DEA Plans Further Cuts in Rx Opioid Supply

By Pat Anson, PNN Editor

For the seventh consecutive year, the U.S. Drug Enforcement Administration is planning to cut the supply of prescription opioids, reducing them in 2023 to levels not seen in nearly two decades.

DEA sets production quotas for opioids and other controlled substances annually, after consulting with the CDC, FDA and individual states about their projected medical and research needs. Based on that input, the DEA is lowering the supply of Schedule II opioids such as oxycodone and hydrocodone by about 5 percent next year.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2023 will decline on average 5.3 percent from calendar year 2022 levels. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone,” the DEA said in a notice published in the Federal Register.   

The production cut in Schedule II opioids is not as steep as in prior years, but continues a trend that began a decade ago. Since their peak in 2013, production quotas have fallen by 65% for oxycodone and 73% for hydrocodone, the two most widely prescribed opioids.

OXYCODONE PRODUCTION QUOTAS (KILOGRAMS)

SOURCE: DEA

The primary goal of the DEA in lowering opioid production is to reduce the risk of diversion, abuse and overdose, but it’s hard to find any evidence the policy is working. Prescription opioid use has fallen by 48% in the last five years, but opioid overdose deaths have climbed to record levels, fueled primarily by street drugs made with illicit fentanyl, a synthetic opioid 50 to 100 times stronger than morphine.

Although DEA is arresting and prosecuting illicit fentanyl dealers, it also continues to actively target doctors who prescribe high doses of opioids. This month it suspended the DEA license of a California doctor for unknown reasons, which led to the death of a chronic pain patient and his wife in a double suicide.

“It’s the end of the road for me with doctors,” Danny Elliott posted on Twitter a few days before his death. Elliott had lived with severe headaches for over two decades and was despondent that he was out of pain medication and unable to find a new doctor.

Low Risk of Diversion    

DEA is required under federal law to estimate the amount of prescription opioids that will be diverted through loss or theft, and then subtract it from the annual production quota. But those estimates reveal just how small the opioid diversion problem actually is.

Using information gathered from prescription drug monitoring programs (PDMPs), pharmacies, hospitals and others in the drug supply chain, DEA estimates that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) will be diverted for use by someone they were not intended for.

The DEA’s 2023 production quotas are also based on an old recommendation from the CDC that prescribers should “avoid increasing dosages of opioids beyond 90 MME for patients with chronic pain.”  CDC recently revised its opioid guideline to remove the 90 MME dosage threshold. The new guideline is more flexible and encourages doctors to make treatment decisions based on the individual needs of the each pain patient and not on any hard limits.

The DEA is accepting public comments on its production quotas until Thursday, November 17. The public response so far has been muted – only 47 comments as of this writing -- likely because the quotas have received little publicity from the media or the DEA itself.

Most of the comments that have been received are critical of DEA plans to reduce the supply of amphetamines and other stimulants used in treating attention deficit hyperactivity disorder (ADHD).  Some of those drugs are already in short supply, but DEA said it has “grown increasingly concerned” that ADHD medications are being diverted and abused by young adults.

To leave your comment on the DEA’s 2023 production quotas, click here.

People With Long Covid Face Barriers to Getting Disability

By Betsy Ladyzhets, Kaiser Health News

When Josephine Cabrera Taveras was infected with covid-19 in spring 2020, she didn’t anticipate that the virus would knock her out of work for two years and put her family at risk for eviction.

Taveras, a mother of two in Brooklyn, New York, said her bout with long covid has meant dealing with debilitating symptoms, ranging from breathing difficulties to arthritis, that have prevented her from returning to her job as a nanny. Unable to work — and without access to Social Security Disability Insurance or other government help — Taveras and her family face a looming pile of bills.

“We are in the midst of possibly losing our apartment because we’re behind on rent,” said Taveras, 32. Her application for Social Security disability assistance, submitted last fall, was rejected, but she is appealing.

Like many others with long covid, Taveras has fallen through the cracks of a system that was time-consuming and difficult to navigate even before the covid pandemic. People are facing years-long wait times, insufficient legal support, and a lack of clear guidance on how to prove they are disabled — compounded by the challenges of a medical system that does not have a uniform process for diagnosing long covid, according to health experts and disability attorneys.

The Biden administration promised support to people with long covid, but patient advocates say many are struggling to get government help.

The Centers for Disease Control and Prevention defines long covid broadly, as a “range of ongoing health problems” that can last “weeks, months, or longer.” This description includes people, like Taveras, who cannot work, as well as people with less severe symptoms, such as a long-term loss of smell.

The Social Security Administration has identified about 40,000 disability claims that “include indication of a covid infection at some point,” spokesperson Nicole Tiggemann said. How many people with long covid are among the more than 1 million disability claims awaiting processing by Social Security is unknown.

In recent months, about 5% of new disability claims filed by Allsup, an Illinois-based firm that helps people apply for Social Security, involved people dealing with covid, said T.J. Geist, a director at the firm. Other firms report similar figures.

The long waits for disability assistance often end in denial, in part because long covid patients don’t have the substantial medical evidence that federal officials require, Geist said. There is no standard process for diagnosing long covid. Similarly, Social Security “has yet to give specific guidance on how to evaluate covid claims” for the government officials who review applications, he said.

A recent report from the Brookings Institution estimates that 2 million to 4 million people are out of work because of long covid. A study published in September by the National Bureau of Economic Research puts the number at 500,000.

Advocates suggest that many people with long covid have yet to recognize their need for government benefits and could start applying soon.

“I did not understand that I was disabled for four years because my ability would fluctuate so much,” said Alison Sbrana, a patient-advocate with the long covid support group Body Politic. She has a chronic disease whose symptoms are similar to long covid’s in many cases and has received Social Security disability payments for several years.

“If you apply my timeline to people with long covid, even people who got sick in early 2020, we’re not going to know the full extent of their ability to work or not until 2024,” she said.

Difficult Application Process

In July 2021, the Department of Health and Human Services formally recognized long covid as a disability. Expanding on the recognition, the department and the White House published a report in August 2022 that summarizes the “services and supports” available for people with long covid and others who have experienced long-term impacts from the pandemic.

But accessing support is not as simple as White House announcements may suggest. First, the July 2021 guidance recognized long covid under the Americans with Disabilities Act but didn’t extend to the Social Security Administration, which runs benefit programs.

Under the ADA, long covid patients who can still work may ask their employers for accommodations, such as a space to rest or a more flexible schedule, said Juliana Reno, a New York lawyer who specializes in employee benefits. Social Security, however, has more stringent standards: To receive disability insurance, people must prove their long covid symptoms are so debilitating that they cannot work.

“The application process is very demanding, very confusing for patients,” Sbrana said. “It also entirely depends on you having this substantial breadcrumb trail of medical evidence.”

Most applications are denied in the first round, according to Sbrana and other advocates. Patients typically appeal the decision, often leading to a second denial. At that point, they can request a court hearing. The entire process can take a year or more and usually requires legal assistance.

The pandemic extended these wait times, as Social Security offices closed and did not quickly shift to remote operations. Moreover, common symptoms such as brain fog can make filling out online applications or spending hours on the phone with officials difficult.

Long covid patients who were hospitalized with severe symptoms can submit paperwork from those hospital stays and are more likely to receive benefits, Geist said. But for the people who had mild cases initially, or who have “invisible-type symptoms” like brain fog and fatigue, Geist said, documentation is more difficult. Finding a doctor who understands the condition and can sign off on symptoms may take months.

