Are Sit-Stand Desks Overrated?

By Pat Anson, PNN Editor

You’ve probably seen commercials touting the health benefits of sit-stand desks. Experts say being able to stand occasionally – instead of sitting at an office desk all day -- helps prevent back pain, diabetes, high blood pressure, obesity and other chronic health conditions.

There may be some truth to that, but some of the health claims range from silly to the absurd.

“Sitting is more dangerous than smoking. We are sitting ourselves to death,” James Levine, MD, an endocrinologist at the Mayo Clinic, told the Los Angeles Times. “The chair is out to kill us.”

Is sitting really that dangerous? It is if you believe Australian researchers, who came to the eye-opening conclusion that sitting for one hour reduces life expectancy by 22 minutes. Their study was about people who watch a lot of television, but it is often cited by sit-stand desk manufacturers.

One desk manufacturer funded a study — which is mysteriously being promoted by the CDC — that looked into the psychological benefits of sit-stand desks. The study found that standing more often at work will not only relieve back pain, but make you feel healthier, happier and improve your self-esteem.

Minimal Health Benefits

Just how reliable is this industry-promoted research?

“There has been a great deal of scientific research about sit-stand desks in the past few years, but we have only scratched the surface of this topic,” says April Chambers, PhD, an assistant professor of bioengineering at the University of Pittsburgh’s Swanson School of Engineering. “I wanted to gather what we know so far and figure out the next steps for how can we use these desks to better benefit people in the workplace.”

Chambers and her colleagues reviewed 53 studies on sit-stand desks and published their findings in the journal Applied Ergonomics. Their research focused on the impact of the desks on behavior, physiology, psychology, work performance, discomfort and posture.

“The study found only minimal impacts on any of those areas, the strongest being changes in behavior and discomfort,” said co-author Nancy Baker, ScD, an associate professor of occupational therapy at Tufts University.

“There are health benefits to using sit-stand desks, such as a small decrease in blood pressure or low back pain relief, but people simply are not yet burning enough calories to lose weight with these devices,” added Chambers.

One of the biggest flaws in current studies is that most were done with young and healthy subjects who were asked to use the desk for a week or month at most. Researchers say it would be beneficial to perform longer studies with middle-aged or overweight workers to get a more accurate measure of the desks’ impact on cardiovascular health and weight loss.

Further study is also needed on desk height, monitor height, the amount of time standing, and the use of anti-fatigue floor mats to soften the blow of so much standing. 

“There are basic ergonomic concepts that seem to be overlooked,” said Chambers. “Many workers receive sit-stand desks and start using them without direction. I think proper usage will differ from person to person, and as we gather more research, we will be better able to suggest dosage for a variety of workers.”

Sit-stand desks range in price from inexpensive models for $179 to nearly $1,000 for motorized adjustable desks that come with settings for different users.

If you’re thinking of buying a sit-stand desk, a good place to start your research is online. In the YouTube video below, David Zhang rates some of desks he’s tried over the past year. David likes having a standing desk, but has doubts about their health benefits and says the desks do not replace the need for a good old-fashioned office chair.

Risky Combination: Opioids and Gabapentin

By Pat Anson, PNN Editor

Opioid medication significantly reduces low back pain, but opioids should not be used in combination with gabapentin (Neurontin) because of their limited effectiveness and potential for abuse, according to the authors of a small new study presented at the annual meeting of the American Academy of Pain Medicine.

"In these days, when we are focusing on reduction of opioids due to opioid crisis in the U.S., gabapentin could be an important part of multimodal non-opioid pain management," N. Nick Knezevic, MD, of the University of Illinois in Chicago told MedPage Today. "However, it should not be given to all patients since the effectiveness in chronic pain patients, particularly in those with low back pain, is limited."

KAISER HEALTH NEWS

In a retrospective study, Knezevic and his colleagues looked at 156 patients with low back pain; half of whom were treated with opioids alone and the other half with a combination of opioids and gabapentin.

“According to our study, the combination of gabapentin with opioids was not statistically superior in providing pain relief, in contrast to opioids alone, in patients with chronic pain. Our results are in line with recent guidelines for low back pain treatment that reflect the need to assess the recommendation of gabapentinoids for chronic pain in patients already taking opiods to mitigate risk factors of abuse and overdose,” researchers found.

Gabapentin is an anticonvulsant that was originally developed as a treatment for epilepsy, but is now widely prescribed for a variety of chronic pain conditions. Its use in primary care as a treatment for chronic back and neck pain has risen by 535% in the last decade, despite little evidence of its effectiveness.

"The fact that anticonvulsants are often advertised to be effective for 'nerve pain' may mislead the prescriber to assume efficacy for low back pain or sciatica," Oliver Enke, MD, of the University of Sydney, told MedPage.

A 2018 study by Australian researchers found that gabapentinoids did not reduce back pain or disability and often had side effects such as drowsiness, dizziness and nausea. Another recent study found that combining gabapentin with opioid medication significantly raises the risk of dying from an overdose than opioid use alone.

There have been increasing reports of gabapentin being abused by drug addicts, who have learned they can use the medications to heighten the high from heroin, marijuana, cocaine and other substances.

The CDC’s opioid prescribing guideline recommends gabapentin as a safer alternative to opioids, without saying a word about its potential for abuse or side effects.

A 2017 commentary in the The New England Journal of Medicine warned that gabapentinoids -- a class of nerve medication that includes both gabapentin and pregabalin (Lyrica) -- are being overprescribed.

"We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” wrote Christopher Goodman, MD, and Allan Brett, MD. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain."

My Daily Persistent Headache

By Warren Cereghino, Guest Columnist

Waking up from my pre-work noontime nap one October day in 2007, I had a headache.  I still have it.

Thinking little of it at the time, I took two acetaminophen capsules (maybe Tylenol; maybe the generic from CVS or Costco) and headed off to work. 

I toiled nightly in a Los Angeles television station’s news department, where I was a news editor contributing to the nightly 10pm newscast.  I liked the work and didn’t mind the night schedule because it kept me out of mischief and off the streets.

That first night, the headache persisted.  And it just never stopped.  Over the next few weeks, I was gobbling pain relievers of one form or another every four hours, all the while trying to find the cause and a cure with all sorts of practitioners.

