Patients Blame DEA for Drug Shortages, Not Monopolies or Middlemen

By Pat Anson, PNN Editor

Two federal agencies are getting more than they bargained for when they asked the public to comment on record shortages of prescription drugs.

In February, the Federal Trade Commission (FTC) and the Department of Health and Human Services (HHS) made a joint Request for Information in the Federal Register, asking how wholesalers and other “middlemen” in the drug supply chain were contributing to persistent shortages.

“When you’re prescribed an important medication by your doctor, and you learn the drug is out of stock, your heart sinks,” HHS Secretary Xavier Becerra said in a press release. “This devastating reality is the case for too many Americans who need generic drugs for ADHD, cancer, and other conditions. (This) announcement is part of the Biden-Harris Administration’s work to tackle healthcare monopolies and lessen the impact on vulnerable patients who bear the brunt of this lack of competition.”

Nearly 10,000 comments have been received so far, with many blaming the federal government for the drug shortages -- not monopolies, middlemen or lack of competition. Drawing the most criticism is the Drug Enforcement Administration (DEA), which sets annual production quotas for opioids, stimulants and other controlled substances. The CDC and FDA also came under fire from frustrated patients.

“The heavy-handed failure of the FDA/DEA to properly and ethically manage the uptick in ADHD prescriptions is creating a crisis on par with their equally underhanded failure in managing the opioid crisis,” wrote Matti Dupre. “Hardworking Americans are left looking at the individuals leading these organizations as a source of pain rather than as a means of support.”

“Millions of people are having a hard time getting their prescription opioid medications filled at pharmacies now. Why? Because the DEA have cut production down so low, pharmacies can't get what they need to fill our prescriptions,” said Candi P. “Wake up! Stop playing with our lives!”

“The government has gone way too far, with their guidelines and regulations regarding opioids,” wrote Julie Anuskewic, who has a painful immune system disorder. “My pain is not controlled because the CDC has scared all doctors into not prescribing. It’s bad enough that they have destroyed the doctor-patient relationship. Now they are destroying the patient-pharmacist relationship.” 

Notably lacking in the FTC and HHS statement about drug shortages is any mention of the National Opioid Settlement, which has forced major drug wholesalers and big chain pharmacies to ration opioids and other controlled substances or risk losing their DEA licenses. Some manufacturers are also cutting back on production of generic opioids because the profit margins are low and the risk of further litigation is high.

A recent PNN survey found that 90% of patients with opioid prescriptions had trouble getting them filled, with one in five unable to get their pain medication even after contacting multiple pharmacies.  

“The FTC is looking in the wrong places for reasons for drug shortages, at least as far as opioids and stimulants are concerned,” wrote Andrea MacNary. “In those cases, the shortages are a direct result of the DEA's policies – with input from the FDA – that have seen annual reductions in the amount of drugs that manufacturers are allowed to produce.

”This results in patients being unable to obtain their legally prescribed medications in a timely manner. Because pharmacies have shortages, patients are then forced to call around to different pharmacies looking for their meds. This is extremely difficult, because not only do pharmacies not want to disclose whether they have the drugs in stock, but if the patient does find them, they must obtain a new prescription from their doctor.”

‘Broken Quota System’

One critic sees the public outreach by the FTC and HHS as a ham-handed attempt to coverup the DEA’s “crude and inadequate system” for regulating controlled substances   

“I believe the FTC is only trying to find cover for the Drug Enforcement Administration.The DEA is the only governmental agency that sets production and distribution quotas for every drug company manufacturing controlled medication,” William Dodson, MD, wrote in a recent op/ed in ADDitude. “This problem traces its roots and long tendrils back to the DEA alone. No other agency has the authority to create and prolong it. 

“The time has long since passed for the DEA to admit its fault and fix its broken quota system. There has already been too much needless suffering by innocent people who did nothing to cause the DEA’s restrictions.”

That’s not how the DEA sees it. This month a top DEA official compared the growing demand for Adderall and other ADHD stimulants to the early stages of the opioid crisis. Matthew Strait claimed the problem isn’t tight supplies, but excessive prescribing of stimulants.

“I’m not trying to be a doomsday-er here,” said Strait, deputy assistant administrator in the DEA’s diversion control division. “It makes me feel like we’re at the precipice of our next drug crisis in the United States.”

If you’d like to make a comment in the Federal Register on the FTC and HHS Request for Information, click here. Comments will be accepted until May 30. 

How ‘Injectrode’ Could Change Treatment of Chronic Pain

By Pat Anson, PNN Editor

An experimental “injectrode” is showing potential as a new neuromodulation treatment for chronic pain, after the first human clinical trial demonstrated the device’s safety and effectiveness in stimulating nerves in the lower back.

The injectrode is a thin and flexible lead wire that is injected by a needle through the skin and placed near an injured nerve. The wire can then be charged by an externally worn stimulator that sends mild electrical impulses to the nerve to block pain signals.

The injectrode is being developed by Cleveland-based Neuronoff, Inc. as a treatment for many types of chronic pain, such as peripheral nerve pain, phantom limb pain and lower back pain. It all depends on the nerve being targeted.

“You can treat knee pain, shoulder pain, lower back pain by stimulating nerve fibers that are providing proprioceptive input sensory input into the spine and thereby help with a reduction of pain perception,” said Manfred Franke, CEO of Neuronoff, who compares the injectrode wire to a Slinky, a toy once popular with Baby Boomers.

“It’s like a spring, like a Slinky, that’s stuck inside a needle,“ he told PNN. “And when that Slinky comes out of the needle, it folds over and it can conform to the anatomy. If you want to take out the injectrode, all you have to do is pull at any point along its length and then the entire injectrode will come out. Nothing is at risk of being left behind.”

This video produced by Neuronoff demonstrates how the device is injected:

Because the injectrode is easy to install in an out-patient procedure, it could potentially be a low-cost competitor to more invasive neuromodulation devices, such as spinal cord stimulators, and reduce the need for pain medication, steroid injections and procedures such as nerve ablation.

“The injectrode represents a paradigm shift in the field of neuromodulation. Its unique flexible design allows for optimal customization to the patient's anatomy and has the potential to be both a temporary and permanent solution without an internal pulse generator,” said Hesham Elsharkawy, MD, an anesthesiologist and clinical advisor to Neuronoff. “The entire procedure takes just 5-10 minutes, making it highly efficient and accessible for patients seeking relief from chronic pain."

In the investigational pilot study, 10 healthy volunteers had injectrodes placed in their lower back and tested. After 30 days, there were no serious adverse events and the injectrodes were removed without analgesics or sutures.

Because the injectrodes work similarly to transcutaneous electrical nerve stimulators (TENS) already on the market, Franke is hopeful the devices will be cleared by the FDA for marketing without more clinical trials, perhaps as soon as early 2025. The key will being getting insurers to cover the injectrodes, which will cost a few thousand dollars, far less than spinal cord stimulators.

“Which is an advantage to the insurance company. And any advantage that you can provide to the insurance company is a benefit for the patient because you're more likely to be receiving prior approval,” Franke said. “The goal is to be cost efficient enough to the insurance companies, so you can replace repeat drug injections or nerve ablations.”   

In addition to pain, Franke says the electrodes have the potential to treat other medical conditions, such as overactive bladders and hypertension. In tests on animals, the devices significantly lowered blood pressure when they stimulated nerves in the neck.

Not Your Parents’ Pot: Cannabis Is More Potent Now

By Dr. Ty Schepis

Eventually, most adults reach a point where we realize we are out of touch with those much younger than us.

Perhaps it is a pop culture reference that sparks the realization. For me, this moment happened when I was in my late 20s and working with adolescents in school settings to help them quit smoking. When other drugs would occasionally come up, I didn’t understand some of the slang terms they used for these drugs. Many people may have that feeling now when the topic of cannabis comes up – especially in its different and newer forms.

As a professor of psychology, I focus my research on substance use in adolescents and young adults. A major change during my time in research is the legalization and explosion of cannabis availability across the U.S.

There are arguments for and against increasing legalization of cannabis for adult use in the U.S., but expanded access to legal cannabis also may have unintended consequences for adolescents. These consequences are compounded by the increasing potency of some cannabis products.

I use the word “cannabis” since it refers to the plant from which the drugs are derived. It also serves as a catch-all term for any substance with chemical compounds from cannabis plants and addresses concerns that the word marijuana has some long-standing racist overtones.

Cannabis now comes in a larger variety of forms than it used to. When most people over 40 think of cannabis, they imagine its dried form for smoking. This cannabis was not particularly strong: The average THC concentration of cannabis seized by the Drug Enforcement Agency in 1995 was 4%, while it was roughly 15% in 2021.