Amanda Martin, a long covid patient and advocate, is one of those lost workers. Martin got covid in April 2020 while working as a subcontractor for the U.S. Navy and lost that job when they were unable to recover quickly.

At first, unemployment benefits provided support, but Martin’s symptoms — including intense fatigue and brain fog — continued. More than two years after the initial infection, Martin is still “on bed rest 90% of the time,” they said. Martin receives food stamps and Medicaid but doesn’t have help paying for other essentials, such as gas. Their application for federal disability benefits has been denied twice.

“I am currently a year into the [application] process; I have eight to 11 months remaining,” Martin said. “I have $50 in my savings account.”

Many people with long covid don’t have the financial resources to hire a lawyer — or access to a doctor who can help with their documentation, which makes the situation even tougher.

Patient advocacy organizations are pushing for a more efficient application process, specific guidance for officials who evaluate long covid cases, and faster eligibility for Medicare coverage after a disability application is approved. (The typical wait is two years.)

The organizations also serve as support groups for people with long covid, sharing resources and providing reassurance that they aren’t alone. Some organizations, such as the nonprofit Blooming Magnolia, even collect funds for direct distribution to people with long covid. But patients say these efforts don’t come close to the scale of funding needed.

Taveras, the Brooklyn mom, said she knows many other people who are grappling with similar issues. “We’re trying to get support from the government, and we’re not getting it,” she said. Taveras set up a GoFundMe page to request support for her family.

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

DEA Suspension of Doctor’s License Leads to Double Suicide

By Pat Anson, PNN Editor

Another chronic pain patient, along with his wife, has fallen victim to the Drug Enforcement Administration’s ongoing war against doctors who prescribe opioid medication.  

61-year-old Danny Elliott and his 59-year-old wife Gretchen were found dead in their Georgia home Monday. Police are calling it a double suicide.

Family and friends say Elliott – who lived with severe intractable pain for over two decades -- was distraught over the suspension of his doctor’s DEA license to prescribe opioids and other controlled substances. Dr. David Bockoff, a longtime pain management specialist in Beverly Hills, California, was notified about the suspension by a Department of Justice attorney last week.

“OMG. I called for my phone appt on Tuesday, apparently just a couple of hours after they took his license to prescribe. Because I was due for my next Rx’s, I’m now totally out,” Elliott posted on Twitter days before his death.

“It’s the end of the road for me with doctors. Not sure what happens now but it’s going to be brutal.”

No reason was given for the suspension, according to Bockoff. The DEA confirmed to PNN that Bockoff’s license to prescribe was suspended, but declined to comment further because the case is under administrative review.

Danny and Gretchen Elliott

“Their blood is on the DEA’s hands,” Bockoff said about the deaths of the Elliotts.

Some of Bockoff’s patients, including Elliott, traveled thousands of miles from out of state to see him because they were unable to find doctors locally who were willing to treat their pain. Bockoff can still practice medicine in California, but without an active DEA license he cannot prescribe opioids – which are essential, life-giving medications to patients like Elliott.

“I talked to my sister on Sunday,” said Eric Welde, Gretchen’s brother. “They were very distraught because they heard that Doctor Bockoff was not going to be able to grant them another prescription because the DEA had gone after him and said he couldn’t prescribe anymore, otherwise he was going to jail or something. That hit them very hard like a ton of bricks.”

Welde says his brother-in-law suffered from severe chronic headaches after he was electrocuted in a freak accident 22 years ago. A former pharmaceutical rep, Elliott was unable to work and was dependent on opioids to have any quality of life.  In the days before his death, Welde says Elliott was so desperate for pain relief that he tried unsuccessfully to buy drugs on the black market.  

“I’m angry at the DEA. And I’m angry at the whole medical system. Because he was clearly in pain. He was not a junkie,” Welde told PNN. “There’s this whole stigmatism towards pain management that you should just be able to get over it. It’s like telling a diabetic that you don’t need insulin anymore. And it’s brutally wrong.   

“But it’s perfectly acceptable to bring thousands of pounds of illegal fentanyl over and sell that on the black market. But this is a more worthwhile cause for the DEA, which just absolutely floors me.”

Bockoff Patients ‘Among the Sickest’

“This unwarranted harassment of long-established pain doctor David Bockoff is almost beyond belief,” says Kristen Ogden, whose husband Louis is a patient of Bockoff’s. The Ogdens live in Virginia and traveled monthly to California to have Louis’ prescriptions written and filled. 

“These patients, including my husband Louis, are among the sickest people there are and yet they have been able to achieve and maintain a good quality of life with Dr. Bockoff's care and the pain medications he prescribed,” Ogden said. “Now Danny Elliott, a man Louis and I were privileged to call our friend, has ended his life because he could no longer endure such horrific pain and his sweet, caring wife Gretchen apparently chose not to live on without him. Who can explain why it was okay to take away this man's medication?” 

“Just sick over Danny and Gretchen. I'm a Bockoff patient as well, all of my meds were due to fill the day his DEA registration was suspended,” says Anne Fuqua, a disabled nurse in Alabama who lives with dystonia and arachnoiditis, two painful conditions that cannot be cured.   

Fuqua and Louis Ogden are both former patients of Dr. Forest Tennant, whose office and home in California were raided by the DEA in 2017.  A DEA search warrant alleged that Tennant ran a drug trafficking organization because many of his patients came from out-of-state and were on high doses of opioids. No criminal charges were ever filed against Tennant, who retired from clinical practice a few months after the raid. 

“I’m alive today because Dr. Tennant and later Dr. Bockoff chose to put themselves on the line for high-dose patients like me,” says Fuqua.  

It cannot be overstated how difficult it is for chronically ill patients like Fuqua to find new doctors. Many pain management doctors have stopped taking new patients or retired, fearing they could be targeted by DEA or other law enforcement agencies for prescribing opioids. 

For some patients, the pain and anxiety become overwhelming. Jennifer Adams, a 41-year-old Montana woman and former patient of Tennant, ended her life in 2018. Friends say Adams’ anxiety about losing her pain medication “was eating her alive.”

‘Not Helpful to Patients’ 

Dr. Bockoff has practiced medicine in California for 53 years and there is no record of him facing any disciplinary action or complaints filed with the state medical board. His office was searched by DEA agents about a year ago and patient records were taken at that time.

Bockoff says there was no warning about his suspension or the reasons for it. 

“You’d have to ask them what their motivation is. I don’t know. But I would say it certainly affects patients. Any patient who has chronic intractable pain is adversely affected by this action,” Bockoff told PNN. “It’s quite scary to think that a person in pain all of a sudden is unable to get their needed medication.” 

Bockoff says the DEA and DOJ agents who visited his office last week left behind a list of emergency rooms in the Los Angeles area, saying they didn’t want any of his patients to go into withdrawal. Such a list would be of no use to out-of-state patients and of little use to those locally. Many patients resist going to emergency rooms because they fear their pain won’t be treated or they’ll be viewed as drug seekers. 

“I’m not sure that’s helpful to my patients,” Bockoff said.       

Legal experts say the DEA has the power to suspend a doctor’s license in “emergency” situations for “imminent danger to the public health or safety.” A doctor then has 30 days to appeal the suspension to an administrative law judge, a process that can take months or years to resolve – too long for patients who have a limited supply of medication. 

While the DEA has no authority to practice medicine or regulate it, the effects of its decisions are far-reaching on both doctors and patients.  

