Natural Herbs for Intractable Pain Syndrome

By Dr. Forest Tennant, PNN Columnist 

Intractable Pain Syndrome (IPS) is defined as constant pain with cardiovascular, metabolic and hormonal complications. IPS is caused by neuroinflammation inside the brain and spinal cord (central nervous system or CNS) that comes from excess electromagnetic energy generated by a painful disease or injury.

Excess electromagnetic energy activates an immune cell in the CNS called “microglia” to produce inflammation that then destroys tissue in the CNS. Unfortunately, tissue destroyed by inflammation impairs or damages the normal CNS mechanisms that shut off or cause pain to cease. A person may, therefore, develop constant (24/7) pain that overstresses the cardiovascular, metabolic and hormonal systems.

Tissue destruction in the CNS is well documented by brain scans. This relatively recent understanding of how neuroinflammation destroys CNS tissues and causes constant pain is arguably the most important discovery for pain treatment in the 21st Century. Why? We now have some ideas on how to treat IPS that can possibly cure or at least permanently reduce pain rather than just provide temporary, symptomatic relief. 

Treating CNS Inflammation 

When someone develops IPS, it is human nature to seek immediate pain relief and ignore its basic cause. If you have constant (24/7) pain, however, one must accept the fact that you have inflammation in the CNS that must be suppressed. Otherwise, you can reasonably assume that the pain will get worse.  

While research has documented that CNS inflammation may spread, it is unknown whether it ever “burns out.” As of yet, there is no blood or x-ray test to know if “burn out” may occur. This means that every person with IPS must take one or more anti-inflammatory agents to stop further tissue destruction and the worsening of pain. 

A problem when suppressing inflammation in the CNS is that only a few of the anti-inflammatory agents which are commercially available cross the blood brain barrier and enter the spinal fluid in sufficient amounts to be effective. This includes the non-specific anti-inflammatory drugs (NSAIDs) and corticosteroids.  

Benefits of Natural Herbal Products

Interestingly, natural products such as botanicals, herbs, enzymes and hormones tend to cross the blood brain barrier and provide anti-inflammatory activity. A well-known common example is aspirin (acetylsalicylic acid), which is derived from willow tree bark.

This has caused a great deal of interest in the use of natural products for suppression of CNS inflammation. Several research studies in both laboratory tests and animals have found that some natural agents do indeed suppress CNS inflammation.

To date, research has identified five herbs that suppress CNS inflammation. There are likely other natural products that suppress CNS inflammation, but this list is a good start:

1. Ginseng

2. Curcumin

3. Resveratrol

4. Ginger

5. Fisetin

Currently, there are very few controlled blind studies in humans to demonstrate the effectiveness of these herbal products. Personally, I have often seen considerable effectiveness of natural products in reducing the pain of IPS. Other anecdotal reports from patients and doctors are also starting to accumulate.

Precise dosages are unknown, but the manufacturer of each herbal product will have some starting instructions on the label. Herbal agents appear quite safe and have few reported side effects. Herbs can be taken with corticosteroids, opioids, naltrexone, electrical stimulators, neuropathic agents, and essentially all medication used for treatment of IPS.

At this time, we believe there is enough research and clinical experience to recommend both herbal, non-prescription as well as prescription anti-inflammatory agents to assist treatment of IPS. The time has come to treat IPS with a broader-based approach rather than just the use of symptomatic pain relievers.

Based on our current knowledge, IPS will likely get worse unless a person’s treatment program includes agents that suppress CNS inflammation.

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

$23 Billion Raised for Rare Disease Drug Development

By Roger Chriss, PNN Columnist

Monday, February 28 is Rare Disease Day, a global effort to recognize and raise awareness of rare diseases. The annual event has been held every year since 2008, but has taken on a new tenor amid Covid-19. Long Covid has become one of the biggest threats the coronavirus poses. But like rare diseases, long Covid is not often discussed in public health messaging about the pandemic.

The National Organization of Rare Disorders officially recognizes over 7,000 rare diseases. But the actual number is much higher. Each year some 250 new rare diseases are identified, and existing rare diseases like Charcot-Marie-Tooth disease and Ehlers-Danlos syndromes have new types and subtypes identified.

Rare diseases are often only familiar to the people who live with them and the specialists who treat them. For the goal of treatment to be met, rare diseases must be named and characterized. In Europe, a disease is classified as rare if it affects fewer than 1 in 2,000 people, while in the U.S. rare diseases are recognized as conditions that affect fewer than 200,000 people nationally.

They may be rare, but their impact is substantial. A recent study in the Orphanet Journal of Rare Diseases estimates that rare diseases affect 25 to 30 million people in the U.S. and more than 300 million people worldwide. Patients and their families have to endure a lengthy “diagnostic odyssey,” often at high financial and emotional cost.

The graphic below helps demonstrate the many barriers that a rare disease patient may encounter in getting a proper diagnosis, such as lack of knowledge about a disease, an overlap of symptoms, lack of diagnostic tests, and inaccurate test results.

According to the U.S. Government Accountability Office, the total cost of rare diseases in 2019 reached $966 billion, counting both direct medical costs and other indirect expenses such as loss of income. But research funding for rare disease has long been limited, in part because of the difficulty in diagnosing them.

Fortunately, that may be changing. A new report by the non-profit Global Genes estimates that nearly $23 billion was raised in 2021 from public and private sources to fund rare disease drug development. That’s a 28 percent increase over the money raised in 2020.

“Rare diseases continue to have a strong allure to investors, as evidenced by the significant capital raised in 2021 to advance companies and pipelines focused on rare conditions,” said Craig Martin, CEO of Global Genes. “We hope and expect that the sector will continue to be strengthened by the vast array of opportunities to advance promising biotechnologies, under expedited review, that can address the tremendous burdens and underlying causes of thousands of rare, genetic conditions currently without approved treatments.”

The past year saw many positive steps toward improving the diagnosis and treatment of rare diseases. Congress is considering the Speeding Therapy Access Today (STAT) Act of 2021,  which requires policy reforms at the FDA to speed up the development of treatments for rare diseases.

Although the STAT Act has yet to pass, the FDA has already taken action to address two rare diseases. The agency recently approved Pyrukynd (mitapivat) tablets to treat hemolytic anemia in adults with pyruvate kinase deficiency and Vyvgart (efgartigimod) for the treatment of generalized myasthenia gravis.

The past year also saw efforts to improve research and data collection for rare diseases. AllStripes added 100 rare disease research programs to its efforts, and RARE-X launched its initial set of data collection programs. And Rare Diseases International started its Collaborative Global Network for Rare Diseases to create a “a person-centered network of care and expertise” for people living with rare diseases.

But more work needs to be done. The EveryLife Foundation for Rare Diseases notes that 93% of rare diseases have no FDA-approved treatment. In some cases, the pathophysiology is not well understood and animal models do not even exist. In other cases, although the disease is known and treatments do exist, there are too few clinicians and too little financial support for patients.

For people with rare diseases, every day is “rare disease day.” Hopefully efforts to recognize and increase awareness of rare diseases will promote more progress in their diagnosis and treatment.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research. 

Closed Pain Clinics Were ‘Always Pushing Injections’

By Anna Maria Barry-Jester and Jenny Gold, Kaiser Health News

On May 13 of last year, the cellphones of thousands of California residents undergoing treatment for chronic pain lit up with a terse text message: “Due to unforeseen circumstances, Lags Medical Centers will be closing effective May 19, 2021.”

In a matter of days, Lags Medical, a sprawling network of privately owned pain clinics serving more than 20,000 patients throughout the state’s Central Valley and Central Coast, would shut its doors. Its patients, most of them working-class people reliant on government-funded insurance, were left without ready access to their medical records or handoffs to other physicians.

Many patients were dependent on opioids to manage the pain caused by a debilitating disease or injury, according to alerts about the closures that state health officials emailed to area physicians. They were sent off with one final 30-day prescription, and no clear path for how to handle the agony — whether from their underlying conditions or the physical dependency that accompanies long-term use of painkillers — once that prescription ran out.

The closures came on the same day that the California Department of Health Care Services suspended state Medi-Cal reimbursements to 17 of Lags Medical’s 28 locations, citing without detail “potential harm to patients” and an ongoing investigation by the state Department of Justice into “credible allegations of fraud.”

In the months since, the state has declined to elaborate on the concerns that prompted its investigation. Patients are still in the dark about what happened with their care and to their bodies.

photo by Kathleen Hayden (KHN)

Even as the government remains largely silent about its investigation, interviews with former Lags Medical patients and employees, as well as KHN analyses of reams of Medicare and Medi-Cal billing data and other court and government documents, suggest the clinics operated based on a markedly high-volume and unorthodox approach to pain management. This includes regularly performing skin biopsies that industry experts describe as out of the norm for pain specialists, as well as notably high rates of other sometimes painful procedures, including nerve ablations and high-end urine tests that screen for an extensive list of drugs.

Those procedures generated millions of dollars in insurer payments in recent years for Lags Medical Centers, an affiliated network of clinics under the ownership of Dr. Francis P. Lagattuta. The clinics’ patients primarily were insured by Medicare, the federally funded program for seniors and people with disabilities, or Medi-Cal, California’s Medicaid program for low-income residents.