In addition to the smoked form, some might remember an edible form, often baked into a dessert like a brownie, or hashish, which is derived from more potent parts of the cannabis plant.

Today there are many different cannabis concentrates that have high levels of THC, typically ranging from 40% to 70%, and more than 80% in some cases, depending on the method of extraction. These include oils that can be vaporized by vape or dab pens, waxier substances and even powders.

Differences in Cannabis Products

THC and cannabidiol, or CBD, are the most common chemicals in cannabis. Each one interacts with the brain in different ways, producing different perceived effects.

CBD does not produce the same “high” that THC does, and cannabidiol may have benefits as a medication for severe epilepsy, as well as other potential but as yet unproven medical uses. The differences between THC and CBD come from how they interact with cannabinoid receptors – the proteins onto which these drugs attach – in the brain and body.

However, CBD can also make people sleepy, alter mood in unintended ways and cause stomach upset. Never use a CBD product without consulting a physician.

THC is the chemical most strongly associated with the high from cannabis. By increasing the amount of THC, concentrated products can increase blood levels of THC rapidly and more strongly than nonconcentrates such as traditional smoked cannabis.

Cannabis concentrates also come in many different forms that range from waxy or creamy to hard and brittle. They are made in a variety of ways that may require dry ice, water or flammable solvents such as butane.

The myriad names for cannabis concentrates can be confusing. Concentrate names include “budder,” which refers to a yellowish paste like frosting; “shatter” is made similarly to budder but comes in a thin, brittle and translucent form; there’s also “wax” or “crumble,” which confusingly is not waxy but is more like a powdery or grainy substance; and “keef” or “kief,” which is powdery in nature and derived from the most potent parts of the cannabis plant. It is similar to hashish.

The names change regularly and can vary by guide or from person to person. It is best to ask what a term means from an open and curious place than to act as if you know all the terminology.

Many concentrates are vaporized and inhaled. Vaporizing is different than smoking, as vaporizing heats the concentrate until it becomes a gas, which is inhaled. Smoking involves burning the compound to produce an inhaled gas.

Many who vaporize concentrates call it “dabbing.” This refers to the dab of concentrate to heat, vaporize and inhale. Another way to vaporize cannabis concentrates is to use a vape pen. Vape pens are sometimes also called dab pens, depending on the local terms.

Cannabis and Adolescents

One of the reasons why young people are drawn to these sorts of products is that vaping or dabbing the concentrated form makes it easier to hide cannabis use. Vaping cannabis does not create the typical smell associated with weed.

A 2021 systematic review found that past-year cannabis vaping nearly doubled from 2017 to 2020 in adolescents - jumping from 7.2% to 13.2%. A more recent study in five northeastern U.S. states found that 12.8% of adolescents vaped cannabis in the past 30 days, a more narrow time frame that suggests potential increases in use. In addition, a 2020 study found that one-third of adolescents who vape do so with cannabis concentrates.

Cannabis use by adolescents is scary because it can alter the way their brains develop. Research shows that the brains of adolescents who use cannabis are less primed to change in response to new experiences, which is a key part of adolescent development. Adolescents who use cannabis are also more likely to experience symptoms of schizophrenia, struggle more in school and engage in other risky behaviors.

The risks of cannabis use are even greater with concentrates because of the high levels of THC. This is true for both adolescents and adults, with greater risk for symptoms of schizophrenia such as hallucinations and delusions, mental health symptoms and more severe cannabis use.

The best analogy is with another drug – alcohol. Most people know that a 12-ounce beer is much less potent than 12 ounces of vodka. Cannabis in smoked form is closer to the beer, while a concentrate is more like the vodka. Neither is safe for an adolescent, but one is even more dangerous.

These dangers make early conversations with kids about cannabis and cannabis concentrates critically important. Research consistently shows that expressing disapproval of drug use makes adolescents less likely to start drug use.

Start these conversations early – ideally before middle school. You can find some helpful online resources to guide the conversation.

While these conversations can be uncomfortable, and you can look like the out-of-touch adult, they can be a major step toward preventing adolescents from using cannabis and other drugs.

Ty Schepis, PhD, is a Professor of Clinical Psychology at Texas State University. His research receives funding from the Food and Drug Administration and the National Institute on Drug Abuse.

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

Risk of Chronic Pain Doubles for People From Lower Socioeconomic Backgrounds

By Pat Anson, PNN Editor

People from lower socioeconomic backgrounds are twice as likely to develop chronic pain after an acute injury, according to UK researchers who found that smoking, fear of movement, and poor social support also raise the risk of chronic musculoskeletal pain (CMP).

The study, published in PLOS One, adds to a growing body of evidence linking economic, social and emotional stress to some chronic pain conditions.   

Researchers at the University of Birmingham analyzed over a dozen systematic reviews of clinical studies involving nearly half a million people with CMP. Their goal was to see what biopsychosocial factors are associated with CMP and potentially make pain treatment more difficult.

“The mechanisms of CMP are different to acute pain in that pain exists despite there no longer being evidence of ongoing healing, but rather due to a sensitized nervous system that creates a continued or repeated experience of pain despite no evidence of actual or potential tissue damage,” wrote lead author Michael Dunn, from the School of Sport, Exercise and Rehabilitation Sciences at University of Birmingham

“This transition from acute to chronic MSK pain is associated with the presence of many biopsychosocial factors such as fear avoidance, low mood, and work satisfaction or strain. Despite this, healthcare services conventionally utilize approaches to treat CMP based on understandings of acute MSK pain, with focus often on identifying and treating perceived injured or irritated MSK structures.”

Dunn and his colleagues say many treatments for MSK pain, such as physical therapy and surgery, work no better than a placebo. That is because they only focus on the injured body part, and fail to account for psychological and social factors that contribute to acute pain becoming chronic.

“Put simply, current healthcare approaches do not address all the reasons people do not get better,” Dunn said in a news release. “Not only are current healthcare approaches inadequate, they may also be discriminatory, with current healthcare approaches that are orientated around the injured body part being geared towards those from higher socioeconomic backgrounds who are less likely to experience these psychological or social factors.”

In addition to socioeconomic factors, Dunn says stress and depression also raise the risk of developing CMP. He doubts that any single risk factor is the sole cause of chronic pain, but a combination of them make recovery from an acute injury more problematic.

Dunn’s findings mirror those of several U.S. studies that found social and economic factors were intertwined with the prevalence of chronic pain. In a 2021 study, for example, nearly 45% of people living below the federal poverty level reported having back pain. Another study found that people who did not complete high school were significantly more likely to have joint pain from arthritis.   

People with less education often have blue-collar jobs requiring manual labor that may contribute to musculoskeletal pain. They also tend to have lower incomes and less access to healthcare.

Princeton researchers Angus Deaton and Anne Case were the first to report on the role socioeconomic issues play in so-called “deaths of despair,” which linked financial and social stress to rising rates of pain, suicide, substance abuse, and death in middle-aged white Americans.

Low-Carb Diets More Effective than Medication for IBS

By Pat Anson, PNN Editor

Diets low in carbohydrates are more effective than medication in treating irritable bowel syndrome (IBS), according to a new study that found over 70% patients had significantly reduced symptoms after changing their eating habits.

IBS is an intestinal condition that causes abdominal pain, cramps, bloating, gas and diarrhea. An imbalance in gut bacteria is suspected as a possible cause of IBS, and symptoms can be aggravated by stress or eating a large meal.

Researchers at the University of Gothenburg in Sweden enrolled over 300 people with severe or moderate IBS symptoms in a randomized clinical trial, dividing them into three groups.

The first group was given traditional IBS dietary advice, while also focusing on a low intake of fermentable carbohydrates, known as FODMAPs. Foods such as lactose, legumes, onions and whole grains were avoided because they are poorly digested, tend to ferment in the colon, and cause IBS pain.

The second group also had a diet low in carbohydrates, but high in protein and fat. In the third group, there were no dietary changes and laxatives, antidiarrheals, antibiotics and other medications were given based on the patient's symptoms. The treatment period for all three groups was four weeks.

The study findings, published in The Lancet Gastroenterology & Hepatology, show that 76% of participants in the FODMAP group had significantly reduced IBS symptoms. That compares to 71% of patients in the low-carb/high protein and fat group, and only 58% in the medication-only group. All three groups reported better quality of life, and less anxiety and depression.

Even after six months, when participants partially returned to their previous eating habits, a large proportion still had significant symptom relief: 68% in the FODMAP group and 60% in the low-carb/high protein and fat group.

“Although we found evidence that dietary treatments were more efficacious than medical treatment after 4 weeks, all three treatment options showed significant and clinically meaningful efficacy,” wrote lead author Sanna Nybacka, PhD, a researcher and dietician at the University of Gothenburg.

