entire market.

A recent analysis found that approximately 40% of generic drugs sold in the U.S. have just one manufacturer, and the share of markets supplied by just one or two manufacturers has increased over time.

Repatriating the Drug Supply

It is hard to quantify the impact of drug shortages on population health. However, a recent survey of U.S. hospitals, pharmacists and other health care providers found that drug shortages led to increased medication errors, delayed administration of lifesaving therapies, inferior outcomes and patient deaths.

What can be done? One option is to simply find ways to produce more generic drugs in the U.S.

California passed a law in 2020 to do just that by allowing the state to contract with domestic manufactures to produce its own generic prescription drugs. In March 2023, California selected a Utah company to begin producing low-cost insulin for California patients.

Whether this approach is feasible on a broader scale is uncertain, but, in my view, it’s a good first attempt to repatriate America’s drug supply.

Geoffrey Joyce, PhD, is director of Health Policy at the USC Schaeffer Center, an associate professor and chair of the Department of Pharmaceutical and Health Economics at the USC School of Pharmacy, and research associate at the National Bureau of Economic Research.

Prior to his position at USC, Dr. Joyce was a Senior Economist at the RAND Corporation and currently co-directs UCLA's post-doctoral program in Health Services Research.

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

Pain Clinic Chain to Pay $11M to Settle Fraud Claims

By Don Thompson, KFF Health News

The owner of one of California’s largest chains of pain management clinics has agreed to pay nearly $11.4 million to California, Oregon, and the federal government to settle allegations of Medicare and Medicaid fraud.

The U.S. Department of Justice and the states’ attorneys general say Francis Lagattuta, a physician, and his Lags Medical Centers performed — and billed for — medically unnecessary tests and procedures on thousands of patients over more than five years.

It was “a brazen scheme to defraud Medicare and Medicaid of millions of dollars by inflicting unnecessary and painful procedures on patients whom they were supposed to be relieving of pain,” Phillip Talbert, U.S. attorney for the Eastern District of California, said in a statement this month.

The federal Medicare program suspended reimbursements to Lags Medical in June 2020, and Medi-Cal, California’s Medicaid program, followed in May 2021. Lags Medical shut down the same day the state suspended reimbursements. The company, based in Lompoc, California, had more than 30 pain clinics, most of them in the Central Valley and the Central Coast.

A KFF Health News review last year found the abrupt closure left more than 20,000 California patients — mostly working-class people on government-funded insurance — struggling to obtain their medical records or continue receiving pain prescriptions, which often included opioids.

Lagattuta and Lags Medical did not admit liability under the settlement. Lagattuta denied the governments’ claims, saying in a statement he was “pleased” to announce the settlement of a “long-standing billing dispute.” As part of the agreement, Lagattuta will be barred for at least five years from receiving Medicare and Medicaid reimbursements.

“Since the Centers have been closed for a couple of years, it made sense for Dr. Lagattuta to settle the dispute and continue to move forward with his other business interests and practice,” Malcolm Segal, an attorney for Lagattuta and the centers, said in the statement.

According to state officials, the federal government will receive the bulk of the money, about $8.5 million. California will receive about $2.7 million, and an additional $130,000 will go to Oregon. The settlement amount is based in part on Lagattuta’s and Lags Medical’s “ability to pay.” It does not cover the governments’ full losses, which the U.S. attorney’s office in Sacramento said are not public record.

Blanket Orders for Unnecessary Tests

A nearly four-year investigation by federal officials and the California Department of Justice found that from March 2016 through August 2021, Lagattuta and his company submitted reimbursement claims for unneeded skin biopsies, spinal cord stimulation procedures, urine drug tests, and other tests and procedures.

Lagattuta began requiring all his clinics to perform various medical procedures on every patient, the officials said, no matter if they were needed or requested by patients’ medical providers. Patients who refused were told they would have their pain medication reduced and could suffer adverse medical consequences.

U.S. and California investigators piggybacked on a federal claim filed in late 2018 by a whistleblower, Steven Capeder, Lags Medical’s former operations and marketing director, who will receive more than $2 million of the settlement.

As part of the settlement, Lagattuta and his company acknowledged that in mid-2016 he began requiring his providers to do at least two to three skin biopsies on Medicare patients each day and told providers to quit if they wouldn’t comply. Such biopsies are used to measure small-fiber neuropathy, which causes burning pain with numbness and tingling in the feet and lower extremities.

