5 Lessons I’ve Learned About Chronic Pain

By Barby Ingle, PNN Columnist

Do you ever feel like your time, energy and hope are running out due to chronic pain or illness? That you aren’t living life to the fullest and may never be able to?

Many people who live with painful disabling conditions have that kind of fear and self-doubt. If you are struggling with similar thoughts, read along while I dive into the five most meaningful lessons I’ve learned about chronic pain.

I wish I had known these things when my journey through the American healthcare system began. I strive to be healthier and wonder if my wellness would be further along if I had known better from the start.

The good news is that changing today can affect your tomorrow. It is never too late to make improvements in your life. Whether you are a longtime chronic pain patient or just starting on your pain journey, these five insights may help save you some heartache and frustration. 

1.  Keep good medical records 

I have long been a proponent of keeping and updating your medical records.  Use technology to your advantage. Advances in health information technology make it easy to store and retrieve data, and facilitates the rapid exchange of patient information. This can help you file insurance appeals and when seeking prior authorizations.

When a provider closes down unexpectedly, having medical records from your patient portal either printed or downloaded in PDF form can also help you find a new provider. This is something I faced this year when my ketamine provider abruptly shut down.  

2.  Not all providers are equal 

Learn everything you can about your illness and keep learning. It is also essential to seek specialists who know about your complex medical condition.

People often look up to their doctors and put total faith in them. However, most doctors are educated and trained in only one specialty in the practice of medicine. Just because a doctor is a neurologist doesn’t mean they can treat diabetic neuropathy, multiple sclerosis or Lyme disease. 

Providers may have expertise in treating one or two conditions, and know only a little about others. With thousands of diseases, conditions and treatments, no provider can know them all in-depth. Learn about your provider's experience and limitations, and encourage them to seek additional knowledge from their peers to help you. Communication is the key to improving trust and faith in your treating doctors.

3.  Your diagnosis does not define you 

In medicine, a diagnosis refers to a specific disease or illness, but not the characteristics of each patient. A condition may present itself and progress differently, depending on the patient’s genetics, lifestyle and environment.

I was once given a diagnosis of thoracic outlet syndrome (TOS) when I was exhausted, over-treated, and scared. It turned out that was an incorrect diagnosis and that the TOS-like symptoms I was having were secondary to the real cause: Reflex Sympathetic Dystrophy (RSD).  

We need to be careful not to jump to easy conclusions. I also realized I had to stop comparing my symptoms and outcomes to others with the same condition. I turned my focus on creating the best me I could be. 

4.  If something is too challenging, break it into smaller pieces 

Do the more manageable actions first, and then see what is left to conquer.

Tackling one problem – like organizing medical records from a single provider -- can give you the positive momentum to take on the more challenging ones. If you find yourself having difficulty -- stop, take a break and work on something else. Get that feeling of success (and the endorphins that come with it), and return to the challenge when you are ready for it. 

5.  Share your journey 

Each of our journeys are unique, but hearing someone else’s experience can offer us hope, options, and ideas that we can use to improve our own lives.

For example, I’ve found that hydration is super essential for coping with RSD. My primary care doctor said I should drink water regularly to help regulate my body temperature, keep my joints lubricated, prevent infections, replace nutrients in my cells, and to keep my organs functioning correctly.

He was right. I learned that when I consistently drink 60-70 oz. of water daily, take my medications on time, and do light stretching, my sleep, cognition and mood also improve.

Continue to share and cultivate habits that support your long-term health and happiness. The more we know, the better our decisions will be. I’ve dedicated my life to helping people with chronic conditions have happier and more meaningful lives. The key is to believe in yourself while building the life that you want. After helping thousands of people worldwide and reading countless success stories, I am confident that you can do that.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and best-selling author on pain topics. Barby has received over 25 awards for her advocacy efforts. You can follow her at www.barbyingle.com.    

Arthritis Pain Varies Widely Across States

By Pat Anson, PNN Editor

People living in West Virginia are three times more likely to have moderate or severe joint pain from arthritis than those in Minnesota, according to a comprehensive new study that highlights how disparities in education and access to social services contribute to chronic pain.

“Very little research has examined the geography of chronic pain, and virtually none has examined the role of state-level policies in shaping pain prevalence,” says co-author Hanna Grol-Prokopczyk, PhD, an associate professor of sociology at the University of Buffalo. “We were excited to identify state characteristics that reduce residents’ risk of pain.”

Grol-Prokopczyk and her colleagues looked at data for over 400,000 adults who participated in the 2017 Behavioral Risk Factor Surveillance System, along with data from all 50 states on social assistance and anti-poverty programs such as the Earned Income Tax Credit, Medicaid and Supplemental Nutrition Assistance Program (SNAP), more commonly known as food stamps.

Their findings, published in the journal PAIN,  show the risk of joint pain was significantly higher in states in Appalachia, the Mississippi Valley and the South, compared to states in the Upper Midwest and West.

Nearly one in four adults in West Virginia (23.1%), Alabama (21.6%) and Arkansas (21.4%) had moderate to severe joint pain. States with the lowest risk of joint pain are Minnesota (6.9%), Hawaii (7.5%) and Utah (7.7%).

SOURCE: PAIN

Digging deeper into the data, researchers found that educational disparities are also associated with pain frequency. People who did not complete high school in West Virginia (31.1%), Arkansas (29.7%) and Alabama (28.3%) were far more likely to have joint pain compared to those with bachelor degrees in California (8.8%), Nevada (9.8%) and Utah (10.1%).

People with less education are more likely to have blue-collar jobs requiring manual labor that may contribute to joint pain. They also have lower incomes and less access to healthcare.

“Education can function as a ‘personal firewall’ that protects more highly educated people from undesirable state-level contexts, while increasing the vulnerability of less educated individuals,” said first author Rui Huang, a sociology PhD student in the UB College of Arts and Sciences.

Researchers also found that states with higher levels of SNAP benefits, social support and community health services had lower levels of pain frequency.

“The increase in the generosity of SNAP benefits could potentially alleviate pain by promoting healthier eating habits and alleviating the life stress associated with food insecurity,” says Huang. “Social factors such as conflict, isolation and devaluation are also among the ‘social threats’ that can lead to physical reactions such as inflammation and immune system changes.”

Previous studies at the University of Buffalo have found that gender, poverty and education play a role in pain frequency and that the overall prevalence of pain is increasing in the United States, affecting virtually every age group, sex, ethnicity and demographic.

Should Suboxone Be Used to Treat Kratom Addiction?

By Pat Anson, PNN Editor

A man with a history of substance abuse – including addiction to kratom – has been successfully treated with buprenorphine/naloxone (Suboxone), according to a case study published in the journal Cureus.  Suboxone is a medication that is normally used to treat opioid use disorder.

Kratom is not derived from the opium poppy and is not an opioid. It’s an herbal supplement that comes from the leaves of a tree in southeast Asia, where it has been used for centuries as a stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat their pain, anxiety, depression and addiction.

The unidentified patient in the case study has a history of using cocaine, marijuana and alcohol, and suffers from anxiety and depression. He was introduced to kratom 12 years ago by his brother for stress relief and as a substitute for oxycodone. Over the years, the patient used more and more kratom, at one point spending up to $600 a week on kratom supplements.

After several failed attempts to wean himself off kratom, which resulted in severe withdrawal symptoms, the patient went to see his primary care physician, Dr. Paul Remick, one of the study’s co-authors. It was Remick who suggested that Suboxone might help him quit kratom.

“He’d been struggling with depression, anxiety, all these various issues. He was pretty reluctant to try therapy like Alcoholics Anonymous or trying to speak to a therapist,” explained lead author Martin Arhin, a medical student at the University of North Carolina at Chapel Hill. “Dr. Remick suggested Suboxone, since kratom has some like opioid-like properties. He felt like it could potentially work. And fortunately, it did.”

After 23 weeks of using Suboxone, the patient’s withdrawal symptoms subsided and he stopped using kratom. He’s also been successfully tapered off Suboxone, a drug that many people wind up taking for life.   