A little research taught me that this was known as “New Daily Persistent Headache.”  It sure as hell was persistent.

My journey took me to the offices of two different chiropractors who had successfully treated the persistent headaches of two referring friends (one was my daughter-in-law, who is a RN).  Both doctors tried, and both were unable to make it go away. 

Next, I tried acupuncture. That didn’t work, either. 

WARREN CEREGHINO

Meanwhile, I kept gobbling acetaminophen and ibuprofen like they were candy.  Determined to find the cause, I turned to neurologists. Two doctors who were with separate practices in Santa Monica evaluated me, had me undergo a scan and tried to figure it out, but to no avail.

By year’s end, I was still struggling with the debilitating effects of the headache and despairing of ever finding the elusive cause and cure. I had to face the fact that the only avenue open to me appeared to be pain management.  

In January 2008, I went to see David Kudrow, MD, whose neurology practice in Santa Monica specializes in pain management.  He treats patients and conducts research.  Dr. Kudrow gave me a thorough interview and then prescribed a nightly dose of 10mg of Elavil, an anti-depressant.

I cannot remember what he predicted in regard to when it would take effect, but a few weeks later I encountered a young man who’d grown up across the street from me and was now a practicing pediatric neurosurgeon.  He said he agreed with the prescription and told me it would take about a month to take effect.  He was right. 

Over the years, the dosage of Elavil (or its generic amitriptyline) has had to be increased, first from 10mg nightly and then to 20mg.  A couple of years ago Dr. Kudrow bumped it up again to 30mg nightly.

Recently he suggested I try to scale back to 20mg nightly. I tried, but it didn’t work. The 20mg dosage didn’t offer enough pharmacological firepower and I went back to 30mg after about ten days. 

Dr. Kudrow saved my life.  I have other health issues, but without his help in pain management I wouldn’t even be able to address the other issues of hypertension, diabetes and pre-clinical heart disease. I’m two months shy of turning 82 as of this writing.  Without Elavil, I would be dead.

Warren Cereghino is a retired TV news producer, writer and editor who spent 55 years at TV stations in Phoenix, Sacramento, San Francisco-Oakland and Los Angeles.  Warren is a graduate of Arizona State and a military veteran who served during the Berlin Crisis of 1961. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Study: Alcohol Relieves Fibromyalgia Pain

By Pat Anson, PNN Editor

Another study is adding to a growing body of evidence that alcohol is an effective – yet risky – way to treat chronic pain.

Researchers at the University of Michigan surveyed over 2,500 patients being treated at a university pain clinic about their drinking habits, pain severity and physical function. Participants were also assessed for signs of depression and anxiety. About a third of the patients were diagnosed with fibromyalgia (FM), a poorly understood disorder characterized by widespread body pain, fatigue, insomnia, headaches and mood swings.

Researchers, who recently published their study in the journal Pain Medicine, found that patients who were moderate drinkers had less pain and other symptoms than those who did not drink alcohol.

“Female and male chronic pain patients who drink no more than 7 and 14 alcoholic drinks per week, respectively, reported significantly lower FM symptoms, pain severity, pain-related interference in activities, depression, anxiety and catastrophizing, and higher physical function,” said lead author Ryan Scott, MPH, of UM’s Chronic Pain and Fatigue Research Center.

“These findings suggest that chronic pain patients with a lesser degree of pain centralization may benefit most from low-risk, moderate alcohol consumption.”

According to the Mayo Clinic, moderate alcohol consumption for healthy adults means up to one drink a day for women of all ages and men older than age 65, and up to two drinks a day for men age 65 and younger.

Of the study participants, over half reported use of opioid medication, which carries serious risks when combined with alcohol. Perhaps for that reason, participants in the UM study drank less alcohol than the general population.

“People with chronic pain may drink less due to the stigma and because they are being told not to drink while on pain medication,” says Scott.

Moderate drinkers with chronic pain were more likely to be white, have an advanced degree and were less likely to use opioids. They reported less pain, lower anxiety and depression, and higher physical function.

Researchers found that fibromyalgia patients who drank moderately reported decreased pain severity and depression, but alcohol had no effect on how widespread their pain was or other symptoms such as cramps, headache, fatigue, poor sleep and cognitive dysfunction.

Scott believes alcohol may stimulate the production of gamma-aminobutyric acid (GABA), a neurotransmitter in the central nervous system that reduces nerve activity. Alcohol and drugs such as gabapentin (Neurontin) that act on GABA typically have relaxing effects.

“Alcohol increases gamma-aminobutyric acid in the brain, which is why we could be seeing some of the psychiatric effects. Even though alcohol helped some fibromyalgia patients, it didn’t have the same level of effect,” said Scott. “You probably need much more GABA to block pain signals and that may be why we’re not seeing as high an effect in these patients.”

Over a dozen previous studies have also found that alcohol is an effective pain reliever. In a 2017 review published in the Journal of Pain, British researchers found “robust evidence” that alcohol acts as an analgesic.

“It could be a stepping stone to increased quality of life, leading to more social interactions,” says Scott. “Fibromyalgia patients in particular have a lot of psychological trauma, anxiety and catastrophizing, and allowing for the occasional drink might increase social habits and overall health.”

Menopause Linked to Chronic Pain

By Pat Anson, PNN Editor

It’s no secret that middle-aged women are far more likely than men to have chronic pain and to feel its effects more severely. A large new study tells us some of the reasons why.

VA researchers analyzed the health data of over 200,000 female veterans between the ages of 45 and 64 and found that women with menopause symptoms were nearly twice as likely to have chronic pain and multiple chronic pain diagnoses.

"Changing levels of hormones around menopause have complex interactions with pain modulation and pain sensitivity, which may be associated with vulnerability to either the development or exacerbation of pain conditions," says JoAnn Pinkerton, MD, Executive Director of the North American Menopause Society (NAMS). "This study suggests that menopause symptom burden may also be related to chronic pain experience."