“They’re certainly making judgements on the practice of medicine and they’re not qualified to do so,” said Michael Barnes, an attorney and chair of the Center for U.S. Policy, a non-profit that seeks to improve healthcare and drug policy. “The DEA is a one trick pony. It knows how to raid. It doesn’t regulate and so it employs it’s war on drug tactics against prescribers, including those who have no criminal intent.” 

Ironically, the suspension of Bockoff’s license comes at a time when opioid hysteria appears to be receding, as more people become aware that street drugs are responsible for the vast majority of overdoses.

This month the CDC revised its controversial opioid guideline, giving doctors more flexibility in using their own judgement to prescribe opioids. In June, the U.S. Supreme Court ruled unanimously in favor of two doctors appealing their convictions for “overprescribing” opioids, saying doctors can prescribe opioids outside the usual standard of medical care, as long as they act in good faith.

The California Medical Board is also modifying its hard stance on opioid prescribing, which resulted in hundreds of threats of disciplinary action against doctors who prescribed high doses or had patients who overdosed. 

None of these efforts, however, have reined in the DEA or prevented tragedies like the suicides of Danny and Gretchen Elliott.

Restoring Blood Flow Reduces Pain in Patients with Peripheral Artery Disease

By Pat Anson, PNN Editor

Restoring blood flow to the legs significantly reduces pain and improves quality of life for people with peripheral artery disease (PAD), according to new research presented this week at the American Heart Association’s Scientific Sessions in Chicago.

Over 200 million people worldwide suffer from PAD -- a narrowing of peripheral arteries throughout the body that can cause severe leg pain, cramping and fatigue after a short walk or even just climbing a flight of stairs. In one out of ten people with PAD, the lack of blood flow can lead to chronic limb-threatening ischemia (CLTI), where people experience pain even when resting. Left untreated, tissue damage in the leg may result in amputation.

To restore blood flow, a common treatment for PAD is leg bypass surgery, in which a passage around the blocked arteries is created by using another vein from the leg of a patient. A less invasive approach is angioplasty, in which a balloon-tipped catheter is inserted into the blocked artery to widen it. A stent is then often placed to keep the artery open.

Few studies have compared the effectiveness of bypass surgery to angioplasty and stenting, which are known as “endovascular” procedures.

“The large body of high-quality evidence that guides treatment of heart disease and stroke does not exist for PAD, and until now, there has been almost no data to inform the care of CLTI patients,” says lead author Matthew Menard, MD, an associate professor of surgery at Harvard Medical School, and co-director of endovascular surgery at Brigham and Women’s Hospital.

In the first large-scale randomized controlled study of its kind, Menard and his colleagues enrolled 1,830 people with severe PAD at 150 centers in the U.S., Canada, Italy, Finland and New Zealand. Participants were surveyed at the beginning of the study about their quality of life and at several follow-up visits for 4 years after their surgery or procedure. The surveys asked about pain, PAD symptoms and severity, physical activity and mental health.

Pain levels were high and quality-of-life scores were low at the beginning of the study, reflecting the poor health and well-being of many patients with CLTI. But after surgery or an endovascular procedure, pain scores decreased significantly and quality-of-life scores improved for all participants.

“Improvement in health-related quality-of-life measures regardless of the type of procedure is very encouraging and highlights the importance of timely restoration of blood flow to the leg and foot,” said Menard.

Menard noted there were some differences initially between the two study groups favoring endovascular procedures, possibly reflecting the longer recovery time for a surgical bypass. But the differences were not “clinically meaningful” and leveled out over time.

“The quality-of-life data are a nice complement to the clinical results and suggest that both revascularization strategies may effectively improve a patient’s quality of life. So, while there is still much work to be done, and quality-of-life measures have not always been the focus in past PAD research, this is an important step forward,” he said.

PAD patients who don’t have bypass surgery or endovascular procedures may want to continue walking despite the pain and discomfort, according to a recent study. Researchers at Northwestern University’s Feinberg School of Medicine found that elderly PAD patients who exercised 5 days a week walked at a faster pace and performed better on physical performance tests than non-walkers.

Between 8 and 10 million people in the United States have PAD. The condition disproportionately affects African-Americans, Native Americans and those with low socioeconomic status.

Why Cannabis Holds Promise for Pain Management

By Benjamin Land, University of Washington Center for Cannabis Research

Drug overdose deaths from opioids continue to rise in the U.S. as a result of both the misuse of prescription opioids and the illicit drug market.

But an interesting trend has developed: Opioid emergency room visits drop by nearly 8% and opioid prescriptions are modestly lower in states where marijuana is legalized.

Marijuana is produced by the cannabis plant, which is native to Asia but is now grown throughout the world. Individuals use marijuana for both its psychoactive, euphoria-inducing properties and its ability to relieve pain.

Chemicals produced by the cannabis plant are commonly known as cannabinoids. The two primary cannabinoids that occur naturally in the cannabis plant are THC – the psychoactive compound in marijuana – and CBD, which does not cause the sensation of being high.

Many marijuana users say they take it to treat pain, suggesting that readily available cannabinoids could potentially be used to offset the use of opioids such as morphine and oxycodone that are commonly used in pain treatment. A safer, natural alternative to opioid painkillers would be an important step toward addressing the ongoing opioid epidemic.

Intriguingly however, research suggests that cannabis use could also lessen the need for opioids directly by interacting with the body’s own natural opioid system to produce similar pain-relief effects.

I am a neuropharmacology scientist who studies both opioids and cannabinoids as they relate to pain treatment and substance abuse. My research focuses on the development of drug compounds that can provide chronic pain relief without the potential for overuse and without the tapering off of effectiveness that often accompanies traditional pain medications.

How Opioids Work

Our bodies have their own built-in opioid system that can aid in managing pain. These opioids, such as endorphins, are chemicals that are released when the body experiences stress such as strenuous exercise, as well as in response to pleasurable activities like eating a good meal. But it turns out that humans are not the only organisms that can make opioids.

In the 1800s, scientists discovered that the opioid morphine – isolated from opium poppy – was highly effective at relieving pain. In the last 150 years, scientists have developed additional synthetic opioids like hydrocodone and dihydrocodeine that also provide pain relief.

Other opioids like heroin and oxycodone are very similar to morphine, but with small differences that influence how quickly they act on the brain. Fentanyl has an even more unique chemical makeup. It is the most powerful opioid and is the culprit behind the current surge in drug overdoses and deaths, including among young people.

Opioids, whether naturally produced or synthetic, produce pain relief by binding to specific receptors in the body, which are proteins that act like a lock that can only be opened by an opioid key.

One such receptor, known as the mu-opioid receptor, is found on pain-transmitting nerve cells along the spinal cord. When activated, mu-receptors tamp down the cell’s ability to relay pain information. Thus, when these opioids are circulating in the body and they reach their receptor, stimuli that would normally cause pain are not transmitted to the brain.

These same receptors are also found in the brain. When opioids find their receptor, the brain releases dopamine – the so-called “feel-good” chemical – which has its own receptors. This is in part why opioids can be highly addicting. Research suggests that these receptors drive the brain’s reward system and promote further drug-seeking. For people who are prescribed opiates, this creates the potential for abuse.

Opioid drugs, which include heroin, oxycodone and fentanyl, are highly addictive.

Opioid receptors are dynamically regulated, meaning that as they get exposed to more and more opioids, the body adapts quickly by deactivating the receptor. In other words, the body needs more and more of that opioid to get pain relief and to produce the feel-good response. This process is known as tolerance. The drive to seek more and more reward paired with an ever-increasing tolerance is what leads to the potential for overdose, which is why opioids are generally not long-term solutions for pain.