Suboxone is only approved for opioid use disorder and there is no clinical evidence that it can treat kratom addiction. Such a use, while legal, would be considered “off-label” by the FDA. But based on this one anecdotal case, Arhin and his co-authors say Suboxone could be a treatment for kratom dependence.

“Currently, there is no established evidence-based consensus for the treatment of kratom addiction and withdrawal, leaving individual providers to decide on the appropriate course of action,” they wrote. “We recognized the patient's dependency on kratom and subsequently implemented a treatment plan utilizing buprenorphine/naloxone, which effectively alleviated withdrawal symptoms and supported the patient's abstinence from kratom. We suggest that this drug combination may be a potential treatment for kratom addiction.”

‘Kratom Saved My Life’

Ironically, many people use kratom as an alternative to Suboxone. In a 2016 PNN survey of over 6,100 kratom users, nearly ten percent said they used kratom primarily as a treatment for opioid addiction. Most said it was very effective (91%) in easing their withdrawal symptoms and worked better than Suboxone, with fewer side effects.

“Kratom saved my life. I tried every other type of treatment for drug addiction over the past 10 years. Subutex, methadone, total abstinence and the 12 step program. Each time I failed. After 2 years of Suboxone, I stopped treatment and began using kratom,” one respondent told us.

“Because of kratom, I no longer have to worry about heroin (or methadone or Suboxone) making me sick. I've been clean for 2 years. I can hold a job now, and I only use it when I need pain relief or need to relax,” another respondent wrote.

“I became hooked on oxycodone and had to take Suboxone to get off it. The problem is Suboxone withdrawals were nearly as bad, so I used kratom to cure that,” another patient said.

“Kratom truly saved my life. I've always suffered from extreme anxiety, but it has decreased drastically since taking it. Withdrawals from opiates and Suboxone are awful. I would not have been able to get clean without kratom. I'm confident in saying that if you make kratom illegal, the number of overdoses will rise,” wrote another kratom user.

The DEA and FDA have tried to make kratom illegal by having it declared a Schedule I controlled substance. So far, those efforts have failed due to a public backlash.

Kratom is sold legally in most U.S. states, but a handful of states and cities have banned it over concerns about addiction and overdoses.  About 100 deaths nationwide have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.

About two million Americans use kratom, primarily to treat chronic pain. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

Although many people use kratom to self-treat opioid addiction and ease withdrawal symptoms, the FDA won’t allow kratom vendors to advertise or promote kratom for addiction treatment or any other medical purpose. This month, the FDA sent a warning letter to the Sunshine Trading Company in Colorado, warning it to stop promoting its kratom products for “opiate withdrawal.”

“You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal,” the FDA said.

In recent years, several other kratom vendors have received similar warning letters from the agency..

Home Delivery of Rx Opioids Would Help Chronic Pain Patients

By Pat Anson, PNN Editor

We hear almost every day from people in pain who say they can’t get an opioid prescription filled because their pharmacy is out of stock. Often, the pharmacist has no idea when the next shipment of pain medication is coming.

“Walgreens cannot fill my prescription. They say the drug is on back order with no ship date available,” a patient recently told us.

“20 years on the same Rx for Vicodin and now CVS says they are out of stock and no idea when it will be available,” another patient wrote.

“Just talked to a pharmacist today that said they are out of Percocet, Vicodin and morphine. They said that their supplier, Cardinal Health, wasn't sure when they would get more,” said another patient.

Now imagine, if you will, what it would be like to have a pharmacy that delivers opioid medication directly to your home. No more standing in line at the pharmacy. No more dirty looks from the pharmacist. No more excuses about being out of stock.

For about 1,000 patients in the Philadelphia area, most of them chronic pain sufferers, that fantasy is a reality. They are customers of a boutique pharmacy in the Delaware Valley that specializes in home deliveries of controlled substances – including high dose opioids.  Prescriptions and refills are delivered on a carefully managed schedule before a patient runs out, becomes disabled by uncontrolled pain, and goes into withdrawal.

“We hand deliver directly to the patient. I have a whole delivery team. They're our own drivers, our own vehicles,” says Brian Dunleavy, CEO of PMC Pharmacy. “Our customers get notified when their delivery is anticipated to arrive at their home. And then every patient has to sign for it. They have to be present or we can't leave it there. Or it has to be an adult that's been authorized to receive the medication.”

I first heard of PMC Pharmacy when it sent out a news release last month to address difficulties that some patients have getting opioids and other controlled medications from other pharmacies in the Delaware Valley. PMC said it could help those patients avoid gaps in drug therapy and was committed to keeping them “on schedule, at home, and independent.”

“We should really have every chronic pain management patient in the Delaware Valley under our care because of the way our program works,” Dunleavy told PNN.

While big chain pharmacies and their wholesale drug suppliers are under increased scrutiny from law enforcement and regulators, PMC flies under the radar because its customers’ medical conditions, prescriptions and insurance claims are carefully documented – reducing the risk of diversion or misuse.     

“We won't take patients from a typical primary care practice, we're only working with chronic pain specialists who give us (patient) chart notes and supporting documentation to satisfy our wholesalers’ desires that we're doing due diligence on all these doctors and all these patients, and making sure that there's a legitimate need for the medication,” Dunleavy explained. “The diversion isn't coming from the people that are legitimate chronic pain patients. Those people hold onto that medication as if it's their lifeline.”

Trifecta of Problems

The supply of opioids and other controlled substances is tight because of a trifecta of problems that have hamstrung the pharmaceutical industry.

First, the Drug Enforcement Administration has been aggressively cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by 65% and hydrocodone by 73% since 2013.

Second is the fallout from opioid litigation. The nation’s three largest drug wholesalers reached a $21 billion settlement with 46 states, requiring them to impose strict limits on opioid shipments to pharmacies. CVS, Walgreens and other pharmacy chains have also paid tens of billions of dollars to settle lawsuits that alleged they helped fuel the overdose crisis by dispensing too many opioids.  

The third reason for tight supplies is a retooling of the generic drug industry. There’s little money to be made in selling most opioids and there’s a risk of further liability, so drug makers are cutting back production of many generic opioids.  One of the world’s largest manufacturers of generics, Teva Pharmaceutical, recently notified the FDA that it was discontinuing production of oxycodone.

It all adds up to an increasing number of drug shortages, involving not just opioids, but medications used to treat cancer, anxiety and attention deficit disorder. Dunleavy thinks the shortages are a direct result of regulatory overreach.

“You have all these things going on and everybody's like, ‘Oh well, there's a shortage of oxycodone out there.’ And in actuality, there isn't. It's a regulatory created shortage, which is why there's a discrepancy between what we're hearing from patients versus what we see at the on the wholesalers’ shelves,” he explained. “The pharmacies can't get those drugs because they're quantity restricted by the wholesalers, based on the programs that the wholesalers have implemented to police the pharmacies.”

Dunleavy says PMC would like to add more patients to its customer base, provided they live in its delivery area in southeastern Pennsylvania and parts of New Jersey and Delaware that border Philadelphia. He’s confident he’ll be able to get the additional medication from suppliers.

“You're not going to have a better adherence and compliance program from a pharmacy than ours,” he said. “Because our program is pain management specific, once we start working with a practice, we start getting quite a few referrals. So it's very easy for us to start growing.”

Could PMC’s business model be adopted by other pharmacies? With pain management under so much scrutiny, Dunleavy says home deliveries to selected patients make sense.

“There's a legitimate need for a pharmacy that puts in a little bit more effort, that's a little bit more specialized. Because the regulatory environment requires it, the patients require it, and the physicians require it,” he said.

“This is a very interesting concept. It almost sounds too good to be true, but if it really works it would be tremendously helpful to many chronically ill people,” says Kristen Ogden, a patient advocate in Virginia. “I think this concept may be really helpful to house-bound patients and persons with limited access to transportation, especially those who don't have an engaged family member helping them.”  

