Cognitive Problems Persist in Patients with Long Covid

By Pat Anson, PNN Editor

About 70% of people with long covid have concentration and memory problems several months after their initial infection with Covid-19, according to new research at the University of Cambridge. The severity of the symptoms appears to be linked to the level of fatigue and headache people experienced during their initial illness.

Long covid is a poorly understood disorder characterized by body pain, fatigue, cognitive impairment and difficulty sleeping. About a third of people infected with coronavirus develop symptoms that can last for many months.   

In their study of 181 long covid patients, published in the journal Frontiers in Aging Neuroscience, researchers found that 78% reported difficulty concentrating, 69% had brain fog, 68% experienced forgetfulness, and 60% had trouble finding the right word to use in speech. They also performed poorly in cognitive tests, with significantly lower ability to remember words and pictures.

“This is important evidence that when people say they’re having cognitive difficulties post-COVID, these are not necessarily the result of anxiety or depression. The effects are measurable - something concerning is happening,” said co-author Muzaffer Kaser, PhD, a psychiatrist and researcher at the University of Cambridge. “Memory difficulties can significantly affect people’s daily lives, including the ability to do their jobs properly.”

The findings are further evidence that Covid-19 will have a lasting impact around the world, long after the pandemic subsides. Cambridge researchers say their study supports other findings that suggest society will face a “long tail” of workforce illness due to long covid.

“Long covid has received very little attention politically or medically. It urgently needs to be taken more seriously, and cognitive issues are an important part of this. When politicians talk about ‘Living with COVID’ – that is, unmitigated infection, this is something they ignore. The impact on the working population could be huge,” said senior author Lucy Cheke, PhD, a psychologist and lecturer at Cambridge.

To help understand the cause of the cognitive problems, Cheke and her colleagues investigated other symptoms that might be linked. They found that people who experienced fatigue and neurological symptoms, such as dizziness and headache, during their initial illness were more likely to have cognitive issues later on.

Participants were assigned to carry out multiple tasks to assess their decision-making and memory. These included remembering words on a list, and remembering which two images appeared together. The results revealed a consistent pattern of memory problems in people with long covid -- problems that were more pronounced in those whose initial neurological symptoms were more severe.

“People think that long covid is ‘just’ fatigue or a cough, but cognitive issues are the second most common symptom - and our data suggest this is because there is a significant impact on the ability to remember. There is growing evidence that COVID-19 impacts the brain, and our findings reflect that,” said Cheke.

Study participants were recruited between October 2020 and March 2021, when the Alpha variant and the original form of SARS-CoV-2 were still the dominant forms of the virus.

Very few of the patients had symptoms severe enough to be admitted to a hospital. But even among those who were not hospitalized, researchers found that people with severe initial symptoms were more likely to develop long covid than those with mild symptoms. They also found that people over 30 were more likely to have severe ongoing symptoms than younger ones.

“Infection with the virus that causes COVID-19 can lead to inflammation in the body, and this inflammation can affect behaviour and cognitive performance in ways we still don’t fully understand, but we think are related to an early excessive immune response,” said Kaser.

As is often the case with chronic illness, half of the patients with long covid reported difficulty getting medical providers to take their symptoms seriously, perhaps because cognitive symptoms do not get the same attention as respiratory problems.

The Cambridge study currently has no data on long covid associated with the Delta or Omicron variants of coronavirus, although new patients are being recruited to fill that void. The researchers say more studies are needed to understand the complex effects of Covid on the brain, cognition and mental health.

One way to reduce your risk of long covid is to get vaccinated. A UK study last year found that people who received the Moderna, Pfizer or AstraZeneca vaccines had significantly lower risk of an infection that turns into long covid.

CDC Censoring Public Comments About Revised Opioid Guideline

By Pat Anson, PNN Editor

The U.S. Centers for Disease Control and Prevention has censored over a dozen public comments about its revised opioid guideline to remove negative references to Dr. Roger Chou, one of the guideline’s co-authors.  

Chou is a controversial figure in the pain community. A prolific researcher and an outspoken critic of opioid prescribing, Chou heads the Pacific Northwest Evidence-based Practice Center (EPC) at Oregon Health & Science University.

Over the last five years, the university has received nearly $2 billion in contracts from the CDC and other federal agencies, much of it going to the EPC to support Chou’s research. That research, which generally discourages the use of opioids, is cited over 100 times in the revised CDC guideline.

The CDC published the revised draft in the Federal Register last month and invited the public to submit comments, with the agency cautioning posters that it “may choose to redact, or withhold, submissions containing private or proprietary information.”

Of the 2,600 submissions received so far, over 280 have been edited in some way, mostly to remove personal information about the poster or their medical provider

SOURCE: REGULATIONS.GOV

But at least 15 comments critical of Chou’s research and his role in writing the opioid guideline have also been edited to remove his name, even though much of the information they contain is already public and not proprietary.

Chou’s name is redacted four times from this post by Emma W:

“I think it’s reasonable for them to redact private information, physicians’ names, clinic names, etc. I’m all for protecting privacy. But it makes no sense to me that they would redact the names of guideline authors and/or the authors of research papers they directly cite as evidence,” said Emma, who asked that we not use her last name. “I did not personally make any offensive, rude, or vulgar remarks about him in my comment, so I’m still at a loss as to why I and some others were singled out.”

In addition to being a co-author of the revised guideline, Chou was one of the authors of the original 2016 guideline, which led to significant cutbacks in opioid prescribing nationwide. He also continues to serve on the CDC’s Board of Scientific Counselors, despite admitting to a financial conflict-of-interest (COI) at a board meeting last year.

“Since CDC funds Chou’s research, which supports their guidelines, my guess is that they’re going above and beyond to protect him from criticism,” Emma told PNN. “I suppose I should’ve expected this, considering absolutely nothing has been done about his continuing involvement in these guidelines despite his COIs.”

“It is outrageous but I’m not surprised,” said Julie Killingworth, whose comment was edited 6 times to remove the names of Chou and others.

“I thought my comment would be removed because I stopped appeasing the CDC with politeness long ago. I’m not surprised the CDC is silencing people they have cruelly targeted to be tortured,” Killingworth told PNN. “The CDC does not deserve the national respect they feel entitled to receive.” 

To be clear, not every post that references Chou has been edited. PNN identified 5 posts where his name has not been redacted. Those comments are also critical of Chou’s extensive involvement researching, developing and writing the guideline.

“I am concerned about the legality of redacting public comments. This in my experience is quite irregular,” says Terri Lewis, PhD, who co-authored a 2021 paper that looked into Chou’s conflicts of interest. “It doesn't change what are legitimate concerns about what are very real conflicts of interest and the failure to disclose same, especially in light of other historical facts that are emerging.”