Hormonal change alone wasn’t the only thing many of the women had in common. Those who were overweight, obese or had a mental health diagnosis were also more likely to have chronic pain. Eighteen percent of the female veterans had been diagnosed with post-traumatic stress disorder (PTSD), 13 percent suffered from depression and 15 percent had anxiety.

Common changes related to menopause and aging include weight gain, decreased physical activity, impaired sleep and negative mood, which can contribute to chronic pain and are also known to affect pain sensitivity and tolerance.

“Both chronic pain and menopause symptoms are strongly and consistently associated with psychosocial factors and health risk behaviors prevalent in and after the menopause transition,” said lead author Carolyn Gibson, PhD, San Francisco VA Health Care System. “Consideration should be given to integrated approaches to comprehensive care for midlife and older women with chronic pain, such as targeted cognitive behavioral therapy coordinated with interdisciplinary care providers.”    

The study findings are published in the journal Menopause.

A large 2018 study also found a strong association between menopause and symptoms of rheumatoid arthritis (RA). Researchers at the University of Nebraska Medical Center found that post-menopausal women with RA had a significant increase in functional physical decline. Menopause was also associated with worsening progression of the disease.  

60 Minutes Fails to Consider Pain Patients

By Laura Mills, Kate M. Nicholson, and Lindsay Baran

In a Feb. 24 segment, CBS’s 60 Minutes accused the Food and Drug Administration (FDA) of igniting the overdose epidemic in the United States with its “illegal approval of opioids for the treatment of chronic pain.” While the program highlighted the adverse consequences of misleading pharmaceutical marketing and lax government oversight, this segment failed to consider the perspective of patients who legitimately use opioids for pain, stigmatized them as drug-seekers, and propagated misconceptions about the overdose crisis, such as the idea that opioid treatment for chronic pain is indisputably illegitimate and is driving overdose deaths in the U.S.

When OxyContin went to market in 1996, its FDA label said that addiction was “very rare” when the medication was used to manage chronic pain. Although that warning was enhanced in 2001, the market for OxyContin was already booming: advertising spending for the drug increased from $700,000 in 1996 to $4.6 million in 2001. Lawsuits allege that Purdue Pharma, the maker of the drug, targeted high-prescribing physicians and continued to aggressively market OxyContin even after it learned its product had become a go-to drug for illicit use. The lack of government oversight and Purdue’s practices certainly deserve media scrutiny that could help shed light on actions that may underlie the overdose crisis.

However, the guests featured in the 60 Minutes segment gave the impression that the use of opioids for chronic pain is illegitimate or illegal, that prescription opioids are still driving overdose deaths in the United States, and that the use of prescribed opioids to manage chronic pain is equivalent to “heroin addiction.”

These are false narratives that do real harm to pain patients, who have been regularly stigmatized in the media and elsewhere as drug-seekers. In presenting this report, 60 Minutes failed to tell the other side of the story: that of pain patients who rely on these medications to function, and that of the medical community which largely agrees that opioids may help patients whose pain isn’t resolved by other means.

Chronic pain is a large category that includes pain associated with incurable illnesses, severe neurological conditions, and catastrophic trauma as well as more common ailments like arthritis. There is growing agreement that using opioids across this broad category was inappropriate and did harm, and that it is important to balance the potential benefits of opioids with misuse and diversion risks. But the medical community still largely agrees that, for some patients, opioids provide benefits. Indeed, the Centers for Disease Control, the Federation of State Medical Boards, a 2011 report by the Institute of Medicine, and all applicable medical and government guidelines on prescribing opioids have reaffirmed that opioids may be appropriate for patients whose chronic pain isn’t resolved by other means. 

Re-evaluating the use of opioids in long-term pain makes sense given recent history, but rushing to judgment before we do so can do real harm and risks violating a fundamental component of the right to health, including the right to adequate treatment for pain.  In over 80 interviews with patients, physicians, and experts, a recent Human Rights Watch report found a disconcerting trend: chronic pain patients are being forced off opioid medications simply because doctors fear regulatory oversight and reprisal. In many cases, physicians acted against their better medical judgment. Even when they believed their patients’ health was improved by long-term opioid treatment, they felt they had no option but to reduce patients’ doses dramatically or cut them off completely. They felt a wide range of pressures, from fear of Drug Enforcement Agency or state medical board scrutiny to the heavy bureaucratic burden created by insurance companies through their efforts to discourage opioid prescribing.

When deprived of their medication, the consequences for patients can be devastating: their health declines to the point where they can no longer work, do simple chores, or take care of their personal hygiene.  Several patients said they had turned to alcohol or illicit drugs to manage their pain when they were deprived of care.

Take Maria Higginbotham, whose story is included in the report. She has undergone 12 operations to prevent the collapse of her spine. Unfortunately these operations, which failed to relieve her pain, also left her with adhesive arachnoiditis, an incredibly painful condition that causes the nerves of the spinal cord to “stick together.”

Re-evaluating the use of opioids in long-term pain makes sense given recent history, but rushing to judgment before we do so can do real harm and risks violating a fundamental component of the right to health.
— Human Rights Watch

Maria is now being forced to a lower dose of medication by a provider who believes she needs opioids, but is afraid of attracting law enforcement scrutiny of his practice. Previously, Maria could function independently; she now requires assistance to go to the toilet.  To suggest that Maria has no legitimate right to these medications—and that her need for them is misguided, inappropriate or the result of drug misuse — is stigmatizing to all patients like her.

Hundreds of leading physicians and experts from with varying views on the efficacy of opioids have called attention to the dangers of involuntarily discontinuing opioids for the estimated 18 million Americans who currently use them for long-term pain, a practice the CDC and other medical bodies do not encourage. These dangers include medical destabilization, the lost ability to work and function, and suicide. The National Council on Independent Living (NCIL), a national disability rights organization, shares these concerns, which have a disproportionate impact on people with disabilities living with chronic pain who already face major barriers to accessing healthcare.  The American Medical Association has similarly criticized the indiscriminate discontinuation of opioids, and has underscored that the stigma surrounding opioids now affects cancer and palliative care patients who, despite explicit exemptions, face increased barriers to access as well

While liberal prescribing undoubtedly caused harm, further perpetuating inflammatory and stigmatizing ideas about people who rely on opioids helps legitimize the growing reluctance of physicians to prescribe these medications to those who they believe need them. At a time when the prescribing of opioids has dropped precipitously and drug overdose deaths are largely attributed to illicit substances, such harm ought to figure into the conversation.