“The sustained positive effects of dietary interventions suggest their potential as first-line treatments for IBS, although patient preference, compliance, cost-effectiveness, and effects on nutritional status and the gut microbiota would need to be accounted for.”

Dietary advice for IBS typically includes sitting down during meals, chewing foods thoroughly, and avoiding excessive intake of coffee, alcohol, fizzy drinks, and fatty or spicy foods.

Foods low in FODMAPs include rice, potatoes, quinoa, and gluten-free pasta and bread, as well as a variety of vegetables, fruits, fish, beef and chicken.

Red Cabbage Juice Improves Gut Health

A new study by researchers at the University of Missouri found that juice from red cabbage can also improve gut health and ease inflammation in the digestive tract caused by Inflammatory Bowel Disease (IBD).

Symptoms of IBD and IBS are similar, but in IBD they become chronic, causing anemia, bleeding, weight loss and fever. About three million Americans live with IBD, including Crohn’s disease and ulcerative colitis.

In studies on laboratory mice with IBD, red cabbage juice relieved their intestinal inflammation. Mice are often used to study IBD because colitis in mice closely resembles ulcerative colitis in humans.

“Red cabbage juice alters the composition of gut microbiota by increasing the abundance of good bacteria, resulting in increased production of short chain fatty acids and other bacteria derived metabolites ameliorating inflammation,” said lead author Satyanarayana Rachagani, PhD, an Associate Professor of Veterinary Medicine & Surgery at the University of Missouri

“Its ability to modulate gut microbiota, activate anti-inflammatory pathways and enhance immune regulation underscores its potential as a valuable therapeutic agent for IBD and related inflammatory disorders.”

The study is published in the International Journal of Molecular Sciences.

Red cabbage juice is rich in antioxidants and Vitamin C, and has long been used as a natural remedy to reduce inflammation and improve overall health. It is also a good source of dietary fiber.

Few Take Advantage of Medicare’s Chronic Care Program

By Phil Galewitz and Holly Hacker, KFF Health News

Carrie Lester looks forward to the phone call every Thursday from her doctors’ medical assistant, who asks how she’s doing and if she needs prescription refills. The assistant counsels her on dealing with anxiety and her other health issues.

Lester credits the chats for keeping her out of the hospital and reducing the need for clinic visits to manage chronic conditions including depression, fibromyalgia, and hypertension.

“Just knowing someone is going to check on me is comforting,” said Lester, 73, who lives with her dogs, Sophie and Dolly, in Independence, Kansas.

At least two-thirds of Medicare enrollees have two or more chronic health conditions, federal data shows. That makes them eligible for a federal program that, since 2015, has rewarded doctors for doing more to manage their health outside office visits.

But while early research found the service, called Chronic Care Management, reduced emergency room and in-patient hospital visits and lowered total health spending, uptake has been sluggish.

Federal data from 2019 shows just 4% of potentially eligible enrollees participated in the program, a figure that appears to have held steady through 2023, according to a Mathematica analysis.

About 12,000 physicians billed Medicare under the CCM mantle in 2021, according to the latest Medicare data analyzed by KFF Health News. By comparison, federal data shows about 1 million providers participate in Medicare.

Even as the strategy has largely failed to live up to its potential, thousands of physicians have boosted their annual pay by participating, and auxiliary for-profit businesses have sprung up to help doctors take advantage of the program. The federal data showed about 4,500 physicians received at least $100,000 each in CCM pay in 2021.

Through the CCM program, Medicare pays to develop a patient care plan, coordinate treatment with specialists, and regularly check in with beneficiaries. Medicare pays doctors a monthly average of $62 per patient, for 20 minutes of work with each, according to companies in the business.

Without the program, providers often have little incentive to spend time coordinating care because they can’t bill Medicare for such services.

‘It Was Put Together Wrong’

Health policy experts say a host of factors limit participation in the program. Chief among them is that it requires both doctors and patients to opt in. Doctors may not have the capacity to regularly monitor patients outside office visits. Some also worry about meeting the strict Medicare documentation requirements for reimbursement and are reluctant to ask patients to join a program that may require a monthly copayment if they don’t have a supplemental policy.

“This program had potential to have a big impact,” said Kenneth Thorpe, an Emory University health policy expert on chronic diseases. “But I knew it was never going to work from the start because it was put together wrong.”

He said most doctors’ offices are not set up for monitoring patients at home. “This is very time-intensive and not something physicians are used to doing or have time to do,” Thorpe said.

For patients, the CCM program is intended to expand the type of care offered in traditional, fee-for-service Medicare to match benefits that — at least in theory — they may get through Medicare Advantage, which is administered by private insurers.

But the CCM program is open to both Medicare and Medicare Advantage beneficiaries.

The program was also intended to boost pay to primary care doctors and other physicians who are paid significantly less by Medicare than specialists, said Mark Miller, a former executive director of the Medicare Payment Advisory Commission, which advises Congress. He’s currently an executive vice president of Arnold Ventures, a philanthropic organization focused on health policy. (The organization has also provided funding for KFF Health News.)

Despite the allure of extra money, some physicians have been put off by the program’s upfront costs.

“It may seem like easy money for a physician practice, but it is not,” said Namirah Jamshed, a physician at UT Southwestern Medical Center in Dallas.

Jamshed said the CCM program was cumbersome to implement because her practice was not used to documenting time spent with patients outside the office, a challenge that included finding a way to integrate the data into electronic health records. Another challenge was hiring staff to handle patient calls before her practice started getting reimbursed by the program.

Only about 10% of the practice’s Medicare patients are enrolled in CCM, she said.

Jamshed said her practice has been approached by private companies looking to do the work, but the practice demurred out of concerns about sharing patients’ health information and the cost of retaining the companies. Those companies can take more than half of what Medicare pays doctors for their CCM work.

Physician Jennifer Bacani McKenney, who runs a family medicine practice in Fredonia, Kansas, with her father — where Carrie Lester is a patient — said the CCM program has worked well.

She said having a system to keep in touch with patients at least once a month has reduced their use of emergency rooms — including for some who were prone to visits for nonemergency reasons, such as running out of medication or even feeling lonely. The CCM funding enables the practice’s medical assistant to call patients regularly to check in, something it could not afford before.

For a small practice, having a staffer who can generate extra revenue makes a big difference, McKenney said.

While she estimates about 90% of their patients would qualify for the program, only about 20% are enrolled. One reason is that not everyone needs or wants the calls, she said.

Outsourcing Chronic Care

While the program has captured interest among internists and family medicine doctors, it has also paid out hundreds of thousands of dollars to specialists, such as those in cardiology, urology, and gastroenterology, the KFF Health News analysis found. Primary care doctors are often seen as the ones who coordinate patient care, making the payments to specialists notable.

A federally funded study by Mathematica in 2017 found the CCM program saves Medicare $74 per patient per month, or $888 per patient per year — due mostly to a decreased need for hospital care.

The study quoted providers who were unhappy with attempts to outsource CCM work. “Third-party companies out there turn this into a racket,” the study cited one physician as saying, noting companies employ nurses who don’t know patients.

Nancy McCall, a Mathematica researcher who co-authored the 2017 study, said doctors are not the only resistance point. “Patients may not want to be bothered or asked if they are exercising or losing weight or watching their salt intake,” she said.

Still, some physician groups say it’s convenient to outsource the program.

UnityPoint Health, a large integrated health system based in Iowa, tried doing chronic care management on its own, but found it administratively burdensome, said Dawn Welling, the UnityPoint Clinic’s chief nursing officer.

For the past year, it has contracted with a Miami-based company, HealthSnap, to enroll patients, have its nurses make check-in calls each month, and help with billing. HealthSnap helps manage care for over 16,000 of UnityHealth’s Medicare patients — a small fraction of its Medicare patients, which includes those enrolled in Medicare Advantage.

Some doctors were anxious about sharing patient records and viewed the program as a sign they weren’t doing enough for patients, Welling said. But she said the program has been helpful, particularly to many enrollees who are isolated and need help changing their diet and other behaviors to improve health.

“These are patients who call the clinic regularly and have needs, but not always clinical needs,” Welling said.

Samson Magid, CEO of HealthSnap, said more doctors have started participating in the CCM program since Medicare increased pay in 2022 for 20 minutes of work, to $62 from $41, and added billing codes for additional time.

To help ensure patients pick up the phone, caller ID shows HealthSnap calls as coming from their doctor’s office, not from wherever the company’s nurse might be located. The company also hires nurses from different regions so they may speak with dialects similar to those of the patients they work with, Magid said.

He said some enrollees have been in the program for three years and many could stay enrolled for life — which means they can bill patients and Medicare long-term.

