Medical Cannabis Is Losing Credibility

By Roger Chriss, PNN Columnist

As more and more states legalize medical cannabis for chronic pain, anxiety, seizure disorders and other common medical conditions, the question of efficacy becomes increasingly important. Recent studies show a lack of efficacy, but so far states are not modifying their list of approved conditions for medical cannabis.

Many states approved cannabis for medical conditions without good evidence. California legalized medical marijuana in 1996, yet nearly three decades later the Medical Board of California is still advising physicians that “there is a lack of evidence for the efficacy of cannabis in treating certain medical conditions.”

We not only still lack evidence, but new research suggests that cannabis doesn’t help and may actually be harmful:

• A small randomized trial in Boston found no significant improvement in pain, anxiety or depression in people given medical marijuana cards, but a higher risk of developing cannabis use disorder.

• A matched cohort study in Hawaii on people 50 or older saw a “significantly greater risk of coronary heart disease, chronic non-cancer pain, stroke, myocardial infarction, cyclic vomiting, and injuries” in people using cannabis compared to non-users.

• An observational study in New York of 29 people with epilepsy given two formulations of cannabidiol (CBD) and tetrahydrocannabinol (THC) concluded that “we found no evidence of efficacy… in treating epilepsy, sleep, or behavior in our population.”

Recent reviews of past studies are similarly disappointing.

• A review of 16 studies of CBD for mental health disorders found that “there is currently not enough high-quality evidence to suggest the clinical use of CBD for any psychiatric disorder.”

• A systematic review of 28 studies on medical marijuana for multiple sclerosis concluded that “the magnitudes of effects on short-term neurological outcomes in MS patients are either small, limited, or moderate.”

Lack of Efficacy

The 2017 National Academies report on cannabis noted the need for more research. Since then, over 6,400 studies have appeared on PubMed on medical cannabis specifically, and a total of 12,100 studies on cannabis in general. More studies are forthcoming, including 460 clinical trials of cannabis that are active or recruiting.

The result so far is a growing body of high-quality studies and clinical trials published in major journals showing a lack of efficacy and a risk of poor outcomes for conditions that cannabis is state-approved for.

Ordinarily, states follow the laws and regulations of the Food and Drug Administration, recommendations from medical societies, and research findings and other sources of major reviews. With almost any other substance with such a weak track record, there would have been a reassessment by now. But not with cannabis.

California still approves medical cannabis for glaucoma, even though the American Academy of Ophthalmology is against it due to lack of efficacy. California is not alone. So far, no state has removed any condition from its approved list for medical cannabis use.

However, the conditions of using cannabis are changing. Some states now require patients in pain management programs to have their urine tested for cannabinoids. Many medication management agreements – known as “pain contracts” – also expressly forbid cannabis use even if it has been legalized in that state. Some medical specialties tell patients to simply avoid cannabis because of risks from drug interactions and contraindications.

Although cannabis may be safer than some prescription drugs, that won’t matter if it has no demonstrable benefit. Cannabis is losing credibility as a therapeutic as studies show poor outcomes for diagnoses that states approve cannabis for.

Holding cannabis to the same standards as other therapeutics would increase confidence in cannabis where it is shown to be beneficial. It will also help improve patient outcomes. As it stands now, however, medical cannabis is starting to look more like medicinal alcohol during Prohibition than a credible therapeutic for 21st-century medicine.

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. 

New CBD Drug Developed for Postoperative Pain

By Pat Anson, PNN Editor

An investigational drug containing a fast-acting formula of cannabidiol (CBD) reduced postoperative pain in patients after shoulder surgery, according to small new study.

Patients who took ORAVEXX tablets after minimally invasive rotator cuff surgery had an average of 23 percent less pain after the first day of surgery than those taking a placebo, according to researchers at NYU Langone Health. The tablets are designed to quickly dissolve in the mouth and the CBD absorbed into the bloodstream in less than 3 seconds.