According to the settlement, a monthly report in early 2018 set a goal of performing 250 biopsies a week. Lagattuta created a separate team that was required to order at least 150 biopsies weekly, often overruling providers. And the company’s chief executive officer in late 2019 texted Lagattuta to report a particularly high number of biopsies, illustrating the text with emojis of a money bag and a smiley face.

Authorities said Lagattuta violated regulations requiring that skin biopsy results be interpreted by a trained pathologist or neurologist. Instead, they say, Lagattuta had the biopsies read by a family member who had no formal medical training and by a former clinic executive’s spouse, who was trained as a respiratory therapist.

Lags Medical clinics performed more than 22,000 biopsies on Medi-Cal patients from 2016 through 2019.

The settlement also alleges Lagattuta encouraged unsuitable patients to undergo spinal cord stimulation. It describes the procedure as “an invasive surgery of last resort,” in which implants placed near the spinal cord apply low-voltage electrical pulses to nerve fibers.

Lagattuta paid a psychiatrist $3,000 each month to falsely certify that every Lags Medical candidate for the procedure had no psychological or substance use disorders that would negatively affect the outcome, according to the settlement. For instance, the settlement says the psychiatrist overruled a Lags Medical social worker to OK the procedure for a young woman who had bipolar disorder with hallucinations that included hearing a man’s voice ordering her out of bed.

He also issued blanket orders for every patient to have urine drug testing, a policy the company’s CEO said “should be a big money maker.”

KFF Health News found that from 2017 through 2019 nearly 60,000 of the most extensive urine drug tests were billed to Medicare and Medi-Cal under Lagattuta’s provider number. Medicare reimbursed Lagattuta $5.4 million for those tests.

The clinics “carefully examined, tested, and treated” more than 60,000 patients during the time covered by the settlement, “when others might have been content to prescribe medication to mask pain,” said Lagattuta’s statement. 

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

FDA and DEA Silent as Rx Opioid Shortages Worsen

By Pat Anson, PNN Editor

Shortages of opioid pain medication in the U.S. appear to be worsening, with no apparent action from the FDA or DEA to ease the suffering of patients left in uncontrolled pain or going into withdrawal.

Last week the American Society of Health-System Pharmacists (ASHP) added another widely used painkiller to its drug shortage list: oxycodone/acetaminophen tablets, which are more widely known under the brand names Percocet and Endocet. The medication is typically prescribed for moderate to severe pain.   

The ASHP reports that five drug makers are either running low or have exhausted their supply of oxycodone/acetaminophen in 2.5, 5, 7.5 and 10mg tablets.  Amneal, Major and Rhodes did not provide ASHP with a reason for the shortage, while Camber and KVK-Tech said they were “awaiting DEA quota approval for active ingredient.”

Amneal, Camber and KVK-Tech said the tablets were on back order with no estimated resupply date. Major and Rhodes said additional supplies were expected in mid-September or early August, respectively. Limited supplies and doses of oxycodone/acetaminophen tablets are still available from other drug manufacturers.

There are already shortages of two other widely used painkillers. The AHSP put immediate release oxycodone on its list of drug shortages in March and added hydrocodone/acetaminophen tablets to the list in May.  

But those shortages have yet to be acknowledged by the FDA. Asked why oxycodone and hydrocodone were missing from the FDA’s drug shortage list, a spokesperson referred PNN to an FDA website for “Frequently Asked Questions about Drug Shortages.”

One possible explanation, according to the website, is that the FDA “focuses on shortages that have the greatest impact on public health.” Shortages are also not reported if they are expected to be resolved quickly, if other substitutes are available, or if there are only local supply issues.

Manufacturers are required to report shortages and supply interruptions to the FDA, while providers, hospitals, pharmacies and consumers can report them by email to drugshortages@fda.hhs.gov.  

‘No One Seemed to Care’

At PNN, we hear from readers almost daily about opioid shortages.

“I am now past my usual fill date,” said Rick Martin, a retired pharmacist in Las Vegas who lives with chronic back pain. “My CVS pharmacist manager told me that she was told by their wholesaler that hydrocodone won't be available until the middle of August.” 