In addition to the Chou redactions, the CDC has censored several comments that mention Dr. Andrew Kolodny by name and other members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that Kolodny founded.

Chou has collaborated on several occasions with PROP, including a 2019 op/ed he co-authored with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”

(3/31/22 Update: Nearly three weeks after we asked CDC why the names of Chou and others are being redacted, we received this reply from a spokesperson:

“Our approach with comments on this FRN (Federal Register Notice) was to redact all individuals’ names to protect privacy. With so many comments, there have been a few that were not redacted in line with this approach, but the intent was to redact names of any and all individuals.”

The spokesperson said the CDC may also “redact or withhold certain submissions” that contain private or proprietary information, inappropriate language, or duplicated public comments that could indicate a mass-mail campaign.)

The CDC will continue to accept public comments about the revised guideline until April 11. Click here to make one.

Ironically, the revised guideline has generally been received favorably by the pain community because it gives doctors more flexibility in prescribing opioids. Some patients and advocates are leery, however, that the revisions won’t restore access to opioid medication or fix all the other problems the original guideline created, such as patients being forcibly tapered or reduced to ineffective doses.

How the Epstein Barr Virus Causes Arachnoiditis

By Dr. Forest Tennant, PNN Columnist

The Epstein-Barr Virus (EBV) has long been known to cause autoimmune complications. For example, I described infectious mononucleosis in kidneys (glomerulonephritis) associated with EBV back in 1969, some 53 years ago.

Recently EBV has been shown to cause multiple sclerosis (MS), as well as certain cancers. Our studies have also revealed that many, if not the majority, of persons with adhesive arachnoiditis (AA) have extremely high EBV antibody levels. We now believe that EBV can cause AA as well as MS. 

Anything that boosts or helps a disorder to develop, is called a “co-factor.” In the case of EBV and AA, the “co-factors” or “co-partners” may include Ehlers-Danlos Syndromes, autoimmune diseases such as psoriasis, Lyme disease, and some other viruses like cytomegalus, coxsackie and covid.

‘Collagen Eaters’

Although almost everyone gets infected with EBV during their lifetime, some persons develop a large number of EBV antigens that literally attack and “eat away” or otherwise cause collagen to deteriorate and weaken. If the body creates large numbers of antigens, large numbers of antibodies are simultaneously made to hopefully counter them.

EBV collagen eating antigens like to attack tissues around the spine that have a lot of collagen. This includes intervertebral discs, cauda equina nerve roots, and the arachnoid-dural covering of the spinal canal. If collagen is weak or absent in spinal tissues, discs may slip, inflammation may form, and fluid leaks and cysts may develop.

Get Tested for EBV

All persons with confirmed or suspected AA should be tested for EBV antibodies.

Laboratories today do three types of tests for EBV. One is to tell if you currently have an active infection and the other two measure antibody levels to determine if you have had EBV in the past. If your antibodies are considerably above normal range, it suggests you have collagen eating antigens that put you at risk of developing AA.

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 Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

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

State Laws Had Little Impact on Opioid Prescribing

By Pat Anson, PNN Editor

When the CDC’s opioid prescribing guideline was released in 2016, dozens of states began efforts to codify the guideline’s “voluntary” recommendations into laws and regulations. To date, according to The Pew Charitable Trust, 40 states limit the dose or initial supply of opioid medication, and all 50 states have implemented prescription drug monitoring programs (PDMPs) to track opioid prescriptions and the doctors who write them.

On the surface, it may appear the state policies are working, because opioid prescribing in the U.S. has plunged over 40 percent, to levels not seen in 20 years. But a large new study found that state laws regulating opioids have had very little effect on prescribing – suggesting that other factors may be at work making doctors reluctant to prescribe opioids.

Researchers at Johns Hopkins Bloomberg School of Public Health studied commercial insurance claims for nearly 7.7 million adults in 13 “treatment states” that limited prescribing, established PDMPs or targeted pill mills. The analysis included data for nearly 2 million patients diagnosed with arthritis, low back pain, headache, fiibromyalgia or neuropathic pain.

The study findings, published in Annals of Internal Medicine, show that prescribing and PDMP laws in treatment states were associated with an average change of less than 1% in the proportion of patients receiving an opioid prescription.

For example, in Idaho an estimated 9.18% of pain patients received an opioid prescription prior to the state passing a mandatory PDMP law that required doctors to look up a patient’s prescription drug history. In the first two years of the law’s implementation, that percentage fell only slightly to 9.03% of patients.

State laws have also had a negligible impact on dose and supply. Patients who received an opioid prescription in treatment states had an average change of less than one day in the supply of opioids and an average dosage change of less than 4 morphine milligram equivalents (MME) per day.

“We did not find an association between state opioid prescribing laws and receipt of opioid prescriptions or guideline-concordant nonopioid pain treatments among commercially insured adults. Across the 13 states that implemented laws, the change in treatment attributable to the law was consistently small in magnitude and not
statistically significant,” researchers reported.

“The findings suggest that the decreasing volume of opioid prescribing in the United States may be driven more by shifting clinical guidelines, professional norms, or other factors than by these laws.”

PNN asked lead author Beth McGinty, PhD, if the “other factors” that caused opioid prescribing to decline were the CDC guideline itself or the chilling effect many doctors felt from expanded investigations by state medical boards, law enforcement and the Drug Enforcement Administration.

“Our study was not designed to identify those other factors, so I can’t say for sure what has driven these declines.  Overall declines could be due to changing clinical practices nationwide in response to the CDC guidelines or many others,” McGinty replied in an email.

“Declines could also be driven by a range of other efforts to curb opioid prescribing, perhaps the DEA investigations you mention but also other efforts like health system interventions to reduce prescribing. As I said above, our study was designed to evaluate just the state laws, not these other factors, so I can’t say for sure."

“It's really hard to tell exactly what the findings here mean, despite a valiant effort on the part of the researchers,” says Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management.

Twillman says the CDC guideline was “weaponized” in so many ways by regulators, insurers and states that it’s difficult to measure the impact of any single policy or regulation. It was the cumulative impact of them all that drove down opioid prescribing.

“In truth, the most that you can conclude from this study is that these laws did not appear to reduce prescribing. Unfortunately, in the context of an avalanche of other policies, that conclusion doesn't paint a very accurate picture of what is happening to patients because of all the policies,” Twillman told PNN.