How THC and CBD Relieve Pain

Both THC and CBD have been shown in numerous studies to lessen pain, though – importantly – they differ in which receptors they bind to in order to produce these effects.

THC binds to cannabinoid receptors that are located throughout the central nervous system, producing a variety of responses. One of those responses is the high associated with cannabis use, and another is pain relief. Additionally, THC is believed to reduce inflammation in a manner similar to anti-inflammatory drugs like ibuprofen.

In contrast, CBD appears to bind to several distinct receptors, and many of these receptors can play a role in pain reduction. Importantly, this occurs without the high that occurs with THC.

Because they target different receptors, THC and CBD may be more effective working in concert rather than alone, but more studies in animal models and humans are needed.

Cannabinoids may also be helpful for other conditions as well. Many studies have demonstrated that cannabinoid drugs approved for medical use are effective for pain and other symptoms like spasticity, nausea and appetite loss.

Along with the pairing of THC and CBD, researchers are beginning to explore the use of those two cannabinoids together with existing opioids for pain management. This research is being done in both animal models and humans.

These studies are designed to understand both the benefits – pain relief – and risks – primarily addiction potential – of co-treatment with cannabinoids and opioids. The hope would be that THC or CBD may lower the amount of opioid necessary for powerful pain relief without increasing addiction risk.

For example, one study tested the combination of smoked cannabis and oxycontin for pain relief and reward. It found that co-treatment enhanced pain relief but also increased the pleasure of the drugs. This, as well as a limited number of other studies, suggests there may not be a net benefit.

However, many more studies of this type will be necessary to understand if cannabinoids and opioids can be safely used together for pain. Still, using cannabinoids as a substitution for opioids remains a promising pain treatment strategy.

The next decade of research will likely bring important new insights to the therapeutic potential of cannabinoids for chronic pain management. And as marijuana legalization continues to spread across the U.S., its use in medicine will undoubtedly grow exponentially.

Benjamin Land, PhD is a Research Associate Professor of Pharmacology at the University of Washington School of Medicine and the UW Center for Cannabis Research. Land receives funding from the National Institutes of Health for cannabinoid research, and has received cannabinoid related funding from the University of Washington Addiction and Drug Abuse Institute and SCAN Design Foundation.

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

A Weird Trick to Get Doctors to Listen to You

By Crystal Lindell, PNN Columnist

There’s a lot of advice out there on how to get a doctor to take you seriously. Most of it is wrong.

Lucky for you, I’ve been in pain for a decade! Through trial and lots of errors, I’ve learned a few things and I’m happy to share them with you.  

First though, a little background on why you might need this information. It’s basically a rite of passage for chronically ill patients to lose their faith in doctors. We go in expecting Dr. Gregory House – the brilliant and grumpy lead character on the TV show House -- to solve the puzzle of our illness. Instead, we’re more likely to be met by a doctor with all of House’s hostility, but none of his determination.  

Doctors are notorious for downplaying symptoms, ignoring concerns, and blaming everything on the patient’s weight/smoking habit/stress/drug-seeking behavior.

They also tend to have a violent aversion to patients who suggest their own diagnoses. Their delicate doctor egos override any rational reaction and, more often than not, patients with chronic illness leave their appointments with no answers.

I used to think this only happened to women, but after attending multiple appointments with men in my family, I have come to realize that it’s just an across-the-board thing. My theory is that many of them became doctors so they can be seen as the smartest person in the room. And they hate it when patients treat them as equals, instead of the superior beings they believe themselves to be.

The problem is, a lot of patients tend to be really good at figuring out what’s wrong with their own bodies. They’re highly motivated to find answers, and they have more access to medical research tools then ever before in human history. Doctors love to mock Dr. Google, but that’s kind of like mocking libraries. Finding information online doesn’t automatically make it less valuable than finding it in a book.

Which brings us to the problem: Once we, as patients, figure out what might be wrong, how do we bring it up to our doctor without offending them?  

In short, it’s all about framing. You need to suggest that someone else is making you ask them about whatever it is you want to bring up. Let me share an example:

Do NOT say: “I think I have Ehlers-Danlos Syndrome.”

Instead, say: “My best friend wanted me to ask you about something. I don’t even think it’s a thing, but she thinks I might have something called EDS. Ehlers-Danlos syndrome, I think? I don’t know. It’s probably rare. But have you heard of it? Do you think I might have it?”

Here’s another example:

Do NOT say: “I think I have ADHD.”

Instead, say: “So my wife said I had to ask you about something. I don’t know if she’s right, but if I don’t bring it up with you, she’ll be really mad at me. She thinks I might have something called attention deficit disorder. And she said you might be able to help.”

Yes, I know, it’s annoying and demeaning. And you’re right, patients shouldn’t have to navigate medical conversations like this. They shouldn’t need to fake ignorance to get a doctor to help them.

But this column isn’t about overturning medical power structures. It’s about getting immediate results in what are often life-threatening situations. And I can assure you, this method works. I speak from experience. It is literally how I got my EDS diagnosis after dealing with chronic pain for years. I have shared this tip with others who have also used it successfully.

It works on every type of doctor, too. This is what you say to them:

To ER doctors: “My husband made me come here to get this chest pain checked out.”

To primary care physicians: “My roommate said I had to ask you about having my thyroid levels checked.”

To pain specialists: “My brother thinks I have rheumatoid arthritis and he wanted me to ask you about it.”

To psychiatrists: “My aunt said I should ask you about anxiety medications.”

This will not only help in getting them to take your symptoms seriously, it will also work on convincing them to order specific tests, offer specific medications, and consider a specific diagnosis.

This approach shifts the focus onto a third party, which helps doctors lower their defenses. If they think medical suggestions from patients are inane, you’re just feigning agreement with them. It effectively puts you on the same side as the doctor ⁠— the two of you against your loved one. Which is fine, because your loved one isn’t relying on them for medical care, so they can take the heat. And when the doctor feels like they’re on your side, they’re more likely to want to help.

This approach also means that the doctor knows you are likely to tell a third party what transpired during the appointment, which means they’ll be held to a higher level of accountability. That alone will often have a big impact on how they treat you.

Yes, it is wrong that patients have to use passive aggressive techniques just to get an MRI. But, as my mom always says, it’s better to be wrong than to be dead right. Sure you could insist on being more direct with your doctor, but if that doesn’t work — and the doctor dismisses your symptoms when they should be treating them — the choice could literally leave you dead. You’d be right, but you’d be dead right.

Hopefully, one day, patients won’t have to navigate their doctor’s fragile egos to get the care that they need. Until that day though, this will help. So go forth and be well. And if you can’t be well, at least be well prepared.

Crystal Lindell is a freelance writer who lives in Illinois. After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome. She and her fiancé have 3 cats: Princess Dee, Basil, and Goose. She enjoys the Marvel Cinematic Universe, Taylor Swift Easter eggs, and playing the daily word game Semantle. 

CDC Revises Opioid Guideline, But Can It Undo the Damage to Pain Care?

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has released a long-awaited final update to its controversial opioid prescribing guideline, expanding the recommendations to include patients suffering from short and long-term pain, while at the same time giving doctors more flexibility when prescribing opioids.