For many years, Kristen and her husband Louis have traveled to California to get the high dose opioids he needs to treat severe pain from arachnoiditis and Ehlers-Danlos Syndrome. Not having to make that monthly cross-country trip for refills would be a welcome relief to the Ogdens.  

“It would be great to think this sort of service would be available to us as we get older, especially since we have no children and no other family members who live in our area to assist us. This could certainly be a big factor in enabling older adults to continue living in their own homes if that's what they prefer to do,” Kristen said. 

The American Society of Health-System Pharmacists put immediate release oxycodone on its list of drug shortages in March and added hydrocodone/acetaminophen tablets to the list in May.  Neither shortage has yet to be recognized by the FDA, although many patients are already well aware that both medications are in short supply. 

“I've been waiting for over a week for oxycodone to come in. Over the last weekend, I went to over 25 different pharmacies searching, until I couldn't drive anymore. It's not fair to any of us!” a pain patient recently told PNN

Patients Squeezed in Fight Over Costly Infusion Drugs

By Samantha Liss, KFF Health News

Health insurers and medical providers are battling over who should supply high-cost infusion drugs for patients, with the tussle over profits now spilling into statehouses across the country.

The issue is that some insurers are bypassing hospital pharmacies and physician offices and instead sending more complex drugs through third-party pharmacies. Those pharmacies then send the medications directly to the medical provider or facility for outpatient infusing, which is called “white bagging,” or, more rarely, to patients, in what is called “brown bagging.” That shifts who gets to buy and bill for these complex medications, including pricey chemotherapy drugs.

Insurers say the policies are needed because hospital markups are too high. But hospitals argue that adding an intermediary results in unnecessary risks and delays, and they say some insurers have their own or affiliated pharmacy companies, creating financial motives for controlling the source of the medications. The patients, meanwhile, are left to deal with the red tape.

Paula Bruton Shepard in Bolivar, Missouri, is among those caught in the middle. Flares of lupus, an autoimmune disease, rob Shepard of her mobility by attacking her joints. She relies on monthly infusions to treat her symptoms.

PAULA SHEPARD

But at times, she said, her treatments were delayed due to UnitedHealthcare’s white bagging infusion policy. And interruptions to her treatments exacerbated her symptoms.

“I once had to use a toilet lift and it was kind of demoralizing to say, ‘I’m a 50-year-old woman and I have to use a toilet lift,’” Shepard said of the medication delays.

This is a tug of war over profits between insurers and medical providers, said Ge Bai, a professor of accounting and health policy at Johns Hopkins University. While insurers claim the arrangement reduces costs, she said, that doesn’t mean insurers pass along savings to patients.

“I don’t think we should have more sympathy toward one party or the other,” Bai said. “Nobody is better than the other. They’re all trying to make money.”

The savings from white bagging can be significant for expensive infusion drugs, according to a report from the Massachusetts Health Policy Commission. For example, Remicade, used to treat a variety of inflammatory diseases, including Crohn’s, cost on average $1,106 per unit in 2015 under hospitals’ traditional buy-and-bill system, the commission found in its review of state claims data. That same drug cost an average of $975 per unit under white bagging, a 12% savings.

But the report also found patients, on average, faced higher cost sharing — what they are responsible for paying — for Remicade and other drugs when white bagging was used. While some patients had only modest increases to their costs under the policy, such as $12 more for a medication, the review found it could mean much greater cost sharing for some patients, such as those on Medicare.

Delays in Care

At Citizens Memorial Hospital in rural Bolivar, more than 1 in 4 patients who receive regular infusions are being forced to use an outside pharmacy, said Mariah Hollabaugh, the hospital’s pharmacy director. Shepard was among them.

Even if the hospital has the exact drug on the shelf, patients must wait for a separate shipment, Hollabaugh said, potentially interrupting care. Their shipped drugs may sometimes be unusable when the doctor needs to change the dosage. Or the medicine comes in a nondescript package that doesn’t get immediately flagged for the pharmacy, potentially subjecting the drugs to damaging temperature fluctuations. For patients, that can mean delays in care.

“They’re in pain, they’re uncomfortable,” Hollabaugh said. “They may be having symptoms that don’t allow them to go to work.”

Siteman Cancer Center, led by physicians from Washington University School of Medicine in St. Louis, has confronted the same issue. But the cancer center’s size has helped it largely avoid such insurer policies.

John DiPersio, a Siteman oncologist and researcher who led the university’s oncology division for more than two decades, said Siteman reluctantly allows white bagging for simple injectables but refuses to accept it for complicated chemotherapies. It does not accept brown bagging. Occasionally, he said, that means turning patients away.

“You’re talking about cancer patients that are getting life-threatening treatments,” DiPersio said, referring to the dangers of chemo drugs, which he said can be fatal if used improperly. “It doesn’t make any sense to me. It’s all stupid. It’s all lunacy.”

At least 21 states, including Missouri, introduced some form of white or brown bagging legislation during the most recent legislative session, according to the American Society of Health-System Pharmacists. And in the past two years, the trade group said, at least 13 states have already enacted restrictions on white bagging, including Arkansas, Louisiana, and Virginia.

ASHP has created model legislation to limit insurers from requiring the practices as a condition of coverage.

“This is a major issue,” said Tom Kraus, a vice president at the trade group. “We see this as central to our ability to coordinate patient care.”

At the heart of the tension is an often-litigated federal program that allows certain hospitals and the clinics they own to purchase drugs at deep discounts. The 340B program, named for a section of the law that created it, allows hospitals to buy certain drugs for much less — sometimes for a total cost of a single penny — than what they are later paid for those drugs. Hospitals are not required to pass along 340B savings to patients.

The program was intended to help hospitals spread scarce resources further to treat patients in poor and vulnerable communities, but it has morphed into a means of enriching hospitals and their affiliated clinics, researchers said in a 2014 Health Affairs report. Hollabaugh said many rural facilities such as Citizens rely on the revenue generated from the 340B drugs to subsidize infusions that have no profit margin.

The number of participating hospitals and their affiliated outpatient clinics has increased significantly since the 340B program was created in 1992. More than 2,600 of the nation’s roughly 6,100 hospitals were participating in the 340B program as of January 2023. That gives them access to discounts that can knock off as much as 50% of a drug’s cost, according to the Health Resources & Services Administration, which oversees the program.

‘People Got Greedy’

The insurance industry argues that hospital markups, especially when made on top of those discounts, have gotten out of control.

“The fact is, people got greedy,” Shannon Cooper, a lobbyist for Blue Cross and Blue Shield of Kansas City, said during a Missouri state Senate hearing in March.

Markups are not unique to 340B hospitals, said Sean Dickson, who helps lead pharmaceutical policy for AHIP, a trade group formerly known as America’s Health Insurance Plans. The markups thrusted on commercial plans are “widely out of line” with what Medicare will pay, he said, and that is driving up costs without providing additional value.

Legislation that targets white bagging hinders an insurer’s ability to rein in such costs, Dickson said, especially when an area lacks competition.

“What we're really trying to focus on here is putting pressure on those markups that are not related to cost or safety,” Dickson said.

Anthem Blue Cross and Blue Shield lobbyist David Smith testified during the March hearing in Missouri that even the idea of white bagging elicited a quick response and that almost every major hospital system in the state said they would drop their prices and come back to the negotiation table.

For now, Citizens Memorial Hospital and other Missouri medical facilities will have to continue to tango with the insurers: Legislation to limit white and brown bagging did not pass during the Missouri General Assembly’s recent session.

Shepard, though, won’t need such legislation.

UnitedHealthcare had been sending her lupus infusion through other pharmacies on and off since 2021, unwilling to cover the drugs if they came from Citizens’ in-house pharmacy. Shepard had to authorize each shipment before it was sent. If she missed the monthly call, she said, it was a “bureaucratic mess” trying to get the medication shipped.

“We are driving unnecessary costs out of the health care system to help make care more affordable, while also maintaining drug safety, effectiveness and quality of care,” UnitedHealthcare spokesperson Tony Marusic wrote.