State Laws Failed to Reduce Overdoses

McGinty’s study is not the first to find that PDMPs have been largely ineffective – and may even be making the opioid crisis worse. A 2021 study by the Reason Foundation found that overdoses from illicit fentanyl and heroin increased in states after PDMP’s were adopted. A 2018 study by researchers at Columbia University and University of California, Davis had similar findings. 

State laws that limit the dose and quantity of prescription opioids have also failed to stop overdoses from increasing.

In 2016, Massachusetts became the first state in the nation to limit the initial supply of opioid prescriptions to 7 days. The law has had little impact on overdoses. Over 2,000 people still die annually from opioid overdoses in Massachusetts, a rate that has remained steady. The most recent data shows that illicit fentanyl was involved in 92 percent of overdose deaths in the state.

It was the 2016 CDC guideline that encouraged Massachusetts and many other states to adopt limits on initial opioid prescriptions. For short-term acute pain, the guideline said that opioids for “three days or less will often be sufficient; more than seven days will rarely be needed.”

A newly revised draft guideline drops any reference to the number of days and gives physicians more latitude, recommending that opioids be prescribed for acute pain “for no longer than the expected duration of pain severe enough to require opioids.”

More Than Just CDC Opioid Guideline Needs Changing

By Roger Chriss, PNN Columnist

The CDC’s draft revisions to its 2016 opioid guideline are generally seen as an improvement by pain management experts because they give doctors more flexibility to prescribe opioids. But how much will prescribing really change?

Forty states have enacted laws that limit the supply or dose of opioid prescriptions, according to the Pew Charitable Trust. Some states may resist making changes.

“For the eased guidelines to have their intended effect, states would need to amend or repeal existing statutes that limit opioid prescriptions to three to seven days and set ceilings on the daily dose doctors can prescribe,” Stateline reported.

The reasons are simple. Amid a deteriorating drug overdose crisis and a complex prescribing landscape, the proposed changes in the CDC guideline are likely to be seen at the state level as a negative for public health. There’s a tangled mess of different opioid regulations that vary from state to state.

“Relaxing those regulations now would wreak havoc on states. They won’t know what to do,” says Gary Franklin, MD, who is Vice-President of State Regulatory Affairs for Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“We’ve made quite a dent in prescription painkiller use,” Franklin told EMS1. “But we’ve still got a lot of work to do.”

Lewis Nelson, MD, Chair of Emergency Medicine at Rutgers New Jersey Medical School, is concerned about plans to drop the guideline’s recommended dose limit of 90 morphine milligram equivalents (MME) per day. Nelson says the CDC’s “watered down recommendations” will lead to more addiction and overdoses.

“By removing this recommended cap … prescribers may feel it is appropriate to prescribe longer initial prescriptions to their patients,” Nelson told The Daily Targum, a student newspaper at Rutgers. “This is one of the key factors that created the opioid crisis in the early 1990s that lasted through today.”  

Nelson and Franklin were both key advisors to the CDC during the drafting of its 2016 guideline, serving on a panel known as the “Core Expert Group.” They did not have a similar role in the drafting of the revised guideline.

Federal Agencies and States Do Their Own Thing

Because they are controlled substances, prescription opioids are not regulated the same way as other medications. Manufacturing levels are determined by the DEA, which annually determines production quotas for opioids based on input from the FDA, CDC, Centers for Medicare and Medicaid Services (CMS), and individual states. The DEA has been steadily reducing production quotas for prescription opioids for almost a decade and seems unlikely to change course anytime soon.

Drug approval falls to the FDA, which says one of its “highest priorities” is reducing the number of Americans addicted to opioids. “This may be achieved by ensuring that only appropriately indicated patients are prescribed opioids and that the prescriptions are for durations and doses that properly match the clinical reason for which the drug is being prescribed in the first place,” the FDA says on its website.

Federal programs like Medicare, Medicaid and VA/Tricare, as well as private insurers and pharmacies, exert considerable influence on clinical practice via formularies, guidelines, and prior authorizations.

States ignore the CDC, FDA and other federal regulations when it suits their ends, as seen with Florida’s new “Buck the CDC” effort against federal mask mandates and covid guidelines.

States also set their own regulations for legalizing cannabis or decriminalizing hallucinogens.

When it comes to healthcare and public health, each state does its own thing, even if they conflict with federal policy and are detrimental to other states.

Patient advocate Richard “Red” Lawhern deftly summarizes the many nuances of the CDC’s draft guidance with “the devil is in the details.”  And the National Pain Advocacy Center has a detailed analysis of the draft, with suggestions for further advocacy.

The CDC has been a convenient scapegoat for the rapid opioid tapering, patient abandonment, and even suicides that have occurred in recent years. But the reality of regulating prescription opioids and treating chronic pain is complex. Even if CDC does finalize the proposed changes in its draft guideline, there is still a long way to go to restore some semblance of order and stability in pain management.

The CDC is one part of a much larger system that probably needs to change as much as the 2016 guideline need to be updated.

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. 

Medical Societies Have New Advice for Treating Surgery Pain in Patients Taking Opioids

By Pat Anson, PNN Editor

The American Medical Association and 14 other medical societies have released new advice for physicians managing surgical pain in “complex patients” who have chronic pain, substance use disorders, or those taking opioid medication prior to surgery.

The seven guiding principles emphasize the coordination of pain care with other providers, and that patients taking opioids be allowed to stay on them before, during and after surgery.  

“Every surgical patient deserves adequate pain relief that aims to prevent opioid reliance, chronic pain and other negative outcomes, but it may be more challenging to achieve this in certain patient populations,” Randall Clark, MD, President of the American Society of Anesthesiologists (ASA), said in a statement.

“The new principles were created to build upon an original set established last year during our first pain summit, but specifically address patients undergoing surgery with chronic pain, those taking opioids preoperatively, and those with substance use disorders.  The new principles give the perioperative care team more guidance to care for these particularly complex patients.”

The new principles come at a time when many U.S. hospitals are reducing the use of opioids for surgical pain. As result, some people in pain have postponed or cancelled surgeries because they fear their postoperative pain would be poorly treated or their current opioid therapy would be disrupted.

For patients on long-term opioid therapy, the principles urge physicians to “continue the baseline opioid dose” and to provide “supplemental analgesia” for postoperative pain. The additional pain treatment should be the coordinated with the patient’s opioid-prescribing clinician, with the goal of returning to “the preoperative dose or lower as soon as possible.”

“This really is meant to be a patient-centered document that says we should invest in making sure these patients have a good experience,” said David Dickerson, MD, chair of the ASA’s Committee on Pain Medicine. “A lot of people don’t even get their baseline meds continued during their surgery. They don’t even get their home meds. And so this now creates a principle that says you need to have a really good reason why you’re going to withhold those meds.