Taken individually, the fees for each procedure are not eye-popping. But when performed at high volume, they add up to millions of dollars.

Take, for example, the punch biopsy, a medical procedure in which a circular blade is used to extract a sample of deep skin tissue the size of a pencil eraser. The technique is commonly used in dermatology to diagnose skin cancer but has limited use in pain management medicine, usually involving a referral to a neurologist, according to multiple experts interviewed. These experts said it would be unusual to use the procedure as part of routine pain management.

KHN used Medi-Cal records to assess the volume of services performed across the entire chain. But the state could not provide totals for how much Lags Medical was reimbursed because of California’s extensive use of managed-care plans, which do not make their reimbursement rates public. Where possible, KHN estimated the worth of Medi-Cal procedures based on the set rates Medi-Cal pays traditional fee-for-service plans, which are public.

Lags Medical clinics performed more than 22,000 punch biopsies on Medi-Cal patients from 2016 through 2019, according to state data. Medi-Cal reimbursement rates for punch biopsies changed over time. In 2019 the state’s reimbursement rate was more than $200 for a set of three biopsies performed on patients in fee-for-service plans.

Laboratory analysis of punch biopsies was worth far more. Lags Medical clinics sent biopsies to a Lags-affiliated lab co-located at a clinic in Santa Maria, according to medical records and employee interviews. From 2016 through 2019, Lags Medical clinics and providers performed tens of thousands of pathology services associated with the preparation and examination of tissue samples from Medi-Cal patients, according to state records. The services would have been worth an estimated $3.9 million using Medi-Cal’s average fee-for-service rates during that period.

In that same period, Medicare reimbursed Lagattuta at least $5.7 million for pathology activities using those same billing codes, federal data shows.

‘Assembly Line’ Pain Care

Much of the work at Lags Medical was performed by a relatively small number of nurse practitioners and physician assistants, each juggling dozens of patients a day with sporadic, often remote supervision by the medical doctors affiliated with the clinics, according to interviews with former employees. Lagattuta himself lived in Florida for more than a year while serving as medical director, according to testimony he provided as part of an ongoing malpractice lawsuit that names Lagattuta, Lags Medical, and a former employee as defendants.

Former employees said they were given bonuses if they treated more than 32 patients in a day, a strategy Lagattuta confirmed in his deposition in the malpractice lawsuit. “If they saw over, like, 32 patients, they would get, like, $10 a patient,” Lagattuta testified.

The lawsuit, filed in Fresno County Superior Court, accuses a Lags Medical provider in Fresno of puncturing a patient’s lung during a botched injection for back pain. Lagattuta and the other named defendants have denied the incident was due to negligent treatment, saying, in part, the patient consented to the procedure knowing it carried risks.

Hector Sanchez, the nurse practitioner who performed the injection and is named in the lawsuit, testified in his own deposition that providers at the Lags Medical clinic in Fresno each treated from 30 to 40 patients on a typical workday.

According to Sanchez’s testimony and interviews with two additional former employees, Lags Medical clinics also offered financial bonuses to encourage providers to perform certain medical procedures, including punch biopsies and various injections. “We were incentivized initially to do these things with cash bonuses,” said one former employee, who asked not to be named for fear of retribution. “There was a lot of pressure to get those done, to talk patients into getting these done.”

In his own deposition in the Fresno case, Lagattuta denied paying bonuses for specific medical procedures.

‘Injections, Injections, Injections’

Interviews with 17 former patients revealed common observations at Lags Medical clinics, such as crowded waiting rooms and an assembly-line environment. Many reported feeling pressure to consent to injections and other procedures or risk having their opioid supplies cut off.

Audrey Audelo Ramirez said she had worried for years that the care she was receiving at a Lags Medical clinic in Fresno was subpar. In the past couple of years, she said, there were sometimes so many patients waiting that the line wrapped around the building.

Ramirez, 52, suffers from trigeminal neuralgia, a rare nerve disease that sends shocks of pain across the face so severe it’s known as the “suicide disease.” Over the years, Lags Medical had taken over prescribing almost all her medications. This included not only the opioids and gabapentin she relies on to endure excruciating pain, but also drugs to treat depression, anxiety, and sleep issues.

Ramirez said she often felt pressured to get procedures she didn’t want. “They were always just pushing injections, injections, injections,” she said. She said staffers performed painful punch biopsies on her that resulted in an additional diagnosis of small fiber neuropathy, a nerve disorder that can cause stabbing pain.

She was among numerous patients who said they felt they needed to undergo the recommended procedures if they wanted continued prescriptions for their pain medications. “If you refuse any treatment they say they’re going to give you, you’re considered noncompliant and they stop your medication,” Ramirez said.

She said she eventually agreed to an injection in her face, which she said was administered without adequate sedation. “It was horrible, horrible,” she said. Still, she said, she kept going to the office because there weren’t many other options in her town.

Lagattuta, through his lawyer, declined a request from KHN to respond to questions about the care provided at his clinics, citing the state investigation. “Since there is an active investigation, Dr. Lagattuta cannot comment on it until it is completed,” attorney Matthew Brinegar wrote in an email. Lagattuta’s license remains in good standing, and he said in his deposition in the Fresno lawsuit that he is still seeing patients in California.

Experts interviewed by KHN noted that medical procedures such as injections can have a legitimate role in comprehensive pain management. But they also spoke in general terms about the emergence of a troubling pattern at U.S. pain clinics involving the overuse of procedures. In the 1990s and early 2000s, problematic pain clinics hooked patients on opioids, then demanded cash to continue prescriptions, said Dr. Theodore Parran, who is a professor of medicine at Case Western Reserve University and has served as an expert witness in federal investigations into pain clinics.

“What has replaced them are troubled pain clinics that hook patients with the meds and accept insurance, but overuse procedures which really pay well,” he said. For patients, he added, the consequences are not benign.

“I mean they are painful,” he said. “You’re putting needles into people.”

Cash Bonuses for Procedures

Before moving to California in 1998, Dr. Francis Lagattuta lived in Illinois and worked as a team doctor for the Chicago Bulls during its 1995-96 championship season. Out West, he opened a clinic in Santa Maria, a Latino-majority city along California’s Central Coast known for its strawberry fields, vineyards, and barbecue. From 2015 to 2020, the chain grew from a couple of clinics in Santa Barbara County to dozens throughout California, largely in rural areas, as well as far-flung locations in Washington state, Delaware, and Florida.

The California portion of the chain is organized as more than two dozen corporations and limited liability corporations owned by Lagattuta. His son, Francis P. Lagattuta II, was a manager for the company.

On the Lags Medical website and in conversation with employees, the elder Lagattuta claimed he was on the vanguard of diagnosing and treating small fiber neuropathy. Much of the website has now been taken down. But pages available via an archival site claim he had pioneered a three-pronged approach to pain management that made minimal use of opioids and surgeries, instead emphasizing testing, injections, mental health, diet, and exercise.

“In keeping with his social justice values, Dr. Lagattuta plans to share these findings to the rest of the world, hopefully to help solve the opioid crisis, and end suffering for millions of people struggling with pain,” touted a biography once highlighted on the website.

Dr. Francis Lagattuta (Twitter)

Numerous Lags Medical patients interviewed by KHN said that even when they were given punch biopsies and a subsequent diagnosis of neuropathy, their treatment plan continued to involve high doses of opioid medications.

Dr. Victor C. Wang, chief of the division of pain neurology at Brigham and Women’s Hospital in Boston, said punch biopsies are occasionally used in research but are not a standard part of pain medicine. Instead, small fiber neuropathy is usually diagnosed with a simple clinical exam.

“The treatment is going to be the same whether you have a biopsy or not,” said Wang. “I always tell the fellows, you can do this test or that one, but is it really going to change the management of the patient?”

Ruby Avila, a mother of three in Visalia, remembers having the punch biopsies done at least three times during her four years as a Lags Medical patient. “I have scars down my leg,” she said. Each time, she said, providers removed a set of three skin specimens that were used to diagnose her with small fiber neuropathy.

Avila, 37, who has lived with pain since childhood, had found it validating to finally have a diagnosis. But after learning more about how common the biopsies were at Lags Medical, she was shaken. “It’s overwhelming to hear that they were doing it on a lot of people,” she said.

Sanchez, the nurse practitioner named in the Fresno lawsuit, spoke of other procedures that garnered bonuses: “Trigger point injections, knee injections, hip injections, foot injections for plantar fasciitis and elbow injections” all qualified for $10 bonuses, he said in his testimony.

Two former employees, who asked not to be named, echoed Sanchez, saying they were incentivized to do certain procedures, including injections and punch biopsies.

In his testimony in the Fresno case, Lagattuta denied paying bonuses for procedures. “It was only for the patients,” he said. “We never did it based on procedures.”

Incentive systems for a specific procedure are “completely unethical,” said Dr. Michael Barnett, an assistant professor of health policy at Harvard. “It’s like giving police officers a quota for speeding tickets. What do you think they’re going to do? I can’t think of any justification.”