But after KFF Health News inquired about Shepard’s case, Marusic said UnitedHealthcare stopped white bagging Shepard’s medication to “prevent potential delays in shipping.” And during her latest infusion in June, her hospital was again able to supply Shepard’s medication directly.

“I'm just so relieved,” Shepard said. “I don't have to take phone calls. I don't have to reply to emails. I just show up.”

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

Millions of People Worldwide Are ‘Left Behind in Pain’

By Pat Anson, PNN Editor

A new report by the World Health Organization (WHO) warns that limited access to morphine and other opioids is leaving millions of people in many parts of the world suffering in preventable pain.

The report, “Left Behind in Pain,” calls morphine a low cost, essential medicine for relieving moderate to severe pain. But access to morphine and other opioids is inadequate in many low and middle-income countries, with consumption patterns in wealthier nations that don’t correspond to medical need. Over 95% of the world’s supply of opioids is distributed in wealthy countries, with only 0.03% distributed in low-income ones.

“Leaving people in pain when effective medicines are available for pain management, especially in the context of end-of-life care, should be a cause of serious concern for policy-makers,” says Yukiko Nakatani, MD, WHO Assistant Director-General for Medicines and Health Products. “We must urgently advocate for safe and timely access to morphine for those in medical need through balanced policy, everywhere.”

The report calls for expanded access to morphine through local and regional distribution centers, changes in restrictive laws and guidelines, and reduced stigma surrounding opioid use.

“Some historical events, cultural beliefs, misinformation and disinformation about pain, and social stigma related to opioid use are known to have caused mistrust of opioids and contributed to fear of using them,” the report found.

Lawsuits and regulatory controls on the pharmaceutical industry are so strong in some countries that drug makers have stopped manufacturing morphine because the profit is low and risk of liability is high.

That may have played a role in Mundipharma’s recent decision to discontinue supplying Ordine, a liquid formulation of morphine, to Australia. Mundipharma is owned by the Sackler family, which has been enmeshed in opioid litigation over its role in the opioid crisis in the U.S. through its operation of Purdue Pharma.

A Mundipharma spokesperson told the Australia Broadcasting Corporation that the company’s third-party manufacturer decided to stop producing Ordine and that "sourcing another manufacturer would not be commercially viable."

Evolving Stance on Opioids

WHO’s position on opioids has evolved over the years. WHO’s guidelines for treating chronic pain, for example, used to say that opioids “are known to be safe and there is no need to fear accidental death or dependence.”

That changed in 2019, after two U.S. congressmen – without any real evidence -- accused WHO of being “corruptly influenced” by opioid manufactures. WHO withdrew the guidelines a month later, citing “new scientific evidence” – although critics said caved in to political pressure and threats to withdraw U.S. funding of WHO.

In 2021, WHO backpedaled further, recommending that morphine only be given to sick children when they are dying. Physical therapy and “biopsychosocial” treatments such as cognitive behavioral therapy were suggested as alternatives for children who are in pain, but expected to live.

WHO’s latest report recognizes the potential harms of opioids, couched in language about the world facing two opioid crises.

“The world is facing two crises related to the use of opioids. In the first, inappropriate use and over-prescription combined with the wide availability of illicit unregulated opioids, such as fentanyl, in some countries is causing significant harm and loss of life. In the second, a lack of access to opioids such as morphine in many parts of the world means that millions of people continue to suffer preventable pain,” said Nakatani.

About 80% of the world’s morphine supply was consumed in North America in 2021, primarily in the United States, although the rest of the developed world is catching up. Opioid consumption in the U.S. has fallen so sharply in recent years that Canada, Australia and several European countries have become the highest consumers of opioid analgesics, according to a 2022 study that ranked the U.S. as being 8th in per capita opioid sales.

Long Covid May Not Be Caused by Covid-19 Virus

By Pat Anson, PNN Editor

An immune system response to the COVID-19 virus has been suspected as a possible cause of Long Covid, a poorly understood disorder that causes chronic fatigue, brain fog, insomnia, chest pain and other symptoms long after the initial infection.  

But a small new study in the UK suggests that Long Covid may not be an inflammatory immune reaction to the SARS-CoV-2 virus. Instead, the body appears to be responding to the activation of dormant viruses many of us already have in our systems.

"Long Covid occurs in one out of 10 COVID-19 cases, but we still don't understand what causes it,” said Laura Rivino, PhD, Senior Lecturer at the University of Bristol's School of Cellular and Molecular Medicine. “Several theories proposed include whether it might be triggered by an inflammatory immune response towards the virus that is still persisting in our body, sending our immune system into overdrive or the reactivation of latent viruses such as human cytomegalovirus (CMV) and Epstein Barr virus (EBV)."

Rivino and her colleagues collected and analyzed blood samples from 63 Covid patients with mild, moderate or severe symptoms who were hospitalized at the start of the pandemic -- before vaccines were available – and tested them again 3, 8 and 12 months after their admission.  

Their findings, published in the journal eLife, show that patients with severe symptoms had significant dysfunction in their T-cell profiles after three months. T-cells are white blood cells released by the immune system to fight bacteria and viruses.

Further analysis showed there was no rapid increase in immune cells targeting SARS-CoV-2, but there was an increase in T-cells targeting CMV -- a common virus that is usually harmless but can stay in the body for life once you’re infected with it. That suggests that the prolonged T-cell activation observed at three months in severe patients may not be driven by SARS-CoV-2, but instead may be "bystander driven" by dormant viruses that were reactivated.  

"Our findings suggest that prolonged immune activation and long COVID may correlate independently with severe COVID-19. Larger studies should be conducted looking at both a larger number of patients, including if possible vaccinated and non-vaccinated COVID-19 patients,” said Rivino. "Understanding whether inflammation and immune activation associate with long COVID would allow us to understand whether targeting these factors may be a useful therapy for this debilitating condition."

The good news for Covid long haulers is that after 12 months, the T-cell levels of patients with severe Covid symptoms were similar to those of patients who experienced mild and moderate symptoms – suggesting that severe cases can resolve over time.

Medical Marijuana Laws Had Little Impact on Opioid Prescribing

By Pat Anson, PNN Editor

The cannabis industry and advocates in the U.S. have long claimed that state laws legalizing medical marijuana could help solve the opioid crisis by reducing demand for prescription opioids.

Various studies have suggested that may be true, like a recent one in New York state that found patients on high-dose opioids significantly reduced their opioid use once they started using medical cannabis. A similar study in 2021 found that cannabis was so effective in reducing chronic pain that most patients were able to reduce or completely stop their use of opioids.

But a large new study of commercially insured adults with chronic non-cancer pain found that the legalization of medical cannabis in 12 states (Arkansas, Connecticut, Florida, Louisiana, Maryland, Minnesota, North Dakota, New Hampshire, New York, Oklahoma, Ohio, Pennsylvania) had little to no effect on opioid prescribing.  

“Some research suggests that perhaps medical cannabis laws reduce opioid prescribing for chronic non-cancer pain because some people may substitute cannabis,” said lead author Beth McGinty, PhD, chief of the Division of Health Policy and Economics at Weill Cornell Medicine. “We found no effects of these laws on opioid prescribing or any types of treatment for chronic non-cancer pain that we looked at.”

McGinty and her colleagues looked at prescription data for over 150,000 chronic pain patients in the four years prior to state legalization and compared it to their medication use in the three years after medical marijuana laws were adopted. That data was then compared to prescription data for over 430,000 pain patients in 17 other states without medical marijuana laws, who served as a control group   

The study findings, published in Annals of Internal Medicine, show that opioid prescribing for chronic pain fell only slightly in states with medical marijuana laws, leading to tiny decreases in the average supply of opioids (0.35 fewer days) and for daily doses in morphine milligram equivalents (0.42 less MME). Small reductions were also noted in the prescribing of non-opioid pain relievers and in treatments such as physical therapy.

Importantly, the decreases were not substantially different than the data from states where medical marijuana remained illegal.

“Medical cannabis laws do not appear to be associated with changes in the prescription opioid or other non-cannabis, non-opioid treatments for chronic non-cancer pain,” McGinty said. “Policy makers trying to curb excess opioid prescribing and overdoses should focus on other strategies.”