“There is an urgent need for viable alternatives for pain management, and our study presents this form of CBD as a promising tool after arthroscopic rotator cuff repair,” says lead investigator Michael Alaia, MD, associate professor in the Department of Orthopedic Surgery at NYU Langone Health.

“It could be a new, inexpensive approach for delivering pain relief, and without the side effects of anti-inflammatory drugs like NSAIDs and addiction risks linked to opiates. Additionally, CBD has the benefit of pain relief without the psychotropic effects associated with THC or marijuana.”

There are a few caveats about the study. First, only 99 patients were enrolled in this early-stage Phase 1/2 trial. They were divided into two groups: one group took 50 mg of CBD in ORAVEXX tablets three times a day for 14 days, while the other group received a placebo or 25 mg of CBD during the study period.

Importantly, patients in both groups were also prescribed opioids, a low dose of Percocet, and told to wean themselves off the medication as soon as possible.

There were no major side effects reported by either group, but the group receiving 50 mg of CBD reported less pain and greater satisfaction in their pain control.

ORAVEXX is manufactured by Orcosa, which has developed a proprietary drug delivery system called the RITe Platform. The company says it buccal tablets dissolve so quickly in the mouth that fewer active ingredients are needed for a medication to work.

In addition to postoperative pain, the company is also planning studies to evaluate ORAVEXX as a treatment for acute and chronic pain, osteoarthritis pain and inflammation. While the initial results are promising, researchers say it could be years before ORAVEXX is available.

“Our study is examining a well-designed, carefully scrutinized product under an investigational new drug application sanctioned by the FDA. This is currently still experimental medicine and is not yet available for prescription,” said Alaia, who presented the initial findings this week at the annual meeting of the American Academy of Orthopaedic Surgeons.

Better Pain Treatment Needed for People with Severe Mental Illness

By Pat Anson, PNN Editor

There is an urgent need to improve the way pain is diagnosed and treated in people with severe mental illness, according to a new review by UK researchers.

Depression and pain commonly co-exist, with pain prevalence in people with depression estimated at 65 percent. Pain is also experienced by 29% of people with bipolar disorder, about double that of healthy people.

But while the association between pain and mental illness is well-established, researchers say pain is not routinely assessed and managed in people with SMI, due in part to discrimination by healthcare providers. Mental health problems carry a fair amount of stigma – just like pain itself -- which impedes treatment.

“Healthcare professionals underestimate pain in the presence of perceived ‘psychosocial’ problems, making discounting of pain in people with SMI particularly likely. Indeed, there is evidence that they experience diagnostic overshadowing for physical healthcare,” lead author Whitney Scott, PhD, Kings College London, reported in PAIN, the official journal of the International Association for the Study of Pain (IASP).

“In addition to limiting treatment access, pain-related invalidation, stigma, and discrimination exacerbate distress. Investigation is needed to understand the impact of intersecting experiences of stigma and discrimination in people with SMI and pain, and how to address these.”

Scott and her colleagues say there is limited knowledge about the effectiveness of pain treatments in people with SMI because they are often excluded from clinical trials due to their perceived “complex mental health needs.”

Even when pain is diagnosed, providers may be reluctant to prescribe analgesics to people with SMI because it may interact with mental health drugs they are already taking.

“Pharmacological management of pain in SMI is complicated by the potential for harmful side effects and interactions with psychotropic medications and the underlying mental health condition,” said Scott. “Antidepressants, including serotonin-noradrenaline reuptake inhibitors, are effective for pain management in the absence of depression and of course may improve co-morbid depression; however, unopposed anti-depressants may destabilise mood in bipolar disorder. Collaborative pharmacological and psychological care for comorbid pain and major depression is promising, but scarce.”

Little is also known about the effectiveness of non-pharmacological pain treatments, such as exercise and physical therapy, because people with SMI often experience isolation, fatigue and mood disorders, making them harder to motivate.  

To overcome these barriers, Scott and her co-authors say pain and mental healthcare need to be more fully integrated, with caregivers, mental health professionals, pain specialists and policymakers working together to enable more personalized care and understanding of the needs of people with SMI.