It’s true that there is a lack of high quality data studying the efficacy of opioids beyond 12 weeks, but it is also the case that most medications approved for the treatment of pain reflect studies of similar duration.  This is in part because doing long-term, placebo-controlled trials with real human beings who are suffering presents practical and ethical challenges. 

FDA Commissioner Scott Gottlieb recently responded to the concerns raised by 60 Minutes, by announcing that the agency will conduct new studies into the efficacy of opioid analgesics for chronic pain, a move that he signaled could have an impact on how these drugs are marketed in the future. We agree that more research is critical and have backed initiatives such as the National Pain Strategy that call for much needed additional research into chronic pain. In the meantime, the dangers of reinforcing an incomplete or incorrect narrative and of stigmatizing patients are real—60 Minutes should ensure it doesn’t do either in its coverage, and should show all sides of the story.

This article was originally published on the Human Rights Watch website and is republished with permission.   

Laura Mills is a health researcher at Human Rights Watch and author of the HRW report, “Chronic Pain, the Overdose Crisis, and Unintended Harms in the U.S.”

Kate M. Nicholson is a civil rights and health policy attorney. She served for 20 years in the Department of Justice’s civil rights division, where she drafted current regulations under the Americans With Disabilities Act. She gave a TEDx talk about chronic pain, “What We Lose When We Undertreat Pain.

Lindsay Baran is the policy analyst at the National Council on Independent Living (NCIL), the longest-running national cross-disability grassroots organization run by and for people with disabilities.

My Constant Daily Companion

By Mia Maysack, PNN Columnist

I've got a companion everywhere I go. The wants and needs of this little bugger consistently require that I prioritize it before myself. It tests my boundaries, my patience, as well as my sanity.

I cannot eat, sleep or even use the restroom uninterrupted. This results in a consistent flow of tailored accommodations to make life easier for all involved. Temper tantrums are not only a daily occurrence, but a humble reminder that I am operating on a clock outside of my control.

I'm not discussing a child. I am referring to my chronic illness.

Migraines and my other ailments wake me up throughout the night, demanding attention. We all know how this works. No one gets any rest until the situation settles down. Pain is a constant companion who must be catered to.

Today, for example, I woke up to what felt like a pitchfork making its way through my cheek and out through my left eyeball.  Grabbing my face out of reflex -- as if somehow that'll ease the discomfort -- I rocked myself back and forth until the severity lessened.

My entire body still feels the aftershock of that attack, but it's only the first of many that'll transpire throughout the day. I know enough to recognize this as a warning.  My brain injury is now triggered, turning an everyday 5/6 on the migraine scale into a solid 8/9.

The impact on my physical body is severe due to the heightened sensitivity of my nerves. Getting up from a sitting position gets harder by the day. At times it is not possible for me to stand up straight or navigate stairs. Sometimes I can barely walk.

There is overwhelming nausea to the point that even breathing seems to aggravate it, so no food or drink remains inside. This causes further complications, as malnourishment and dehydration only worsen things. The dizziness gets so severe it hinders my eyesight.

Despite the fact I am on no drugs whatsoever, I feel “out of it” to the point that all I can do is write because I'm unable to verbally speak.  

If you're so sick, how can you type?  Lowest brightness. Special glasses. I document this so the world can understand and because I am currently on bed rest.

It doesn't take long for the darkness to creep in, with special guests anxiety, grief, stress and panic. Despite how much it hurts, keeping my mind busy is imperative. So I write.  

What I'd really love to do is rest, but it hurts to close my eyes. And even though quality sleep is what my body needs most, it further heightens my head pain.  In other words, the self-care that has been my saving grace actually worsens things.

I'm not a violent person, but if someone suggested a Tylenol or something like it, I'd have to fight the urge to use my last ounce of energy to punch them in the face.

No work was done today, meetings were cancelled, my dog didn't get a walk and I am barricaded in a blacked-out room. Another rescheduled dinner date with the girls, unable to answer phone calls or messages, couldn't run errands or get any chores done. The world continues to spin without me.

Missing out on life and feeling the weight of disappoint is a crippling side effect of all these symptoms. With broken hearts we mourn the lives we've lived and who we once were.

I have always been the one to take care of everybody -- the nanny, teacher, nurse. Now I struggle just to keep up with what's going on internally. As if that’s not difficult enough, we have to fight to be taken seriously or even believed. That is unacceptable.

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook support group, and Peace & Love Enterprises, a wellness coaching practice focused on holistic health.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA Commissioner Resigns Unexpectedly

By Pat Anson, PNN Editor

The head of the U.S. Food and Drug Administration resigned unexpectedly Tuesday, just days after a critical report on 60 Minutes that alleged the FDA “opened the floodgates” to the opioid crisis.  

“I’m immensely grateful for the opportunity to help lead this wonderful agency,” FDA commissioner Scott Gottlieb, MD, tweeted. ”This has been a wonderful journey and parting is very hard.”

In a lengthier statement to FDA staff, Gottlieb cited family reasons for his departure.

“There’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three young children,” Gottlieb said, indicating he would remain on the job until next month.

Gottlieb is a 46-year old cancer survivor and a former consultant to several drug companies. He commutes to Washington DC from his home in Westbury, Connecticut, where he lives with his wife and three daughters.   

President Trump tweeted that Gottlieb “has done an absolutely terrific job” and “he and his talents would be greatly missed!”

SCOTT GOTTLIEB, MD

There was no indication that Gottlieb was in trouble or that he was forced out. The FDA is currently involved in a number of complex and controversial regulatory issues, from high drug prices and e-cigarettes to medical marijuana and the opioid crisis.

The timing of Gottlieb’s departure is puzzling, however, because he tweeted two months ago that he had no intention of resigning after hearing from friends about speculation in the news media that he was leaving.

“I want to be very clear — I’m not leaving. We’ve got a lot of important policy we’ll advance this year,” Gottlieb tweeted, adding a famous quote from Mark Twain that reports of his death “have been greatly exaggerated.”