Although voluntary and only intended for primary care providers treating chronic pain, the original 2016 guideline was adopted as a mandatory opioid policy by many states, insurers, medical societies and even law enforcement agencies, resulting in millions of patients being reduced to lower ineffective doses or taken off opioids and forced into withdrawal. The newly revised guideline is intended to end the “one-size-fits-all” approach to pain care and a public health experiment gone wrong.

“Fundamentally, the framing of the guideline is that pain happens in many different ways, in different intensities, and patients respond to different treatments in different ways. And so it is paramount that clinical decisions are based on the individual needs of the patient,” said Christopher Jones, PharmD, Acting Director of CDC’s National Center for Injury Prevention and Control and a guideline co-author.

“In some cases opioids, even opioids at high doses, are the right thing to do for the patient. It’s more about working with the patient to set expectations and goals and look at the full range of treatments. And if opioids are the right thing or opioids plus non-pharmacological treatments, or opioids plus NSAIDs, if that’s the right thing and the patient is doing well and meeting their goals, this guideline supports that. It doesn’t dictate any particular type of care that any particular patient has to receive.”

Benefits vs Risks

To be clear, the revised guideline still takes a dim view of opioid pain medication and its potential to result in addiction and overdose. Doctors are advised to “maximize” the use of non-opioid drugs and non-pharmacological treatments, and should “only consider initiating opioid therapy if expected benefits for pain and function are anticipated to outweigh risks to the patient.” When opioids are prescribed, it should be at the “lowest possible effective dose.”   

Other notable changes in the guideline:

• A more cautious, slower approach to opioid tapering that strongly encourages patient buy-in before doses are reduced

• Drug testing only recommended when “appropriate.” Doctors should first “consider the benefits and risks of toxicology tests”

• Instead of “extreme” caution about taking opioids with benzodiazepines and other anti-anxiety drugs, “particular” caution is recommended

• Patients should not be dismissed for failing a drug test or because of information found in prescription drug databases (PDMPs)

Importantly, the revised guideline also removes a recommendation in the 2016 guideline that daily opioid doses not exceed 90 MME (morphine milligram equivalents), which was widely seen as a hard limit. It is replaced with cautionary language about doses above 50 MME being “more likely to yield diminishing returns.”  

“There are tweaks, but I think they are tweaks that are meaningful. That doesn’t mean its not still built on a rotten core,” says Kate Nicholson, Executive Director of the National Pain Advocacy Center (NPAC), who belonged to an independent advisory panel that advised the CDC to drop all references to MME.

Nicholson is concerned the 50 MME threshold – which is mentioned two dozen times in the revised guideline – will be misapplied as the new hard limit.

“They still overly focus on MME’s,” she told PNN. “They do qualify it whenever they mention it, but it’s still there, it’s there a lot, and it’s aligned strongly with risk. My concerns are misapplication, even though they say repeatedly ‘Do not apply this as a strict threshold.’”

Nicholson is also concerned about the guideline’s expansion beyond chronic pain (pain lasting three months or more) to include people with short-term acute pain from trauma or surgery, as well as “sub-acute” pain lasting one to three months.

“It’s good to cover all pain and not just single out chronic pain. So in theory I think it’s fine, but in practice, given that they acknowledge again and again the problems of the 2016 guideline. Usually, you check your safety features on the airplane before you expand the fleet. And they didn’t. They did it all at once,” she said. “I also have concerns that it’s a clinical practice guideline written mostly by non-clinicians and by people who are not experts in pain. And it’s now going to cover how all pain should be treated?”

For some patient advocates, no amount of revisions are acceptable. They want the CDC guideline revoked.

“False claims of one-size-fits-all dose thresholds are alive and well in this final draft. More than ever, I am convinced that the CDC must be restricted by law from issuing practice guidelines of this type,” says patient advocate Richard “Red” Lawhern. “It doubles down on lies and cherry-picked research intended to further suppress opioid prescribing at the expense of undertreating patients and driving clinicians out of pain management practice.”

Most of the mainstream media coverage of the revised guideline portrayed it as a weaker or softened version of the 2016 guideline. That is puzzling to Andrew Kolodny, MD, founder and president of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), who believes the new guideline is “much stronger” than the original.

“Press coverage of the CDC opioid guideline is wacky,” Kolodny wrote on Twitter. “CDC issued a guideline much stronger than the 2016 version (high dose defined as 50 MME/day instead of 90) but press headlines say CDC softened guideline.”

Reversing the Damage

Many patient advocates believe it will be hard to unwind the damage caused by the 2016 guideline to patients, pain management practices, and the healthcare system in general.

“Many laws, regulations, and policies were implemented from the rigid application of the 2016 opioid dosage thresholds. I believe this means many physicians may remain reluctant to prescribe opioids when indicated for chronic pain, and patients may continue to find access to treatment a challenge,” said Dr. Lynn Webster, Senior Fellow at the Center for U.S. Policy and past president of the American Academy of Pain Medicine

“To reverse the damage, the CDC could take an active and vocal public role in publicizing the statements about the guideline not being a law, regulation or policy. The agency should make sure that governmental and enforcement entities know there’s a new CDC statement on these matters.”

Chris Jones said the CDC would monitor how the revised guideline is implemented by states, insurers and others to prevent further misapplication. But he was vague about how it would be done, saying it needs to be handled on a case-by-case basis and while recognizing that “states do what states do.” The CDC has no legal authority to enforce its recommendations.

 “As with any clinical practice guideline, the work doesn’t stop today. It really starts as we engage with the clinical community, as we engage with patient organizations with educational opportunities. Certainly engaging with insurers and others to say, ‘Here’s the latest evidence about the range of treatment options that can be effective,’” he told PNN. “But we’re still working through, from a policy perspective when we see misapplication, how to respond to that.”

Jones said he would be speaking next month to the National Conference of State Legislatures about the revised guideline and to reinforce the need for individualized patient care. He and the other guideline co-authors also published an op/od in The New England Journal of Medicine that cautions providers about misapplying the CDC’s recommendations.

Webster thinks the CDC’s efforts to combat addiction and overdoses should be refocused on illicit fentanyl and other street drugs, which are involved in the vast majority of drugs deaths. In 2021, nearly 108,000 Americans died from overdoses, a record number.

“I think it is important to remember that the goal of the guideline was to reduce the number of overdose deaths by reducing the opioid supply or amount prescribed. It hasn’t worked out that way,” Webster said. “Over the past decade, opioid prescribing has plummeted, but the number of overdoses has skyrocketed. The CDC should now focus on the cause of most opioid-related overdose deaths, which is to bring attention to the social and economic factors that create the demand for so many Americans to escape the pain of living.” 

Study Finds Harmful Effects of Chronic Pain Persist Throughout Life

By Pat Anson, PNN Editor

If you have chronic pain in middle age, chances are you will continue to have pain and poor overall health as you enter your senior years, according to a large new study in the UK that found pain has wide-ranging effects throughout life. Pain sufferers are significantly more likely to be unhappy, depressed and unemployed as they grow older.  

Researchers followed the health data and survey responses of over 12,000 people who were born in England, Scotland and Wales in March 1958. The study began in 2003, when most of the respondents were age 44, and continued until they turned 62 in 2021

The research findings, published in PLOS ONE, show that pain can persist for decades and may even be passed from one generation to the next.

“Tracking a birth cohort across their life-course we find chronic pain is highly persistent. It is associated with poor mental health outcomes later in life including depression, as well as leading to poorer general health and joblessness. We hope the study highlights the need for academics and policy makers to focus more attention on the problems of chronic pain,” wrote lead author Alex Bryson, PhD, a Research Fellow at University College London.