Martin said pharmacists at Walgreens, Smith’s and Sav-on have also told him they were out of oxycodone and hydrocodone tablets.  

“It's been spotty for 6 months but now seems entrenched. I got switched to tramadol. Not as effective, but I can just barely get by. I've heard that's what doctors are doing. Tramadol or Tylenol with codeine,” he told PNN.

Steve Keating, another Las Vegas resident, has been taking oxycodone for chronic neck pain after his vehicle was rear-ended by another driver. He had no problems getting his prescription refilled at either Walgreens or CVS, until last month. Now he is out of pain medication. 

“I began having withdrawal symptoms. No one seemed to care,” said Keating, who turns 73 this month. “The pharmacy recommendations were to obtain tramadol, which I've tried in the past and found ineffective.  I cannot take opiates with acetaminophen as it upsets my stomach.   

“It seems that there is a huge gap between prescribers, pharmacies and whatever governmental agencies are involved.  Do these governmental idiots not realize how important the medication we've been prescribed for months or years is to give us some degree of a better quality of life?” 

There are several reasons behind the opioid shortages. It started with misleading information that demonized prescription opioids and the false portrayal of patients and doctors as the primary cause of the “opioid epidemic.” That was followed by medical guidelines that discourage opioid prescribing and a tsunami of opioid litigation that cost drug makers, wholesalers and pharmacies tens of billions of dollars. 

Egged on by politicians, the Drug Enforcement Administration also aggressively cut production quotas for opioids and other controlled substances, reducing the supply of oxycodone by 65% and hydrocodone by 73% since 2013.  

DEA PRODUCTION QUOTAS FOR OXYCODONE (KILOGRAMS)

SOURCE: DEA

The DEA quotas are rigidly enforced, making it difficult for a drug maker to boost production of opioids when another manufacturer has shortages or discontinues production, like Teva Pharmaceutical recently announced.

It’s not just opioids in short supply. Drugs used to treat cancer and attention deficit disorder (ADHD) are also hard to get. These problems have been building in plain sight for years, yet the FDA’s commissioner says there is little his agency can do to correct them.

“We wish that we could fix all these things, but we don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in a May interview. 

That’s not exactly true. The DEA sets annual production quotas for drug makers only after consulting with the FDA. The 2023 DEA quotas for hydrocodone, oxycodone and several other opioids were cut — for the 7th year in a row — based on the advice of the FDA.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2023 will decline on average 5.3 percent from calendar year 2022 levels,” the DEA said in a notice published last year in the Federal Register.   

DEA administrator Anne Milgram, meanwhile, has not made any public comments about shortages of opioid medication. In a recent appearance on Meet the Press, she said illicit fentanyl was being used to make counterfeit versions of prescription opioids — the same legal drugs that are now in short supply due to DEA actions.

“They're pressing it into these fake pills made to look exactly like oxycodone or Percocet or or Adderall, when it's just fentanyl and filler. So tens of thousands of Americans are dying without having any idea that they're taking fentanyl,” Milgram said.

(Update: On August 1, Milgram and Califf released a joint letter saying the FDA and DEA were working “as quickly as possible” to resolve the drug shortages, but took no responsibility for causing them. The letter only addressed shortages of prescription stimulants used to treat ADHD, binge eating and narcolepsy. It makes no mention of opioid shortages.)

My Story: Riding the Merry-Go-Round of Pain Care

By Christopher Matthews, Guest Columnist

About two and a half years ago, I began to feel a tight painful knot on the side of my neck. Any movement would trigger an intense shock up the back of my skull to the top of my head. Ultrasound, MRI and X-ray scans all came back negative, so we tried anti-inflammatory medications, ice, deep tissue message, chiropractic, and some lifestyle changes.

Over the next few months, the pain began radiating to my cervical spine and intensified. No OTC pain medication was touching this pain.  It felt like a hot steak knife was lodged in my back. The constant, unbearable pain and symptoms of neuropathy seemed to indicate that some minor disc bulging in my spine may be more severe than we thought.

It took 4 months to get an appointment with a specialist in neurosurgery at a prominent hospital in Massachusetts. The surgeon looked at me for 5 minutes and ordered more tests. They found some abnormalities in my arms and legs, but the imaging didn’t warrant surgery. They recommended that I see a neurologist, which meant waiting another 5 months for an appointment.