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

Pain Patients Challenge DEA’s ‘Bogus Judicial System’

By Pat Anson, PNN Editor

Patients of a California doctor whose license to prescribe opioids and other controlled substances was suspended by the DEA have launched another long shot legal bid to get his license reinstated.

DEA administrator Anne Milgram suspended the license of Dr. David Bockoff in 2022, largely based on allegations that five of his pain patients were receiving dangerously high doses of opioids. Bockoff’s abrupt suspension left 240 patients – including many who suffer from severe and incurable pain conditions -- scrambling to find new providers and pain medication.

At least three of those patients have since died, including one who committed suicide with his wife and another who died after buying opioid medication in Mexico.

“Every time you take away a doctor's license without giving them any opportunity to fight it, you put a patient on the street who's a chronic pain patient and they've just been abandoned. No explanation or anything,” says attorney John Flannery. “And the government doesn't give a damn. They don't care at all.”

Flannery represents nine Bockoff patients who have tried repeatedly to gain legal standing as interested parties in the DEA case against the Beverly Hills doctor. Their efforts so far have failed. An Administrative Law Judge would not let them attend DEA hearings on the case, and a federal judge refused to grant a temporary restraining order that would have restored Bockoff’s license while he appeals his suspension.

Recently, a three-judge panel on the District of Columbia’s U.S. Court of Appeals declined to intervene in the case, saying the patients provided the court with “no credible factual submissions” that document how they were harmed by Bockoff’s suspension. The judges’ order makes no mention of the patients who died.

‘We Were Entirely Hamstrung’

Part of the problem is the closed administrative system that the DEA uses to discipline doctors, in which the agency essentially serves as the prosecutor, judge and executioner. Flannery calls it a “bogus judicial system” that the DEA created for itself. Even the rulings of a supposedly independent Administrative Law Judge (ALJ) can be rejected by the DEA Administrator.

“There is much talk about how the government is ‘open’ and transparent, but DEA’s proceedings are entirely opaque to patients and the public,” Flannery wrote in his latest appeal, in which he asks the full DC Court of Appeals for an en banc review of the case.

“We were entirely hamstrung to proceed to seek review in any DEA proceedings as we had no right to review any pleadings, to attend any hearings, to monitor the proceedings, to review any of the ‘evidence,’ to hear the arguments, and the only decision made available to us by the ALJ related to the (unsuccessful) motion to intervene.”

Flannery says federal law allows any “interested persons” or “person aggrieved” by the DEA to have a legal standing in its administrative hearings. If the Appeals Court accepts that argument, it would set a major precedent that would affect all future DEA cases against doctors by giving their patients a seat at the table.

Flannery says the DEA’s disciplinary actions against Bockoff and other doctors interfere with the practice of medicine.

“I hate to say it’s a witch hunt, but I think we found a witch and the witch is the present DEA administrator,” Flannery told PNN. “She's part of a machine that just keeps chugging along, hurting and hurting and hurting. How does one go into government to do that? Who do they think they're saving? They found five patients that they claim were harmed, and so the other 235 patients, they have no idea about them, and they just cut them off. How do you justify that?”

Flannery’s appeal also cites the DEA’s “flimsy evidence” against Bockoff, most notably the agency’s expert witness, Dr. Timothy Munzing, a family practice physician who has launched a lucrative second career for himself as a government witness against doctors accused of overprescribing opioids. Munzing has made over $3.4 million testifying for the federal government in dozens of cases against doctors. In an Ohio case, a judge declared a mistrial after Munzing contradicted himself during testimony.

“The DEA’s expert, Dr. Timothy Munzing, was, by any fair review, ‘damaged goods’ by DEA’s overuse of his ‘skills,’” Flannery wrote. “On information and belief, this impeachment material involving Dr. Munzing, the DEA’s sole expert witness, was withheld from Dr. Bockoff in the DEA Administrative proceeding.”

A protracted legal challenge of this kind is expensive and a GoFundMe campaign has been created by the nine Bockoff patients to help support it. Over $10,000 has been raised so far.

“Please know that we'll be working as hard as we can to keep this fundraiser and our effort going,” said Kristen Ogden, the wife of one of the patients. “Our donors are helping so much in this effort to make a difference for chronic pain patients and doctors. As John (Flannery) says, we are doing something that hasn't been done before... seeking to intervene so that patients can have a voice.”

How Gut Bacteria Changes the Immune System

By Dr. Narveen Jandu  

The human immune system changes with age. Immune responses start to become less robust as people get older, which makes them more vulnerable to certain infections and diseases.

However, immune system aging looks different from person to person. Research has shown that changes to the composition and diversity of the microorganisms in the gut may explain these differences in immune system aging.

The gut microbiome — the population of microorganisms that lives in the gastrointestinal tract — helps the body maintain a stable internal environment when it is faced with external changes. This is known as homeostasis. The gut microbiome supports homeostasis in different ways, such as through helping to keep the immune system alert, and digesting dietary fibre into short-chain fatty acids to strengthen the intestinal wall.

The gut microbiome also helps us to regulate our inflammatory reactions. Inflammation helps the body fight microorganisms that cause disease, and helps repair damaged tissues. However, as the composition of our gut microbiome changes with age, a low level of inflammation can become constant throughout the body. This is called inflammaging.

When inflammaging develops in the gut, it leads to a decrease in immune responses, which puts people at a higher risk for infection and disease.

Let’s take a closer look at the gut microbiome and how it changes with age.

Diversity of Bacteria Decreases with Age

Our gastrointestinal tract can be compared to a densely populated city inhabited by a variety of different bacteria, fungi, archaea and viruses collectively called the gut microbiota. In fact, compared to other parts of the body, the gut microbiome has the largest number of bacteria. In a healthy gut microbiome, there are four dominant families (or phyla) of microorganisms, including Firmicutes, Bacteroidetes, Proteobacteria and Actinobacteria.

Firmicutes and Bacteroidetes make up around 80 to 90 per cent of the gut microbiota in the digestive tract. Firmicutes help with the production of short-chain fatty acids to support intestinal health and the secretion of mucus to improve intestinal wall defence. Bacteroidetes metabolize complex carbohydrates into vitamins and nutrients, and help promote glycogen storage to improve glucose metabolism.

The gut microbiome and immune system work closely together. The microorganisms in the gut send out signals that are detected by immune sensors. This allows the immune system to regulate the beneficial bacteria in the gut, helping maintain immune homeostasis. Through this interaction, the adaptive immune system also receives stimuli from harmful substances called antigens, which trigger an immune reaction.

However, as people age, the composition and balance of microorganisms in the gut changes. This gives rise to microbial dysbiosis, which means there is a reduction in the number of beneficial bacteria in the gut, alongside a higher number and pro-inflammatory organisms and bacteria that can cause disease. In addition to this, research has also shown that the general diversity of bacteria in our gut also decreases with age.

Over time, the shortage of beneficial bacteria such as Firmicutes in older adults starts to compromise the integrity of their intestinal barrier, causing it to become leaky. This is because the Firmicutes family plays a very important role in keeping the intestinal wall healthy and strong by producing a short-chain fatty acid called butyrate. Short-chain fatty acids such as butyrate help provide nutrients to strengthen the intestinal wall, inform immune responses and lower inflammation.

When intact, the intestinal barrier works to prevent harmful bacteria from passing through the intestinal wall, entering the circulatory system and reaching important organs. However, when there are not enough gut bacteria to produce the short-chain fatty acids that are needed for the intestinal wall to function, bacteria are able to enter the bloodstream. This contributes to the formation of intestinal inflammaging, which refers to a low level of inflammation that becomes steady throughout the body with age.

Inflammaging creates an environment that is prone to inflammation, which is caused and maintained by several factors. These can include microorganism imbalances in the intestines (microbial dysbiosis), psychological stress, physical inactivity, poor nutrition and chronic infections.

When the body is exposed to these factors on a regular basis, cellular senescence occurs. Cellular senescence is a state in which cell growth is permanently arrested, which means that cells are no longer able to self-renew. Eventually, this leads to a decrease in immune responses, which are important to prevent foreign substances and pathogens from entering the body.

How to Maintain a Healthy Balance of Bacteria

There is a common saying that claims “you are what you eat.” Indeed, nutrition and diet play an important role in regulating the number of different microorganisms that live in the gut. This means that diet may also play a key role in the immune function of older adults.

The Mediterranean diet, known for its lower intake of refined carbohydrates, saturated fats, dairy products and red meat, has been shown to have a positive effect on the balance of microorganisms in the gut and the strength of the intestinal barrier. The Mediterranean diet has also been linked to a lower risk of Type 2 diabetes in older adults, allowing these individuals to live a longer and healthier life.