“In our health system, if someone has pre-op opioid use, we know that they’re going to need more opioids in the wake of their surgery or they’re going to need more anesthetic even while they’re on the table having their care,” said Dickerson, an anesthesiologist who is section chief for pain medicine at the NorthShore University HealthSystem in Chicago.

In addition to the ASA and AMA, these medical organizations have adopted the new guiding principles:

• American Academy of Orthopaedic Surgeons

• American Academy of Otolaryngology-Head and Neck Surgery

• American Association of Neurological Surgeons

• American Association of Oral and Maxillofacial Surgeons

• American College of Obstetricians and Gynecologists

• American College of Surgeons

• American Hospital Association

• American Society of Addiction Medicine

• American Society of Breast Surgeons

• American Society of Plastic Surgeons

• American Society of Regional Anesthesia and Pain Medicine

• American Urological Association

• Society of Thoracic Surgeons

‘CDC Guideline Falls Flat’

Dickerson emphasized the new guiding principles are only meant as a resource for physicians managing surgical pain and are not intended to be a guideline or standard of care. He also expressed concern about some of the proposed changes to the CDC’s opioid prescribing guideline, which now includes recommendations for treating postoperative pain.

“I think that the CDC guidelines, as they are proposed in their draft format right now, is not an incredibly functional document. It doesn’t really shape what great pain care looks like. All it talks about really is mitigating the effects of opioid injury. It offers up ideas, but I don’t think it’s a comprehensive summary of what we do for patients,” Dickerson told PNN.

The CDC’s draft revision is actually quite similar to the medical societies’ new principles for treating surgery pain. It allows for patients on long-term opioid therapy to get additional opioids “for the duration” of their postoperative pain, with a return to their baseline doses as soon as possible.  

But Dickerson says there are many different types of surgery that require different forms of pain control, and some complicated patients may need more pain relief and different therapies than others. He thinks medical societies should set their own guidelines for their own specialties, and not rely on the generic advice of the CDC.

“I think that societies when they come together to do things like this are really best-tasked as experts to do this. To expect primary care physicians to write a guideline about how to manage surgical populations is limited from the start,” he said. “I think the CDC guideline falls flat.”

The Devil in the Details of Revised CDC Opioid Guideline

By Richard Lawhern, PNN Contributor

Last month, the U.S. Centers for Disease Control and Prevention circulated a revised and greatly expanded draft update to its 2016 guideline on prescribing opioids to adults with chronic non-cancer pain. The new version expands to include short-term acute and “subacute” pain, and it acknowledges some of the harms done by the “misapplication” of its predecessor. 

The draft also proclaims that clinicians and their patients should be free to tailor pain therapy to the needs and circumstances of each individual, rather than applying the guidelines as a mandatory or legal standard of care. 

Many media commentators have focused on the easing of restrictions on opioid pain therapy. But as often happens, the devil is in the details -- which many commentators have either not read or paid appropriate attention to. In my view, the revised draft is simply version 2.0 of the same “Little Shop of Horrors: published in 2016. 

The authors of the revised guideline set out to deceive the public with the appearance of giving doctors more discretion in prescribing opioids. But that new “flexibility” is overwhelmed by wording that subtly informs doctors that they may risk sanctions if they prescribe opioids to anyone, at any level above 50 morphine milligram equivalents (MME) dose per day.

The underlying bias and predetermined agenda of the CDC writers is apparent in the wording of the draft:

• The words “risk” or “risks” appear 512 times, while “benefits” appears 167 times. Clinicians are repeatedly admonished to evaluate “risks versus benefits” of opioid therapy when deciding to prescribe opioids or increase the dose. But the draft acknowledges that “there is no validated, reliable way to predict which patients will suffer serious harm from opioid therapy and no reliable way to predict which patients will benefit from opioid therapy.”  In more accurate words, clinicians are on their own when they prescribe these medications.

• “Taper” or “tapering” or “tapers” are mentioned 200 times. Although “abrupt discontinuation” of opioids is discouraged, clinicians are still advised to “appropriately taper and discontinue opioids” for patients on high doses.

• The writers repeat their false claim from 2016, that opioids are not a proven long-term therapy because there are few long-term randomized double-blind trials for opioids versus placebo. They ignore the fact that the rarity of long-term trials reflects high dropout rates among patients who experience breakthrough pain when treated with placebos.  This error can be corrected by the use of enriched enrollment trials, which is unmentioned in the draft.

• The writers also assert that “additional dosage increases beyond 50 MME/day are progressively more likely to yield diminishing returns in benefits relative to risks to patients.” However, they offer scant scientific evidence for this assertion. They fail to reference case reports from patients who do well on high doses exceeding 1000 MME.

• Most fundamentally, the entire CDC draft is organized around the concept of “Morphine Milligram Equivalent Dose” – which is now known to be junk science unsupported by any real data.

Errors and distortions of the CDC draft are also apparent in the wording of their 12 recommendations:

• Seven of the recommendations are identified as “Category A recommendations [which] indicate that most patients should receive the recommended course of action.” Any reasonable clinician will recognize these words as a standard of practice that they violate at their own peril. 

• The 2nd recommendation is that “nonopioid therapies are preferred for subacute and chronic pain.”
  Ignored in this phrasing is the fact that several of the CDC referenced studies on non-steroidal anti-inflammatory drugs (NSAIDs) employed deeply flawed protocols. Likewise, there have been no trials of non-drug therapies as substitutions for opioids in moderate to severe pain. Thus, non-opioid therapies cannot possibly be “preferred.”

• Also glossed over by the draft writers is the strength of evidence supporting seven of the recommendations is rated as “type 4 evidence” (clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations). Freely translated, this level of evidence simply represents the opinions of the writers, rather than any general consensus among actual practitioners. 

The revised guideline is almost as interesting for what it does not discuss as for what it does. Missing from the draft is any mention of the World Health Organization’s “Pain Ladder.” First published in 1986 and oriented to cancer pain, it is now widely used in both doctor training and common practice for all types of pain.

• The first level of the ladder is Tylenol (ibuprofen) and other NSAIDs -- which are used in the short term for mild to moderate pain.

• Second level of the ladder is weak opioids like tramadol, used in longer lasting or more intense moderate to severe pain.

• Third level is strong opioids like hydromorphone or medical fentanyl, used in very severe or treatment-resistant pain.

• Non-drug treatments like acupuncture or massage can be integrated with pain therapy at any level of the ladder, to assist patients in managing pain and increasing function. These are not, however, replacements for drug treatment.