During the interim, my primary care doctor wanted to be proactive. She was the only one taking me seriously. I did physical therapy 3 days a week and about a dozen courses of oral steroids. I was hopped up on cortisone for months. I also had a series of injections into my spine. None of it seemed to help.

I finally saw the neurologist, who ordered another MRI, which showed the bulging discs in my back were getting worse. But I was still not a candidate for surgery.

I’ve now been hospitalized 4 times due to loss of function, pain flares or passing out from pain in public places. The pain is that bad. Some days I can’t even get out bed because my knees won’t work. Some days I have close to no use of my arms, because my elbows are on fire. I’ve been getting more and more bacterial infections.          

My primary care doctor is the only one who believes my pain is real. She showed mercy and set up a pain management contract with me. We started with 5mg hydrocodone/acetaminophen 3 times a day. I had never touched an opiate before in my life. What a relief! I was so happy I could cry, just for a few hours of pain relief.  

I got a second opinion from another neurologist, who ordered more imaging and blood tests. The images came back as they have in the past, but the blood tests also showed there was severe inflammation – a possible sign of autoimmune disease. So off to rheumatology I go. 

After another 5-month wait for an appointment, the rheumatologist orders more blood tests and an in-depth panel for autoimmune disease. Eight of those tests come back elevated and 4 of them are so high they’re alarming. I think to myself, “This may be terrible news or it may be good news. Either way, I’m finally getting a diagnosis.” 

Not even close. I get all these test results sent to me in an app, with a message from the doctor saying everything “looks fine.” He suggests aspirin and ibuprofen, and that I get off the hydrocodone.  

I lost my temper at that point. How dare you insinuate I’m drug seeking! Like I didn’t try every other option first. All those needles driven into my spine, the steroids, and off-label antidepressants. The months of physical therapy, chiropractic and emotional therapy, all before finally resorting to actual pain medication. 

Some of these doctors and pharmacists with their discriminatory attitudes and actions are disgusting. If it was about the drugs, I’d drive 10 minutes into town and buy them at a fraction of the price I pay at the pharmacy.  

This whole ordeal between deductibles and loss of wages has easily cost me over $100,000. I could have done so much with that money. My wife would have her student debt paid off by now. Instead, it all goes into the for-profit healthcare system. We’re not patients, we’re profits.  

Being on opioid medication now for 2 years, I cannot function without them. Without my pain medication, I feel like someone with industrial grade tools is trying to physically remove my head from my neck. 

CVS is a nightmare and the other pharmacies aren’t any better. They give you that look when you walk in or call to check on a prescription: “Oh, it’s you again. We spoke last month. You’re too early. We know why you people do that.” 

Excuse me, but I’m allowed to pick up my medication the day before I am out, so that I have medication available when I wake up the next day. So that I don’t have call you at 9am when you get in and then have to wait until 3 in the afternoon to pick it up. 

For a while, CVS was taking GoodRx coupons, which cut my insurance price in half. Recently, they told me there’s a new state law that prescription coupons were no longer valid for opioids. I checked with the state and no such law exists. The pharmacist does have the right to turn coupons away, but they flat out lied to me and said it was someone else making them do it.   

The number of days I’ve gone into withdrawal with brutal pain I wouldn’t wish on my worst enemy. All because CVS can’t find the prior authorization or they don’t tell me they are out of stock until I’m at the window to pick it up. Or some other excuse they can drum up. Just so they don’t have to give this “junkie” his drugs. It’s sickening.   

Now, all of a sudden, I can’t get hydrocodone of any dosage at any pharmacy within 50 miles of me. And none of them know when it’ll be back in stock. I found one pharmacy that had a three-week supply of hydrocodone, but by the time I got it called in and got there they said they only had two weeks supply for me because another patient needed a week.  

I’m officially up shirts creek without a paddle and don’t know what to do. I’m in the most pain I’ve ever felt in my life. It is 24/7 and unrelenting. It’s destroying my life, my marriage, my chance at children, my business, and my finances. I get sent from one specialist to another, and at each stop on the merry-go-round they extract $5 to $10 thousand from me in out-of-pocket tests.   

I’m not sure how much longer I can take it.  