The use of probiotics and prebiotics can also help fight age-related inflammation. Probiotics, such as Lactobacilli and Bifidobacteria, are live microorganisms that can be consumed to support overall health. More specifically, probiotics help improve the function of the intestinal barrier and regulate immune responses by modifying the composition of the gut microbiome. However, there is still some debate around whether the acidic conditions in the stomach allow probiotics to survive long enough to be able to move into the intestine.

It is clear that the immune system has an intricate relationship with the gut microbiome. A healthy and well-balanced gut microbiome will strengthen the intestinal barrier, which helps to reduce inflammation throughout the body and support the immune system.

To achieve this, it is important to maintain a healthy and well-balanced lifestyle as we grow older. This can include lower intake of dairy products and red meats, and harnessing the benefits of probiotics and prebiotics.

Narveen Jandu, PhD, is a faculty member with the School of Public Health Sciences at the University of Waterloo in Canada. As a biomedical researcher, Dr. Jandu’s research has focused on studying the cellular mechanisms and pathophysiological consequences of infectious diseases.

This article was co-authored by Flore Van Leemput. a student in health sciences at the University of Waterloo.

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

Meet the Chronic Pain Patient Running for Arizona Legislature

By Barby Ingle, PNN Columnist

As a rare disease and chronic pain patient, I have spent over 20 years advocating for others and myself in the pain community. I’ve worked on legislation to help patients in more than 30 states, including my home state of Arizona, where two of the bills I supported have become law.

I am now running for the Arizona House of Representatives from District 7, which includes Pinal, Gila, Coconino and Navajo counties, as well as the cities of Flagstaff and Apache Junction, where I live.

My campaign focuses on healthcare access, pain management and disability rights. I believe that everyone should have access to individualized healthcare and proper pain management. This can get people working again and participating in society, which would ultimately save taxpayers money.  

In a recent interview with the Arizona Liberty Podcast, I shared my experiences running for office as a chronic pain patient. I explained that I was running to help make a difference in my community and to create positive change for those often overlooked by the political system. 

As a patient with algoneurodystrophy, a severe nerve disease also known as Complex Regional Pain Syndrome (CRPS), running for office is not an easy task. I have faced many challenges during my campaign, including physical limitations and the need for frequent breaks. Sometimes I have to sit down while everyone around me is standing.  

I am determined to push through these challenges to make a difference. I believe my unique perspective as a chronic pain patient can inspire others to engage in the political process and advocate for their needs. 

In addition to my campaign work, I am a motivational speaker, author, and the immediate past president of the International Pain Foundation. Over the years, I have used my platform to raise awareness about chronic pain and to advocate for better treatment options. Education and awareness are crucial to improving the lives of those with chronic pain. 

My campaign has made waves in my district and garnered attention from the pain community, with financial support and endorsements from patients and providers. Volunteers are also helping me get the word out about my candidacy.

I want laws that restore the patient-provider relationship and give pain management providers the ability to treat each patient individually.

I want to change Arizona’s “red cap” law, which requires all Schedule II opioids dispensed by a pharmacist to have a red cap, in addition to a warning label about potential addiction. The label is fine, but the red cap stigmatizes pain patients and the medications they need. 

We are also currently short about 5,000 healthcare providers in Arizona, a state that attracts many senior citizens and patients with chronic or rare diseases who need specialized care. We must address that so all Arizonans can get the healthcare they deserve.

I hope my dedication and perseverance will inspire others to fight for their communities and better healthcare options. Despite the adversity we all face, positive change is possible.

You can learn more about me and my campaign at barbyingle.com.  I hope to get your vote in the Republican primary on July 30, 2024. 

U.S. Drug Shortages Reach Record Levels

By Pat Anson, PNN Editor

Shortages of opioids and other medications reached a record level in the U.S. during the first quarter of 2024, according to the American Society of Health-System Pharmacists (ASHP). The 323 medications listed in short supply are the highest number since the ASHP began tracking drug shortages in 2001.

Some of the most acute shortages are for basic, life-saving injectable drugs used in hospitals for pain control, sedation and chemotherapy.

Most of the drug manufacturers contacted by the ASHP did not provide a reason for the shortages, but some blamed supply/demand issues (14%), manufacturing problems (12%), business decisions (12%) and raw material issues (2%).

The ASHP also cited reduced DEA production quotas and the fallout from opioid litigation settlements, which have curtailed the supply of opioid medication at many pharmacies.

“New DEA quota changes, along with allocation practices established after opioid legal settlements, are exacerbating shortages of controlled substances,” the ASHP said in its latest report.

The Drug Enforcement Administration has been cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by over 68% and hydrocodone by nearly 73% since 2015. The DEA says it acts on the advice of the Food and Drug Administration, which projected a 7.9% decline in the “medical need” for opioids in 2024, months before the new year even began.

Many pain patients question whether the demand for opioids is really going down. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy. Nearly 20% were unable to get their pain medication, even after contacting multiple pharmacies.

“The pharmacist said they could not get my medication because the supplier informed them that they had reached their yearly max and the DEA would not let them supply anymore medication,” one patient told us.

“I am terrified of the cuts being pushed by the DEA,” said another patient. “Several times I have had to wait over a week until my local CVS got my medication back in stock. Honestly, I have such intolerable pain I had no choice but to turn to illicit street drugs to fill in the gaps.”

Shortages of stimulants used to treat attention-deficit/hyperactivity disorder (ADHD) get far more attention than shortages of opioids, which the FDA and DEA have largely ignored. The DEA modestly raised production quotas for ADHD drugs in 2024, but they remain in short supply.

About 12% of the 323 drugs currently listed in shortage by the ASHP are controlled substances regulated by the DEA because they are potentially addictive.

University of Utah Drug Information Service

“I can’t say for sure that every single controlled substance shortage is due to quota issues, but it’s a contributing factor for some,” says Erin Fox, PharmD, Senior Pharmacy Director at University of Utah Health, which tracks drug shortages for the ASHP. “DEA changed their quota process to try to help with ADHD drug shortages, but didn’t take into account how their change affects injectable manufacturers.”

Fox shared a recent letter sent by Pfizer to U.S. hospitals warning of “additional supply interruptions and potential stock outs” due to DEA quota changes. The letter warns of limited supplies of several injectable medicines made by Pfizer, including meperidine (Demerol), hydromorphone and morphine.  

“I understand that DEA is working to prevent drug diversion and was under fire for the ADHD medication shortages, but injectable manufacturing is very different than oral products and DEA did not take into account all of the special processes that are required for injectables,” Fox said in an email to PNN.

Nearly half of the drugs on the ASHP’s shortage list are injectables. Opioids, stimulants and other drugs that affect the central nervous system are the leading class of medication in short supply, followed by antibiotics, hormonal agents, and chemotherapy drugs.

The FDA, which uses a different system to track drug shortages, currently lists only 153 medications in short supply, less than half the number listed by the ASHP.

Painful Choices About a Safe Space

By Cynthia Toussaint, PNN Columnist

It’s no secret. For me, there’s no better medicine than self-care.

To that point, I’m a proud member of my local YMCA. In fact, it’s been my ultimate safe-space for 15 years: around the block, accessible, a generous lap swimming pool, topped by a loving community of warm and caring people. A lot of perfect for someone who can’t walk a block due to Complex Regional Pain Syndrome, but can swim a mile.

To give back some, I’ve done quite a bit of fundraising to provide low-cost memberships for families in need, and landed one of the Y’s aquatic teachers a national ABC News print piece, the angle being the benefits of pool therapy for women in pain as I believe devotedly in the healing power of water.

All was going swimmingly, until COVID. When we returned in mid-2021, my heart sank when I spied a new member, Annie, who I sensed was going to be trouble with a capital T. What little lap swimming she did was overwhelmed by her excessive yelling and joke-telling mid-pool with the lifeguard.

Day after day, I became increasingly stressed while others rolled their eyes and donned ear plugs. To make matters worse, Annie soon blew past personal boundaries by jumping in on my conversations, often physically pulling friends away from me. My place of serenity was turning into a high-decibel scrum.      

CYNTHIA TOUSSAINT

It dawned on me that what was driving Annie’s aberrant behavior was a boatload of childhood trauma. She was deregulated and manic, showing earmarks of a deeply wounded woman. Annie flouted pool rules by wearing inappropriate, oversexualized swimwear (shorts and a braless t-shirt) with no cap for her long, black locks.

In one of the few encounters with Annie before things went south, she boasted about freezing her brother out, emphasizing all the legal folk he had to circumvent to get to her. Annie’s cackle as an exclamation point, her pure joy of hurting another person, was darkly disturbing.                     