Dr. Carl Johnson, 77, is a pathologist who directed Lags Medical’s Santa Maria lab from 2018 to 2021. Johnson said the only specimens he looked at came from punch biopsies, the first time in his long career as a pathologist that he had been asked to run such an analysis. On an average day, he said, he examined the slides of about 40 patients, searching for signs of small fiber neuropathy. Lagattuta gave him papers to read on peripheral neuropathy and assured him they were on the cutting edge of care for pain patients.

Johnson said he “never thought there was anything untoward going on” until he arrived on his last day and was told to pack up his belongings because the entire operation was shutting down.

Nerve Ablations and Drug Tests

Lags Medical performed other procedures at rates that also set them apart. From 2015 through 2020 — the span for which KHN had state data — Lags Medical performed more than 24,000 nerve ablations, a procedure in which part of a nerve is destroyed to reduce pain, on Medi-Cal patients. That’s more than 1 in 6 of all nerve ablations billed through Medi-Cal during that period.

An analysis of federal data also shows Lagattuta was an outlier. For example, in 2018 he billed Medicare for nerve ablations more often than 88% of the doctors in his field who performed the procedure.

Lags Medical also used the in-house lab to run drug tests on patients’ urine samples. From 2017 through 2019, Lags Medical facilities often ordered the most extensive — and expensive — set of drug tests, which check for the presence of at least 22 drugs, according to state and federal data.

For perspective, in 2019, more than 23,000 of the most extensive drug tests were ordered on Medi-Cal patients under Lagattuta’s provider number, more than double the number tied to the next highest biller. The next five top billers were all lab companies.

Overall, from 2017 through 2019, nearly 60,000 of the most extensive drug tests were billed to Medicare and Medi-Cal under Lagattuta’s provider number. Medicare reimbursed Lagattuta $5.4 million for these tests during that period. Using state fee-for-service rates, the testing billed to Medi-Cal would have been worth an estimated $6.3 million. That doesn’t include less extensive drug screens or those billed under other providers’ numbers.

Pain management experts described the use of extensive screening as unnecessary in routine pain treatment; the overuse of such tests has been the subject of numerous Medicare investigations in recent years.

Private pain clinics like Lags Medical are only loosely regulated and generally are not required to hold a special license from the state. But the physicians who work there are regulated by the Medical Board of California.

In December 2019, a patient who’d visited clinics in both Visalia and the Central Coast filed a complaint against Lagattuta with the medical board claiming, among other things, that she received biopsies that were not properly performed, that she underwent excessive testing, and that positive drug tests had been falsified. The medical board had another pain management doctor review more than 300 pages of documents and found “no deviations from the standard of care” and “did not find any over testing, or improperly performed biopsies.”

He did, however, find some record-keeping problems, including numerous procedures in which patient consent was not documented. He also found instances in which procedures were performed and repeated without documentation that they were effective. The patient who filed the complaint was given a medial branch nerve block in November 2014, followed by a radiofrequency ablation in December, and another in February. No improvements for the patient were ever noted in the charts, the investigating doctor found.

The medical board chalked it up to a record-keeping error and fined Lagattuta $350.

Opioids Needed for ‘Halfway-Normal Life’

On a warm evening in late July, Leah Munoz drove her power wheelchair around the long plastic tables at the Veterans Memorial Building in Hanford, a dusty farm town in California’s Central Valley. Senior bingo night was crowded with gray-haired players waiting for the game to begin. She found an empty spot and carefully set out $50 worth of bingo cards, alongside her collection of 14 brightly colored daubers.

Munoz, 55 and a mother of six, said she has suffered from a litany of illnesses — thyroid cancer, breast cancer, lupus, osteoarthritis — that leave her in near-constant pain. She’s been playing bingo since she was a little girl, and said it helps distract from the pain and calm her mind. She looks forward to this event all week.

Munoz was a Lags Medical patient for about four years and, while her pain never disappeared, the opioids prescribed provided enough relief for her to continue doing the things she loved. “There’s a difference between addiction and dependence. I need it to live a halfway-normal life,” Munoz said.

leah and ramon munoz

After Lags Medical closed in May, her primary care doctor initially refused to refill her opioid prescriptions. She said she called the Lags Medical offices to try to get a copy of her medical records to prove her need, and even showed up in person. But she said she was unable to get them. As the pills dwindled and the pain surged, Munoz said, it became hard to leave her home. “I missed a lot of bingo, a lot of grocery shopping, a lot of going to my grandkids’ birthday parties. You miss out on life,” she said. Ultimately, she said, her primary care doctor referred her to another pain clinic, and she was able to resume her prescription.

Even with pain medications, Munoz said, she never received true relief during her time as a patient at Lags Medical. She said she felt coerced to get several injections, none of which seemed to help. “If I didn’t get the procedures, I didn’t get the pain medication,” she said. Her husband, Ramon, a landscaper who was also a patient, received an injection there that he said left him with permanent stiffness in his neck.

Munoz knows at least five other people at bingo night who were former patients at Lags Medical. One of them, Rick Freeman, came over to her table to chat. He swayed back and forth as he walked, his knees, he explained, swollen after 35 years living with HIV. At Lags Medical, Freeman said, he felt pressured by staff to receive injections if he wanted to continue receiving his opioid prescriptions. “If you don’t cooperate with them, they would reduce your meds down,” he said.

At the front of the room, Gail Soto, who ran the event, sold bingo cards to the latecomers. Soto, 72, said she injured her back while working an administrative job at a construction company years ago and suffers from spinal stenosis, rheumatoid arthritis, and fibromyalgia. She, too, was a patient at Lags Medical for years. In addition to her opioid prescription, Soto said, she received repeated injections and three nerve ablations. At first, the ablations helped, but what staff members didn’t tell her, she said, was that the nerves they destroyed could grow back. Ultimately, she said, the procedures left her in worse pain.

Soto’s biggest concern is the spinal stimulator that she said Lags Medical surgically inserted into her back five years ago. She said the doctors told her the device would work so well that she would no longer need her pain pills. She said they didn’t explain that the device would work only two hours a day, and on one side of her body. She remained in too much pain to give up her meds, she said, and, five years later, the battery is failing.

Soto sleeps in a recliner chair in her three-bedroom mobile home in Lemoore, another small city near Hanford. It’s well kept but humble, and she and her husband keep a collection of wind chimes on the front porch that create a wave of gentle music when a breeze passes by.

The couple take good care of each other and their two beloved Chihuahuas, but life has become increasingly difficult for Soto. As the battery on her spinal stimulator has started to fail, she said, she has sudden electrical pulses that shoot up her body.

GAIL SOTO

“My husband says sometimes when I sleep that my body will just jump up in the air,” she said. But now that Lags Medical is closed, she said, she can’t find a doctor willing to remove the device. “Most doctors are telling me right now, ‘We can’t, because we didn’t [put it in]. We don’t want nothing to do with that.’”

Waitlists and Withdrawal

Audrey Audelo Ramirez said she picked up her final refill from Lags Medical on June 4 and by July 4 had no meds left to treat her pain. Ramirez said she called every pain management clinic in Fresno, but none were taking new patients.

“They left us all high and dry,” she said. “Everybody.”

In the weeks that followed the closures, county officials throughout the Central Valley saw a flood of patients on high doses of opioids in search of new providers, they said. Patients couldn’t access their medical records, so other providers had no idea what their treatments had been.

“We had to create a crisis response to it because there was no organized response at that time,” said Dr. Rais Vohra, the interim health officer for Fresno County.

Fresno County’s health system is already lean, Vohra said. Toss in this abrupt closure and you end up in the kind of crisis rarely seen in other fields of medicine: “You’d never do this with a cancer clinic,” he said. “You’d never abruptly stop chemo.”

The state asked Dr. Phillip Coffin, director of substance abuse research for the San Francisco Department of Public Health, to run provider training and persuade doctors to take on new patients. Many practices have rules against taking new patients on opioids, or will refuse to prescribe doses above certain thresholds.

“We know that when you stop prescribing opioids, some people end up with death from suicide, overdose, increased illicit opioid use, pain exacerbations. It’s really important to have a continuity, and that is not really possible in the current opioid-prescribing culture,” Coffin said. The threat to patients is so severe that the FDA issued a warning in 2019 against cutting patients off from prescription opioids.

Gina, a retired nurse who asked to be identified by only her first name for fear she’d be discriminated against by other doctors, had been a Lags Medical patient for six years. She said she called every practice she could find in her Central Coast town, and was put on a waiting list at one. Suffering from a severe case of scoliosis, she started rationing the pain pills she had come to rely on.

When she finally secured an appointment, she said, she was told by the doctor she was on “some very strong meds” and he would fill only one of her two prescriptions. “You’re like a criminal,” she said. “You’re branded as ‘we don’t trust you.’”

She started experiencing withdrawal symptoms — sweating, lost appetite, sleeplessness, anxiety. Worst of all, her pain “came back with a vengeance,” she said.

“I think about this, what I’d have been like if I’d never gone through pain management. I sometimes wonder if I’d be better off.”

