Surgery Patients Rarely Misuse Opioid Meds

By Pat Anson, Editor

A large new study being published in the British Medical Journal is debunking some popular myths about the causes of opioid addiction.

One such myth is that many hospital patients abuse and become addicted to opioid pain medication while recovering from surgery.

But in a data analysis of over 568,000 patients who were prescribed opioids for post-surgical pain, researchers at Harvard Medical School identified only 5,906 patients (0.6%) who were later diagnosed with opioid dependence, abuse or a non-fatal overdose -- collectively known as opioid misuse.

Of those, only 1,857 patients (0.2%) showed signs of misuse in the first year after surgery – suggesting that the dependence or abuse that others later developed may have had little or nothing to do with the surgery itself.

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But the remarkably low rate of opioid misuse by surgery patients was not the primary focus of the study. What researchers really wanted to know is whether the dose and duration of an opioid prescription influences future chances of abuse and addiction.

And here another myth was dispelled.

Researchers found that high doses of opioids after surgery appear to have little impact on misuse rates. Their findings, to be published January 20 in BMJ, show that how long a patient takes opioids is a more reliable predictor of misuse than how much medication they took. Dosage only emerged as a risk indicator for those who took opioids for extended periods.

"Our results indicate that each additional week of medication use, every refill is an important maker of risk for abuse or dependence," said study co-author Denis Agniel, a statistician at the RAND Corporation and a part-time lecturer in the Department of Biomedical Informatics at Harvard Medical School.

Researchers found that each additional week of opioid use increased the risk for dependence, abuse or overdose by 20 percent. And each refill boosted the risk by 44 percent.

But for those who had a single prescription with no refills – the vast majority of patients -- misuse occurred at a rate of only 145 cases per 100,000 patient years. The rate was still minuscule for those who refilled a prescription -- 293 cases per 100,000 patients years. And for patients who took high doses for short periods -- two weeks or less -- the risk of misuse was no greater than those who took an average dose.

Agniel and his colleagues say their research indicates that opioids -- even at high doses -- can be safely prescribed to patients with post-surgical pain.

“These findings suggest a more nuanced understanding of the relationship between duration and dosage with a focus on early appropriate treatment of pain (including higher doses) for a limited time,” researchers concluded.

“Such findings suggest that optimal post-operative prescribing, which maximizes analgesia and minimizes the risk of misuse, may be achieved with moderate to high opioid dosages at shorter durations, a combination that merits further investigation in population-based and clinical studies.”

Anti-opioid activists and government regulators have long made sensational claims that even just a few painkillers can lead to addiction and death.

“The bottom line here is that prescription opiates are as addictive as heroin. They’re dangerous drugs,” former CDC Director Thomas Frieden told the Washington Post in 2016. “You take a few pills, you can be addicted for life. You take a few too many and you can die.”

The Harvard Medical School study was not the first to find that long term opioid use after surgery is rare. A 2016 Canadian study found that less than one percent of older adults were still taking opioid medication a year after major elective surgery.  

Many patients are dissatisfied with the quality of their pain care in hospitals. In a survey of over 1,200 patients by PNN and the International Pain Foundation, 60 percent said their pain was not adequately controlled in a hospital after surgery or treatment. And over half rated the quality of their hospital pain care as either poor or very poor.

Why I Am Closing My Pain Practice

(Editor’s note: Patient abandonment is a serious and growing problem in the pain community. Thousands of patients have been discharged by doctors who have grown fearful of treating chronic pain and losing their medical licenses for prescribing opioid medication. We were recently contacted by a nurse practitioner, who offered her perspective on this disturbing trend. The author asked to remain anonymous.)

I am a nurse practitioner who has been in the field of pain management for the past 4 years. Prior to that, I spent years as an intensive care unit nurse and in primary care as an advanced registered nurse practitioner (ARNP).

Working with chronic pain patients has been the highlight of my professional career. I absolutely love my job and about 99% of my patients. I have had two complaints about me made to the Washington State Department of Health, both of which accused me of prescribing too much opioid medication to my patients. Both complaints were investigated by the state and I was found to be practicing within the standards of care -- and essentially told to continue. Which I did.

Then the Seattle Pain Centers closed in 2016, leaving thousands of untreated pain patients in the Puget Sound area. I inherited some of their patients. I felt like I had been "vetted" by the state, and believed that if I continued to do everything according to the law, I would be safe from any legal action.