One day, out of the blue, a deep freeze set in as Annie began avoiding me. This was terribly awkward, compounded by the Y pool and dressing room being an intimate place where everyone knows everyone’s business. I continued basic pleasantries until Annie yelled me down for doing so.

Next day, in an attempt to fix things, I asked Annie if I’d done something to offend her. Without looking my way, she briskly responded, “No, nothing’s wrong. We’re fine.” But I knew better.

Bad turned to worse when, at that point, Annie completely shut me out. It was as though I didn’t exist as she avoided eye contact altogether. This tactic was deeply uncomfortable and hurtful as she appeared to be in good standing, even sweet, with others. 

Due to Annie’s puzzling cruelty, I started dreading going to my “safe space.” My lower-body pain amp’d and my nervous system was in fight or flight mode before I’d head out to the Y. Even my anticipation the day prior was becoming unhealthy, and I often woke in the night with worry.

Because I couldn’t bear to lose my beloved pool and community, I went to a therapist whose assessment provided strong insight. She suspected Annie was “negatively transferring,” meaning that because I remind her of an abusive person in her childhood, she’s delusional about my power over her. My psychologist advised that this is a targeted psychotic process and, for safety sake, I swim elsewhere.  My close friends seconded that emotion. 

With heavy heart, I tried other Ys and fitness centers. In the end though, none of them worked because of my pain and limitations, e.g., I had to use my wheelchair to get to the pool, there were no exit stairs, and/or my partner and caregiver John couldn’t run necessary errands because we were far from home.

When I fearfully returned to my now toxic Y, John accompanied me in the pool to rehab an injury and offer support in the event of an encounter. Annie’s behavior immediately escalated when she spread a nasty rumor about me to a fellow swimmer who I adore. Zoe shared the gossip out of concern for my well-being, along with being disturbed by the grim energy now shrouding our community.

Before entering the pool the next day, Annie yelled at me twice and, for the first time, physically threatened me by raising her hand to my face. That was it. I went to member relations and made a thorough complaint. Luckily, Zoe, who’d witnessed the happenings, made one as well.

Fortunately, since the Y spoke to Annie, her behavior has simmered. While still avoiding conversation and eye contact, she’s not threatening me, though I’m aware her anger’s just below the surface. Better, but far from okay. What was once heavenly, now casts a pall.

If I was a fully functional person without high-impact pain, I’d have left this Y many moons ago and created a healthy community elsewhere. But because of limitations and specific needs, my only choice is to tolerate an unsafe, dysfunctional situation, to make the best of a bad.

Let’s face it. My choice was really no choice. And that’s the way it is with folk hammered by pain and disability. Pickings are slim and the best solutions are generally the ones that are physically do-able. This not only applies to our places of exercise and community, but also where we live, shop and work. Really, everything we do.   

But let’s not let a bully bury the lead. Come hell or high water, I’m continuing to swim, which is one of the best self-care cards I hold. And when it comes to wrangling with the pitfalls of pain and chronic illness, holding onto what health we can maintain and preserve, is always our best choice.               

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

Evidence Lacking for Spinal Cord Stimulators

By Drs. Ian Harris, Adrian Traeger and Caitlin Jones

In an episode of the Australian Broadcasting Corporation’s “Four Corners” this week, the use of spinal cord stimulators for chronic back pain was brought into question.

Spinal cord stimulators are devices implanted surgically which deliver electric impulses directly to the spinal cord. They’ve been used to treat people with chronic pain since the 1960s.

Their design has changed significantly over time. Early models required an external generator and invasive surgery to implant them. Current devices are fully implantable, rechargeable and can deliver a variety of electrical signals.

However, despite their long history, rigorous experimental research to test the effectiveness of spinal cord stimulators has only been conducted this century. The findings don’t support their use for treating chronic pain. In fact, data points to a significant risk of harm.

People with chronic pain are suffering infections, shocks and even more pain from a device advertised as safe and effective. There are now calls for them to be recalled following a Four Corners investigation. https://t.co/qb1i0A47Lv

— ABC News (@abcnews) April 9, 2024

What Does the Evidence Say?

One of the first studies used to support the effectiveness of spinal cord stimulators was published in 2005. This study looked at patients who didn’t get relief from initial spinal surgery and compared implantation of a spinal cord stimulator to a repeat of the spinal surgery.

Although it found spinal cord stimulation was the more effective intervention for chronic back pain, the fact this study compared the device to something that had already failed once is an obvious limitation.

Later studies provided more useful evidence. They compared spinal cord stimulation to non-surgical treatments or placebo devices (for example, deactivated spinal cord stimulators).

A 2023 Cochrane review of the published comparative studies found nearly all studies were restricted to short-term outcomes (weeks). And while some studies appeared to show better pain relief with active spinal cord stimulation, the benefits were small, and the evidence was uncertain.

Only one high-quality study compared spinal cord stimulation to placebo up to six months, and it showed no benefit. The review concluded the data doesn’t support the use of spinal cord stimulation for people with back pain.

The experimental studies often had small numbers of participants, making any estimate of the harms of spinal cord stimulation difficult. So we need to look to other sources.

A review of adverse events reported to Australia’s Therapeutic Goods Administration found the harms can be serious. Of the 520 events reported between 2012 and 2019, 79% were considered “severe” and 13% were “life threatening”

.We don’t know exactly how many spinal cord stimulators were implanted during this period, however this surgery is done reasonably widely in Australia, particularly in the private and workers compensation sectors. In 2023, health insurance data showed more than 1,300 spinal cord stimulator procedures were carried out around the country.

In the review, around half the reported harms were due to a malfunction of the device itself (for example, fracture of the electrical lead, or the lead moved to the wrong spot in the body). The other half involved declines in people’s health such as unexplained increased pain, infection, and tears in the lining around the spinal cord.

More than 80% of the harms required at least one surgery to correct the problem. The same study reported four out of every ten spinal cord stimulators implanted were being removed.

The cost here is considerable, with the devices alone costing tens of thousands of dollars. Adding associated hospital and medical costs, the total cost for a single procedure averages more than $A50,000 (US$ 32,542). With many patients undergoing multiple repeat procedures, it’s not unusual for costs to be measured in hundreds of thousands of dollars.

Rebates from Medicare, private health funds and other insurance schemes may go towards this total, along with out-of-pocket contributions.

Insurers are uncertain of the effectiveness of spinal cord stimulators, but because their implantation is listed on the Medicare Benefits Schedule and the devices are approved for reimbursement by the government, insurers are forced to fund their use.

Industry Influence

If the evidence suggests no sustained benefit over placebo, the harms are significant and the cost is high, why are spinal cord stimulators being used so commonly in Australia? In New Zealand, for example, the devices are rarely used.

Doctors who implant spinal cord stimulators in Australia are well remunerated and funding arrangements are different in New Zealand. But the main reason behind the lack of use in New Zealand is because pain specialists there are not convinced of their effectiveness.

In Australia and elsewhere, the use of spinal cord stimulators is heavily promoted by the pain specialists who implant them, and the device manufacturers, often in unison. The tactics used by the spinal cord stimulator device industry to protect profits have been compared to tactics used by the tobacco industry.

A 2023 paper describes these tactics which include flooding the scientific literature with industry-funded research, undermining unfavourable independent research, and attacking the credibility of those who raise concerns about the devices.

More than three million Australians are living with chronic pain, and it's become a breeding ground for exploitation.

Watch Four Corners: Pain Factory, now on ABC iview.#4Cornershttps://t.co/cZ9Qrt0Lsk

— ABC News (@abcnews) April 8, 2024

Many who suffer from chronic pain may feel disillusioned after watching the Four Corners’ “Pain Factory” report. But it’s not all bad news. Australia happens to be home to some of the world’s top back pain researchers who are working on safe, effective therapies.

New approaches such as sensorimotor retraining, which includes reassurance and encouragement to increase patients’ activity levels, cognitive functional therapy, which targets unhelpful pain-related thinking and behaviour, and old approaches such as exercise, have recently shown benefits in robust clinical research.

If we were to remove funding for expensive, harmful and ineffective treatments, more funding could be directed towards effective ones.

Ian Harris, MD, is a Professor of Orthopedic Surgery at University of New South Wales.  He is a practicing orthopedic trauma surgeon and directs a research unit specializing in surgical outcomes and the evidence base for surgery.

Adrian Traeger, PhD, is a Research Fellow at the Institute for Musculoskeletal Health at The University of Sydney. He is a physiotherapist who specializes in treating low back pain and other musculoskeletal conditions.

Caitlin Jones, PhD, is a postdoctoral research associate at the University of Sydney. Her research evaluates the benefits and harms of treatments for musculoskeletal conditions.