The 60 Minutes report alleged that the FDA caved into lobbying pressure from the pharmaceutical industry in 2001 by changing the warning labels on OxyContin and other opioid medications to indicate they were effective for long term use.

Gottlieb was not working at FDA when the agency made its labeling decision, but pledged last week in a lengthy essay that the FDA would “learn from past mistakes” and take “a much more aggressive approach to regulatory action” involving opioids.

Gottlieb joins a long list of agency directors and cabinet members who have resigned from the Trump administration, including former Health and Human Services Secretary Tom Price, who was forced out over excessive travel expenses and other ethical lapses, and former CDC director Brenda Fitzgerald, who resigned after it was disclosed she invested in tobacco and drug companies.

How Sodas and Smoking Worsen Disability

By Pat Anson, PNN Editor

Most doctors will tell you that smoking and drinking sweetened beverages like soda every day will lead to poor health. They can also worsen your risk of disability if you have rheumatoid arthritis or multiple sclerosis, according to new studies.

Researchers in Germany wanted to know how diet can affect the progression of multiple sclerosis (MS), a chronic disease that attacks the body’s central nervous system, causing numbness, difficulty walking, paralysis, loss of vision, fatigue and pain.  

They surveyed 135 MS patients to see how close their diet was to the Dietary Approaches to Stop Hypertension (DASH) diet – which limits foods that are high in saturated fat and sugar – and recommends whole grains, fruits and vegetables, low-fat dairy products, lean meats, poultry and fish, nuts and legumes.

Researchers did not find a link between what the participants ate and their level of disability, but there was a strong association with what they drank.

"While we did not find a link with overall diet, interestingly, we did find a link with those who drank sodas, flavored juices and sweetened teas and coffees," said study author Elisa Meier-Gerdingh, MD, of St. Josef Hospital in Bochum, Germany.

MS patients who consumed the largest amounts of sugar-sweetened beverages – averaging about 290 additional calories per day -- were five times more likely to have severe disability than people who rarely drank sweetened beverages.

"While these results need to be confirmed by larger studies that follow people over a long period of time, and the results do not show that soda and sugar-sweetened beverages cause more severe disability, we do know that sodas have no nutritional value and people with MS may want to consider reducing or eliminating them from their diet," said Meier-Gerdingh, who will present her findings at the American Academy of Neurology's annual meeting in Philadelphia in May.

Smoking Worsens Risk of Rheumatoid Arthritis

Previous studies have also found that smoking increases your chances of having MS and several other chronic pain conditions.

A new study by researchers at Brigham and Women's Hospital in Boston demonstrated for the first time that women who stop smoking can reduce their risk of developing the most severe form of rheumatoid arthritis (RA). But it takes time to have a beneficial effect.

"Ours is the first study to show that a behavior change can reduce risk for seropositive RA. Risk isn't just about genes and bad luck--there's a modifiable environmental component to the onset of this disease and a chance for some people to reduce their risk or even prevent RA," said corresponding author Jeffrey Sparks, MD, of the Division of Rheumatology, Immunology and Allergy at the Brigham.

Sparks and colleagues analyzed data from the Nurses' Health Study, which tracked the long-term health of registered nurses from across the U.S.  Brigham researchers identified over 1,500 nurses who developed RA, but they were most interested in those with "seropositive" RA as opposed to "seronegative" RA. Patients with seropositive RA generally have more severe joint deformities and disability.

For seropositive RA, the risk of disability began to go down about five years after women quit smoking and continued to decrease the longer they stayed non-smokers. Participants who quit for good reduced their risk of seropositive RA by 37 percent after 30 years. The team did not find any association between seronegative RA and smoking.

"One of the lessons here is that it takes sustained smoking cessation to reap the full benefit," said Sparks, who published his findings in the journal Arthritis Care & Research.

"Whereas for other diseases, such as cardiovascular disease, quitting smoking can provide a more immediate effect, here we're seeing benefits decades later for those who quit smoking permanently."

RA is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing pain, inflammation and bone erosion. While the biological mechanisms that link smoking and the development of RA are unclear, Sparks believes that smoking may contribute to the formation of RA-related antibodies that increase inflammation.

In future studies, Brigham researchers want to extend their investigations to include men and to see if smoking cessation can prevent the formation of RA-related antibodies and stop progression of the disease.

A Recap of Rare Disease Week on Capitol Hill

By Barby Ingle, PNN Columnist

Last week was Rare Disease Week on Capitol Hill, and I was excited to join hundreds of patients, advocates and caregivers in Washington, DC to raise awareness about rare diseases.

I was once again chosen as the Arizona “team leader” by the EveryLife Foundation, and led our group in meetings with our Senators and Representatives. I handled logistics for the legislative conference, helped organize the strategy for the meetings and kept the group on task during our discussions.

The EveryLife Foundation is a science-based advocacy organization that works to bring lifesaving treatments to 30 million Americans with rare diseases. There are more than 7,000 rare diseases. The foundation’s focus is on educating and advocating for rare disease patients to ensure they are heard by policy makers in government and by healthcare organizations.

The week kicked off on Sunday with a cocktail reception and Rare Disease documentary screening at the Ronald Reagan Building. We spent Monday at a legislative conference, where we heard from industry lobbyists about important federal bills and learned how the National Institutes of Health (NIH) is researching new treatments for rare diseases.

On Tuesday we split up and went to scheduled meetings with our members of the House and Senate on Capitol Hill. This day of lobbying was for patients, caregivers, and patient advocacy groups only.

Patient and fellow advocate Mike Heil joined me and my husband Ken as we visited the offices of Sen. Kyrsten Sinema (D-AZ), Sen. Martha McSally (R-AZ) and Rep. Paul Gosar (R-AZ).

One of my favorite parts of the week was Wednesday, when there was a briefing by the Rare Disease Congressional Caucus at the Dirksen Senate Office Building. The caucus is a bipartisan group of over 100 senators and representatives that meets to pursue common legislative objectives to help rare disease patients. You don’t hear much about bipartisanship these days on Capitol Hill, but this group has been active since 2010.