Chronic Pain Worsened for Many During Pandemic

By Pat Anson, PNN Editor

Nearly nine out of ten people with chronic pain say their symptoms have either not improved (51%) or gotten worse (36%) during the pandemic, according to a new Harris poll that found nearly half of respondents (44%) experienced delays in getting treatment due to Covid-19.

The online survey of 810 U.S. adults with chronic back or leg pain was conducted in October and November 2021. It was commissioned by Medtronic, which makes spinal cord stimulators and other neuromodulation devices that treat pain.

Nine in ten pain sufferers said pain impacts their lives on a daily basis, with poor sleep (63%) being the most common reported problem. Pain also negatively affects their mental health (60%), exercise habits (53%), mobility and function (51%), ability to enjoy hobbies (44%), social life (32%) and occupation (33%).

Over one in five (22%) said pain impacts their romantic relationships, including being intimate with a partner or spouse.

"This data bears out what we've heard from our clinician customers and patients for two years – the pandemic has been especially hard on those with chronic pain," Charlie Covert, Vice President & General Manager of Interventional Pain Therapies at Medtronic, said in a press release.

The survey found that nearly one in five pain sufferers (17%) said they have canceled a medical appointment or procedure without rescheduling, with the primary reason being fear of Covid-19 exposure. Only a third of surveyed patients (34%) feel comfortable going into a healthcare facility, and 5% say they will never feel comfortable returning to their provider.

The overwhelming majority of respondents (90%) wish there were more treatment options available to manage their pain. While most are aware of traditional treatments such as physical therapy and oral pain relievers, far fewer are familiar with options such as targeted drug delivery (38%) or spinal cord stimulation (34%).

"There is a tangible human cost to deferred procedures and delayed care. As COVID-19 hopefully begins its transition to a more endemic disease, we expect many of these patients to urgently seek relief through new or more effective treatment modalities,” said Covert. “Our survey demonstrated that an overwhelming majority want more treatment options, yet awareness of spinal cord stimulation and targeted drug delivery options remains relatively low."

The pandemic continues to affect the bottom line for Medtronic. Last month, the company said revenue losses were in the “low-double digits” for its neuromodulation and pain therapy devices.

In a conference call with analysts, Medtronic said the surge of omicron infections in January created “acute periods of worker absenteeism” with its customers, suppliers and staff. While conditions are improving, the company expects pandemic-related issues such as inflation, supply chain issues and healthcare worker shortages to linger.

Study Warns of ‘Kratom Use Disorder’

By Pat Anson, PNN Editor

Nearly a third of people who use the herbal supplement kratom develop symptoms of withdrawal and tolerance that could be signs of kratom use disorder (KUD), according to a small survey by the National Institute on Drug Abuse. Withdrawal symptoms included gastrointestinal upset, restlessness, anxiety, irritability and fatigue.

Kratom 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. An estimated two million Americans use kratom to self-treat their pain, depression, anxiety and addiction.

NIDA researchers recruited 129 past and current kratom users in the U.S. to participate in the online survey, asking them about their symptoms and demographic information.

The study findings, recently published in the Journal of Addiction Medicine, found that over half of kratom users showed no signs of addiction. But 29.5% met the diagnostic criteria for KUD, such as increased use, tolerance, withdrawal, unsuccessful attempts to quit, and craving. Most reported KUD symptoms that were mild or moderate, with about one in four with KUD having severe symptoms.  

Nearly 10% of participants also reported “psychosocial impairments,” such as decreases in social, occupational, or recreational activities because of their kratom use.

“As assessed here, tolerance and withdrawal are primary KUD features rather than psychosocial impairments. As kratom is often used among persons with a myriad of health conditions, clinicians should be aware of and assess for kratom use and withdrawal,” wrote lead author Kirsten Smith, PhD, who heads much of the kratom research at NIDA.