As for Ramirez, her primary care doctor finally secured an appointment for her at another pain clinic, she said. It was in the same space as the old Lags Medical clinic, and she said she recognized many of the staff members. But now there was a new name: Central California Pain Management. From her perspective, it was as if nothing had changed. And she still doesn’t know whether she needs to worry about the care she received during more than four years at Lags Medical.

This story was produced by Kaiser Health News. Senior correspondent Jordan Rau and Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

I Was Mask Shamed for Having Invisible Illness

By Carol Levy, PNN Columnist

For years I have worn shirts on which I write my political position. I love wearing them. And I wear them proudly. But since the onset of covid and masking, I have worn a different shirt that reads:

“Can’t mask due to medical issue. Trigeminal neuralgia. I have a doctor's note. I am fully vaccinated and boosted.”

This shirt I do not wear proudly. My medical situation is no one's business but my own. But to keep people from yelling at me, I wear the shirt. And it works. People are usually nice about it.

That was not the case when I went to my local hospital for a blood test. Since covid, if I needed to go to the hospital, I called first to tell them, “I can't mask due to a medical issue. Will this be a problem?”

I was told I had to get permission from administrators, but ultimately got the go-ahead to come in.  I’ve been to the hospital a few more times for tests. Each time they let me in with no or little fuss, so when I had to go the last time, I did not call first.

The welcome desk receptionist signed me in, no issue. The registrar signed me in, no issue. I sat for about 20 minutes, noticed by employees and ignored by them, while waiting for my name to be called.

Then a woman dressed in medical scrubs came over to me with a mask in her hand. She did not take me aside. She confronted me right in front of other patients: “You have to wear a mask or leave.”

“No, I can't wear a mask for medical reasons,” I told her. “In fact, I have been in here two or three times with no problem.”

She reiterated: “You have to put on a mask.”

“No, I can't mask. I have a facial pain disorder and can't wear a mask. That why I wear this shirt,” I said, pointing to my shirt.

Another woman joined the fray: “You have to leave if you won’t mask.”

I was getting angry. “I have trigeminal neuralgia. Do you know what that is? Are you nurses?” I asked. “If not, go look it up. I can't wear a mask. And I have come here a few times since covid with no problem about my not being able to mask. Do you think I like wearing this shirt?  You shouldn’t be talking to me like this in a public setting.”

The two women walked away, only to call me back a few minutes later, into a room that was still within earshot and view of other patients. A man in lab clothes had joined them. The woman in purple scrubs (I found out later neither she nor the other woman were nurses or medical people) held out a plastic shield, “You can wear this.”  

I felt defeated, but no one was going to force me to set off the pain by wearing a shield. “No, I told you. I can't have anything on my face.” 

She pushed the plastic shield towards me. “You have to wear one of these then.”

I was trying to remain calm. “Do you know what trigeminal neuralgia is? There is a reason they call it the worst pain known to man and the suicide disease.”  

She continued to insist, “You have to mask.” Then the man spoke up.  "I'm the lab tech.  I won't let you in the lab or take your blood unless you mask.”   

Finally, for some unbeknownst reason, they capitulated. Immediately after registration I was told to walk to the lab. The technician who stated unequivocally that he wouldn't let me into the lab or take my blood did both. 

It was a horrid experience, humiliating because it was done publicly. Mortifying in that I had to defend having pain from an invisible illness. Despicable in that I was forced to fight to stop them from demanding I make the pain worse. Just one more unanticipated horror of being a chronic pain patient.  

Had I said, “I can't mask. I have a lung issue,” and they saw an oxygen tank, chances are good I would have been left alone or quickly taken care of. 

But I said I had something they couldn't see and had never heard of. To them it seemed bizarre. “You can’t touch your face without pain?” That must be made up. 

In the world of covid, how much extra do we have to endure?   I ask myself, often, will there ever be a time, covid or not, when I won't have to explain myself?

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.

Revised CDC Opioid Guideline a ‘Band Aid for a Stab Wound’

By Emily Ullrich, Guest Columnist

After years of state sanctioned torture, people in pain have finally received a small reprieve from the Centers for Disease Control and Prevention, in the form of a revised draft of the agency’s opioid prescribing guideline.

In the new draft, the CDC acknowledges some of the harm inflicted by its 2016 guideline, by adding language that gives doctors more flexibility in prescribing opioids and encourages them to practice “individualized patient centered care.”

While this perspective is a welcome departure from the original guideline, we need to go further. As a disabled chronically ill patient, I have personally experienced the stigma and misinformation that comes with being prescribed opioids. As a patient advocate, I’ve also watched in horror as an untold number of suffering patients deprived of opioids committed suicide.

There are four main issues that still need to be addressed by the CDC. The first is that many patients on long-term opioid therapy have rare diseases such as Complex Regional Pain Syndrome (CRPS) and Ehlers-Danlos syndrome. Because these and other incurable illnesses aren’t even mentioned in the guideline, it is assumed that most pain patients have treatable conditions such as low back pain or acute injuries that will improve with time. This is not the case. There is a large segment of the patient population that cannot be cured. For them, symptom management with opioid medication is their only option.

Second, it’s important to emphasize that all patients are different. Individual factors like genetics, metabolism, tolerance and more can determine how opioids affect a patient.  A dose that may be “a lot” for one patient might be very ineffective and too low a dose for others.

Third, because of the harms that have been imposed upon pain patients, it is extremely important that providers be advised to treat them with compassion and respect.  Stigma, shame and puritanical morals-based thinking that paints people with pain as having “character flaws” only inflicts more harm and makes it more difficult for them to get help.

Finally, although the CDC has abandoned its previous recommendation that daily opioid doses not exceed 90 morphine milligram equivalents (MME), I can't help but notice new language in the guideline draft that cautions doctors about exceeding 50 MME, a dose that is low for many patients. I fear that 50 MME will be taken above all the other verbiage of the 2022 guideline and be enforced as the new hard limit.

The revised guideline is a small step in the right direction, but patients need more than a band aid for a stab wound.

Emily Ullrich lives with CRPS, Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, endometriosis, Interstitial Cystitis, migraine, fibromyalgia, osteoarthritis and chronic pancreatitis.

Pain Patients Have Low Rates of Illicit Drug Use

By Pat Anson, PNN Editor

Anti-opioid activists have long claimed that opioid medication is a gateway drug to heroin and other street drugs. That myth is so ingrained in the medical community that many pain patients are discriminated against by doctors and pharmacists, who suspect they are abusing their medication or using illicit drugs.

But a large new study by Millennium Health pokes a hole in that myth, finding that patients being treated in pain management practices are far less likely to use heroin, fentanyl, cocaine and methamphetamine than other patients.

The drug testing firm analyzed the lab results of two million urine tests from 2015 to 2021 – nearly 600,000 coming from pain patients -- and found that patients seeing primary care physicians, behavioral health doctors (psychiatrists and psychologists), or getting substance use disorder (SUD) treatment were significantly more likely to test positive for street drugs than patients of pain management providers.

SOURCE: MILLENNIUM HEALTH

“That’s one of the reasons why we decided to put this out there in the public domain, because it’s important. Because clearly there are differences across these groups,” said Eric Dawson, PharmD, Vice President of Clinical Affairs at Millennium Health.

For example, the positivity rate for fentanyl in urine samples is about 2% for pain management patients – a level that remained stable throughout the 6-year study period.

But Millennium found that for primary care and behavioral health patients, the positivity rate for fentanyl has ticked up to about 5 percent.

In patients getting SUD treatment, the positivity rate has skyrocketed to about 17 percent, no doubt a reflection of the growing presence of illicit fentanyl in street drugs.

Positivity rates for methamphetamine are also rising for most patients – but not for pain patients – while cocaine use has remained relatively flat. Positivity rates for heroin have declined steadily for all patients since 2015, according to Millennium.

“Generally speaking, the pain population that’s treated with opioids is an older population and uses illicit drugs at a very low rate,” said Steven Passik, PhD, VP of Scientific Affairs and Head of Clinical Data Programs at Millennium.

“Not only are they low, they remain low,” says Dawson. “So many of the other groups, over time their positivity rates are increasing. The pain population started low and remains low. And that says they are different than the other groups.”

What makes the findings even more striking is that they include the first two years of the covid pandemic, a time when stress, isolation and depression led many people to abuse drugs.

“But that did not happen in the pain patients. You can actually see that,” says Passik, who believes regular drug testing makes pain management patients less likely to take risks that might affect their healthcare. He thinks the Millennium study should be reviewed by both providers and policymakers to get a better understanding of people in pain.

“There isn’t that much data like this out there. I think it’s unique and very positive about this population. And I think that should be factored in when people are talking about access to opioids,” Passik told PNN.

In addition to fentanyl, heroin and other street drugs, the Millennium study also looked at positivity rates for marijuana, which have soared in recent years due to the legalization of medical and recreational cannabis in many states. By the end of 2021, the positivity rate for cannabis had reached nearly 32 percent for most patients. But, like the other drugs, cannabis use remained relatively low for pain patients.  

Study Finds Low Risk of Muscle Pain From Statins

By Pat Anson, PNN Editor

Have you experienced muscle pain, memory loss or other side effects from statins? If so, you’re not alone. A many as one in two patients stop taking the cholesterol-lowering drugs because they don’t like the side-effects.