The caucus meeting was followed by a reception that featured a collection of art from across the rare disease community. This event was designed to help educate Congress about rare diseases and to empower patients to express their pain through artwork.

Thursday was full of action as we gathered at the NIH headquarters in Bethesda, MD to mark the global observance of Rare Disease Day. The day featured multiple interactive panel discussions on rare disease research, patient registries and cancer research initiatives, with the theme being "no disease left behind, no patient left behind."

Other highlights included posters and exhibits by rare disease groups and researchers as well as artwork, videos and campus tours. Global Genes participants were encouraged to wear their favorite pair of jeans and to use the social media tag, #RDDNIH to help raise awareness.

This was my second time participating in Rare Disease Week on Capitol Hill. I hope you join me in person or online next year for Rare Disease Week 2020. For more information on the next event, visit the website of Rare Disease Legislative Advocates (RDLA).

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain FoundationShe is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Laser Spine Institute Shuts Down

By Pat Anson, PNN Editor

The Laser Spine Institute, which once ran a nationwide chain of surgery centers that specialized in “minimally invasive” spinal procedures, has abruptly ceased operations due to financial problems.

The company had four remaining surgery centers in St. Louis, Cincinnati, Scottsdale and Tampa, Florida, where it is headquartered. It recently closed three other surgery centers in an effort to control costs and restructure.

Despite “significant cost saving” in recent months, Laser Spine Institute said in a new release that it was “unable to attract the necessary financing” to continue operating while it sought Chapter 11 bankruptcy protection. About 600 employees are affected.

"My heart goes out to our great, dedicated staff who have stuck with us through all of our adversity and worked so tirelessly to help us right the ship," said Jake Brace, Laser Spine Institute's CEO, who was brought in last year to help restructure the company.

The company said it would contact patients slated for surgery and those in post-operative care and refer them to other medical facilities in their area.

Laser Spine Institute treated patients with neck and back pain caused by spinal stenosis, degenerative disc disease, pinched nerves, bone spurs, herniated discs, sciatica and other chronic conditions.

Although it claimed to have 98% patient satisfaction rate, the company was hit with dozens of malpractice lawsuits, including one by superstar wrestler Hulk Hogan, who claimed its treatments were ineffective and cost him $50 million in lost revenue. Hogan reportedly settled out of court for $10 million.

Last year the family of a Pennsylvania woman who died hours after being discharged from a Laser Spine Institute surgery center was awarded $20 million in a wrongful death lawsuit.

A competing surgery center also sued Laser Spine Institute for offering illegal incentives to patients, such as paying for their airfare and hotel expenses, which is prohibited under Medicare guidelines. Nine surgeons told Bloomberg Businessweek that the company was doing spinal surgeries that were often unnecessary or inappropriate.

How Has CDC Opioid Guideline Affected You?

By Lynn Webster, MD, PNN Colomunist

The controversial CDC Guideline for Prescribing Opioids for Chronic Pain was released on March 15, 2016 in an effort to curb the opioid crisis. While “largely supportive” of the guideline at the time, the American Medical Association had concerns about how it would be implemented.

“We remain concerned about the evidence base informing some of the recommendations; conflicts with existing state laws and product labeling; and possible unintended consequences associated with implementation, which includes access and insurance coverage limitations for non-pharmacologic treatments, especially comprehensive care; and the potential effects of strict dosage and duration limits on patient care,” said Patrice Harris, MD, then board chair-elect of the AMA.

Dr. Harris proved to be prescient. In the last three years, insurance companies, healthcare systems and dozens of states have imposed limits – based on the CDC guideline -- on the quantity and dose of opioids dispensed to people with pain.

Oregon has even drafted a plan to stop opioid prescribing for many Medicaid patients and require that they use alternative treatments. Here was my response to Oregon's plan, in which I warned that “forcing opioid tapers is not an appropriate or compassionate solution” and could drive some patients to suicide.

Pharmacies are also imposing limits. In 2017, CVS announced it would limit the number of pills for new patients with acute pain to 7 days’ supply, saying “the CDC Guideline should become the default approach to prescribing opiates.”

That same year, the giant prescription benefits manager Express Scripts also started limiting new opioid prescriptions and set a dosage limit “based on CDC prescribing guidelines.” 

This January, the Centers for Medicare and Medicaid Services made it more difficult for over a million Medicare patients to receive doses above 90 MME (morphine milligram equivalent) which they consider a high dose. CMS also imposed a seven-day limit on all patients receiving a new opioid prescription. The CMS rules are based on evidence “cited in the CDC Guideline.”  

‘Revisit This Guideline’

When it first published its recommendations, CDC pledged to “revisit this guideline as new evidence becomes available” and said it was “committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.” 

In a recent statement to PNN, the CDC said there are “several studies underway with external researchers” evaluating the impact of its guideline on opioid prescribing and patient outcomes. The agency also said it recently commissioned a review by Agency for Healthcare Research & Quality (AHRQ) “to determine what new scientific evidence has been released” on the effectiveness of opioid and non-opioid pain relievers.

In the meantime, no revision of the guideline is being planned.    

The CDC guideline was well-intentioned and included many wise principles of opioid prescribing. But it appears to be more about limiting the supply of opioids than improving clinical care for pain patients. Limiting opioid access may be good for some patients, but for many it means more pain and a worsened quality of life.  

There is little evidence that limiting supply reduces opioid addiction and overdoses. Opioid prescribing in the United States has significantly declined since 2012, yet opioid overdoses continue rising – primarily due to illicit fentanyl, heroin and counterfeit drugs, not prescription opioids. The CDC's reevaluation of the guideline should take this into consideration.  

In 2018, the National Institutes of Health’s Interagency Pain Research Coordinating Committee recommended that the CDC "engage with advocates and patients, who have been negatively impacted by the unintended consequences of the CDC guideline." It also called on the FDA and the CDC to work together to "update and improve" the guideline.  