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In my practice, we fight ALL THE TIME for our patients, against the state, insurance companies, pharmacies and even the patient's families sometimes (when they don't understand). I'm not afraid of a good fight, because I have seen patients’ lives turned around when they are finally given the correct amount of opioids. I believe in opioid therapy.

Of course, all the tools in the box should be used, and I refer routinely to physical therapy, interventional pain specialists, surgeons, acupuncturists, chiropractors and others, in addition to prescribing opioids for pain.

Now I find how naive I have been. I have been to national conferences to learn more about pain management, and have heard the top doctors and researchers talk. One of these giants, Dr. Forest Tennant, was recently raided by the DEA. With Jeff Sessions as Attorney General, there is apparently more money being allotted to these raids and more are promised in the future. I also went to a website called "Doctors of Courage" and learned more about the DEA.

My interpretation of the facts is that it doesn't matter if I practice legally anymore. The DEA will look at my prescribing patterns, and tell me that I MUST have known that the ONLY reason any patient would get that much medication is if they are selling it on the street. And therefore, I am a "drug trafficking organization.” The Justice Department takes over the case and the provider is prosecuted.

If convicted, which seems to be the case recently, the provider becomes a felon and serves a prison term. Medical license is lost, time is served and because it is a "drug crime," asset forfeiture law may be used to confiscate everything I own.

'My Fear Is Very Real'

I am married, with a daughter still at home. I cannot do this to my family. So I am joining the legions of others who are closing their pain practices. I have just begun to tell my patients, and have had many, many tears, thoughts of both suicide and homicide, and one very special patient who told me that she will no longer be able to keep her service dog because she will be unable to care for him.

This whole thing is making me literally sick to my stomach. I've cried a million tears for my patients already, and I'm just beginning. I will be carefully weaning them all down to 90 MED per day over the next 6 months, or arranging transfer of care to anywhere the patient would like. What a joke that is -- there is no one else prescribing effective doses of opioids for chronic pain patients. If I am to be thrown in prison, it should be for that -- not for keeping them on therapy that enriches their lives.

I keep asking my husband to tell me that I am overreacting, but as wonderful and encouraging as he has always been, he is scared too.

Please tell all patients that what may have started merely as a provider being paranoid about his or her license has recently morphed into something truly dangerous for us. I will be absolutely no good to anyone, once locked up. If I can stay clear of the DEA's witch hunt, perhaps I can remain a voice of advocacy for pain patients. God help us all.

Please don't use my name if you post this. I can tell you, my fear is VERY real, and I don't want to call any attention to my practice right now. Thank you for understanding.

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Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org

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.

The Difference Between Intractable and Chronic Pain

By Forest Tennant, MD, DrPH

The current attempts by a number of parties to castigate and humiliate pain patients and their medical practitioners is not just pathetic and mostly false, it is dangerous to the fate and life of many intractable pain (IP) patients.  If it wasn’t so serious, some of the claims, biases and beliefs would make good comedy.

First and foremost there has been no discussion about the difference between intractable pain and chronic pain.  There really is no bigger issue. 

The proper identification and treatment of the IP patient is not only essential for the health and well-being of the IP patient, it is a major key to the prevention of overdoses and diversion of abusable drugs.  IP patients must have special care and monitoring.  

The basic definition of IP is a “moderate to severe, constant pain that has no known cure and requires daily medical treatment.” 

Chronic pain, on the other hand is a “mild to moderate, intermittent, recurring pain that does not require daily medical treatment.” While there are millions of persons with chronic pain, only about 10% are intractable.

The cause of “intractability” is two-fold:

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  1. The initial injury or disease which initiated IP was severe enough to cause a pathologic transformation of the microglial cells in the spinal cord and/or brain.  It is this transformation that produces neuroinflammation and the constancy of the pain.  This process is known as “centralization” or “central sensitivity.”
  2. To have enough injury to cause “centralization” one must have a most serious disease or condition of which the most common are: adhesive arachnoiditis, traumatic brain injury, reflex sympathetic dystrophy, post-viral encephalopathy, or a genetic disease such as Ehlers-Danlos Syndrome, porphyria, or sickle cell disease.    

Medical practitioners must have minimally-restricted prescribing authority and autonomy to adequately treat IP.  For example, the proper treatment of IP not only requires analgesics, opioids and non-opioid, but specific anti-inflammatory, hormonal, and corticosteroid agents that will cross the blood brain barrier and control inflamed and pathologic microglial cells.  Treatment of IP has to be individually tailored and may require non-standard, off-label, or an unusual treatment regimen.  