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

How Insurers Take Advantage of Copay Assistance Programs

By Barby Ingle, PNN Columnist 

With the prices of many medications soaring, copay assistance programs are gaining in popularity. Drug manufacturers create copay programs to help insured patients afford expensive medications by covering all or part of their deductible, copays and other out-of-pocket expenses. That can save patients hundreds or even thousands of dollars on a single prescription.

But when insurers, pharmacy benefit managers (PBMs) and employers no longer count the copay assistance toward a deductible, it can lead to unexpectedly high bills for patients, including many who are chronically or terminally ill. The patient is often shocked when they receive a bill for a medication that is significantly higher than usual.  

“When insurers and PBMs do not count the value of copay assistance toward cost-sharing requirements, patients often experience a ‘copay surprise’ at the pharmacy counter and may be forced to walk away without their needed medication because they cannot afford it,” says California Assemblymember Akilah Weber, MD, (D-La Mesa).

Weber recently introduced AB 2180 to ban these copay “accumulator” programs by requiring PBMs and insurers to apply copay assistance towards a patient’s deductible and other out-of-pocket expenses. The goal is to ensure that copay assistance helps the people it is intended for – patients -- rather than lower an insurer’s costs. 

Accumulator programs, also known as "accumulator adjustments" or "copay maximizers,” have already been banned in 19 states, including Arkansas, Arizona, Colorado, Connecticut, Delaware, Georgia, Illinois, Kentucky, and Louisiana.

Over 80 national and California advocacy organizations that make up the All Copays Count in California Coalition have endorsed AB 2180, saying it would protect the most vulnerable patients from “harmful and deceptive insurance schemes.” According to one study, up to 70% of patients abandon their prescriptions when their out-of-pocket costs reach $250 or more.

“Chronic and terminal illnesses create tremendous financial challenges for patients and their families. When insurers utilize copay accumulator policies which do not count third-party payment towards the deductible or out-of-pocket maximum, patients often cannot afford their medications, which has serious health implications,” Siri Vaeth, Executive Director of the Cystic Fibrosis Research Institute, said in a statement.

But PBM’s and insurers say the criticism is unfair. They say copay assistance programs are often little more than marketing ploys by the drug industry to discourage patients from switching to lower cost medications. Insurers say capturing that copay money – by not applying it towards deductibles -- helps them slow the rising cost of premiums. Some are working with third-party companies like PrudentRX and SaveOnSP to identify and implement more of these costs savings.  

There has been bipartisan legislation introduced in Congress at the federal level, which will require financial assistance to count toward deductibles and other out-of-pocket costs. The Help Ensure Lower Patient Copays Act would apply to plans not already subject to state rules. The bill was introduced last year, but has yet to get past the committee stage. 

As the healthcare industry continues to evolve, it is likely that insurers will create more of these “maximizer” programs. If you are paying for more out of pocket expenses due to insurance policies, I encourage you to share your story here and on social media.  

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 the founder and former President of the International Pain Foundation. You can follow Barby at www.barbyingle.com. 

Living on False Hope

By Carol Levy, PNN Columnist

I live on false hope. I think hope is what keeps many of us afloat. And when the medical community tells you, “I have nothing left to offer you,” false hope is all there is.

And then I open my email, and there is a story in KevinMD, a medical site that I trust. It’s about using ultrasound as a treatment for pain. My heart soars with anticipation. Maybe, maybe this time, the answer has arrived.

The headline, “Ultrasound shows promise as new pain treatment, targeting a specific brain region,” sets off a specific area of my brain. I feel the false hope lifting and true hope taking its place.

And then I read the article.

Just like too many other studies I have read, this is not research that can be applicable to many people. The researchers only used a sample population of 23 people. That is just too small a number to extrapolate out to the larger pain community.

I have had many brain surgeries for my trigeminal neuralgia, so I'm not put off by a treatment that targets the brain. But the author of the article wonders if stimulating areas of the brain with ultrasound could be used for nefarious purposes, such as torture. 

I was going to do research to see what other new ideas and treatments are out there. Then I realized I didn’t really want to know, because most of the research doesn’t pan out or involves too few people to take it seriously.

I want to read about research involving enough participants that there is real hope in what they found. A study that uses a large number of people and with results so positive that it may be a realistic treatment option.

So far, I haven’t seen that. I know the pharmaceutical industry is working on non-opioid pain relievers, but I think the better way to go would be to find something that minimizes our pain. I'm afraid there may be no way to ever truly eradicate many painful conditions. 

Until I find a study involving hundreds or thousands of participants using a new pain treatment that actually works, is affordable, and has few side effects, I suppose false hope is better than none. 

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

The Horrors of TMJ: Futile Treatments for Chronic Jaw Pain

By Brett Kelman, KFF Health News, and Anna Werner, CBS News  

A TMJ patient in Maine had six surgeries to replace part or all of the joints of her jaw.

Another woman in California, desperate for relief, used a screwdriver to lengthen her jawbone daily, turning screws that protruded from her neck.

A third in New York had bone from her rib and fat from her belly grafted into her jaw joint, and twice a prosthetic eyeball was surgically inserted into the joint as a placeholder in the months it took to make metal hinges to implant into her jaw.

“I feel like Mr. Potato Head,” said Jenny Feldman, 50, of New York City, whose medical records show she’s had at least 24 TMJ-related surgeries since she was a teenager. “They’re moving ribs into my face, and eyeballs, and I feel like a toy … put together [by] somebody just tinkering around.”

These are some of the horrors of temporomandibular joint disorders, known as TMJ or TMD, which afflict up to 33 million Americans, according to the National Institutes of Health.

Dentists have attempted to heal TMJ patients for close to a century, and yet the disorders remain misunderstood, under-researched, and ineffectively treated, according to an investigation by KFF Health News and CBS News.

JENNY FELDMAN

Dental care for TMJ can do patients more harm than good, and a few fall into a spiral of futile surgeries that may culminate in their jaw joints being replaced with metal hinges, according to medical and dental experts, patients, and their advocates speaking in interviews and video testimony submitted to the FDA.

TMJ disorders cause pain and stiffness in the jaw and face that can range from discomfort to disabling, with severe symptoms far more common in women. Dentists have commonly treated the disorder with splints and orthodontics. And yet these treatments are based on “strongly held beliefs” and “inadequate research” — not compelling scientific evidence nor consistent results — according to the National Academies of Sciences, Engineering and Medicine, which reviewed decades of research on the topic. The NIH echoes this message, warning that there is “not a lot of evidence” that splints reduce pain and recommends “staying away” from any treatment that permanently changes the teeth, bite, or jaw.

“I would say that the treatments overall have not been effective, and I can understand why,” said Rena D’Souza, director of the NIH’s National Institute of Dental and Craniofacial Research. “We don’t understand the disease.”

For this investigation, journalists with KFF Health News and CBS News interviewed 10 TMJ patients with severe symptoms who said they felt trapped by an escalating series of treatments that began with splints or dental work and grew into multiple surgeries with diminishing returns and dwindling hope.

In every interview, the patients said the TMJ pain worsened throughout their treatment and they regretted some, if not all, of the care they received.

“The grand irony to me is that I went to the doctor for headaches and neck pain, and I’ve had 13 surgeries on my face and jaw, and I still have even worse neck pain,” said Tricia Kalinowski, 63, of Old Orchard Beach, Maine. “And I live with headaches and jaw pain every day.”

TMJ has become an umbrella term for about 30 disorders that afflict roughly 5% to 10% of Americans. Minor symptoms may not require treatment at all, and many cases resolve by themselves over time. Severe symptoms include chronic pain and may limit the ability to eat, sleep, or talk.

In a comprehensive study of TMJ disorders by the national academies, including input from more than 110 patients, experts found that most health care professionals, including dentists, have received “minimal or no training” on TMJ disorders and patients are “often harmed” by “overly aggressive” care and the lack of proven treatments.

The American Dental Association, which represents about 160,000 dentists nationwide and establishes guidelines for the profession, declined an interview request. In a written statement, ADA President Linda Edgar said that TMJ disorders are “often managed rather than cured” and that it sees “great potential” in new efforts to research more treatment options.

Terrie Cowley, a longtime TMJ patient who leads the TMJ Association, an advocacy group that has spoken with tens of thousands of patients, said she was so disillusioned with dental care for TMJ that she advises many patients to avoid treatment entirely, potentially for years.

“Almost 100 years this has been in dentistry, and look at what we have,” Cowley said. “A whole ton of people pretending they know everything, and we don’t know anything.”

‘Not Taken Seriously’

Scientific studies have found that TMJ disorders arise up to nine times as often in women, particularly those in their 20s and 30s, leading to theories that the cause may be linked to reproductive hormones. But a true understanding of TMJ disorders remains elusive.