Federal health officials have long taken a dim view of kratom and made unsuccessful attempts to ban it. In 2018, former FDA Commissioner Scott Gottlieb, MD, claimed that kratom was an opioid, addictive, and should not be used to treat any medical condition.

“Kratom use disorder” is a relatively new diagnosis and does not appear often in medical literature.  One of the first references to it is in a 2019 study that called kratom an “emerging public health threat.” Researchers said healthcare providers need to be aware that kratom use was “typically accompanied by increasing tolerance and dependence making it highly problematic.”

A kratom advocate said the new NIDA study shows the risk of kratom addiction is low and that symptoms are often mild. 

“I thought the results of this research were particularly interesting because of the growing number of addiction recovery centers expanded their service-for-hire to include kratom use disorder (KUD) and characterizes this condition as mirroring opioid use disorder (OUD) that requires intensive drug interventions of different substances,” said Mac Haddow, a lobbyist and Senior Fellow for the American Kratom Association, which represents kratom vendors and consumers.  

“Importantly, the study concludes that tolerance of kratom over time, and withdrawal from that level of dependence are the primary outcomes rather than psychosocial impairments that are largely debilitating among drug addictions. The study also recognizes that kratom continues to be a harm reduction alternative for those suffering from polydrug use addiction issues and that accounts for its increasing use as the drug overdose crisis deepens in the U.S.” 

Kratom is often used as a treatment for addiction. A 2016 PNN survey of over 6,400 kratom users found that nearly 12% used it to reduce their cravings for alcohol or opioids. Nine out of ten said kratom was “very effective” at treating their substance use disorder. And over 98% of all respondents don’t believe kratom is harmful or dangerous.

A Pained Life: Living Unseen

By Carol Levy, PNN Columnist

AARP Magazine recently had an interview with Michael J. Fox, the actor who has Parkinson's disease. Fox spends much of his time working to teach others about the disease.

“I am a motivator and someone who tries to demystify and normalize Parkinson's - to take away any shame or sense that it should be hidden. Because unfortunately, it will inevitably reveal itself,” Fox said.

I read those words and thought, how can the pain community do this? Is there any way we can demystify and reveal what chronic pain is like? My answer is invariably, no.

Pain does not reveal itself easily to others, absent people in pain grimacing, making painful sounds (“Ouch, that hurts!”) or being vocal about their pain (“I can't go, because of my pain.”) Often those behaviors are seen as dramatizing, being lazy or a hypochondriac.

I contrasted this with a recent cooking competition I watched on TV. Prior to entering the studio cooking area, the contestant chef said, “I recently hurt my shoulder.” He added that he hoped the pain would not affect his performance. And it didn't.  He won.  

Afterwards the contestant said, “I didn't notice the pain in my shoulder until after the round was concluded, although the pain was there the entire time.”

No host or judge was there to comment, but I wondered. When he said he had pain, it was just accepted. There was no one in the wings asking, “How can it be you had the pain but could still function in the kitchen?” or “If your pain is so bad, how were able to get past it?”

Or, had he lost the contest, someone might have asked, “Did you intend to use your shoulder pain as an excuse if you lost?”

I come back to this issue -- the invisibility of our pain -- because other disorders like Parkinson’s have visibility. You can see how they impact the lives of Michael J. Fox and others.  

I wrote in a recent column about my experience of being “mask shamed” for not wearing a mask at a hospital. The week after that incident, I was mask shamed again by a conductor on a train into Philadelphia for refusing to mask.

While masks are mandated on public transportation, there are exemptions for certain groups of disabled. Because I have trigeminal neuralgia, I fall into one of those groups.  I bring this up because, when I talked with a manager, I found myself in a small debate with him.

“Had I had an oxygen tank with me, there would have been no issue. The conductor would not have done what she did,” I said.

The manager responded, “Well that is a very different situation.”

“Why is that? That person can’t wear a mask and I can’t mask either.”

“But you can see the reason for why she can't mask,” he replied.

I found myself having to educate him in the only way we can.