• Interventional treatments like nerve blocks, epidural corticosteroid injections, spinal cord stimulators or fusion surgery may be used when pain is resistant to drug therapy. 

The rationale for excluding discussion of this framework from the CDC guideline is nowhere made clear in either the 2016 or 2022 documents.  The implied reason for this policy choice seems to be that prescription opioid analgesics were assumed by the writers to carry significant danger of addiction and misuse, even when administered at low doses and for short periods. 

It is now clear, however, that such reasoning is seriously wrong on facts. Prescription opioids did not cause and are not sustaining America’s so-called “opioid crisis.”  That distinction belongs to illegal street drugs, notably illegal fentanyl.

Given the many failings of the Little Shop of Horrors 2.0, it is reasonable to ask, “What should be next?”  In my opinion, it is time to burn this shop to the ground and start all over.

The development of practice standards for pain treatment should be taken entirely out of the CDC and allocated to medical specialty boards and academies whose members are practicing clinicians -- rather than public health bureaucrats who have never treated patients face-to-face.

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.

Drug Derived from Ticks Could Take Bite Out of Pain

By Pat Anson, PNN Editor

If you’ve experienced Lyme disease, probably the last place you’d look for pain relief is ticks. The insects are notorious for spreading Lyme, a bacterial illness that causes chronic fatigue, muscle and joint pain, cognitive issues and other symptoms that can last for years.  

But UK researchers say a protein found in tick saliva – called Votucalis – shows potential as a treatment for chronic pain. In experiments on laboratory animals, Votucalis provided pain and itch relief to mice subjected to neuropathic pain. Their findings were recently published in the journal Frontiers in Pharmacology.

“It is amazing that a protein found in the saliva of this tiny creature could prevent chronic pain and itching in people,” says co-author Ilona Obara, PhD, Director of Research in the School of Pharmacy at Newcastle University. “These are conditions that bring a huge amount of misery, and current medication displays limited efficacy, and can also often be detrimental to patients.

“Votucalis has already been tested in humans with other conditions, including conjunctivitis, without major side-effects, so the potential for this to be developed into a drug to tackle chronic pain and itching is definitely there.”

Obara began her research at Durham University with co-author Paul Chazot, PhD. Their research focused on tick saliva because it has pain relieving, anti-inflammatory and anti-coagulant effects on mammals. Ticks are parasitic blood feeders that rely on their “hosts” to be unaware that they have uninvited dinner guests.

Researchers found that Votucalis is particularly good at binding to histamine and preventing it from activating histamine cell receptors, resulting in reduced itching and pain sensations when a host animal is bitten.

“Our study is the first to show evidence of the anti-itch and pain relief potential of Votucalis, which is very exciting. We could be on the brink of discovering a viable alternative to opioid and gabapentinoid drugs,” said Chazot, an Associate Professor in the Department of Biosciences at Durham University.

The next step is to develop a drug delivery system to effectively administer Votucalis at the site of itch and pain. The research is being funded by the government of Saudi Arabia – where ticks are emerging as a public health problem -- and Akari Therapeutics, a pharmaceutical company that hopes to turn Votucalis into a treatment for neuropathic and inflammatory pain.

Unlike opioids, Votucalis does not enter the brain, which means it is not addictive and less likely to cause side effects.

“We are delighted to be working with Drs. Chazot and Obara on the pipeline drug Votucalis. The exciting new data in pain and itch supports the potential that the unique mode of action of Votucalis, inhibiting all four histamine receptors, opens exciting therapeutic opportunities in pain management and dermatology," Clive Richardson, CEO of Akari Therapeutics, said in a statement.

Akari is developing another drug derived from ticks – called nomacopan – for the treatment of a rare skin disease and ophthalmic conditions in the eye.  

What Do You Think About Changes to CDC Opioid Guideline?

By Pat Anson, PNN Editor

Do you think the proposed changes to the CDC’s opioid guideline are an improvement over the original 2016 guideline? Will the changes make doctors more or less willing to prescribe opioids? Should the guideline be expanded to include recommendations for treating conditions like migraine and low back pain?

Those are some of the questions we’re asking in a new PNN survey on the long-awaited draft revision of the guideline that was unveiled last month by the CDC.  In addition to giving healthcare providers more flexibility in using opioid medication to manage chronic pain, some experts say the changes effectively transform the guideline into a national “standard of care” for pain management – one that would apply to most doctors and patients, regardless of the severity or duration of their pain.

While the guideline changes have been applauded by professional societies like the American Medical Association for removing “arbitrary doses thresholds” for opioids, some worry that the expansion goes too far and could harm patients -- like the original guideline did -- by depriving them of effective pain treatments.

“The CDC is outside its lane to be recommending how physicians should practice pain medicine. Would they recommend how to treat hypertension or diabetes? If they did, it too would be inappropriate, unless it was in collaboration with one or more of the medical professional societies devoted to those areas,” says Lynn Webster, MD, Senior Fellow at the Center for U.S. Policy and past president of the American Academy of Pain Medicine.

“I have a lot of concerns about the new version. It is better, but still terribly misleading and not grounded in science, which is terrible disappointing.” 

90 MME Threshold Dropped

Perhaps the biggest change to the 2016 guideline is the CDC’s decision to drop a recommendation that opioid doses not exceed 90 morphine milligram equivalents (MME) per day, which quickly became a hard limit for many providers, insurers, states and regulators.

While the CDC still recommends caution about doses exceeding 50 MME, that advice is not enough for Lewis Nelson, MD, a longtime critic of opioid prescribing who advised the agency when the original guideline was created. He thinks the 90 MME limit is based on sound evidence.

“There are good data to support that there is an inflection point at 90 MME. It’s clear that high-dose chronic opioid therapy is associated with a number of adverse consequences -- including addiction, unintentional overdose and potentially death,” says Nelson, the Chair of Emergency Medicine at Rutgers New Jersey Medical School. “In a way, it’s a race to the bottom in pain management, because if you’re not getting better with a reasonable dose of an opioid, there’s nothing to support that additional opioid is going to carry significant benefit and is known to markedly increase the risk.”

Dr. Webster says the use of MME to guide prescribing is misleading because not all opioids are the same or convert well to MME doses. Like others, he worries that 50 MME will become the new hard threshold for opioid doses.

“I think any reference to conversion tables and MME will be interpreted as validation of them. We saw that with the 2016 guideline,” Webster told PNN. “The CDC needs to explicitly state the lack of scientific basis for both and that their use could be dangerous in some cases. They should not cite 50 MME threshold anywhere, as it is meaningless, misleading and will lead to further misapplication of the recommendation. You would think that they would have learned that by the 2016 guideline.” 