Christopher Matthews is a pseudonym for the author, who asked that his full name not be used. He is 35 years old and played 3 years of professional soccer after graduating from college.

Do you have a “My Story” to share? Pain News Network invites other readers to share their experiences about living with pain and treating it.

Send your stories to editor@painnewsnetwork.org.

Can Risk Scores Help Predict if Chronic Pain Will Spread?

By Pat Anson, PNN Editor

The term “biopsychosocial” is a bit of a dirty word in the pain community. Many patients feel that studying the biological, psychological and social factors involved in chronic pain trivializes their physical pain by linking it to anxiety, fatigue, trauma and other stressful life experiences – suggesting the pain is “all in your head.”

But researchers at McGill University in Montreal think biopsychosocial risk factors play a key role in determining the severity and spread of chronic pain to other parts of the body. And that could lead to better ways of treating and preventing pain.   

"By identifying common biopsychosocial factors associated with chronic pain, health care professionals could better personalize treatment plans and improve patient outcomes," said co-author Etienne Vachon-Presseau, PhD, Assistant Professor in the Faculty of Dental Medicine and Oral Health Sciences at McGill University.

Using data from the UK Biobank, a large biomedical database in the United Kingdom, McGill researchers analyzed nine years of health data for nearly 50,000 people who reported a common pain condition such as osteoarthritis, migraine, fibromyalgia and spinal disc degeneration. By the end of the study period, nearly half of the participants (44%) reported their pain had spread to more than one body site.

Why did some people develop chronic overlapping pain conditions (COPCs), while others did not?

To find out, the research team dug deeper into the data, using machine learning algorithms to study 99 different physical, psychological, demographic and sociological factors about the participants, such as their education, mental health, substance use, and socioeconomic status.

The study findings, published in Nature Medicine, identified the biggest risk factors associated with COPC: depression/anxiety, insomnia, neuroticism (feeling fed-up), fatigue, stressful life events, and a body mass index (BMI) above 30.

“Our findings suggest that the biopsychosocial model not only shapes pain experience and maintenance, but also predisposes the development of new pain sites, a phenomenon we refer to as the ‘spreading’ of pain sites,” researchers reported. “Furthermore, we found that the pain site co-occurrence was not random, with a strong dependence between proximal pain sites, shown from either acute or chronic pain sites and from correlations between pain intensity ratings. Thus, biopsychosocial risk scores developed for headache will also moderately predict knee pain and vice versa.”

Based on those findings, the McGill team developed a pain risk score that utilizes six simple questions:

Risk of Pain Spreading Screen

1. Do you have difficulty falling asleep at night or do you wake up in the middle of the night?

2. Do you often feel ‘fed-up’?

3. Over the past 2 weeks, how often have you felt tired or had little energy?

4. Have you ever seen a GP or psychiatrist for nerves, anxiety, tension or depression?

5. In the last two years, have you experienced a serious illness, assault, death of a spouse/partner or close relative, separation/divorce, or financial difficulties?

6. Is your BMI over 30?

McGill researchers say their questionnaire will help providers quickly assess the risk of a pain patient developing more severe pain and how the pain might spread across their body.

“Our model predicted chronic pain spreading across multiple body sites in nearly 50,000 out-of-sample individuals,” researchers said. “We showed that high sensitivity and specificity could still be obtained for certain chronic pain conditions using only six questions. The ability to predict chronic pain, particularly COPCs and its severe forms, with minimal effort has the potential to benefit both research and clinical practice.”

JAMA: Patients on Long-Term Opioids Often ‘Irrational’

By Pat Anson, PNN Editor

Do pain patients on long-term opioid therapy make irrational decisions? Is their mental capacity so diminished by opioids that they shouldn’t be involved in treatment decisions with their doctors?

The answer to both questions is often yes, according to a controversial new op/ed published in JAMA Internal Medicine. At issue is a recent update to the CDC’s opioid prescribing guideline, which calls for shared decision-making (SDM) when a prescriber considers tapering a patient or abruptly discontinuing their opioid treatment. The guideline was revised last year after reports of “serious harm” to patients caused by forced tapering.

“In situations where benefits and risks of continuing opioids are considered to be close, shared decision-making with patients is particularly important,” the 2022 guideline states.