Researchers say the minimal impact of medical cannabis on opioid prescribing may be due to the slow implementation of medical marijuana laws. Surveys show that most doctors are reluctant to discuss cannabis with their patients, and have doubts about its safety and effectiveness.

Doctors may not approve, but nearly a third of U.S. adults with chronic pain have used cannabis as a pain reliever and over half of them have reduced their use of pain medication. Many had no choice but to look for alternatives. Nationwide, opioid prescribing for commercially insured adults has fallen by 51% since 2011.

Hydrogel Shows Promise as Treatment for Arthritic Joints

By Pat Anson, PNN Editor

An experimental hydrogel that helps regenerate bone and cartilage tissue is showing promise as a treatment for arthritic joints, according to new research by Chinese and Canadian scientists. The gel is biodegradable and mimics the articular cartilage found in knee and hip joints.

In tests on laboratory animals, researchers say the gel showed signs of repairing articular cartilage 12 weeks after being implanted in rabbits, with no gel remaining and no rejection by the animals’ immune systems, according to findings published in the journal Nature.

Further animal testing is needed, but if the hydrogel proves useful in human trials, it could be used someday as an alternative to knee and hip replacement surgery. About one in four adults in the United States have some form of arthritis, which causes thinning of cartilage and progressive joint damage. Many resort to risky joint repair and replacement procedures.

“Cartilage is tricky,” says senior author Dr. Hongbin Li, a professor in the University of British Columbia’s department of chemistry. “Articular cartilage repair represents an important medical challenge because naturally speaking, it doesn’t repair itself.”

A delicate balance is needed to make biodegradable cartilage implants tough and stiff enough to support muscle-bearing tissues. They can’t be too stiff, or they’ll break when bent too far. Conversely, if they are too soft, they may not be useful in a joint.

In animal studies, researchers say a stiffer version of the gel had better results than a softer version, because it formed a scaffold that was more compatible with bone and cartilage tissue. That provided a physical cue to the body for tissue regeneration.

Dr. Linglan Fu holding the hydrogel

“This just shows how complex this area of research is, and the need to take into account the many different physical and biochemical cues and factors when designing these scaffolds,” says co-author Dr. Qing Jiang, a professor and surgeon at Nanjing University.

The research team used a new approach to stiffen biomaterials in the gel without sacrificing toughness, by physically entangling the chains of a protein.

“These entangled chains can move, which allows energy, for instance, the impact from jumping, to be dissipated, just like shock absorbers in bikes. In addition, we combined this with an existing method of folding and unfolding proteins, which also allows for energy dissipation,” says first author Dr. Linglan Fu, who conducted the research as a doctoral student at UBC’s department of chemistry.

The resulting gel is tough, able to resist slicing with a scalpel, and is more stiff than other protein-based hydrogels. Its ability to resist compression was among the highest achieved by any such gel, according to researchers, who say it compared favorably with actual articular cartilage. The gel was also able to rapidly recover its original shape after compression, as real cartilage does.

Researchers at Duke University are also working on an experimental hydrogel to replace damaged knee cartilage. The gel is made with thin sheets of cellulose fibers infused with a water absorbing polymer, creating a Jello-like material that is surprisingly strong. The cellulose fibers act like the collagen in natural cartilage, giving the gel strength when pulled or stretched.  

Restoring Safe Supply of Rx Opioids Would Reduce Overdoses

By Pat Anson, PNN Editor

A decade long effort to reduce the supply of opioid pain medication in the U.S. has contributed to a surge in overdose deaths and made the illicit drug supply more toxic, according to a new study.

“A big reason that we have such a problem with addiction in this country is because people can't access legitimate pain medication,” said lead author Grant Victor, PhD, an assistant professor at Rutgers University School of Social Work. “Our findings support a change in policy.”

Victor and his colleagues analyzed toxicology data from nearly 2,700 accidental overdose deaths in the Indianapolis metropolitan area (Marion County, Indiana) from 2016 to 2021, comparing them to patient records in the state’s prescription drug monitoring program (PDMP).

Their findings, published in the Journal of Substance Use and Addiction Treatment, show that less than half the people who overdosed (43.3%) had any kind of PDMP record, meaning they were never prescribed an opioid pain reliever or buprenorphine (Suboxone), a medication used to treat opioid use disorder.

Most of the decedents who did have a prescription for an opioid analgesic or buprenorphine had not filled one in the 30 days prior to their deaths, indicating that prescription opioids are not driving overdose deaths in Marion County. Overdoses there increasingly involve illicit fentanyl, a synthetic opioid 100 times more potent than morphine, which accounts for nearly 90% of the county’s overdoses.  

There were 637 drug deaths in Marion County in 2021, nearly twice the number that died in 2016. During that period, opioid prescriptions in the county fell by nearly a third.

MARION COUNTY PUBLIC HEALTH DEPT.

Toxic Drug Market

Victor says many of the overdose deaths could have been prevented if a safer supply of prescription opioids was still accessible – both to legitimate patients and those who misuse the drugs.

“There was a wave of policy initiatives that effectively tamped down on the diversion of prescription opioids, but did so primarily by increasing surveillance of prescribing practices for opioids. And through a number of mechanisms, that made it more difficult for individuals with legitimate pain concerns to access these types of medications,” Victor told PNN.

“When you remove a certain class of drugs that is federally regulated and can be monitored and dosed appropriately, it leaves folks with few options. Options that are currently available are illicit and the potency of these drugs is highly variable. The drug market in general, as we know it today, is very toxic and that is one of the main drivers in the overdose crisis.”

Victor says some of his own family members have chronic pain and after years of taking opioids safely, they’ve been cutoff and told to take Tylenol. He said it’s rare for a pain patient to die from an overdose and few meet the diagnostic criteria for substance use disorder.   

“There are a number of researchers who are trying to drive this point home and hope to reverse some of the policy initiatives that have unfolded over the last few years that have been perhaps unintentionally harmful to public health and to chronic pain patients,” he said.

“We've been swept up in this kind of frenzy about prescription opioids. They're still making movies about the Sackler’s (owners of Purdue Pharma). My opinion of them is not all that high, but I think it is a convenient kind of scapegoat to portray pharmaceutical companies as the evil here, when they’re not a primary concern. When you're looking at public health and what's currently driving overdose deaths, it’s not prescription opioids.”

Few previous studies have compared overdose deaths directly to prescription drug data, which would seem to be an obvious way to get to the bottom of what’s causing the overdose crisis.  One such study looked at opioid overdoses in Massachusetts, finding that only 1.3% of those who died had an active prescription for opioids.

Low Dose Opioids Ineffective for Acute Lower Back and Neck Pain

By Pat Anson, PNN Editor

A low dose of prescription opioids works no better than a placebo in relieving acute lower back or neck pain, according to a new study in Australia.  

The blinded, placebo-controlled trial was relatively small – just 345 participants – but was unusual because patients were followed for up to a year, a rarity for a clinical trial that studies pain.  Half the participants received a combination of oxycodone and naloxone for six weeks at a low daily dose of 20mg or about 30 morphine milligram equivalents (MME). The other half received placebo tablets that looked similar to oxycodone.   

It's important to note that the study only included people with mild or moderate pain of less than 12 weeks duration -- not the severe, long-term back and neck pain caused by degenerative disc disease, spinal injuries, arthritis, and other chronic conditions. Participants were excluded if they had that type of pain.  

The study findings, published in The Lancet, showed no significant difference in pain severity between the opioid and placebo groups. On a scale of zero to 10, the average pain score was 2.8 in the opioid group after six weeks, compared to 2.3 in the placebo group. After a year, the average pain score was 2.4 in the opioid group, versus 1.8 in the placebo group. 

Pain Severity Over 52 Weeks

THE LANCET

Researchers say patients who received opioids had a slightly higher risk of opioid misuse at the end of the study, a finding based on a mental health survey that screens patients for drug related behavior.