Take Our Survey

This is the fifth survey PNN has conducted on the CDC guideline. All of them found that the vast majority of patients and providers believe the guideline was harmful, worsened the quality of pain care, and led some patients to contemplate suicide or turn to street drugs.    

For those who think surveys are a waste of time and the CDC doesn’t pay attention to them -- think again. On Page 53 of its revised opioid guideline, the agency cites PNN’s 2017 survey and has a footnote linking to it:

"An online (non-peer reviewed) survey of over 3000 patients 1 year after the release of the 2016 CDC Guideline found that 84% reported more pain and worse quality of life and 42% said they had considered suicide; however, the survey did not attempt to sample patients with chronic pain using a rigorous methodological approach.”  

It’s true the PNN survey was not peer-reviewed and that patients were not sampled with a “rigorous methodological approach.”  It’s also true that CDC has not conducted a large survey of its own to measure the impact of its guideline on patients. The agency has focused on counting opioid prescriptions — not patient outcomes — as a measure of whether its guideline is working.

To take our new survey, click here.

It should only take a few minutes to complete. We’ll share the results in mid-April.

'This is an opportunity for patients, caregivers, clinicians and others to share their impressions of the 2022 revised and expanded CDC practice guidelines for treatment of acute and chronic pain,” says patient advocate Richard “Red” Lawhern, PhD.

“This guideline will ultimately steer pain care for the foreseeable future, for better or worse. The more involved and informed every part of our community is, the more we can help shape its impact. This survey is one more way to get involved and help guide future efforts,” said Tamera Lynn Stewart, Policy Director for P3 Political Action Alliance.

You can read the revised draft of the CDC guideline and leave an online comment in the Federal Register by clicking here. Comments must be received by April 11.

Strict Low-Calorie Diet Reduces Fibromyalgia Symptoms

By Pat Anson, PNN Editor

Fibromyalgia patients with obesity experienced a significant reduction in pain and other symptoms after three weeks on a strict low-calorie diet, according to a new study that suggests limiting calories – not just weight loss – can have an analgesic effect.

Researchers enrolled nearly 200 patients diagnosed with fibromyalgia who were participating in a weight management program at the University of Michigan Health System. Participants had an average body mass index (BMI) of 41, which is considered severe obesity.

For 12 weeks, they were put on a very low energy diet (VLED) that limits bread, rice, potatoes and other foods that are high in carbohydrates. VLED is designed to shift the body away from using glucose in sweet or starchy foods to burning its own body fat for energy. Study participants were limited to just 800 calories a day, less than half the amount recommended for adult women and only a third of the amount recommended for men.

After just three weeks on the restricted diet, nearly three out of four participants (72%) experienced symptom reductions of 30% or more, regardless of the amount of weight lost. Patients who showed little or no improvement had a higher BMI at the start of the study and were more likely to have had a diagnosis of depression.

“Our results show, for the first time, that individuals following aggressive calorie restriction, ie, a VLED, had rapid and significant improvements in pain distribution and common pain-related comorbid symptoms and, importantly, prior to the achievement of significant weight loss,” researchers reported in the journal ACR Open Rheumatology.

“Furthermore, improvement at week 3 was strongly associated with improvement over the entire 12-week course of VLED, suggesting that patients who respond are likely to show these effects early in the process. These findings provide preliminary support for the hypothesis that calorie restriction, per se, can reduce pain and comorbid symptoms in individuals with obesity.”

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. The FDA has approved three drugs to treat fibromyalgia -- duloxetine (Cymbalta), milnacipran (Savella) and pregabalin (Lyrica) -- but many patients say the drugs are ineffective and often have side effects.  

Previous studies have suggested that weight loss can help lower pain levels, but the improvement was thought to be caused by reduced stress on knees, hips and lower back – parts of the body that are weight-bearing.  

The new study suggests that a strict diet alone can significantly reduce fibromyalgia pain without major weight loss, but researchers caution that more studies are needed to fully understand the biological processes at work.

“The implications of this study suggest an early association between caloric restriction, through a VLED, and fibromyalgia symptoms. Although a larger study with a control group would be the next step in investigating this association, this provides important information for clinicians who counsel patients on alternatives to pharmacologic treatments for pain and other somatic symptoms,” researchers concluded.     

Many previous studies have shown that a low calorie diet can help reduce pain levels. A 2018 study at the University of Michigan found that obese patients on a low-calorie liquid diet for 12 weeks not only had lower pain levels in their knees and hips, but also in unexpected areas such as the abdomen, arm, chest and jaw. Study participants who lost 10% of their weight also reported better mental health, improved cognition and more energy.

Endometriosis: My Long Road to Diagnosis and Treatment

By Victoria Reed, PNN Columnist 

My first experience with chronic pain occurred early in life. As a teen, I often had unexplained bouts of pelvic pain and very severe menstrual pain, which left me vomiting and incapable of functioning for at least a full day every month.  

Although Advil (ibuprofen) is a common treatment for menstrual pain, I didn’t discover its use for menstrual cramps until I was over the age of 20. Before then, I tried other over-the-counter pain relievers, but they were all ineffective at controlling the pain.  

In between the painful periods, a dull pelvic ache settled in. It was always there, and after a while it just seemed like a normal part of life for me. But one day I came to the realization that it wasn’t normal to have near constant pelvic pain and decided to seek the help of a doctor.  

I first consulted with a doctor who was in my HMO medical plan. He decided to perform a diagnostic laparoscopy. That’s a surgical procedure in which a scope is used to view the abdominal and pelvic organs. I was told that nothing abnormal was seen.  

Not convinced that everything was normal, I sought the help of another doctor about a year later. The new doctor performed another laparoscopy and found evidence of endometriosis. However, he ended the procedure without doing anything to fix it. At the time, I didn’t really know what endometriosis was and the doctor said that the treatment for it was outside of his skill set. I knew I had to keep looking for a doctor that could actually help. 

After some time passed, I saw a third doctor who did weekly ultrasound “treatments” on my pelvis. I’m not exactly sure how that was supposed to work for pain relief, because it didn’t improve anything. I thought it was a little strange, but was willing to try anything. That doctor would later be convicted of gross sexual imposition for his inappropriate conduct with female patients.  

By the time I was in my mid 20’s, I once again decided to seek help for the unrelenting menstrual and pelvic pain. The fourth (and final) doctor I chose was a reproductive endocrinologist and OB/GYN. Little did I know, I hit the jackpot with this one! Not only was he kind and compassionate, but he was skilled at restoring fertility. At the time, I was convinced that I was going to be unable to have babies, as I had read that endometriosis could cause infertility.  