Make no mistake about it.  The new treatment approach to IP is quite effective in reducing pain, controlling neuroinflammation, and allowing patients to biologically function well enough to have a good quality of life.  Also be advised that the new IP approach is not just reducing pain but treating the underlying cause of pain.  Consequently, a lot of expensive procedures, therapies, and opioids are no longer needed. 

As long as I am practicing I will continue to push forward this new approach.

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Dr. Tennant specializes in the research and treatment of intractable pain at the Veract Intractable Pain Clinic in West Covina, California, which remains in operation after recently being raided by DEA agents. Many of Dr. Tennant's patients travel from out-of-state because they are unable to find effective treatment elsewhere.

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.

Medical Cannabis Laws Cause Confusion for Travelers

By Roger Chriss, Columnist

Health problems do not care about maps. But the patchwork of medical marijuana laws in different states does make a map handy for anyone who travels and uses cannabis for a medical condition.

The recent decision by Attorney General Jeff Sessions to resume enforcing federal marijuana law further muddies this already complicated landscape. Even if medical cannabis remains insulated from prosecution by the Rohrabacher-Blumenauer Amendment, there is one important issue for people with chronic pain and related disorders that remains unaddressed.

What happens when someone who is using medical cannabis lawfully for an approved use in their own state has to travel to another state for diagnosis or treatment?

The rarer a medical condition is, the more likely local healthcare providers will prove inadequate and travel will be necessary. A wide range of disorders, including inborn errors of metabolism like porphyria, muscle diseases like nemaline myopathy, and hereditary neuropathies like Charcot-Marie-Tooth disease, require visits to specialists for evaluation and diagnosis. These specialists are often not nearby, making travel an essential step in medical care.

But state rulings on the approved uses for medical cannabis vary significantly and are changing rapidly.

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In Colorado, for example, a person simply has to have “severe pain” to be considered for medical cannabis. By contrast, Connecticut and Illinois maintain extensive and detailed lists of dozens of qualifying medical conditions, from rheumatoid arthritis to Hepatitis C to Tourette syndrome.

Oregon compromises by giving examples of what it calls “debilitating medical conditions” and allows for specific symptoms such as cachexia and severe pain.

Moreover, states like Minnesota, Pennsylvania and Washington define intractable pain as pain unrelieved by standard medical treatments or medications. But they do not agree on what constitutes standard care, with Pennsylvania including “opiate therapy” while Minnesota does not.

Thus, a person could be in full compliance with his or her own state’s laws and regulations, but be unable to qualify for medical cannabis in another state. This would impact out-of-state travel for medical care.

In general, traveling with medical cannabis is very challenging. State governments can only pass laws within their borders. This means that air travel is effectively out of the question, because federal law says that it is illegal to carry marijuana in airline baggage or transport it across state lines.

Obtaining medical cannabis outside of one’s home state is similarly problematic. Some states accept out-of-state medical cannabis cards, but the number remains small and acceptance is at the discretion of the dispensary owner. Each such state has its own rules about medical cannabis possession as well, and these rules change frequently.

All of this creates a difficult landscape for people trying to navigate the U.S. healthcare system outside their home state. As state laws now stand, people with chronic pain disorders could end up breaking both federal and state law while seeking medically recommended cannabis products.

Further, a person who is on a stable regimen of medical cannabis in one state may not be able to visit or relocate to another state without losing that regimen. This may impact education and professional opportunities in a way presumably not intended by state laws.

Medical science and clinical practice should not change with state boundaries. State laws and accepted indications for medical cannabis need to be revised in order to create an environment that benefits people in need and does not inadvertently create legal conflicts or pitfalls. At present, there is simply too much room for error and harm.

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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.

Fibromyalgia Linked to Overactive Brain Networks

By Pat Anson, Editor

Many fibromyalgia sufferers have been told that the pain is “all in their head.” New research indicates there may be some truth to that, and that overactive brain networks could play a role in the hypersensitivity of fibromyalgia patients.

Fibromyalgia is a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, mood swings and insomnia. There is no known cause and successful treatments have been elusive.

In a lengthy study published in the journal Scientific Reports, an international team of researchers at the University of Michigan and in South Korea report that patients with fibromyalgia have brain networks primed for rapid responses to minor changes. This abnormal hypersensitivity is known as called explosive synchronization (ES).