Bryson and his colleagues found that two-fifths of respondents reported suffering from chronic pain in their 40’s. Of those, 84% still reported “very severe” pain at age 50. Having chronic pain at 44 was also associated with poor mental health, lower life satisfaction, pessimism about the future, poor sleep and joblessness at age 55.

In the last year of their study, researchers found that having pain at midlife also raises the risk of a covid infection at age 62, a finding that supports previous studies showing that people in poor health are more susceptible to Covid-19.

The study pinpointed several factors that predict pain at a later age, including a father’s social and economic status. Respondents whose fathers were professionals, managers or administrators when they were born were significantly less likely to report chronic pain 44 years later.

The UK study reached many of the same conclusions as U.S. researchers, who have found that less-educated, working class Americans have higher rates of pain, social isolation, drug abuse, disability and suicide than those with college degrees. Efforts at treating physical pain, either with opioids or non-opioid therapies, have failed to turn the tide.  

“Our evidence on the persistence of pain across the life-course suggests efforts to counter it have not been wholly successful,” said Bryson. “We have shown that it is, in part, passed from one generation to the next, with those from lower social classes suffering most. Pain appears to be another source of inter-generational disadvantage, and one that is potentially as problematic as other aspects of social deprivation.”

FDA Warns Amazon and Walmart About Selling Misbranded Drugs

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has issued another warning to consumers not to purchase or use dietary supplements marketed for pain relief under the brand names “Artri” or “Ortiga” due to potentially dangerous pharmaceutical ingredients. Use of the products has led to liver toxicity and at least one death, according to the agency.

The FDA issued its first first warning about the supplements in January and followed up with a second warning  in April. The latest warning includes Amazon, Walmart and another retailer that continued to sell the supplements, which are marketed with claims that they treat arthritis and osteoarthritis, restore cartilage, and stop joint deterioration.

In a warning letter sent to Amazon last week, the FDA said it had purchased Artri and Ortiga supplements through its website and had them delivered through the company’s delivery service.

Laboratory testing confirmed the supplements purchased through Amazon contained diclofenac, a non-steroidal anti-inflammatory drug (NSAID), and dexamethasone, a corticosteroid used to treat inflammatory conditions.

Neither drug is mentioned on product labels, which list ingredients such as glucosamine and turmeric. The FDA warned Amazon that introducing or delivering a misbranded drug is a violation of federal law.  

“Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. Please submit a written response to this letter within fifteen working days from the date of receipt, explaining the specific steps you have taken to address any violations,” the FDA letter states.

Similar warning letters were sent to Walmart and Latin Foods Market, which had previously issued voluntary recalls for the supplements, but still continued to sell them.

It appears the Artri and Ortiga supplements have now been removed from the websites of all three companies. The supplements were being marketed primarily to Spanish-speaking consumers, with claims they are “highly effective in restoring cartilage” and “fights arthritis.”  

Diclofenac raises the risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal bleeding and damage. When used long term or in high doses, dexamethasone and other corticosteroids can result in serious withdrawal symptoms if a consumer suddenly stops taking them. Both drugs can also interact with other medications.

The FDA encourages healthcare providers and patients to report side effects involving use of the products to its Adverse Event Reporting System. .

Smoking Marijuana More Effective Than CBD Extracts for Back Pain

By Pat Anson, PNN Editor

One of the reasons many medical marijuana users prefer edibles over smoking is that they are perceived as healthier.  Marijuana smoke contains many of the same chemicals and carcinogens as cigarette smoke, and could have harmful effects on people with respiratory or cardiovascular problems.

But a small new study conducted in Israel found that smoking marijuana is better than ingesting it, at least when it comes to treating chronic lower back pain. Researchers enrolled 24 adults with MRI or CT scans that showed evidence of disc herniation or spinal stenosis, and had them try two different types of cannabis treatment.

The first was a cannabis extract rich in cannabidiol (CBD), which was taken sublingually under the tongue daily for 10 months. After a month of no treatment, the same group smoked cannabis flowers rich in tetrahydrocannabinol (THC) up to four times a day for 12 months. Participants were allowed to take pain medication as needed, including oxycodone and acetaminophen.

The study findings, published in the Rambam Maimonides Medical Journal, showed there was little to no improvement in back pain when participants took the extract, but significant improvement when they smoked cannabis. The use of analgesic drugs also dropped significantly while smoking.

Notably, three patients dropped out of the extract phase of the study because it wasn’t helping them, but then returned to participate in the smoking phase.

“The current study is the first, to our knowledge, to indicate that THC-rich smoked therapy is more advantageous in ameliorating LBP (lower back pain), than low THC CBD-rich sublingual extracts. Despite the small number of patients, our data indicate that THC-rich smoked therapy is helpful in mitigating LBP,” researchers reported.

The most commonly reported adverse events during the study were nausea, dizziness, drowsiness and fatigue during the extract phase; sore throat and drowsiness were reported during the smoking phase. All of the adverse symptoms disappeared after a dose tolerance was reached. Most of the adverse effects were in female patients.

A 2019 study of medical marijuana users also found that smoking cannabis provided more pain relief than ingesting it. Over 3,300 people logged their symptoms on a mobile app while using a variety of cannabis products, including dried flower, edibles, tinctures and ointments. Smoking the dried flower provided more pain relief than any other cannabis product, regardless of the amount of THC.

Another problem with CBD edibles is that they are frequently mislabeled. A recent study of 80 CBD oils found that only 43 had concentrations of cannabidiols that were within 10% of their label claims – an accuracy rate of just 54 percent.

Newly Discovered Gut Bacteria Linked to Rheumatoid Arthritis

By Meagan Chriswell, University of Colorado Medicine

Rheumatoid arthritis affects 1 in 100 people worldwide. It causes inflamed, painful and swollen joints, often in the hands and wrists, and can lead to loss of joint function as well as chronic pain and joint deformities and damage. What causes this condition has been unknown.

In our recently published study, my colleagues and I found an important clue to a potential culprit behind this disease: the bacteria in your gut.

Rheumatoid arthritis is an autoimmune condition, meaning it develops when the body’s immune system starts to attack itself. Proteins called antibodies, which usually help fight off viruses and bacteria, begin to attack the joints instead.

The origins of the antibodies that cause rheumatoid arthritis have been an area of study for many years. Some research has shown that these antibodies can start forming at sites like the mouth, lung and intestines over 10 years before symptoms arise. But until now, it was unclear why researchers were finding these antibodies in these particular areas.

We wanted to investigate what could trigger the formation of these antibodies. Specifically, we wondered if bacteria in the microbiome, a community of microorganisms that live in the intestines, might be the ones activating the immune response that leads to rheumatoid arthritis.

Since microbes commonly live at the same sites as the antibodies driving rheumatoid arthritis, we hypothesized that these bacteria could be triggering the production of these antibodies. We reasoned that though these antibodies were meant to attack the bacteria, rheumatoid arthritis develops when they spread beyond the intestines to attack the joints.

First, we sought to identify the intestinal bacteria targeted by these antibodies. To do this, we exposed the bacteria in the feces of a subset of people at risk for developing rheumatoid arthritis to these antibodies, allowing us to isolate just the bacterial species that reacted and bound to the antibodies.

We found that one previously unknown species of bacteria was present in the intestines of around 20% of people who were either diagnosed with rheumatoid arthritis or produce the antibodies that cause the disease.