“Our findings show that even judicious, short-term use of an opioid conferred no benefits in pain reduction and led to a small increase in pain at the medium-term and long-term compared with placebo. The opioid group had worse quality-of-life mental health scores than the placebo group,” researchers reported. “Although no difference was found in overall time to recovery, more people in the placebo group recovered in the first 14 days compared with those in the opioid group.”

Most medical guidelines recommend exercise and over-the-counter pain relievers for short-term back or neck pain, with opioids only used as a last resort. The authors of the Lancet study say even that limited use is inappropriate.

“Opioids should not be recommended for acute back and neck pain, full stop,” said lead investigator Christine Lin, PhD, a professor in the School of Public Health at University of Sydney. “Not even when other drug treatments are not able to be prescribed or have not been effective for a patient.”

The Lin study is somewhat similar to the 2018 Krebs study, which found that low doses of oxycodone were no more effective than over-the-counter pain relievers in treating chronic back and osteoarthritis pain. Critics say the Krebs study was biased from the start and this one is no better.

“They generalise enormously,” Michael Vagg, MD, Dean of Pain Medicine at the Australian and New Zealand College of Anaesthetists, told the Medical Republic. “They studied oxycodone and naloxone in a modified-release formulation. But modified-use opioids have never been on-label for use in acute pain and they are not recommended as such… to which I and everyone in pain medicine would say ‘We figured that out ages ago’. That’s not how you use opioids in acute pain.

“In layman’s terms, they’ve done a study where they tried to look at doing push-ups to help with back pain and then they’ve decided that all exercise is no good for the back pain.”

Lower back pain is the world’s leading cause of disability and neck pain is the fourth largest, but there is surprisingly little evidence about the best ways to treat them.

A previous study published in The Lancet by an international team of researchers found that lower back pain was often treated with bad advice, inappropriate tests, risky surgeries and painkillers. The authors said there was limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) were not recommended at all. Most patients responded better to physical and psychological therapies that kept them active.

Australian Guideline Calls for Safer Opioid Tapering

By Pat Anson, PNN Editor

Public health experts in Australia have released what is being called the first international guideline to help primary care doctors safely reduce or stop prescribing opioids to adults with chronic non-cancer pain.

The Guideline for Deprescribing Opioid Analgesics contains 11 recommendations developed by a panel of general practitioners, pain specialists, addiction specialists, pharmacists, nurses and physiotherapists. The guideline emphasizes slow and individualized tapering for patients when long-term opioid use does not improve their pain and quality of life or when they experience adverse side effects. Tapering is not recommended for anyone nearing the end-of-life.

“Internationally, we were seeing significant harms from opioids, but also significant harms from unsolicited and abrupt opioid cessation. It was clear that recommendations to support safe and person-centred opioid deprescribing were required,” said lead author Aili Langford, PhD, a pharmacist and Research Fellow at Centre for Medicine Use and Safety, Monash University.

Millions of pain patients in the U.S. were tapered or cut off cold turkey after the CDC released its 2016 opioid prescribing guideline. Both the American Medical Association and the FDA warned that rapid tapering was causing “serious harm” to patients, including withdrawal, uncontrolled pain, substance abuse and suicide.

In response to that criticism, the revised 2022 CDC guideline took a more cautious approach to tapering, recommending a dose reduction of just 10% a month, a much slower rate than the 10% a week that the agency previously recommended.

The U.S. Department of Veterans Affairs and Department of Defense (VA/DoD) also modified their approach to tapering, which at one time called for tapers of up to 20% every four weeks.  The updated VA/DoD guideline says there is “insufficient evidence to recommend for or against any specific tapering strategies.”

The Australian guideline doesn’t get caught up in fractions or percentages. It simply calls for “gradual tapering” that is tailored to each patient’s needs and preferences. A key recommendation is to discuss tapering as early as possible with patients, to develop a plan when they are first prescribed opioids.  

“Shared decision-making and ensuring that patients have ways to manage their pain are essential when a deprescribing plan is being discussed,” said Liz Marles, MD, a general practitioner and clinical director at the Australian Commission on Safety and Quality in Health Care.  

“These new guidelines further support appropriate use of opioid analgesics and how to safely prescribe and stop prescribing them. They ask clinicians to consider reducing or stopping opioids when the risk of harm outweighs the benefits for the individual.”

One in five adults in Australia have chronic pain, but few actually wind up taking opioids long-term. The guideline authors estimate that only 5% of opioid “naive” patients become long-term users, well below misleading claims by anti-opioid activists that over 25% of pain patients develop opioid dependence or opioid use disorder.

“I am curious to know how many people who are on chronic opioid therapy feel a need to be tapered,” said Lynn Webster, MD, a pain management expert and Senior Fellow at the Center for U.S. Policy.  “Only 5% of opioid-naïve patients remain on opioids for 3 months or longer. Considering the fact that about 10% of the population has severe enough pain to affect quality of life, this statistic argues against the theory that just being exposed to an opioid leads to chronic opioid use.”

Webster says most of the recommendations in the Australian guideline are practical, but he’s concerned that some of the evidence used to support them is “misunderstood and misleading.”

“They make it abundantly clear that tapering should not be forced and that there are serious consequences to forced tapering. But they also use the common yet flawed statement that there is little evidence that opioids are effective for chronic non-cancer pain. Of course, the lack of evidence is not evidence,” Webster said.

Although opioids have been used for thousands of years for pain relief, the clinical evidence for or against their use remains thin. Most of the evidence used to support the Australian guideline was deemed by the authors to be insufficient, unclear or weak. Only one of the 11 tapering recommendations was supported by evidence of “moderate certainty.”

Burden of Pain: How the CDC and DEA Criminalized Medicine

(Jay K. Joshi, MD, is a primary care physician in Indiana who spent nearly a year in prison after pleading guilty to prescribing opioids without a “legitimate medical need” to an undercover DEA agent who was posing as a pain patient. Joshi now regrets that guilty plea and is trying to vacate his conviction due to alleged DEA misconduct.

While in prison, Joshi began writing “Burden of Pain: A Physician’s Journey through the Opioid Epidemic.” His book is a cautionary tale about misguided public health policy and overzealous law enforcement, which often portray doctors as drug dealers and patients as addicts.

PNN editor Pat Anson recently spoke with Joshi, who is practicing medicine again and hopes to regain his license to prescribe opioids. This interview has been edited for content and clarity.)

JAY K. JOSHI, MD

Anson: Dr. Joshi, who is your book intended for and what is the main message you're trying to send?

Joshi: The book really is for the general public and those that have a vested interest in helping to rectify misguided federal policy, as it pertains to not just the opioid epidemic, but the overdose crisis as a whole.

My main message is that we have to understand that healthcare has a lot of uncertainty and complexity. And if we just use simplified rubrics, like cookie cutter medical guidelines or restrictive laws, we're going to create unintended consequences. It's time that we start to re-examine clinical decisions and health policy as a whole, so that we can make better informed decisions.

Anson: Do you think the general public has a good understanding of the opioid crisis and what caused it? Or is there misinformation going around that they've bought into?

Joshi: I would say there's a strong degree of misrepresentation among policymakers, who should have known better before and certainly should know better now. I think the narrative of opioid prescriptions running amok and creating this overdose crisis is a story that’s taken on a life of its own.

Did prescription opioids contribute to the overdose crisis that we see now? Yes. Was it the main driving factor? No. But there were trends in drug use and drug policy through the 2000’s and 2010’s that falsely conflated prescription opioids with illicit opioids. Policymakers should now understand that there are fundamental differences in how opioids are abused versus how they're used in a proper clinical setting.

Anson: Given what's transpired over the last few years, with overdoses soaring from illicit fentanyl and opioid prescriptions declining, do you think policymakers now know better?

Joshi: You know, in life as a general rule of thumb, often you learn more about what a person doesn't say, than what they do say. And this kind of hollow resonance in connecting fentanyl overdoses to previous manifestations of the overdose crisis to me is a glaring omission of responsibility from federal policymakers at the CDC level and law enforcement at the DEA and state level.