But the authors of a large new study say statin intolerance is over-estimated and over-diagnosed, resulting in too many patients raising their risk of heart disease because they refuse to take the drugs.

An international team of researchers conducted a meta-analysis of 176 clinical studies involving over 4 million statin users and found that only about 9 percent have statin intolerance. Their findings are published in the journal European Heart Journal.

“I believe the size of our study, which is the largest in the world to investigate this question, means we are able to finally and effectively answer the question about the true prevalence of statin intolerance,” said lead author Maciej Banach, MD, a cardiologist and professor at Medical University of Lodz and the University of Zielona Góra in Poland.

“Patients need to know that statins may prolong their life, and in cases where side effects appear, we have enough knowledge to manage these effectively. The most important message to patients as a result of this study is that they should keep on taking statins according to the prescribed dose, and discuss any side effects with their doctor, rather than discontinuing the medication.”

The research team found that patients who are older, female, obese, diabetic, or suffering from an under-active thyroid or chronic liver or kidney failure were more likely to be statin intolerant.

Patients taking drugs used to control an irregular heartbeat or calcium channel blockers for chest pain and high blood pressure were also more likely to have side effects, as did those with high alcohol consumption.

“It is critically important to know about these risk factors so that we can predict effectively that a particular patient is at higher risk of statin intolerance. Then we can consider upfront other ways to treat them in order to reduce the risk and improve adherence to treatment. This could include lower statin doses, combination therapy and use of innovative new drugs,” said Banach. 

“Most cases of statin intolerance observed in clinical practice are associated with effects caused by patients’ misconceptions about the side effects of statins or may be due to other reasons. Therefore, we should carefully evaluate symptoms, assessing in detail patients’ medical histories, when the symptoms appeared, specific details of pain, other medications the patients are taking, and other conditions and risk factors. Then we will see that statins can be used safely in most patients.”

Previous research on side effects from statins have had mixed results. A 2017 study found that only about 2 percent of patients on Lipitor (atorvastatin) had muscle pain. That finding is in marked contrast to a Cleveland Clinic study, which found that 42% of patients taking Lipitor reported muscle pain and weakness.

In 2014, the Food and Drug Administration required warning labels on statins, cautioning that statins can cause a muscle injury called myopathy, which is characterized by muscle pain or weakness. In rare instances, the FDA says statins can also cause liver injury, diabetes and memory loss.

A Painful Shift in News Coverage

By Roger Chriss, PNN Columnist

Chronic pain has not gone away. But media coverage of it has dropped off. Not only are there fewer news stories about chronic pain, but the focus has shifted. Most stories about opioids these days deal with lawsuits and overdoses, not how they are helpful in treating pain.

U.S. media coverage and public interest in chronic appears to be trending downward. According to Google Trends, the number of web searches using the term “chronic pain” peaked in 2018 and have dropped to levels of a decade ago.

Google searches for “opioids” also peaked in 2018 and are now trending downward.

Searches for “medical cannabis” are likewise trending downward. The focus of news coverage is also changing. Stories today about medical cannabis tend to look at legislation and business, not whether cannabis is useful for medical conditions.

Even the opioid crisis turns out not be so interesting anymore. Google Trends shows searches for “opioid crisis” peaking in 2017 and a steep decline ever since.

There is, fortunately, some ongoing interest in pain management. Google Trends shows only a slight decline in searches for “pain management” in recent years.

Americans are losing interest in not only opioids and pain, but also addiction and public health. In 2018, according to Pew Research, 42% of U.S. adults said drug addiction was a major problem in their community. By October 2021, only 35% said that.  

It would be easy to attribute this to the pandemic. But Americans are losing interest in that, too. Surveys taken as the Omicron variant crested early this year across the U.S. showed that more Americans now believe we should “learn to live” with the pandemic and “get back to normal,” rather than treat it as an ongoing public health emergency.  

“The findings come at a possible turning point in the pandemic, as several Democratic governors announced intentions to ease some mask mandates over the next month. The growing frustration with pandemic restrictions may help explain some of those early announcements — even as cases reach record levels,” Press News Agency reported. 

But the prevalence of chronic painful disorders has not changed. In fact, the problem is getting worse because long Covid is fast becoming a new painful long-term illness for millions of people  And the pain of cancer, trauma and life-limiting chronic illness remains the same. But there is, sadly, less and less interest in the subject. 

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research. 

FDA Urged to Regulate Poppy Seeds

By Pat Anson, PNN Editor

A consumer advocacy group is once again calling on the Food and Drug Administration to establish and enforce regulations that limit opiate contamination of poppy seeds.

Over a year ago, the Center for Science in the Public Interest (CPSI) petitioned the FDA to set a safe threshold for opiate alkaloids in imported poppy seeds, most of which come from Afghanistan. The tiny black seeds can become contaminated with trace amounts of codeine, morphine and other opiates when they are harvested from opium poppies.

Washed poppy seeds are often found in baked goods, but drug users have found they can use unwashed seeds to make a potent homemade tea. PNN has reported that some pain sufferers use the tea as an analgesic, although the bitter brew is mostly consumed by people who simply want to get high.     

In its petition, CSPI cited a study estimating that 19 people in the U.S. suffered fatal overdoses involving poppy seeds in recent years.

In a letter recently sent to the FDA Center for Food Safety and Applied Nutrition, CSPI renewed its call for the agency to take action to prevent more deaths.

“The time is overdue for the FDA to establish standards that will protect U.S. consumers from ingesting dangerous levels of opiates through the food supply,” wrote Peter Lurie, MD, President of CSPI wrote.  

The European Food Safety Authority established maximum levels of morphine and codeine in poppy seeds last year, which are scheduled to take effect in July.

In 2019, the U.S. Drug Enforcement Administration classified unwashed poppy seeds as a Schedule II controlled substance and closed a loophole that allowed them to be sold legally in the U.S.  

Enforcement actions since then have been scant. In October 2021, federal regulators filed a civil forfeiture action against an Oklahoma bakery to halt the sale of unwashed seeds. But within a few weeks the company was selling them again on its website, with a disclaimer saying the seeds “may contain trace amounts of opiate alkaloid residue” and should be thoroughly washed before consuming.

To date, the only action the FDA has taken on the CSPI petition was to post a notice in the Federal Register asking for public comment on the need for poppy seed regulation. Over 3,000 people responded, most of them supporting the petition. Asked to comment on the CSPI’s new letter, an FDA spokesperson said the issue remains under review.

“As part of our review of CSPI’s petition, we are considering the points raised in the petition and the over 3,200 comments submitted to the docket. The FDA has been engaging with other federal partners in this effort to help protect the public’s health,” the spokesperson told PNN in an email. 

To be clear, consuming unwashed poppy seeds is risky. Home brewers usually have no way of knowing where the seeds came from or how heavily they are contaminated with opiates. The Internet is filled with cautionary stories from illicit drug users who nearly overdosed or became addicted to the tea and went into withdrawal when they tried to taper.

“I woke up yesterday with a migraine (that’s typical when I quit) and by the afternoon the withdrawals had started: sweating, anxious, can’t get comfortable, want to crawl out of my skin,” a person recently posted on Reddit. “I want to get off this merry go round. I feel like my brain is totally normal except that little piece that is constantly scheming where my next opiates are coming from. They don’t even make me high, they just make me feel ‘normal’, so what’s the point? I want to be free of this.”

For people in pain, there’s an added risk to poppy seeds. A recent study found that consuming just few seeds in a muffin or bagel could result in a positive drug test – a finding that could get a patient taken off opioids or dismissed by their doctor.

Why CDC Dropped One-Size-Fits-All Approach to Pain Care

By Pat Anson, PNN Editor

The reaction from patients, advocates and the medical community to a revised draft of the CDC’s opioid guideline has largely been positive, with many cheering the flexibility it gives doctors in deciding whether to prescribe opioids for pain.  

Although voluntary and only intended for primary care physicians, the original 2016 guideline’s dose limits became hard thresholds for doctors in all specialties, who feared scrutiny from regulators and law enforcement if they didn’t follow them. The revised draft still recommends caution when prescribing opioids, but emphasizes that physicians should use their own judgement.

“Treating pain is complex. There are a variety of factors at play. And we know that patients respond differently to different types of pain. We tried to incorporate that nuance so that we’re not coming out with something that’s a one-size-fits-all. It really needs to be individualized and flexible,” said Christopher Jones, PharmD, Acting Director of the CDC’s National Center for Injury Prevention and Control.”

People who’ve been closely following the guideline process were surprised at how extensive the changes are. At a July 2021 public meeting, an independent panel advising the CDC expressed alarm that the agency seemed intent on keeping a recommendation that opioid doses be limited to no more than 90 morphine milligram equivalents (MME) per day.

In the last six months, that dose threshold was taken out of the revised draft, which was published Thursday in the Federal Register.

“It was exciting to open up the draft and see a significant pivot,” said David Dickerson, MD, who chairs the American Society of Anesthesiologists’ Committee on Pain Medicine. “I think the CDC authors have acknowledged that they wanted to do it different this time.”