Kyriacos Athanasiou, a biomedical engineering professor at the University of California-Irvine, said it was because TMJ disorders are more prevalent among women that they were historically dismissed as neither serious nor complex, slowing research into the cause and treatment.

The resulting dearth of knowledge, which is glaring when compared with other joints, has been “a huge disservice” to patients, Athanasiou said. In a 2021 study he co-authored, researchers found that the knee, despite being a much simpler joint, was the subject of about six times as many research papers and grants in a single year than the jaw joint.

D’Souza agreed that TMJ disorders were “not taken seriously” for decades, along with other conditions that predominantly affect women.

“That has been a bias that is really long-standing,” she said. “And it’s certainly affected the progress of research.”

Patients have felt the effect too. In interviews, female patients said they felt patronized or trivialized by male health care providers at some point in their TMJ treatment, if not throughout. Some said they felt blamed for their own pain because they were viewed as too stressed and clenching their jaw too much.

“We desperately need research to find the reasons why more women get TMJ disease,” wrote Lisa Schmidt, a TMJ Association board member, in a 2021 newsletter from the organization. “And surgeons need to stop blaming this condition on women.”

Schmidt, 52, of Poway, California, said she was diagnosed with TMJ disorder in 2000 due to headaches, and an orthodontist immediately recommended her for a splint, braces, and surgery.

After wearing the splint for only three days, Schmidt said, she was in “excruciating pain” and could no longer open her mouth far enough to eat solid food. Schmidt said she spent the next 17 years stuck on a “surgery carousel” with no escape, and eventually was in so much pain she abandoned her career as an aerospace scientist who worked alongside NASA astronauts.

Schmidt said her low point came in 2016. In an attempt to restore bone that had been cut away in prior surgeries, a surgeon implanted long screws into Schmidt’s jaw that protruded downward out of her neck. Schmidt said she was instructed to tighten those screws with a screwdriver daily for about 20 days, lengthening the corners of her jaw to restore the bone that had been lost. It didn’t work, Schmidt said, and she was left in more pain than ever.

“Every time you have a surgery, your pain gets worse,” Schmidt said. “If I could go back in time and go talk to younger Lisa, I would say ‘Run!’”

LISA SCHMIDT AND A 2017 MEDICAL SCAN OF HER FACE

Lack of Sufficient Evidence

Many of the shortcomings of TMJ care were laid bare in the 426-page report published by the national academies in March 2020 that received limited public attention amid the coronavirus pandemic. The report’s 18 authors include medical and dental experts from Harvard, Duke, Clemson, Michigan State, and Johns Hopkins universities.

Sean Mackey, a Stanford professor who co-led the team, said it found that patients were often steered toward costly treatments and “pathways of futility” instead of being taught to manage their pain through strategies and therapies with “good evidence.”

“We learned it’s a quagmire,” Mackey said. “There is a perverse incentive in our society that pays more for things we do to people than [for] talking and listening to people. … Some of those procedures, some of those surgeries, clearly are not helping people.”

Among its many findings, the national academies said it has been widely assumed in the field of dentistry that TMJ disorders are caused by a misaligned bite, so treatments have focused on patients’ teeth and bite for more than 50 years. But there is a “notable absence of sufficient evidence” that a misaligned bite is a cause of TMJ disorders, and the belief traces back to “inadequate research” in the 1960s that has been repeated in “poorly-designed studies” ever since, the report states.

Therefore, TMJ treatment that makes permanent changes to the bite — like installing braces or crowns or grinding teeth down — has “no supporting evidence,” according to the national academies report. The NIH warns that these TMJ treatments “don’t work and may make the problem worse.”

Dental splints, the most common TMJ treatment, also known as night guards or mouth guards, are removable dental appliances that are molded to fit over the teeth and can cost hundreds or even thousands of dollars out-of-pocket, according to the TMJ Association. Like most medical devices, splints generally go through the FDA’s 510(k) clearance process, which does not require each splint to be proven effective before it can be sold, according to the agency.

The national academies’ report states that splints produce “mixed results” for TMJ patients, and even when splints succeed at reducing jaw pain it is not understood why they work. Hundreds of splint designs exist, the report states, and some dentists reject research that challenges the use of splints unless it focuses on the specific design they prefer.

“Because of the hundreds of variations in [splint] design, it is unlikely that any study could ever be conducted that will be considered sufficient to a particular dentist with a pre-existing belief about the effectiveness of one appliance,” the report states.

Other treatments fare no better. The FDA has not labeled any drugs specifically for TMJ disorders, and pain medicines can be too weak or addictive to be a long-term solution, according to the TMJ Association. Botox injections may ease pain but have raised concerns about bone loss during animal testing. The NIH warns that minor surgeries that flush the jaw with liquid bring only temporary pain relief and that more complex surgeries should be reserved for severe cases because they have yet to be proved safe or effective in the long term.

To improve care, the national academies called for better education about TMJ disorders across medicine and dentistry and more research funding from the NIH, which has a “ripple effect” on research and training across the nation.

Since the 2020 report, the NIH has launched a TMJ research collaborative and increased annual research funding from about $15 million to about $34 million, D’Souza said. TMJ care was added to the standards that dental schools must teach to be accredited in 2022. The national academies launched an ongoing forum on TMJ disorders last year.

But TMJ funding still pales in comparison to other ailments. The NIH spends billions each year to research deadly diseases, like cancer and heart disease, that also afflict large numbers of Americans. It spends millions more on research of non-life-threatening conditions like arthritis, back pain, eczema, and headaches.

Mackey noted that much of the NIH’s spending is allocated by Congress.

“If Congress comes in and says, ‘We want to devote X amount of money to [TMJ],’ all of the sudden you will see an increase in money,” Mackey said. “So that’s my message to people out there: Raise your voices. Write your legislator.”

Total Jaw Replacement

Plagued by TMJ symptoms, and after failed treatments, some patients turn to a last resort: replacing their jaw joint with synthetic implants. Surgeons might replace the cartilage disk at the core of the joint or use “total joint replacement surgery” to fasten a metal hinge to the bones of the skull.

But the implants have a harrowing history: Several disk implants were recalled or discontinued in the ’90s due to dangerous failures. The FDA now classifies TMJ implants among its most closely monitored medical devices because the products on the market today can cause “adverse health consequences” if the devices fail, according to the agency’s website.

JENNY FELDMAN HAD 2 TOTAL JAW REPLACEMENTS

Two companies, Zimmer Biomet and Stryker, make the only total jaw replacement implants currently sold in the U.S.

Zimmer Biomet, which has made its implant for more than two decades, described it in email statements as “a safe and efficacious solution” for patients who need their jaw joint replaced, either due to TMJ disorders, failed surgeries, injuries, or other ailments. An FDA-mandated study completed in 2017 found about 14% of patients who get the Zimmer Biomet implant require additional surgery or removal within 10 years, said agency spokesperson Carly Pflaum.

Stryker, which in 2021 bought a company that made a total jaw replacement implant and now makes the implant itself, declined to comment. Although the NIH has advised TMJ patients to avoid surgery since at least 2022, Stryker launched a “patient-facing website” for the implant last year and is recruiting surgeons to be added to a “surgeon locator” feature on the site, according to posts on Facebook and LinkedIn.

A study of the Stryker implant’s success rate was mandated by the FDA and completed in 2020, but the agency has yet to make the results public.

D’Souza, the NIH official, said that based on her professional experience, she estimates that most total jaw replacement surgeries are ultimately ineffective.

“The success rate is low,” D’Souza said. “It is not very encouraging.”

Multiple patients provided KFF Health News and CBS News with medical records showing their total jaw replacement implants had to be removed due to malfunction, infection, or previously unknown metal allergies. Several patients said that since their implants were removed months or years ago, they have lived with no hinge in their jaw at all.

Kalinowski, the TMJ patient in Maine, has had portions of her jaw joint replaced six times, including receiving four implants. Her medical records show that the cartilage disk on her right side was replaced in 1986 with an implant that was later recalled and again in 1987 with another that was later discontinued. Her left and right disks were replaced in 1992 with a muscle flap and rib graft, respectively, and her entire right joint was replaced with yet another implant that was later discontinued in 1998. Both joints were replaced again in 2015, her records show.

Since then, Kalinowski said, her artificial jaw has functioned properly, although she remains in pain and cannot move her jaw from side to side. Her mouth hangs open when her face is at rest, and she drinks protein shakes for lunch because it’s easier than struggling with solid food.

But the “worst part,” Kalinowski said, is that her surgeries caused nerve damage on her lower face, and so she has not felt her husband’s kisses since the ’90s.

“If there was one moment in my life I could take back and do over again, it would be that first surgery. Because it set me on a trajectory,” Kalinowski said. “And it never goes away.”

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