As a member of the Cherokee Nation of Oklahoma, I suggested we name this species Subdoligranulum didolesgii (“didolesgii” means arthritis or rheumatism in Cherokee) as a nod to the contributions that other Indigenous scholars have made to science as well as the fact that rheumatoid arthritis affects Indigenous people at a higher rate than other populations.

Subdoligranulum didolesgii has not been detected in the feces of healthy people before, and it is currently unknown how prevalent this bacteria is in the general population.

We also found that these bacteria can activate specialized immune cells called T cells in people with rheumatoid arthritis. T cells drive inflammatory responses in the body, and have been linked to the development of different autoimmune diseases.

These findings suggest that these gut bacteria may be activating the immune systems of people with rheumatoid arthritis. But instead of attacking the bacteria, their immune system attacks the joints.

Why This Bacteria?

It is still unknown why people with rheumatoid arthritis develop an immune response to Subdoligranulum didolesgii. But we think it may be the culprit when it comes to rheumatoid arthritis because this bacteria is found only in the intestines of people with rheumatoid arthritis, and not in the intestines of healthy people.

While many immune responses happen in the intestines, they are usually self-contained and do not spread to other areas of the body. However, we believe that a particularly strong intestinal immune response against Subdoligranulum didolesgii could allow antibodies to bypass the intestinal “firewall” and spread to the joints.

To confirm our hypothesis, we gave mice an oral dose of Subdoligranulum didolesgii and monitored their reaction. Within 14 days, the mice began to develop joint swelling and antibodies that attacked their joints.

My colleagues and I hope this research can shed light on the origins of rheumatoid arthritis. Our next goal is to discover how common these bacteria are in the general population and test whether the presence of these bacteria in the gut may lead to the development of rheumatoid arthritis in people.

It’s important to note that antibiotics are unlikely to be helpful treatment for the microbiomes of patients with rheumatoid arthritis. Although Subdoligranulum didolesgii may be triggering an autoimmune response for some people with rheumatoid arthritis, antibiotics eliminate both helpful and harmful bacteria in the gut. Additionally, removing the bacteria won’t necessarily stop the immune system from attacking the joints once it has started.

Nevertheless, we believe that these bacteria can be used as tools to develop treatments for rheumatoid arthritis and hopefully ways to prevent disease from happening in the first place.

Meagan Chriswell is a MD/PhD Candidate in Immunology at the University of Colorado Anschutz Medical Campus. She does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article.

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

‘Super High Concentration’ of Kratom Involved in Georgia Man’s Death

By Pat Anson, PNN Editor

The family of a 23-year-old Georgia man who died last year after ingesting a potent kratom extract has filed a wrongful death lawsuit against a kratom manufacturer and a trade association that promotes the company for following good manufacturing standards.

Ethan Pope was found dead on the kitchen floor of his apartment on December 3, with his dog by his side. Pope had recently purchased bottles of Black Liquid Kratom made by Optimized Plant Mediated Solutions (OPMS).

An autopsy concluded that Pope died as a result of cardiac arrest due to mitragynine intoxication, and his death was ruled an accident by the Georgia Bureau of Investigation.

Mitragynine is an alkaloid and one of the active ingredients in kratom, which comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

ETHAN POPE

In recent years, kratom has become a popular supplement in the United States, where it is used by millions of people to self-treat their pain, anxiety, depression and substance use problems. It is sold legally in most states, including Georgia, where it can be purchased at gas stations and smoke shops.

Kratom is normally consumed as a dry unadulterated powder, but the Black Liquid Kratom allegedly consumed by Pope is a highly concentrated 50:1 extract, with up to 375mg mitragynine per bottle.

“This super high concentration can be felt with just a drop or two of the extract added to your tea or coffee. Even veteran users of kratom should start slow with this liquid extract because it is so different from other liquid extracts on the market,” is how one kratom vendor markets Black Liquid Kratom.

Another kratom vendor specifically cautions that OPMS extracts are “too strong for use on a daily basis.”

It’s not clear how long, how often or why Pope had been taking kratom, but at a news conference this week his parents said they found a to-do list in his apartment that included the words “Stop taking kratom.”

The family’s lawsuit was originally filed in May and an amended complaint was filed this week, naming over a dozen different individuals, vendors and organizations, including OPMS and the American Kratom Association (AKA).    

“You don’t expect to go into a store and find something similar to heroin between energy drinks and breath mints. We intend to hold every single person and entity involved in the distribution and sale of these products responsible,” attorney Matt Wetherington said in a statement.

The lawsuit drafted by Wetherington makes frequent references to kratom as a heroin-like substance, but there is no relationship between the two. Heroin is derived from opium plants, while kratom comes from mitragynine speciosa trees. Both act on opioid receptors in the brain, however, which has led to claims that kratom is an opioid.

OPMS has not commented publicly on the lawsuit, and the AKA issued a short statement saying it rejected the lawsuit’s claims and filed a motion to be dismissed from the case.

‘100% Natural and Never Adulterated’

OPMS is featured on the AKA’s website as one of the first kratom vendors to comply with its Good Manufacturing Practice Standards Program (GMP), an effort to enhance the safety of kratom products. To get “GMP Qualified” status, vendors have to agree to annual audits, inspections and testing of every production lot of kratom.    

“Optimized Plant Mediated Solutions has been the leader in the Kratom and Kava extract industry since 2010 due to its unique cold water extraction process. All O.P.M.S. products are 100 percent natural and never adulterated,” the AKA says on its website, which includes a link where OPMS products can be purchased directly from the company.

OPMS did not immediately respond to a request for comment from PNN. The company’s website cautions consumers that “several companies illegally counterfeit” its products, adding “dangerous ingredients” that pose a “serious health threat.” It urges consumers to report any suspicious products.

Taken in low doses, kratom acts as a mild analgesic and stimulant. Consumers generally take higher doses to combat severe pain and cravings caused by substance addiction. Most users do not experience a “high” or euphoria after taking kratom.

The Food and Drug Administration has not approved kratom for any medical use and vendors can run into trouble with the agency if they claim kratom can be used to treat health conditions. The FDA tried for years -- unsuccessfully – to schedule kratom as a controlled substance, which would effectively ban its sale and use in the United States. The FDA says kratom’s effects on the brain are similar to morphine and that kratom has “properties that expose users to the risks of addiction, abuse, and dependence.”

Not all federal agencies take such a dim view of kratom. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

About 100 deaths have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.  A toxicology test on Ethan Pope found antihistamine and antidepressant medications in his system, but no illegal drugs or alcohol were detected.

Brain Changes Found in Patients with Long-Term Lyme Disease

By Pat Anson, PNN Editor

Researchers at Johns Hopkins University have documented changes in the brains of patients with post-treatment Lyme disease that may explain symptoms such as brain fog, memory loss and other cognitive issues. The finding could also have implications for patients with long covid, fibromyalgia, multiple sclerosis, chronic fatigue and other health conditions who have cognitive problems.    

Lyme disease is a bacterial illness spread by ticks that causes a rash, flu-like aches and fever, joint pain and fatigue. Most patients fully recover when treated early with antibiotics, but up to 20% of those with post-treatment Lyme disease (PTLD) have long-term symptoms, including depression, insomnia and cognitive difficulties. There is usually no clinical or laboratory evidence to explain their ongoing issues.

“Objective biologic measures of post-treatment Lyme symptoms typically can’t be identified using regular MRIs, CT scans, or blood tests,” says John Aucott, MD., director of the Johns Hopkins Lyme Disease Clinical Research Center.