Rather than seeing the CDC guideline as a resource or helpful tool, many prescribers live in fear of it. The DEA now routinely monitors prescription drug databases, looking for “red flags” that indicate a doctor is prescribing opioids at doses above those recommended by the CDC. The AMA last year took a stand against this “inappropriate use” of the guideline, and passed a resolution stating that doctors should not be subject to criminal prosecution or other penalties solely for prescribing opioids at higher dosages.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

3 Advances in Hormonal Pain Care

By Forest Tennant, MD, Guest Columnist

There are three new discoveries or innovations in hormonal pain care that I dearly love. I believe they are real trend-setters, but keep in mind that the “next big thing” may not endure.  Nevertheless, I’m so excited about these three newcomers to the hormone and pain care movement, that I wish to share them.

Hormone Derivative Treatment

Some really smart scientists know how to make derivatives or analogues out of the “real McCoy.” Why do this? Because the derivative can boost the potency of the basic hormone several fold. 

There are two hormonal derivatives that, in my hands, have been extremely beneficial to sub-groups of chronic pain patients.  The first is medroxyprogesterone, which is a derivative of progesterone.  In my experience, medroxyprogesterone is far more potent in treating intractable pain patients than is plain progesterone. 

I have administered medroxyprogesterone to intractable pain patients and most found that it reduced their pain and their need for opioids.  The causes of intractable pain in these patients were multiple and included Lyme disease, post-traumatic headache, post-stroke and arachnoiditis. We have often made a topical medroxyprogesterone (skin massage) cream for use over arthritic joints and over the lumbar spine of adhesive arachnoiditis patients.

The second hormone is nandrolone, which is a derivative of testosterone.  When a derivative is made from testosterone, it is often called an “anabolic steroid” because it grows tissue.

Anabolic steroids have a generally pejorative or negative view since they have been used to grow the muscles and nerves in athletes that wish to gain athletic advantage.  Don’t be too offended by the term.  After all, the pain patient needs to grow some nerves and muscle to relieve pain. 

The U.S. Food and Drug Administration has approved nandrolone for use in “wasting” or “catabolic” conditions that cause tissue degeneration.  Many severe pain patients qualify.  A big problem today in pain practice is the Ehlers-Danlos syndrome (EDS) patient whose nerves, muscles and connective tissue genetically and progressively degenerate. Nandrolone is proving to be a Godsend to some of these suffering individuals. 

One really good thing about the derivatives medroxyprogesterone and nandrolone is that patients can safely try these hormonal agents for only a month to see if they get a positive response.    

Medrol Test

Medrol is the commercial and best-known name for the cortisone derivative methylprednisolone. It’s an old drug, but ranks as a top-notch newbie because it is the cortisone derivative that best crosses the blood brain barrier and suppresses neuroinflammation. 

To date, we don’t yet have a reliable blood test to determine if there is neuroinflammation in the brain or spinal cord, but it is essential to know if active neuroinflammation is in the central nervous system (CNS). 

Step one on the mending road is to suppress and hopefully eliminate neuroinflammation.  A Medrol test is, in my experience, your best bet to know if you have active neuroinflammation.  There are 2 ways to take the Medrol test.  One is to take an injection of Medrol for 2 consecutive days.  The other is to obtain what is a 6-day dose pack.  You take a declining dose of Medrol over a 6-day period.  All MD’s, nurse practitioners and physician assistants are familiar with the Medrol dose pack. So ask for it.   

Here’s the payoff.  If you feel better with less pain and better physical function, appetite and sleep, you have just determined that you have active neuroinflammation that is not only causing pain today but will worsen your condition in future days. 

If you have active neuroinflammation, you will need to start medicinal agents that are known to suppress neuroinflammation.  If your Medrol test is negative -- meaning it didn’t reduce your pain or improve other symptoms -- it means you don’t have much neuroinflammation and that your pain is due to nerve damage and scarring.  In this case you will have to rely on symptomatic pain relievers and perhaps try some long-term neuro-regenerative anabolic hormones to hopefully regrow or revitalize some nerve tissue.  

Hormonal Extracts

Years ago, including the days of the medicine man and shaman, extracts of whole glands, particularly the adrenals, gonads, pancreas and thyroid, were given to the sick.  In the early part of the last century, this practice was known as “glandular medicine” and whole gland extracts were administered by practicing physicians. Many a person today still finds that an extract of thyroid (made by the Armour Company) is superior to a single component of the thyroid gland or a synthetic thyroid. 

Some commercial companies have brought back whole adrenal and gonadal extracts.  These extracts are non-prescription and are starting to be used by chronic pain patients.  To date, they appear to be essentially void of complications or side-effects. Some chronic pain patients are reporting positive results for pain reduction and improvement in energy, appetite and sleep.  They are a safe, inexpensive way for patients and physicians who don’t like steroids or cortisone.

Hormonal treatments for chronic pain patients are fundamentally essential if a chronic pain patient wants some curative effects. 

Although hormones are a great advance, with more progress to come, they will never be a total replacement for symptomatic care with opioids, neuropathic agents and medical devices. Many long-term intractable pain patients have damaged and scarred nervous systems that neither hormones nor other known treatment can cure. 

Hormone treatments should be initiated as early as possible if a person develops chronic pain.  I recommend hormone blood testing at least twice a year.
— Dr. Forest Tennant

Hormone treatments should be initiated as early as possible if a person develops chronic pain.  I recommend hormone blood testing at least twice a year with a six-hormone panel.  You should replenish any hormone that is low in the blood stream. 

The hormone oxytocin has, as one of its natural functions, pain relief.  It is an excellent short-term pain reliever that can be taken with other symptomatic pain relievers to avoid an opioid.  There are other hormones made in the CNS that protect nerve cells by suppressing neuroinflammation and then regenerating them. To download a full copy of my latest report on hormones and pain care, click here.

Hormones and their derivatives are beginning to be used by chronic pain patients.  All chronic pain patients can and should ask their medical practitioners for a short-term therapeutic trial to find one that fits them.  While one size doesn’t fit all, all can find one size that does fit.  It’s the way forward.  

Forest Tennant, MD, MPH, DrPH, recently retired from clinical practice but continues his groundbreaking research on the treatment of intractable pain and arachnoiditis.

The Tennant Foundation has updated its free handbook for patients and families living with adhesive arachnoiditis and intractable pain. The handbook features the latest groundbreaking research on hormones and pain care. To see and download a copy, click here.