They’ve failed to acknowledge that the current fentanyl crisis is a manifestation of restrictive and overly simplified opioid policies that began nearly a decade ago. And I think the fact that people are not correlating that when the data clearly shows it indicates there is a willful understanding and a willful intent to not accept responsibility for prior failures and opioid policies.

Anson: Do you think the CDC and the DEA made the fentanyl crisis worse?

Joshi: It's difficult to say because when you use the word “worse,” then you almost have to apply some sort of causality. I like to look at the overdose crisis a little differently.

Did the CDC with their opioid policy guidelines contribute to the trends and overdoses that we're seeing now? Yes. By not recognizing that the guidelines would be codified into law and policy, and deliberately affect clinical decision making. They're not taking accountability for all the damaging effects. So, by that logic, you can say the CDC made the opioid epidemic worse.

But I would instead reframe it to say the CDC needs to better educate itself. What you see from them is a conflation of words, reflecting a lack of proper understanding. That's how I would define the revised 2022 CDC opioid prescribing guideline.

They talk a lot about nuances. They talk a lot about “uncertainty,” although not using that word as much as I believe that they should. But then eventually they revert to the same policy trend of creating overly simplified stipulations using morphine milligram equivalents (MME) as this rubric of clinical care, even though it was never intended to be used as a clinical decision-making tool.

The CDC needs to be better aware of its own conflicts of interest in the leadership making policy decisions. We can go down line by line looking at these individuals and assessing their conflicts of interest. And I certainly have seen things that would be quite alarming for anybody who values scientific objectivity.

But I feel like when you go down that pathway, you're simply entrenching people in their own lease, meaning the CDC will simply double down and say,”No, what we're doing is right” and the DEA will simply double down and say,” No, what we're doing is right.”

Anson: Do you think the CDC should even have an opioid guideline?

Joshi: It is odd that a public health organization would get involved with something that has, for all intents and purposes, a direct patient to physician relevancy. It's hard for me to understand how the CDC initially thought that when the guidelines made it a public health issue. It was almost as if it became a self-fulfilling prophecy.

The CDC felt like prescription opioids were a public health issue, and therefore created guidelines that affected the patient-physician relationship, thereby creating undue stigmatization in a clinical encounter that should otherwise be based upon a foundation of trust and respect.

And by doing so, they almost exacerbated the overdose crisis into a public health issue. It's very difficult to understand why they felt like those guidelines would help, as opposed to focusing on keeping prescription opioids within the framework of the patient-physician encounter, as it already had been.

I guess they were looking at rising overdose rates and conflated illicit opioids, heroin and fentanyl with prescription opioids. I'm not sure where that direct line of logic really came from. It's difficult to really justify that.

Anson: And what about the DEA? As you very well know, a lot of doctors have stopped prescribing opioids or have really scaled back the doses that they give to patients, because they don't want to go to prison like you did.

Joshi: Definitely, and I can understand that. What's interesting is that I've had direct engagements with DEA officers, and from my perspective they lack the necessary understanding of prescription opioids and the benefit it provides patients. They lack the healthcare context.

What the DEA does is correlate the clinical encounter with what you would see in a routine drug transaction. In their eyes, having a hammer as the only tool, everything looks like a nail. So the drug dealer in Mexico running Chinese products through a drug cartel entering the United States is cognitively equivalent to a physician treating patients with chronic pain.

They don't have the ability to discern context and the role clinical need plays in how patients are treated. And I think that really does an injustice to both the patients and the physicians, because effectively the only tool the DEA has to address prescription opioid use is fear. And when you use fear in the clinical context, you’ve harmed the most vulnerable patients. It's a shame that the DEA is not acknowledging this.

I wrote an op/ed in Medpage Today about a month ago, in which I asked the DEA to take a stance on harm reduction. Many medical societies talk about how harm reduction is a better overall policy to help patients. But medical societies are not implementing the laws, the DEA is implementing the laws.

So regardless of how high-minded the policies may be, unless implementation of the policies aligns with intent, you're not going to have patients being treated the way that they should be. And I think what the DEA really needs to do is to assess its role in the clinical encounter and make honest determinations on whether they have the capabilities to understand clinical need for opioids as it pertains to patients with chronic pain or acute pain. I think the DEA is lacking in that capacity.

Anson: Is the DEA practicing medicine? They say they don't.

Joshi: I know. And I disagree. I would say that the DEA is very much involved in the practice of medicine. If you are influencing clinical decisions through fear, you are engaging in the practice of medicine.

What is clinical medicine? If you present to me with headache and vision changes, and I checked your vitals and see that you have extremely high blood pressure, I'm going to consider you as somebody in hypertensive crisis. I'm making that decision based upon the facts presented to me and then, based upon that decision, I will implement a certain form of treatment. Clinical medicine is a series of decisions made in the face of uncertainty.

Should I trust my blood pressure monitor that the readings are correct? Should I trust you when you say that you have a headache and vision changes? How much of that uncertainty is simply assumed to be true when any clinical decision is made?

Now, the moment you incorporate fear into that clinical decision making, you're influencing how the decisions are made and the eventual course of clinical action.  So very much the DEA is practicing medicine, and I would greatly appreciate if they were honest about that.

Anson: You've obviously given this a lot of thought and, at the same time, you don't sound that bitter about what happened to you. Why is that?

Joshi: You know, when I was in federal prison, I was extremely depressed. I lost my medical practice. I lost my freedom. But I always felt like, in the end, things would turn out right and the truth would come out. Whether that was a delusional belief sitting in a federal prison, I don't know. But I held onto that belief.

It's through that belief that I improved my writing abilities and hand wrote the first version of “Burden of Pain.” It’s through that belief that I regained my medical license and was reinstated as a Medicare provider.

I don't feel bitter because I feel that I have a responsibility to patients and to physicians who might be going through similar situations. And if I can behave in a certain way that is productive, that can turn what I went through into an overall good for patients and for society as a whole, then I’ll feel like what I went through was worth it.

“Burden of Pain” and other books are featured in PNN’s Suggested Reading section.

DEA Ending Lenient Telehealth Rules in November

By Arielle Zionts, KFF Health News

Federal regulators want most patients to see a health care provider in person before receiving prescriptions for potentially addictive medicines through telehealth — something that hasn’t been required in more than three years.

During the COVID-19 public health emergency, the Drug Enforcement Administration allowed doctors and other health care providers to prescribe controlled medicine during telehealth appointments without examining the patient in person. Controlled medications include many stimulants, sedatives, opioid painkillers, and anabolic steroids.

The emergency declaration ended May 13, and in February, the agency proposed new rules that would require providers to see patients at least once in person before prescribing many of those drugs during telehealth visits.

Regulators said they decided to extend the current regulations — which don’t require an in-person appointment — until Nov. 11 after receiving more than 38,000 comments on the proposed changes, a record amount of feedback. They also said patients who receive controlled medications from prescribers they’ve never met in person will have until Nov. 11, 2024, to come into compliance with the agency’s future rules.

The public comments discuss the potential effects on a variety of patients, including people being treated for mental health disorders, opioid addiction, or attention-deficit/hyperactivity disorder. Thousands of commenters also mentioned possible impacts on rural patients.

Opponents wrote that health care providers, not a law enforcement agency, should decide which patients need in-person appointments. They said the rules would make it difficult for some patients to receive care.

Other commenters called for exemptions for specific medications and conditions.

Supporters wrote that the proposal would balance the goals of increasing access to health care and helping prevent medication misuse.

Special Referrals for Rural Patients

Zola Coogan, 85, lives in Washington, Maine, a town of about 1,600 residents northeast of Portland. Coogan has volunteered with hospice patients and said it’s important for very sick and terminally ill people in rural areas to have access to opioids to ease their pain. But she said it can be hard to see a doctor in person if they lack transportation or are too debilitated to travel.

Coogan said she supports the DEA’s proposed rules because of a provision that could help patients who can’t travel to meet their telehealth prescriber. Instead, they could visit a local health care provider, who then could write a special referral to the telehealth prescriber. But she said accessing controlled medications would still be difficult for some rural residents.