"For the first time, this research shows that the hypersensitivity experienced by chronic pain patients may result from hypersensitive brain networks," says co-senior author Richard Harris, PhD, an associate professor of anesthesiology at Michigan Medicine’s Chronic Pain and Fatigue Research Center.

In ES, a small stimulus can lead to a dramatic synchronized reaction throughout the network, as can happen when a power outage triggers a major grid failure or blackout. Until recently, this phenomenon was studied in physics rather than medicine. Researchers say it's a promising avenue to explore in the quest to determine how a person develops fibromyalgia.

"As opposed to the normal process of gradually linking up different centers in the brain after a stimulus, chronic pain patients have conditions that predispose them to linking up in an abrupt, explosive manner," says first author UnCheol Lee, PhD., a physicist and assistant professor of anesthesiology at Michigan Medicine.

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The researchers tested their theory by conducting electroencephalogram (EEG) tests on the brains of 10 female patients with fibromyalgia. Baseline EEG results showed the patients had hypersensitive brain networks, and that there was a strong correlation between the degree of ES conditions and the self-reported intensity of their pain during EEG testing.

Lee's research team and collaborators in South Korea then used computer models of brain activity to compare the stimulus responses of the fibromyalgia patients to those of healthy ones. As expected, the fibromyalgia model was more sensitive to electrical stimulation.

"We again see the chronic pain brain is electrically unstable and sensitive," Harris says.

Harris says this type of modeling could help guide future treatments for fibromyalgia. Since ES can be modeled outside of the brain in computers, researchers can test for influential regions that transform a hypersensitive network into a more stable one. These regions could then be targeted in living humans using noninvasive brain modulation therapies such as transcranial magnetic stimulation, which is currently used to treat fibromyalgia and depression.

“We expect that our study may ultimately suggest new approaches for analgesic treatments. ES provides a theoretical framework and quantitative approach to test interventions that shift a hypersensitive brain network to a more normal brain network,” researchers reported. 

“It may be possible to convert an ES network to a non-ES network just by modulating one or two hub nodes. Indeed, transcranial magnetic stimulation and/or transcranial direct current stimulation may be improved by ‘targeting’ these sensitive hub nodes. The application of deep brain stimulation to critical nodes that could modify ES conditions is another therapeutic possibility that could be explored.”

The research was funded by the Cerephex Corporation, James S. McDonnell Foundation, and the National Institutes of Health

FDA: Opioid Cold Meds Too Risky for Kids

By Pat Anson, Editor

The Food and Drug Administration has ordered stronger warning labels for cough and cold medications containing opioids and said they should no longer be prescribed to patients younger than 18. The agency also signaled it that it could enact new limits on the dose and duration of other types of opioid prescriptions.

“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction,” said FDA Commissioner Scott Gottlieb, MD. “It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population.”

The FDA action involves nine different types of cough and cold medicines, four of which contain codeine and five that have hydrocodone. The brand names include Tuxarin ER, Tuzistra XR, Triacin C, FlowTuss and Zutripro. Several of the medications also come in generic form.

The FDA said it conducted an extensive review of the products and convened a panel of pediatric experts, who said the risk of misuse, abuse and addiction outweighed the benefits in patients younger than 18.

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“These products will no longer be indicated for use in children, and their use in this age group is not recommended.  Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated.  For those children in whom cough treatment is necessary, alternative medicines are available,” the FDA said in a statement.

The agency also ordered stronger “Black Box” warning labels on opioid cough and cold medicines to make them more consistent with safety warnings that come with opioid pain medications.

‘Too Many People Prescribed Opioids’

The FDA this week also released its 2018 Strategic Policy Roadmap, which outlines four priority areas in the year ahead.

The agency's first goal is to reduce the abuse of opioid medication. The FDA said opioid addiction and overdoses were claiming lives at a “staggering rate” of 91 deaths every day – although it failed to point out that most of those deaths involve illegal opioids such as heroin and illicit fentanyl, not prescription pain medication. Also unmentioned in the “roadmap” is that opioid prescriptions have been declining since 2010.

“Too many people are being inappropriately prescribed opioid drugs. When these prescriptions are written, they are often for long durations of use that create too much opportunity for addiction to develop,” the FDA said.

“We need to take steps to reduce exposure to opioid drugs by helping to make sure that patients are prescribed these drugs only when properly indicated, and that when prescriptions are written, they are for dosages and durations of use that comport closely with the purpose of the prescription.” 

Several states have already enacted limits on opioid prescriptions for acute, short term pain. Minnesota, for example, recently adopted strict new guidelines that limit the initial supply of opioids for acute pain to just three days. 