This report is provided as a public service by the Arachnoiditis Research and Education Project of the Tennant Foundation and is republished with permission. Correspondence should be sent to veractinc@msn.com

Future Pain Pills

By Roger Chriss, PNN Columnist

The Food and Drug Administration announced this week that it would require drug makers to conduct new studies on the effectiveness of opioid pain medication and whether long-term use of the drugs lead to addiction. The FDA’s unprecedented action was due in no small part to a 60 Minutes report that said the agency “opened the floodgates” to the opioid crisis by approving the use of opioids for chronic pain. 

With opioid medication coming under scrutiny again – and perhaps more regulatory action – this is a good time to assess where we stand with development of newer and safer painkillers.  

Many analgesics already on the market have too many risks or too few benefits. A recent meta-analysis in JAMA concluded that opioids “may provide benefit for chronic noncancer pain, but the magnitude is likely to be small.”

And a new Cochrane review on acetaminophen (Tylenol) for hip or knee osteoarthritis found “only minimal improvements in pain and function.”

So new analgesics, whether safer opioids or non-opioid drugs, are urgently needed. Fortunately, there has been significant progress.

NKTR-181, from Nektar Therapeutics, is a new kind of opioid under “fast track” FDA review. It was designed with safety in mind, because it enters the nervous system slowly as a result of its unique chemical structure. NKTR-181 is the only abuse-deterrent opioid in the drug development pipeline designed to reduce the “high” and “drug liking” that can lead to addiction. Practical Pain Management recently gave it four out of five stars as a future analgesic.

Desmetramadol, from Syntrix Pharmaceuticals, is another opioid in early testing. Developed with support from the National Institute on Drug Abuse, desmetramadol is designed as a safer version of tramadol, a Schedule IV opioid. Researchers are looking at the results of a recent clinical trial to see whether the new drug “provides the safety and pain relief of tramadol without its metabolic issues.”

VX-150, from Vertex Pharmaceuticals, is a sodium channel inhibitor that late last year finished a “proof-of-concept” Phase II trial successfully. It acts specifically on sodium channels to block the pain caused by small fiber neuropathy. Because these channels are not expressed in the brain, VX-150 should have few if any cognitive side effects. Phase III clinical trials are expected to start later this year.

Tanezumab, from Pfizer and Eli Lilly, just completed a Phase III clinical study for chronic low back pain. The results showed that tanezumab injections were associated with a statistically significant improvement in low back pain compared with placebo. Tanezumab is also being studied as a treatment for osteoarthritis, although there are some lingering concerns about its side-effects.

Finally, the novel compound AT-121 from Astraea Therapeutics is showing promise as a non-addictive opioid analgesic. Researchers created AT-121 to bind to both the mu opioid receptor and the FQ peptide receptor, a combination that blocks the unwanted side effects of current opioid analgesics. Preclinical testing of AT-121 in animals found that it was more potent than morphine, but did not produce physical dependence or tolerance at high doses. The National Institute on Drug Abuse recently called AT-121 a “promising alternative to opioid pain medications.”

Improved understanding of the nervous system and of chronic painful disorders is also contributing to drug development. A recent review in Frontiers in Pharmacology looks at emerging “safer opioids” that provide effective pain relief with fewer side effects. The review explains that the new goal of drug developers is to target opioid receptors in injured or diseased tissues, while avoiding the brain to reduce cognitive side effects and minimize risk of abuse, addiction and overdose.

And new genetic research is identifying genes involved in painful neuropathies. For instance, a recent case report found that a variant in the gene PMP22 is linked to painful peripheral neuropathy in Charcot-Marie-Tooth Disease.

With the prevalence of chronic pain increasing as the population ages, the development of safer, more effective analgesics is critical. Advances in drug development techniques and better understanding of painful disorders should accelerate the process.  

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.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Study: THC More Effective Than CBD in Treating Pain

By Pat Anson, PNN Editor

The psychoactive ingredient in marijuana -- tetrahydrocannabinol (THC) – is more effective than cannabidiol (CBD) in treating chronic pain and other medical conditions, according to a new study that challenges the widespread belief that THC is harmful and has limited value in medical cannabis products.

Researchers at the University of New Mexico used the Releaf App, a mobile software program, to analyze self-reported data from over 3,300 people who logged their responses in nearly 20,000 user sessions to a variety of cannabis products, including natural dried flower, edibles, tinctures and ointments.

Dried flower was the most commonly used product and was generally associated with greater pain relief than other cannabis products, regardless of the amount of THC.

"Despite the conventional wisdom, both in the popular press and much of the scientific community that only CBD has medical benefits while THC merely makes one high, our results suggest that THC may be more important than CBD in generating therapeutic benefits,” said Jacob Miguel Vigil, PhD, a professor in UNM’s Department of Psychology.

“In our study, CBD appears to have little effect at all, while THC generates measurable improvements in symptom relief. These findings justify the immediate de-scheduling of all types of cannabis, in addition to hemp, so that cannabis with THC can be more widely accessible for pharmaceutical use by the general public.”

Hemp is a strain of marijuana that was legalized by Congress in the 2018 Farm Bill. It has very low levels of THC, but is being grown commercially as a source for CBD.

UNM researchers found that indica strains of cannabis were more effective than sativa strains in treating pain and insomnia. Both strains have substantially higher levels of THC than hemp, but are illegal Schedule I controlled substances under federal law.

“Only THC potency levels showed independent associations with symptom relief and experiences of both positive and negative side effects, with higher levels (of THC) resulting in larger effects,” Vigil said.

Researchers say the relative weakness of CBD in treating symptoms may be due to inaccurate labeling of CBD content in cannabis products, which is a widespread industry problem. It’s also possible that THC simply heightens the experience or awareness of symptom relief.

Vigil published his findings in the journal Scientific Reports. Three of his co-authors developed the Releaf App, which has collected information from cannabis users since 2016. The app is an important data source for researchers, who are currently limited in conducting clinical studies of cannabis because of federal regulations.

Two previous studies by Vigil using data from the Releaf App found that cannabis provides significant relief from a wide range of symptoms associated with chronic pain, including insomnia, seizures, depression, anxiety and fatigue.