“It could end up being a very sticky wicket” for some patients to access care, she said. “It’s not going to be easy, but it sounds like it’s doable.”

Some health care providers may hesitate to offer those referrals, said Stefan Kertesz, a physician and professor at the University of Alabama at Birmingham whose expertise includes addiction treatment. Kertesz said the proposed referral process is confusing and would require burdensome record-keeping.

Ateev Mehrotra, a physician and Harvard professor who has studied telehealth in rural areas, said different controlled drugs come with different risks. But overall, he finds the proposed rules too restrictive. He’s worried people who started receiving telehealth prescriptions during the pandemic would be cut off from medicine that helps them.

Mehrotra said he hasn’t seen clear evidence that every patient needs an in-person appointment before receiving controlled medicine through telehealth. He said it’s also not clear whether providers are less likely to write inappropriate prescriptions after in-person appointments than after telehealth ones.

Mehrotra described the proposed rules as “a situation where there’s not a clear benefit, but there are substantial harms for at least some patients,” including many in rural areas.

Beverly Jordan, a family practice doctor in Alabama and a member of the state medical board, supports the proposed rule, as well as a new Alabama law that requires annual in-person appointments for patients who receive controlled medications. Jordan prescribes such medications, including to rural patients who travel to her clinic in the small city of Enterprise.

“I think that once-a-year hurdle is probably not too big for anybody to be able to overcome, and is really a good part of patient safety,” Jordan said.

Jordan said it’s important for health care practitioners to physically examine patients to see if the exam matches how the patients describe their symptoms and whether they need any other kind of treatment.

Jordan said that, at the beginning of the pandemic, she couldn’t even view most telehealth patients on her computer. Three-fourths of her appointments were over the phone, because many rural patients have poor internet service that doesn’t support online video.

The proposed federal rules also have a special allowance for buprenorphine, which is used to treat opioid use disorder, and for most categories of non-narcotic controlled substances, such as testosterone, ketamine, and Xanax.

Providers could prescribe 30 days’ worth of these medications after telehealth appointments before requiring patients to have an in-person appointment to extend the prescription. Tribal health care practitioners would be exempt from the proposed regulations, as would Department of Veterans Affairs providers in emergency situations.

Many people who work in health care were surprised by the proposed rules, Kertesz said. He said they expected the DEA to let prescribers apply for special permission to provide controlled medicine without in-person appointments. Congress ordered the agency to create such a program in 2008, but it has not done so.

Agency officials said they considered creating a version of that program for rural patients but decided against it.

Denise Holiman disagrees with the proposed regulations. Holiman, who lives on a farm outside Centralia, Missouri, used to experience postmenopausal symptoms, including forgetfulness and insomnia. The 50-year-old now feels back to normal after being prescribed estrogen and testosterone by a Florida-based telehealth provider. Holiman said she doesn’t think she should have to go see her telehealth provider in person to maintain her prescriptions.

“I would have to get on a plane to go to Florida. I’m not going to do that,” she said. “If the government forces me to do that, that’s wrong.”

Holiman said her primary care doctor doesn’t prescribe injectable hormones and that she shouldn’t have to find another in-person prescriber to make a referral to her Florida provider.

Holiman is one of thousands of patients who shared their opinions with the DEA. The agency also received comments from advocacy, health care, and professional groups, such as the American Medical Association.

The physicians’ organization said the in-person rule should be eliminated for most categories of controlled medication. Even telehealth prescriptions for drugs with a higher risk of misuse, such as Adderall and oxycodone, should be exempt when medically necessary, the group said.

State Laws Burden Patients

Some states already have laws that are stricter than the DEA’s proposed rules. Amelia Burgess said Alabama’s annual exam requirement, which went into effect last summer, burdened some patients. The Minnesota doctor works at Bicycle Health, a telehealth company that prescribes buprenorphine.

Burgess said hundreds of the company’s patients in Alabama couldn’t switch to in-state prescribers because many weren’t taking new patients, were too far away, or were more expensive than the telehealth service. So Burgess and her co-workers flew to Alabama and set up a clinic at a hotel in Birmingham. About 250 patients showed up, with some rural patients driving from five hours away.

Critics of the federal proposal are lobbying for exemptions for medications that can be difficult to obtain due to a lack of specialists in rural areas.

Many of the public comments focus on the importance of telehealth-based buprenorphine treatment in rural areas, including in jails and prisons.

Rural areas also have shortages of mental health providers who can prescribe controlled substances for anxiety, depression, and ADHD. Patients across the country who use opioids for chronic pain have trouble finding prescribers.

It also can be difficult to find rural providers who prescribe testosterone, a controlled drug often taken by transgender men or people with various medical conditions, such as menopause. Controlled medications are also used to treat seizures, sleep disorders, and other conditions.

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

Why You Shouldn’t Be Afraid to Ask for Help

By Barby Ingle, PNN Columnist

We all have lives to lead and sometimes we must focus on ourselves before we can help others. There's nothing wrong with that.

But what if your health (or lack thereof) prevents you from accomplishing something good for yourself and others? What can we do to become more independent and productive while living with a chronic pain condition or disease? 

Here are three things to consider:

1. Social isolation is not healthy

2. Independence can be healthy

3. It's okay to ask for help  

One of the people in my life is the most independent person I know. “Em” only asks for help when she needs it, but often fails to recognize when the need arises. If Em asked for help more often, things might have gone differently in her life and been much easier.

I've been thinking about this recently. I've been balancing my need for independence as a person in pain with my desire to be more open with people. We all want to feel more independent from our caregivers, family and friends. But we also want to stay connected. Seeing some of the challenges in Em’s life reminds me to ask for help more often.

In my books and columns, I have freely shared my life experiences, tips, tools and resources to help others. That helps me feel open and transparent, but it's usually about things I have been through and already found solutions for. When faced with a new challenge, I recognize that I isolate more than I should.

Like my friend Em, I need to find more ways to connect and ask for help when needed. We all need support from others, even if it's just someone listening or offering advice on handling a situation.

When I’ve asked for help, it didn't always go how I envisioned. I may have asked the wrong person for support or had expectations I put on that person that they could not live up to. I had to learn to be okay with the service they offered, rather than be upset and sad when they could not provide what I expected.

The more I learned about their strengths and what they could do, the better I felt asking for their assistance. Asking for help shows that I trust them enough to let them into my world. When you ask for help, you are not weak. You are human.

Asking is not always easy. You have to stop pretending that you can handle everything yourself and that everything is fine. You need to accept the support of your friends and family without feeling like you’re burdening them or making them feel bad about themselves. Asking shows them how much they mean to you.

Here is an excellent example of a recent conversation I had with Em about a friend who wanted to be more social and live life more fully. Em recognized her own limitations. 

"She asked me to meet with her more regularly. Saying she needs people in her life at this difficult time. I am unable to 'be there' for people. I am okay with hanging out occasionally, but I barely have the energy to do basic things each day," Em told me.

My response to Em was this:

"I get it. Explain that you are a chronically ill patient and enjoy connecting when you are up to it, but physically hanging out or texting, talking and engaging cognitively takes a toll on your energy and health. You understand her desire to remain social and the life challenges it takes to follow through. You do best by text, when you have the flexibility and health to answer. You understand her need to be flexible too. She will be in your prayers. Tell her not to be upset if you have to turn down an invite. It doesn't mean you don't want to connect, just that you will participate when you can." 

We must learn how to manage our emotions better so that they don't rule our lives. That means taking a step back so that we don't make decisions while in the middle of a panic attack or depressive episode. And sometimes we just need to hear the answer and decide what to do with it.

Asking for help is complex and we won’t always get what we want. At the same time, we have to step out of our discomfort to make social connections, take down our protective walls, and connect with humanity. Being your best advocate, having others in your life, and maintaining boundaries will help you live life to the fullest. 

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and best-selling author on pain topics. Barby has received over 25 awards for her advocacy efforts. You can follow her at www.barbyingle.com.