Dickerson was not only pleased to see the 90 MME threshold go away, but a stronger focus on the many different types of pain, whether its temporary acute pain from surgery or chronic pain from a disabling, incurable disease.  

“I think the text of this manuscript is really well done in its draft form right now. When I read through it, it was a great refresher and highlighted some studies that perhaps I had missed,” Dickerson told PNN. “They are instructive, they’re specific, but they also have an intentional vagueness to them to allow for clinicians to practice medicine.”

Importantly, the guideline also makes clear that it shouldn’t be used by third parties to dictate how pain should be treated.

“This voluntary clinical practice guideline provides recommendations only and is intended to be flexible to support, not supplant, clinical judgment and individualized, person-centered decision-making. This clinical practice guideline should not be applied as inflexible standards of care across patient populations by healthcare professionals, health systems, pharmacies, third-party payers, or state, local, and federal organizations or entities.”

“States and insurers have turned the guideline into laws and unbending regulations, preventing physicians from treating patients as individuals with specific needs,” Bobby Mukkamala, MD, Chair of the American Medical Association’s Board of Trustees, said in a statement. “The list of misapplications of the 2016 guideline is long, and its impact has been tremendous harm.

“The CDC’s new draft guideline — if followed by policymakers, health insurance companies and pharmacy chains — provides a path to remove arbitrary prescribing thresholds, restore balance and support comprehensive, compassionate care.”

Nearly 40 states have codified the 2016 guideline in some way, often by limiting the number of opioid pills that can be dispensed for an initial prescription to seven days’ supply or less.  Dickerson hopes those states will review and revise their laws and regulations to better reflect what the CDC recommends in its revised draft – that enough opioids be prescribed for “the expected duration of pain.”

“We should right-size our care for the individual patient and be procedure specific. Before it was one-size-fits-all, three to seven days’ (supply),” Dickerson said.  

He also thinks the Department of Justice (DOJ) and Drug Enforcement Administration (DEA) should reconsider their aggressive prosecution of doctors for prescribing high doses.

“The work that the DOJ and DEA is doing, I want to believe is done in good intent,” he said. “I think that many of their cases will look at the prescriptions or the doses, but they might not look at the context for why the patient was receiving that care or why they were receiving those medicines.”   

The CDC is not expected to finalize its draft guideline until late this year. You can read the guideline and leave an online comment in the Federal Register by clicking here. Comments must be received by April 11.

Revised CDC Opioid Guideline Gives Doctors More Flexibility

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has released a long-awaited draft revision of its 2016 opioid prescribing guideline, making significant changes to recommendations so that healthcare providers have more flexibility in how they manage pain.  

Although voluntary and only intended for primary care physicians treating chronic pain, the original guideline was widely misapplied as a rigid “standard of care” by many states, insurers, providers and law enforcement, causing millions of patients to be taken off opioids or forcibly tapered to lower doses. As result, many went into withdrawal, became bedridden and disabled, committed suicide or were abandoned by their doctors. And while opioid prescribing declined, drug overdoses soared to record levels.  

“We certainly have learned and recognized the harm that has resulted when aspects of the 2016 guideline have been applied as inflexible, rigid standards that really go beyond the intent of what we wanted to occur,” said Christopher Jones, PharmD, Acting Director of the CDC’s National Center for Injury Prevention and Control. “We wanted to be very clear in this guideline that this is a clinical tool. It’s intended to support individualized patient centered care.

“There is a role for opioids in pain management and if the decision between a provider and a patient is to use them, here’s how we think that can be done in a safe manner.”

The updated draft guideline has been published in the Federal Register, where it will be available for public comment for 60 days. A final revised document is not expected until late this year.

Perhaps the most significant change to the guideline is the elimination of dose thresholds. The original guideline strongly encouraged providers not to exceed daily opioid doses of 90 morphine milligram equivalents (MME).

The revised guideline still maintains that opioids should not be used as first-line or routine therapy for pain, but takes a more nuanced and flexible approach to dosing. Providers are urged to be careful about increasing doses above 50 MME and to weigh the individual needs of each patient.

The revised guideline also has a strong warning to providers not to abruptly taper patients. And it drops a previous recommendation that limits the initial supply of opioids to a few days for acute, short-term pain. Rather than a specific number of days, the guideline recommends that opioids be provided for the “expected duration of pain severe enough to require opioids” – essentially leaving it up to providers to determine how long that may be.  

“I think we want to avoid something being seen as a rigid standard of care.  We’re quite explicit that is not the goal here,” Jones told PNN in an exclusive interview. “I think we’ve tried to frame the recommendations with more nuance than what was done in 2016, based on the latest science and feedback from the clinical community and patients that when there are hard thresholds, it is very easy for those to be misapplied and go beyond the intent of why they were there.”

‘They Listened to People in Pain’

Patients advocates who have lobbied the CDC for years to withdraw or revise the 2016 guideline were generally pleased with the updated version.

“I feel like they listened to people in pain,” says Kate Nicholson, Executive Director of the National Pain Advocacy Center and a member of the “Opioid Workgroup” that advised the CDC as the guideline was being rewritten. “It’s better than I feared. It’s trying to be more balanced. And I do feel there’s some intent to listen to people with pain and their experience, and acknowledge the guideline’s flaws. You’ve got to be grateful to them for that, that they listened. It’s a pretty big change for a federal agency.”

“The wording of the recommendations themselves is much improved over the 2016 version. In particular, the elimination of specific dosage numbers is welcomed because those were very easy for policymakers and payers to latch onto in setting policies,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management.  

“While it's good that they are removing those, I fear that it's a bit like closing the barn door after the horse has escaped. There is a lot of work that needs to be done to modify or eliminate policies that were tied to the specific numbers in the 2016 guideline, and I'd like to see CDC play a role in that work.”  

Twillman, who was a stakeholder consulted by the CDC during the drafting of its original guideline, said he was pleased to see the agency caution against the use of “step therapy,” which requires insured patients to try non-opioid treatments first before moving on to stronger pain relievers. He believes treatments should be decided by patients and providers, not insurers.    

“I'm gratified to see that they did what I advised them (twice) to do with the 2016 guideline, in that they are calling for clinicians and patients to jointly determine the goals of care,” Twilllman said in an email. “That is absolutely vital, and it's really nice to see the emphasis on that. Developing some tools that help patients and clinicians do that seems to be a task that needs to be done.” 

The transparent rollout of the revised guideline is in marked contrast to how CDC handled the release of the original guideline in 2015, a process that was cloaked in secrecy and included little input from patients or pain management experts. The agency initially refused to disclose who they consulted with, which included several anti-opioid activists.

The CDC’s secrecy sparked distrust in the pain community, which only worsened when the agency ignored early complaints that the guideline was being misapplied. It wasn’t until 2019 the CDC admitted the guideline was harming patients and that revisions were needed.

Six years have now passed since the original guideline was released. More work remains and the CDC is hoping to get additional feedback from patients, providers and others on its revisions.

“It’s important to point out that the guideline is not final and the step that we’re at now is a real critical point in the process to wrestle with and get feedback on the issues that you’re raising,” said Jones. “And that’s why it’s important that we hear from readers of Pain News Network to get feedback, to get that experience, so as we move toward a final guideline, we can incorporate that feedback. We hope that insurers, medical community, law enforcement and others will also review the guideline and provide feedback.”

You can leaver an online comment in the Federal Register by clicking here. Comments must be received by April 11.

Feds Use Mob Laws to Target Spine Surgery Fraud

By Fred Schulte, Kaiser Health News

A Texas consulting company that arranges spine surgery and other medical care for people injured in car crashes has come under scrutiny in a widening federal bribery investigation.

Meg Health Care, run by Dallas personal injury attorney Manuel Green and his wife, Melissa Green, is the focus of a search warrant recently unsealed by a Massachusetts federal court in an alleged health care fraud prosecution there. The probe is unusual because it uses a little-known law meant to crack down on organized crime racketeering across state lines.

Investigators alleged in the 2019 affidavit that the Texas company accepted thousands of dollars in bribes from SpineFrontier, a Massachusetts medical device company. SpineFrontier; its CEO, Dr. Kingsley Chin; and its chief financial officer, Aditya Humad, were indicted in September on charges of paying kickbacks to surgeons. All have pleaded not guilty.

No charges have been filed against the Greens or their company, and federal officials declined to discuss the investigation, which is detailed in the now-unsealed 2019 search warrant.

The Greens could not be reached for comment.

Meg Health Care sets up spine surgery and other medical treatment through “letters of protection,” or LOPs, legal contracts in which patients agree to pay medical bills using proceeds from a lawsuit or other claims against the party responsible for their injuries. These contracts are common in personal injury cases when people either lack health insurance or choose not to use it to pay for medical treatments after an accident. The downside is that patients can be left to foot the bill if their cases settle for less than they owe.

On its website, Meg Health Care says it “represents a group of doctors and hospitals who were tired of seeing injured people without access to medical care they needed after an accident. We hold firm to the belief that under the law, and as a matter of basic decency, the person or business that caused the injury should be held responsible.”

According to investigators, Manuel Green steered injured patients with LOPs to a local neurosurgeon who used SpineFrontier implants in surgeries at two Dallas-area hospitals.