“If I had cancer, diabetes or heart disease, you can see none of those but that doesn’t mean I don’t have them.”

He was quiet for a moment. “Oh yeah, I see your point.”

“I am invisible, understand, simply because people refuse to see me,” wrote Ralph Ellison in the Invisible Man. “When they approach me they see only my surroundings, themselves or figments of their imagination, indeed, everything and anything except me.”  

Ellison was writing about being unseen as a person of color, but the description defines pain sufferers as well. 

Maybe, when we try to explain our invisible illness, we need to point out the obvious, as Akiko Busch did in her book, How to Disappear: “The entire world is shining with things we cannot see.”

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

Study Warns of High Risk of Addiction in Medical Marijuana Users

By Pat Anson, PNN Editor

Medical marijuana is often touted as a treatment for chronic pain, but a new clinical trial found cannabis provided no significant improvement to people who took it for pain, anxiety or depression. Marijuana did help people sleep better, but it also raised their risk of cannabis use disorder (CUD).

“There have been many claims about the benefits of medical marijuana for treating pain, insomnia, anxiety and depression, without sound scientific evidence to support them,” says lead author Jodi Gilman, PhD, with the Center for Addiction Medicine at Massachusetts General Hospital (MGH). “We learned there can be negative consequences to using cannabis for medical purposes. People with pain, anxiety or depression symptoms failed to report any improvements, though those with insomnia experienced improved sleep.”

Gilman and her colleagues enrolled 186 people in the study and randomly assigned them to one of two groups. The first group was allowed to immediately obtain a medical marijuana card, while the second group had to wait 12 weeks before getting one. Both groups were allowed to choose their cannabis products at a dispensary, with no limits on the dose or frequency of use.

Participants in the immediate card acquisition group reported significantly more cannabis use in the study period, with nearly one in five (17%) developing CUD symptoms such as craving, tolerance and withdrawal within 12 weeks. The odds of having CUD were nearly 3 times higher in the immediate acquisition group than in the delayed acquisition group.

“This trial showed that CUD can develop at a fast rate within the first 12 weeks of medical marijuana card ownership, suggesting that those with a card may develop CUD at a similar rate as those who use cannabis recreationally and that the (medical) motive for use may not be protective,” researchers reported in in JAMA Network Open.

“Although most cases of CUD onset in the trial were mild, with 2 to 4 symptoms, these symptoms developed over a short, 12-week initial exposure. The most commonly reported CUD symptoms were higher tolerance and continued use despite the recurrent physical or psychological problems caused or exacerbated by cannabis.”

People with anxiety or depression -- the most common conditions for which medical cannabis is sought -- were at significantly higher risk of developing CUD than those with pain and insomnia.

Incidence of Cannabis Use Disorder

SOURCE JAMA NETWORK OPEN

“Our study underscores the need for better decision-making about whether to begin to use cannabis for specific medical complaints, particularly mood and anxiety disorders,” said Gilman, who called for more regulation of medical marijuana.  “There needs to be better guidance to patients around a system that currently allows them to choose their own products, decide their own dosing, and often receive no professional follow-up care.”

Cannabis advocates say Gilman’s findings are at odds with larger observational studies (here, here and here) that found cannabis use disorder declined in states that legalized medical marijuana. They feel the study also lacked detail of CUD symptoms or what impact they had.

“Although the authors stress the notion that those in the card-holders groups were more likely to be diagnosed with symptoms of CUD, they never identify what these symptoms were, their severity, or how disruptive they were to these individuals daily lives and functioning — or even if in fact they were at all,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group. 

“Finally, it should be recognized that virtually all therapeutic agents possess varying safety profiles. Medical cannabis is not innocuous. But its safety profile is far superior to that of many conventional pharmaceuticals for which it can provide an alternative, including opioids and benzodiazepines — even if one is to take these findings at face value.” 

A recent survey found that twice as many Americans are now using cannabis or cannabidiol (CBD) to manage chronic pain than opioid medication.

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.