After our initial consult, the doctor came up with a plan to give the pelvic organs a “rest” by inducing a menopause-like condition with a hormone treatment called Lupron. Lupron has been used to treat endometriosis since 1990 and was found to reduce pain in the pelvis and abdomen. It works by suppressing the amount of estrogen in the body and essentially stops the menstrual periods.  

I had two Lupron injections over a period of six months and felt great! However, I wasn’t allowed to stay on the medication indefinitely due to potentially damaging side effects.  

Unfortunately, after some time off the medication, my symptoms gradually returned. In another year or two, I went ahead with another 6-month course of Lupron. Again, during the time I was on it, I felt no pain. It is believed that the endometrial lesions respond directly to circulating estrogen, so pain intensity can fluctuate with the changes throughout the menstrual cycle. The lesions can land anywhere inside the body, including the colon, bladder, lungs or other internal organs and can cause pain that’s not confined to just the pelvic area.  

After my second course of Lupron, I was told that if the symptoms returned, I could consider yet another laparoscopy. As expected, the pain returned again and I consented to a third surgery. However, this laparoscopy would be different. My doctor performed a lysis of adhesions -- a procedure that destroys the misplaced endometrial tissue that cause pain.

He was also able to free up pelvic adhesions and use a procedure to unblock a fallopian tube, thereby restoring my fertility. This surgery was life-changing. Finally!  

The chronic pelvic pain improved, and I went on to have four pregnancies and three successful births. Unfortunately, the menstrual periods continued to be quite painful.  

It’s been a long road, but I was lucky and feel very grateful to find a doctor who was willing and capable of doing what was necessary to help relieve my pain. I recommend that anyone with a diagnosis of endometriosis seek out a reproductive endocrinologist for the best possible treatment. I also advise anyone with this diagnosis to never give up. There is help and hope!

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis. 

Mindfulness Program Reduced Chronic Pain and Opioid Use

By Pat Anson, PNN Editor

A mindfulness therapy program reduced chronic pain and emotional distress in patients on long-term opioid therapy, in what’s being touted as the first randomized clinical trial to demonstrate the effectiveness of psychotherapy in reducing pain and opioid use simultaneously.

Researchers at the University of Utah enrolled 250 patients being treated for chronic pain at primary care clinics in the Salt Lake Valley. Most participants took oxycodone or hydrocodone, reported two or more painful conditions, and met the clinical criteria for major depression. Over two-thirds had also been diagnosed with opioid use disorder.

Study participants were randomly assigned to either a standard psychotherapy support group or a mindfulness program called Mindfulness-Oriented Recovery Enhancement (MORE). Both groups met for 8 weekly two-hour sessions. Patients in the MORE group were trained to meditate on their breathing and body sensations, and to practice 3 minutes of mindfulness before taking opioid medication -- focusing on whether their opioid use was due to drug craving or the need for pain relief.

The study findings, published in JAMA Internal Medicine, showed sustained and significant reductions in pain symptoms, depression and opioid use in the MORE group nine months after treatment ended. Researchers say 45% of MORE participants were no longer misusing opioids (compared to 24% in the support group) and 36% had cut their opioid use in half.

“MORE demonstrated one of the most powerful treatment effects I’ve seen,” lead author Eric Garland, PhD, director of the Center on Mindfulness and Integrative Health Intervention Development at the University of Utah, said in a press release. “There’s nothing else out there that works this well in alleviating pain and curbing opioid misuse.”

Garland believes the sustained benefits of MORE might be related to the program’s ability to restructure the way the brain processes rewards, helping patients shift from valuing the physical and psychological effects of drugs to valuing natural, healthy rewards like a beautiful sunset or the smile on the face of a loved one. 

“Remarkably, the effects of MORE seem to get stronger over time,” said Garland, who has been studying mindfulness for over a decade. “One possible explanation is that these individuals are integrating the skills they’ve learned through MORE into their everyday lives.”  

MORE participants are taught to reevaluate the experience of pain and opioid craving, “zooming in” on what they are feeling and breaking it down into different sensations like heat, tightness or tingling. They learn how those experiences change over time, and to adopt the perspective of an observer.

“Rather than getting caught up in the pain or craving, we teach people how to step back and observe that experience from the perspective of an objective witness,” Garland explained. “When they can do that, people begin to recognize that who they truly are is bigger than any one thought or sensation. They are not defined by their experiences of pain or craving; their true nature is something more.”

Garland said the findings are particularly noteworthy because many participants had multiple chronic pain conditions, were on high-opioid doses and also had psychiatric disorders. The average pain duration of participants at the start of the study was nearly 15 years and their average pain score was 5.5 on a 1 to 10 pain scale.

Supreme Court Hears Arguments in Key Opioid Prescribing Case

By Pat Anson, PNN Editor

The U.S. Supreme Court heard oral arguments today in the case of two doctors appealing their convictions for criminal violations of the Controlled Substances Act (CSA) -- a case that could have a significant impact on opioid prescribing nationwide.

Dr. Xiulu Ruan and Dr. Shakeel Kahn were sentenced to lengthy prison terms for prescribing high doses of opioid medication to patients, including one who died from an overdose. Their combined appeals focus on whether jurors were properly instructed that doctors are allowed to prescribe opioids outside the usual standard of medical care, as long as they act in good faith and with a medical purpose.

“It is important for me to be clear that my client didn’t get that instruction,” said attorney Saul Robbins, who represents Ruan. “His jury was told if he was outside the bounds of medicine, you may convict him. Full stop. No good faith, no ‘knowingly or intentionally,’ none of that.”

Kahn’s lawyer told the high court that a strict interpretation of the CSA was having a chilling effect on many doctors, who worry about their “medical morals” being policed by the Drug Enforcement Administration.

“I think that raises the real risk the DEA becomes the de facto national medical board. That’s never been authorized,” said attorney Beau Brindley.

Much of the 90-minute hearing focused on legal semantics and whether the CSA gives doctors the discretion to prescribe medications as they see fit. Some of the court’s most conservative justices asked the toughest questions of a Department of Justice attorney who argued against the doctors’ appeals.

“Many things disturb me about some of the arguments. One is the ungrammatical reading of the statute itself,” said Justice Neal Gorsuch, who openly speculated that Ruan and Kahn could not only be entitled to new trials, but the indictments against them could be dismissed.  

Justice Brett Kavanaugh said the CSA was too vague.

“The problem here, the core as I see it, is the statute says ‘except as authorized’ and the regs (regulations) say ‘legitimate medical purpose.’ That’s very vague language in my estimation,” said Kavanaugh. “Write more specific regs if you have the problem that you’re talking about. But ‘legitimate medical purpose’ is a very vague thing on which reasonable people can disagree.