“In exchange for attorney Green’s referral, SpineFrontier agreed to pay attorney Green forty percent (40%) of the revenue SpineFrontier received in connection with those surgical procedures as a bribe,” according to the search warrant affidavit.

Chin and SpineFrontier were the subjects of a KHN investigation published in June that found that manufacturers of hardware for spinal implants, artificial knees and hip joints paid more than $3.1 billion to orthopedic and neurological surgeons from 2013 through 2019.

Government officials have argued for years that payments from device makers to surgeons and other medical providers can corrupt medical decisions, endanger patients and inflate health care costs. The SpineFrontier indictment alleges that the company paid millions of dollars in bogus consulting fees to spine surgeons in exchange for their using its products, often in surgeries paid for by Medicare or other government-funded health insurance plans.

The Texas investigation adds a new dimension to the case by focusing on medical care that is paid for privately, which is not covered under federal anti-kickback statutes. Instead, the search warrant alleges violations of a law called the Travel Act. Enacted by Congress in the early 1960s to combat the mob, the Travel Act makes it a federal offense to commit crimes like bribery, prostitution, and extortion across state lines, including through the mail or by phone or email. Convictions can bring up to five years in prison, more if violence is involved.

Jonathan Halpern, a New York white-collar criminal defense attorney, said that such a use of the Travel Act reflects “an aggressive expansion” of the U.S. government’s power to prosecute health care fraud.

One of the first health care fraud prosecutions under the Travel Act took place in Texas and led to convictions on bribery and kickback charges of 14 people, including six doctors, associated with Forest Park Medical Center in Dallas. They drew a combined sentence of 74 years and were ordered to pay $82.9 million in restitution.

Chris Davis, a Dallas lawyer who specializes in government investigations, said the Travel Act grants federal prosecutors jurisdiction in cases “where you don’t have state or federal money involved.”

The Meg Health Care search warrant cites payments of more than $93,000 in 10 checks allegedly sent by SpineFrontier to the Texas company between April 2017 and October 2018. Investigators allege that the money was paid as a bribe for referring patients for surgeries using SpineFrontier products.

Investigators also cited a February 2016 email in which Melissa Green told the device company that a patient’s legal case had been settled and asked: “Please let me know when MEG can expect to receive payment per our agreement. Thank you!”

About two months later, the device maker cut the company a check for $3,953.60, according to the search warrant.

Nine of the 10 checks were signed either by Chin, a Fort Lauderdale spine surgeon and SpineFrontier’s founder, or Humad, according to the search warrant affidavit. Chin and Humad are the two executives indicted in September. Their lawyers had no comment.

‘Significant Medical Need’

Federal investigators sought the search warrant for Melissa Green’s email account at Meg Health Care in August 2019, arguing that they had “probable cause” to investigate the company for Travel Act violations, court records show. A federal judge in Massachusetts unsealed the warrant and related documents late last year.

Meg Health Care invites lawyers whose clients have a “significant medical need” to apply to the company, according to its website. If approved, Meg Health Care schedules an appointment with one of its doctors. “From there, our doctors will handle every aspect of the treatment sought, including surgery (if necessary),” the website says.

In a 2019 court filing in Dallas County, unrelated to the search warrant issued in the Massachusetts case, Manuel Green said he was the “founder and owner” of the company. He said it “assists physicians and medical facilities with reducing their exposure to risk when providing treatments to patients under [a] letter of protection.”

He went on to say the company’s “business model and the consulting services it provides are unique within the healthcare industry in the state of Texas.” The company’s website lists medical providers in 11 Texas cities.

According to investigators in the Massachusetts case, Green referred patients with LOPs to Dr. Jacob Rosenstein, an Arlington, Texas, neurosurgeon who used implants that SpineFrontier sold to two hospitals, Pine Creek Medical Center in Dallas and Saint Camillus Medical Center in Hurst, Texas. Pine Creek has since declared bankruptcy.

Neither Rosenstein nor representatives of the hospitals could be reached for comment.

Although proponents say that LOPs may be the only option for uninsured or underinsured crash victims to get medical care, a recent KHN investigation found that doctors and hospitals that accept them often charge much higher rates than Medicare or private insurance would pay for similar care and that the process can saddle patients with medical debt or expose them to safety risks.

Disputes over the size of medical bills and even whether the care was necessary are common in personal injury lawsuits in Texas. In one 2016 Dallas County case, for instance, a spine surgeon billed more than $100,000 for his services, while the hospital charged more than $435,000. By contrast, an expert hired by the defense set a reasonable fee at less than $4,000 for the surgeon and about $25,000 for the hospital, court records show. The case has since been settled.

Christine Dickison, a Texas nurse and medical coding consultant, said she routinely sees “hugely inflated” bills in car-crash lawsuits — and in some cases doubts whether the care was necessary.

“I see people who are undergoing surgery when there are literally no objective findings that support it,” Dickison said. “That is very disturbing to me.”

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

A Rising Storm: Preparing for Revised CDC Opioid Guideline

By Richard Lawhern, PNN Contributor

Last month, the U.S. Centers for Disease Control and Prevention announced that a revised draft of its 2016 guideline for prescribing opioid pain relievers would soon be posted in the Federal Register and be available for public comment for 60 days. For patients in pain, their caregivers and their doctors, CDC might as well have issued an invitation to a gunfight at the OK Corral.

Revisions to the CDC opioid guideline have been underway since 2019.  During this period, much has changed in public awareness about chronic pain and addiction. Much more may change in the coming year as the CDC finalizes its draft revisions.

1. Despite the 2019 CDC admission that the opioid guideline has been “misapplied” by many states, insurers and physicians as hard limits on opioid prescribing, the Department of Justice (DOJ) and Drug Enforcement Agency (DEA) have continued selectively targeting doctors for prosecution when they prescribe opioids at high doses. As a result, the number of physicians still willing to treat pain with opioid analgesics has dropped precipitously.  And many thousands of patients have been involuntarily tapered or withdrawn from opioid therapy. 

2. DOJ, state and local prosecutors have recently announced multi-billion dollar settlements with major pharmaceutical companies for false advertising and promoting opioid pain relievers.  However, a judge in Orange County, California threw out an opioid lawsuit against four Pharma companies. The Oklahoma Supreme Court also overturned a lower court verdict on appeal.  In both cases, judges found no evidence to establish that the use or advertising of opioid painkillers is a “public nuisance.”  These cases offer precedents that might overturn other settlements or deny other government lawsuits against pharmaceutical companies. 

3. Two physicians convicted of inappropriate prescribing have taken their appeals to the US Supreme Court. Their case will be heard in March. Prominent medical associations and law firms have submitted “Friend of the Court” (amicus curae) briefs, pointing out that there is presently no accepted “standard of practice” for prescription of opioids, against which to evaluate appropriateness. Thus, a presumption of physician good faith should prevail in the absence of conclusive evidence of intentional opioid misuse.  If accepted, this premise will significantly narrow the grounds under which a physician can be prosecuted by DEA or DOJ for inappropriate opioid prescribing.

4. On July 16, 2021, the Board of Scientific Counselors of the CDC National Center for Injury Prevention and Control met in an online session to consider the report of their appointed Opioid Workgroup (OWG) evaluating progress in revising the 2016 CDC opioid guidelines. The OWG report provided a top-level “sneak peak” into the content of the proposed revisions, without the supporting data or references used by five authors rewriting the guideline.  For patients and advocates, this peek revealed a little shop of horrors. The OWG voiced fundamental concerns for unsupported or incorrect assertions concerning underlying science and medical practice.  

The problems revealed six months ago have since been compounded in at least two ways. First, research has shown that the underlying rationale of the CDC guideline and the proposed revisions is grounded upon a concept that is best characterized as “junk science.” 

Much of the damage done by the 2016 CDC guideline was caused by daily dose recommendations based on morphine milligram equivalents (MME). However, MME is not a single metric or even the correct one to base decisions on. In fact, there are four different models for MME which generate significantly different estimates for the “equivalence” between various opioid medications. Likewise, a June 2021 FDA Workshop on MME research revealed significant  weaknesses in the methods and protocols from which these models were developed.

Finally, a recently published review of the clinical literature for opioids and chronic pain reveals a 15-to-1 range in minimum effective dose for opioids used in long term therapy for moderate to severe pain. Much of this range appears to be caused by genetic differences in key liver enzymes which metabolize opioids. The literature also reveals very low risks of addiction among pain patients actively managed on opioids. Many papers mistake “pseudo-addiction” for drug tolerance or addiction.

Conflict of Interest

There is also evidence that CDC violated its own internal standards for objectivity when it selected the writers of the opioid guideline and recent revisions. Dr. Roger Chou, one of the co-authors of the original and revised guideline, has an established history of collaboration with key figures in anti-opioid organizations. 

Moreover, as pointed out by the OWG, a disproportionate number of publications where Chou was a principal author were used as source research for the guidelines as published. Chou not only led research on opioid outcomes and contributed to writing the guidelines, he also sits on the Board of Scientific Counselors that appointed the OWG.  He was thus in a position to lobby actively for his own work as a national standard of care. This is a fundamental professional conflict of interest.