But that advice about consulting with patients goes too far, according to the lead author of the JAMA op/ed, Mark Sullivan, MD, a professor of psychiatry at the University of Washington and a longtime board member of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“The value of SDM has been recognized for many years but also has its limitations, including where patients make irrational or short-sighted decisions,” Sullivan wrote. “Long-term opioid therapy induces a state of opioid dependence that compromises patients’ decisional capacity, specifically altering their perception of the value and necessity of the therapy; and although patients with chronic pain are not usually at imminent risk of death, they often can see no possibility of a satisfying life without a significant and immediate reduction in their pain.”

Sullivan and his two co-authors, Jeffrey Linder, MD, and Jason Doctor, PhD, have long been critical of opioid prescribing practices in the U.S. In their conflict of interest statements, Sullivan and Doctor disclose that they have worked for law firms involved in opioid litigation, a lucrative sideline for several PROP members.

Sullivan, Linder and Doctor call for more “structured” decision-making that includes the patient’s family and friends, “motivational interviewing” of patients about opioid risks and treatment goals, and education about non-drug alternatives such as yoga and meditation.

“We believe that a fully individualized, unstructured decision-making process will not be adequate to protect patients receiving long-term opioid therapy,” they wrote.

“In the case of opioid prescribing, and especially opioid tapering, working to persuade the patient is almost always the best clinical strategy. But there are circumstances where tapering should occur even if the patient objects.”

— Dr. Mark Sullivan

And what happens if a patient refuses to have their dose reduced? The op/ed doesn’t explicitly state it, but in an email to PNN, Sullivan said forced tapering would be acceptable in some situations.

“In the case of opioid prescribing, and especially opioid tapering, working to persuade the patient is almost always the best clinical strategy. But there are circumstances (opioid use disorder, diversion, serious medical risks) where tapering should occur even if the patient objects,” Sullivan wrote.

Opioid diversion by patients is actually rare. The DEA estimates that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) will be used by someone they were not intended for.

As for patients on opioids behaving “irrational,” Sullivan and his co-authors cite an op/ed published 33 years ago in The New England Journal of Medicine (NEJM). But that article doesn’t even discuss opioids or tapering, it’s about whether patients and doctors should collaborate in making decisions about end-of-life medical care.  It also makes an important disclaimer that “even the irrational choices of a competent patient must be respected if the patient cannot be persuaded to change them."

Sullivan rejects that approach to opioid treatment.

“We cite (the NEJM article) to demonstrate that SDM does not exclude or prevent irrational decisions,” he wrote in his email.  “You are right that we do not endorse the conclusion you cite, that patient’s irrational decisions must be respected.”

In a rebuttal to Sullivan’s op/ed also published in JAMA Internal Medicine, Mitchell Katz, MD, and Deborah Grady, MD, dispute the notion that a patient’s choices shouldn’t be respected.

“Primary care professionals generally highly value the inclusion of the patient’s perspective in decision-making, consistent with the principles of patient autonomy and self-determination, and are loathe to go against a patient’s wishes,” they wrote.

“As primary care professionals, we have found it helpful to tell patients that it is not recommended to take more than a specific threshold of opioids and that we do not want to prescribe something that is not recommended. However, that does not mean sticking to rigid cut points for dose and duration of opioid use, abandoning patients, or having them undergo too rapid a taper.”

Others questioned JAMA’s decision to publish Sullivan’s op/ed.

“While I recognize the editors’ legitimate intellectual interest in providing a forum for open discussion on the opioid policy space, I question their decision to publish an editorial that represents an ongoing call for broad, ill-defined reductions in opioid prescribing,” said Chad Kollas, MD, a palliative care specialist who rejects the idea that patients shouldn’t be involved in their healthcare choices.

“Errantly embracing a lower evidentiary standard for medical decision-making capacity creates an unacceptable risk for harm to patients with pain by violating their rights of medical autonomy and self-determination.”

Opioids were once commonly prescribed in the U.S. for both acute and chronic pain, but those days are long over. Opioid prescribing has been cut in half, to levels not seen since the 1990’s. And many patients today have trouble just getting their prescriptions filled at pharmacies due to opioid shortages.

Despite that, fatal overdoses have climbed to record levels, with illicit fentanyl and other street drugs involved in the vast majority of drug deaths, not prescription opioids.