“There are going to be close calls on what the evidence shows objectively was legitimate. And so, if you’re on the wrong side of the close call as the doctor, you go to prison for 20 years.”

“I don’t think that’s going to be the case for doctors who make innocent mistakes,” replied Eric Feigin, a U.S. deputy solicitor general. “We do not think a doctor can be convicted for something that other doctors would recognize as within the boundaries of medicine.”

It could take several months for the Supreme Court to make a ruling on the case. The high court will not determine whether the doctors are guilty or innocent, but will decide if they were lawfully prosecuted and if new trials are needed. Complicating the appeals of both doctors is that they were also convicted of crimes outside of the CSA.

Ruan, who practiced in Alabama, often gave patients Subsys, an expensive and potent fentanyl spray made by Insys Therapeutics that was only approved by the FDA for breakthrough cancer pain. Ruan prescribed Subsys “off label” to patients who didn’t have cancer, a practice that led to several other doctors being targeted by the DEA. Ruan was also convicted of taking kickbacks from Insys. He was sentenced to 21 years in prison.    

Kahn, who practiced in Wyoming and Arizona, was convicted of prescribing excessive amounts of oxycodone and running a criminal enterprise that resulted in the death of a patient. He is serving a sentence of 25 years.

Fizzy Pain Relievers Are Bad for the Heart

By Pat Anson PNN Editor

Long-term use of the pain reliever acetaminophen has long been associated with liver, kidney, heart and blood pressure problems.  A new study has also found that some acetaminophen tablets are so loaded with salt that they significantly raise the risk of a heart attack or stroke in as little as one year.

At issue are dissolvable acetaminophen tablets that are mostly used to treat cold and flu symptoms, as well as minor aches and pains. The tablets quickly dissolve in water because of their high salt (sodium) content, creating a fizzy, effervescent drink that is absorbed more quickly in the digestive system than a standard tablet.

Some of the fizzy tablets contain as much as 440 milligrams of sodium per pill. A recommended daily dose of two tablets taken four times a day adds up to over 3,500 milligrams – more sodium than three McDonald’s Big Macs – and nearly double the daily amount recommended for healthy adults.

Since high salt content has long been associated with cardiovascular problems, a team of researchers looked at the health records of 300,000 people enrolled in Britain’s National Health Service who were prescribed acetaminophen (paracetamol) to see what impact the medications may have.

Their findings, recently published in the European Heart Journal, showed that patients with a history of high blood pressure (hypertension) taking fizzy acetaminophen tablets were up to 45% more likely to suffer a heart attack, stroke or heart failure within a year. Just one prescription for the tablets increased their risk of dying by 177 percent, and those with five or more prescriptions were 264% more likely to die.

The risk of a heart attack, stroke or death for patients without high blood pressure also rose with a prescription for fizzy acetaminophen, but to a lesser degree.

“The direct message from this study is clear—there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” wrote Aletta Schutte, PhD, and Bruce Neal, PhD, in an accompanying editorial.

“Fortunately, only a small proportion of paracetamol formulations contain sodium but, with ‘fast-acting’ and ‘fizzy’ medications increasing in popularity, the adverse effects of medication-related sodium intake look set to rise rather than fall.”

The risk isn’t limited to fizzy tablets with acetaminophen. Other effervescent medications containing aspirin, ibuprofen and even vitamins also contain high levels of sodium.  

With or without salt, long-term acetaminophen use can be risky. A recent study at the University of Edinburgh found that acetaminophen significantly raised the risk of heart disease and stroke in people with high blood pressure. Researchers said the increased risk of cardiovascular problems was similar to that seen with non-steroidal anti-inflammatory drugs (NSAIDs).

Acetaminophen is the most widely used over-the-counter pain reliever in the world — and is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications. But a 2021 review found little or no evidence to support the use acetaminophen for most pain conditions.

Lobbying for Better Access to Migraine Care

By Mia Maysack, PNN Columnist

Last week the Alliance for Headache Disorders Advocacy held its 15th annual Headache on the Hill, with over 200 patients and advocates from 48 states visiting close to 300 congressional offices to lobby and raise awareness about migraine and headache disorders. Like last year, most of the participants attended virtually online due to the pandemic. 

As a person living with never-ending head pain from a traumatic brain injury for over two decades, it has been an honor to participate in this event for multiple years. During that time, we've continued to make progress, such as more funding for migraine research, expanding options for symptom management, obtaining access to oxygen therapy, and helping to launch the VA’s Headache Centers of Excellence — which are all meaningful strides towards healthcare reform.

However, I have never been prouder to be a part of this year’s Headache on the Hill (HOH), which had two major “Asks” for our congressional representatives:

Ask #1

Support investment in Headache Centers of Excellence for Indigenous Communities, with $5 million per year in additional appropriations. The goal is to have the Health & Human Services Secretary designate 6 new headache centers in mostly rural reservations, with an emphasis on expanding options for telehealth, so that Native Americans and Alaskan Natives living in isolated areas will be able to connect with and consult with medical professionals online.

Ask #2

Have the General Accountability Office (GAO) issue a report on funding priorities for the National Institutes of Health (NIH), specifically as it relates to headache disorders. Although migraine impacts roughly 40 million Americans and is the main cause of disability for women under 50, migraine research still receives some of the least funding from NIH, even though it has a strategic plan to consider the "burden of individual diseases” when making funding decisions.   

There is a pressing need for more migraine research if we are to find new treatments, invest in viable solutions and alleviate the need for more providers who specialize in treating head pain. Headache and migraine disorders need to be prioritized at NIH -- not above or before any other health condition, but alongside them. 

Government accountability is a part of public service. We need to know in what ways are we moving forward and how our money is being spent.   

Navigating the healthcare system can be challenging. I cannot begin to keep track of the countless hours I've devoted to sitting in waiting rooms at clinics, fighting for insurance coverage, begging for referrals, convincing providers that my ailments are real, and attempting many treatments in desperation for relief.

But as horrendous as my experiences have been at times, nothing compares to the malpractice and neglect that is experienced by patients in marginalized communities. 

It has been documented that Native Americans and Alaskan Natives have the highest rates of disabling headache disorders. They are 40% higher than other races, with a particularly high impact on men. Despite this, Indigenous communities on average have only one neurologist for every 125,000 people!   

Health resources that are caring, regardless of cause or condition, are investments in people. We have huge disparities in equitable care. Why is it that communities with the biggest needs have the fewest resources?

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