As we near the release of a revised draft CDC guideline, one central trend seems clear.  If the writers of this guideline insist on doubling down on the errors of their original effort in 2016 – as they apparently did in July 2021 – then it will be time to remove CDC from its oversight of the practice of pain medicine, perhaps in favor of FDA or the National Academies of Medicine. 

As an advocate for people in pain and their doctors, it is from this frame of reference that I will approach my reading of the Federal Register.  I’m going into the review process “loaded for bear.”  I hope patients and their physicians will join me.

Richard “Red” Lawhern, PhD, has for over 25 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids. Dr. Lawhern has written or co-authored over 150 papers and articles published in medical journals and mass media.

Only 1 in 7 Chronic Pain Patients Use Opioids

By Pat Anson, PNN Editor

Have you tried physical therapy? What about yoga or Tai Chi? Did massage help you feel better?

Just about everyone in chronic pain has been asked that by family members, friends, doctors and sometimes even complete strangers.  The questions are innocent enough and usually well-meaning, but they often imply that a pain sufferer hasn’t looked beyond opioids for pain relief.

A new study shows that most people with chronic pain make extensive use of non-opioids and other “alternative” pain treatments – and that it’s relatively rare for a patient to only use opioids for pain relief.

The findings, published in JAMA Network Open, are based on answers to the 2019 National Health Survey by nearly 32,000 U.S. adults with chronic pain. The 2019 survey was the first to ask people about their use of 11 pain management techniques during the previous three months.

It turns out most people with chronic pain (54.7%) only used non-opioid pain management. And nearly a third (30.2%) used no pain therapy whatsoever. The rest either used opioids alone (4.4%) or a combination of opioids with one or more alternative treatments (10.7%).

That means only about 1 in every 7 adults with chronic pain even use opioids – a startling number when you consider the constant harping from anti-opioid activists and public health officials about how opioids are “overprescribed” in the U.S.   

“This study found that adults with chronic pain in the US use a variety of pain management techniques, including opioids,” wrote lead author Cornelius Groenewald, MB, a pediatric anesthesiologist and associate professor at the University of Washington School of Medicine. “Nonpharmacologic and nonopioid pharmacologic therapies are preferred treatments for chronic pain, and it is encouraging to note that most adults with chronic pain use a combination of various nonopioid modalities for treatment.”

Alternative Chronic Pain Therapies Used in 2019

• 18.8% Physical Therapy

• 17.6% Massage

• 15.6% Meditation or Relaxation Techniques

• 11.6% Spinal Manipulation or Chiropractic Care

• 8.5% Yoga or Tai Chi

• 5.1% Pain Self-Management Workshops

•  3.8% Psychological or CBT Therapy

• 1.8% Peer Support Group      

Nearly 40% of chronic pain sufferers reported using other therapies that were not listed in the survey. That may include treatments such as cannabis, kratom, medical devices, acupuncture or even ice packs. It would be good to include more of those options in future surveys.

Groenewald and his colleagues were disappointed that so few people used psychological techniques such as cognitive behavioral therapy (CBT), which was the only alternative pain therapy that they said was “underused.”   

The researchers found that complementary, psychological or psychotherapeutic therapies were more likely to be used by younger adults, females and people with more education. Adults using physical, occupational or rehabilitative therapies were more likely to be older, female, highly educated and have medical insurance.

A Disabled Activist Speaks Out About Feeling ‘Disposable’

By Rachel Scheirer, Kaiser Health News

In early January, one of the country’s top public health officials went on national television and delivered what she called “really encouraging news” on covid-19: A recent study showed that more than three-fourths of fatalities from the omicron variant of the virus occurred among people with several other medical conditions.

“These are people who were unwell to begin with,” said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention.

Walensky’s remarks infuriated Americans with disabilities, who say the pandemic has highlighted how the medical establishment — and society at large — treats their lives as expendable. Among those leading the protest was San Franciscan Alice Wong, an activist who took to Twitter to denounce Walensky’s comments as “ableism.” Walensky later apologized.

Wong, 47, moves and breathes with the aid of a power wheelchair and a ventilator because of a genetic neuromuscular condition. Unable to walk from around age 7, she took refuge in science fiction and its stories of mutants and misunderstood minorities.

Her awakening as an activist happened in 1993, when she was in college in Indiana, where she grew up. Indiana’s Medicaid program had paid for attendants who enabled Wong to live independently for the first time, but state cuts forced her to switch schools and move back in with her parents.

Wong relocated to the Bay Area for graduate school, choosing a state that would help her cover the cost of hiring personal care attendants. She has since advocated for better public health benefits for people who are poor, sick, or older or have disabilities.

Eddie Hernandez for KHN

The founder of the Disability Visibility Project, which collects oral histories of Americans with disabilities in conjunction with StoryCorps, Wong has spoken and written about how covid and its unparalleled disruption of lives and institutions have underscored challenges that disabled people have always had to live with. She has exhorted others with disabilities to dive into the political fray, rallying them through her podcast, Twitter accounts with tens of thousands of followers, and a nonpartisan online movement called #CriptheVote.

Wong is nocturnal — she typically starts working at her computer around 9 p.m. On a recent evening, she spoke with KHN via Zoom from her condo in the city’s Mission District, where she lives with her parents, immigrants from Hong Kong, and her pet snail, Augustus. The interview has been edited for length and clarity.

Q: Why do you often refer to people with disabilities as oracles?

Disabled people have always lived on the margins. And people on the margins really notice what’s going on, having to navigate through systems and institutions, not being understood. When the pandemic first hit, the public was up in arms about adjusting to life at home — the isolation, the lack of access. These are things that many disabled and chronically ill people had experienced. Disabled people had been trying forever to advocate for online learning, for accommodations in the workplace. The response was: “Oh, we don’t have the resources. It’s just not possible.”

But with the majority inconvenienced, it happened. Suddenly people actually had to think about access, flexibility. That is ableism, where you don’t think disabled people exist, you don’t think sick people exist.

Q: Have you noticed that kind of thinking more since the pandemic began?

Well, yes, in the way our leaders talk about the risks, the mortality, about people with severe illnesses, as if they’re a write-off. I am so tired of having to assert myself. What kind of world is this where we have to defend our humanity? What is valued in our society? Clearly, someone who can walk and talk and has zero comorbidities. It is an ideology, just like white supremacy. All our systems are centered around it. And so many people are discovering that they’re not believed by their doctors, and this is something that a lot of disabled and sick people have long experienced.

We want to believe in this mythology that everybody’s equal. My critique is not a personal attack against Dr. Walensky; it’s about these institutions that historically devalued and excluded people. We’re just trying to say, “Your messaging is incredibly harmful; your decisions are incredibly harmful.”

Q: Which decisions?

The overemphasis on vaccinations versus other mitigation methods. That is very harmful because people still don’t realize, yeah, there are people with chronic illnesses who are immunocompromised and have other chronic conditions who cannot get vaccinated. And this back and forth, it’s not strong or consistent about mask mandates.

With omicron, there is this huge pressure to reopen schools, to reopen businesses. Why don’t we have free tests and free masks? You’re not reaching the poorest and the most vulnerable who need these things and can’t afford them.

Q: How has your life changed during the pandemic?

For the last two years, I have not been outside except to get my vaccinations.

Q: Because you’re so high-risk?

Yeah. I have delayed so many things for my own health. For example, physiotherapy. I don’t get lab tests. I’ve not been weighed in over two years, which is a big deal for me because I should be monitoring my weight. These are things I’ve put on hold. I don’t see myself going in to see my doctor any time this year. Everything’s been online — it’s in a holding pattern.

How long can I take this? I really don’t know. Things might get better, or they might get worse. So many things disabled people have been saying have been dismissed, and that’s been very disheartening.

Q: What kinds of things?

For example, in California, it was almost this time last year when they removed the third tier for covid vaccine priority. I was really looking forward to getting vaccinated. I was thinking for sure that I was part of a high-risk group, that I’d be prioritized. And then the governor announced that he was eliminating the third tier that I was a part of in favor of an age-based system. For young people who are high-risk, they’re screwed. It just made me so angry.

These kinds of decisions and values and messages are saying that certain people are disposable. They’re saying I’m disposable. No matter what I produce, what value I bring, it doesn’t matter, because on paper I have all these comorbidities and I take up resources. This is wrong, it’s not equity, and it’s not justice. It took a huge community-based effort last year to get the state to backtrack. We’re saying, “Hey we’re here, we exist, we matter just as much as anyone else.”

Q: Do you think there’s any way this pandemic has been positive for disabled people?

I hope so. There’s been a lot of mutual aid efforts, you know, people helping each other. People sharing information. People organizing online. Because we can’t wait for the state. These are our lives on the line. Things were a little more accessible in the last two years, and I say a little because a lot of universities and workplaces are going backward now. They’re doing away with a lot of the hybrid methods that really gave disabled people a chance to flourish.

Q: You mean they’re undoing things that helped level the playing field?

Exactly. People who are high-risk have to make very difficult choices now. That’s really unfortunate. I mean, what is the point of this if not to learn, to evolve? To create a new normal. I can’t really see that yet. But I still have some hope.

This story was produced by Kaiser Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.