Aucott and his colleagues recruited 12 PTLD patients and 18 people without a history of Lyme to undergo functional MRI (fMRI) scans while performing a short-term memory task. The scans allow investigators to track blood flow and other changes in the brain in real time.

Their findings, published in the journal PLOS ONE, suggest that cognitive difficulties in PTLD patients are linked to functional and structural changes in the “white matter” of the brain, which is crucial for processing and relaying information. The imaging tests revealed unusual activity in the frontal lobe, an area of the brain responsible for memory recall and concentration. Patients with post-treatment Lyme needed longer periods of time to complete the memory task.

“We saw certain areas in the frontal lobe under-activating and others that were over-activating, which was somewhat expected,” said lead author Cherie Marvel, PhD, an associate professor of neurology at Johns Hopkins.

“However, we didn’t see this same white matter activity in the group without post-treatment Lyme.”

To confirm their finding, researchers used another form of imaging called diffusion tensor imaging (DTI) on all 12 patients with Lyme and 12 of the non-Lyme participants. DTI detects the direction of water movement within brain tissue. Water was diffusing, or leaking, in the the same white matter regions identified in the fMRI.

Researchers believe the increased activity they saw in white matter may reflect an immune system response in the PTLD patients, which may also explain cognitive issues in patients with other chronic health conditions.

PLOS ONE

“Results reported here may have implications for other diseases in which white matter pathology has been demonstrated (e.g., multiple sclerosis) or in illnesses in which cognitive complaints follow disease onset,” researchers said. “The use of multimodal neuroimaging methods, like the ones used in the current study, may be a viable approach for obtaining information on brain function and structure to identify biomarkers of disease burden.”

Researchers say larger studies with more patients will be needed to confirm their findings, as well as long-term tracking of brain changes from the initial Lyme infection through development of PTLD.

Nearly 500,000 people are believed to get Lyme disease each year in the United States. Diagnoses of Lyme have soared over the past 15 years, according to a recent analysis of insurance claims that found Lyme cases rose 357% in rural areas and 65% in urban areas. The highest rates of Lyme were in New Jersey, Vermont, Maine, Rhode Island and Connecticut.

Deaths of Intractable Pain Patients Often Mistaken as Overdoses

By Dr. Forest Tennant, PNN Columnist

Unexpected and sudden death commonly occur in persons who have poorly controlled pain caused by Intractable Pain Syndrome (IPS). Many persons with IPS who have died unexpectedly have been falsely accused of an “overdose” because drugs were found in their body fluids at autopsy. In reality, the cause was almost always cardiac arrest, hypoglycemia or adrenal failure.

Cardiac Arrest

Pain flares during cardiac arrest may cause the adrenal glands to pump out so much adrenalin that their blood pressure and pulse rate jump up dramatically. This causes blood vessels, including the coronary arteries and those in the brain, to constrict and shut off blood flow. The result may be a heart attack, stroke or arrhythmia.

Chronic, recurrent coronary constriction may cause heart pain called “angina.” A person with IPS who has their medications, usually opioids or benzodiazepines, reduced too rapidly is very prone to cardiac arrhythmia and cardiac arrest.

Hypoglycemia

Insulin is normally made and secreted by the pancreas to lower blood sugar in order to digest food and stabilize metabolism. In times of pain, cortisol and blood sugar are raised. When this occurs, insulin is pumped out by the pancreas to heal injured or damaged tissues. Too much insulin caused by a pain flare can force blood sugar to drop to such a low level – a condition known as hypoglycemia -- that death may occur.

The long-term effect of constant pain on the pancreas is an insulin deficiency, so high blood sugar levels (diabetes) are regularly found in persons with IPS.

Adrenal Failure

Uncontrolled constant pain may exhaust the adrenal glands to a point that the hormone cortisol drops too low, causing Addison’s disease or adrenal insufficiency. Symptoms such as darkened skin, abdominal pain and weakness usually appear slowly, but if there’s rapid onset of symptoms it could lead to adrenal failure and death.

Addison’s Disease is named after Dr. Thomas Addison, who described 11 cases of adrenal failure in 1855. About half his cases had histories of severe pain. Persons who die of adrenal failure often do so in their sleep.

Many persons with IPS have unexpectedly and suddenly died and have been falsely accused of drug overdose. To prevent sudden death, persons with IPS must be in a pain treatment program that is balanced and doesn’t rely just on just one or two medications.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from a bulletin recently issued by the Intractable Pain Syndrome Research and Education Project.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Green Eyeglasses Improve Anxiety and Wellness in Fibromyalgia Patients

By Pat Anson, PNN Editor

Fibromyalgia is well known as one of the most difficult chronic pain conditions to treat. The Food and Drug Administration has approved a handful of medications for fibromyalgia, but many patients find them ineffective in treating the muscles aches, joint pain, fatigue, anxiety and other symptoms that are common in fibromyalgia.  

Researchers at Duke University may have found an easy way to reduce some of those symptoms without the use of drugs. In a small study of fibromyalgia patients being treated with opioids, those who wore eyeglasses with specially tinted green lenses reported a significant improvement in their anxiety and overall sense of wellness. And while their pain levels were unchanged, their use of opioids declined.

“My research has been focused heavily on finding alternatives to opioids for pain management,” says lead author Padma Gulur, MD, Executive Vice Chair of the Department of Anesthesiology at Duke University. “One of the things we discovered early on was that there were visually mediated triggers for pain. We definitely could see that with headaches, but also that it could actually impact pain itself, the pain pathways. While we still don’t fully understand the mechanism of how pathways for pain get activated with visual mediation, it definitely does happen.

“We narrowed it down over some years to the hypothesis that with green light, particularly in the green spectrum, there was an opportunity where it was influencing pain, both chronic pain and acute pain.”

Previous research has found that green light therapy has a calming effect on the brain and is useful in treating fibromyalgia and migraines. But in those studies, participants were confined to a room where they were immersed in green light and told to avoid activities like watching TV or using their cellphones.

Gulur thought there must be an easier way to experience the benefits of green light.

“People want pain relief, but they also want to live their lives. And spending hours and hours in a room or exposure takes away from that quality of life,” she told PNN. “On the other hand, wearing eyeglasses is something we’re all very comfortable doing and, thankfully these days, colored eyeglasses are all the thing.”

Gulur and her colleagues studied 34 fibromyalgia patients who were randomly selected to wear various shades of eyeglasses at least four hours a day for two weeks: 10 patients wore blue eyeglasses, 12 wore clear eyeglasses and 12 wore green eyeglasses.

DUKE UNIVERSITY

Their findings, presented this week at the annual meeting of the American Society of Anesthesiologists, showed that participants who wore green eyeglasses were four times more likely to have reduced anxiety than those in the other two groups, who reported no reduction in anxiety. They also reported feeling better.

“We found that although their pain scores remained the same, those who wore the green eyeglasses used fewer opioids, demonstrating that their pain was adequately controlled,” said Gulur, who noted that patients who wore the green eyeglasses asked if they could keep them at the end of the study.

“They didn’t want to give them back. We had no trouble getting the blue and the clear back, but none of them wanted to return the green glasses.”

Unfortunately, they had to give them back. The eyeglasses are specially formulated to filter a specific wavelength on the green light spectrum and were needed for further study. You can’t buy the glasses online or at your local drug store. At least not yet.

Gulur and her team are planning further studies with green eyeglasses on patients with diabetic neuropathy and chronic back pain.