An Open Letter to My Senator: CDC Has Killed Me

(Editor’s Note: Charles Malinowski is a 59-year old Paso Robles, California man who lives with Reflex Sympathetic Dystrophy (RSD), degenerative disc disease, ankylosing spondylitis, spinal stenosis and other chronic pain conditions.  He recently wrote this open letter to U.S. Senator Kamala Harris (D-CA). We thought his letter worth sharing with PNN readers.)

Dear Senator Harris,

The CDC has killed me!

Let me repeat that: The CDC has killed me!

I have a severe neurological condition that causes me unspeakable and crippling pain. Pain medication is literally the only thing keeping me alive. But with the issuance of the CDC’s short sighted, so-called voluntary opioid prescribing guidelines -- which are being rammed down the throats of medical providers -- my pain management doctor has cut me off of opiates.

For the last 10 years, I have been subjected to nearly every type of physical therapy, medical treatment and medication applicable to my affliction. The one and only thing that has ever had any demonstrable benefit in even temporarily suppressing my pain to a tolerable level has, unfortunately, been opiates.

In early October, I was told that I would have to stop taking either the oral opiates or the intrathecal opiates, as it was now illegal for a person to receive two different types of opiates via two different delivery methods concurrently. This was a major problem, as even with both oral and intrathecal opiates, my pain was severely under-managed to the point where I was almost completely bedridden. I left the house only to go to doctor's appointments.

When I was told that my pain management regimen - specifically the opiates - was going to be cut in half, even though my pain was already grossly under-managed, I spoke out about this.

CHARLES MALINOWSKI

CHARLES MALINOWSKI

As a result, not only was I cut off from the oral opiates, I got kicked out of the pain management practice where I have been a patient for more than seven years. The doctor said he didn't want to risk his license - but was perfectly willing to risk my life - over the CDC opioid guidelines.  These guidelines are supposed to be voluntary and are not supposed to take desperately needed pain medication away from legitimate chronic pain sufferers such as myself.

I expect that within 60 days, I will be dead from either heart failure or a stroke due to my body's inability to cope with the stress of the unrelenting pain. My neuropsychologist, who has been treating me for nearly 10 years, has consistently rated my level of pain as moderate to extreme, even while being medicated with both oral and intrathecal opiates, which I am now denied.

I'm not dead yet, but within 60 days I expect that the CDC will have effectively killed me. I honestly don't see myself being able to tolerate the pain any longer than that.

Congress, in going along with this blindly, will be explicitly complicit in this negligent homicide - or homicide by depraved indifference, take your pick - of one Charles James Malinowski, that being myself.

I would like to thank you, Senator, and all the rest of your colleagues for murdering me.

To help ease your conscience, it is not just me that Congress is complicit in murdering, but thousands, possibly tens of thousands of people in like positions.

Sincerely,

Charles Malinowski

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Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org

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.

Ibuprofen Linked to Reduced Male Fertility

By Pat Anson, Editor

If you’re a man who uses ibuprofen regularly for muscle pain or  headache, you could be compromising your ability to have children, according to a small new study.

French and Danish researchers enrolled 31 young male volunteers between the ages of 18 and 35 in the study, and gave about half of them 600 milligrams of ibuprofen twice a day -- the highest recommended dose. The other participants were given a placebo.

After just 14 days, the researchers noted signs of hormonal dysfunction in the men who took ibuprofen, who had high levels of luteinizing hormone, which the pituitary gland produces to stimulate testosterone production in the testicles. 

That condition -- known as hypogonadism -- is usually seen in older men who have low testosterone levels. Hypogonadism is associated with reduced fertility, lower sex drive, depression, fatigue and an increased risk of cardiovascular problems.

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“We normally see this condition in elderly men, so it raises an alarm,” study co-author Bernard Jégou, PhD, of the French National Institute of Health and Medical Research, told The Guardian. “We are concerned about it, particularly for healthy people who don’t need to take these drugs. The risk is greater than the benefit.” 

Researchers say the disorder was mild in the ibuprofen group and went away when the men stopped taking ibuprofen. But they worry what would happen to men who take the pain reliever for longer periods. Many professional athletes regularly take high doses of ibuprofen.

“Our immediate concern is for the fertility of men who use these drugs for a long time,” said co-author David Møbjerg Kristensen, PhD, a professor of biology at the University of Copenhagen. “These compounds are good painkillers, but a certain amount of people in society use them without thinking of them as proper medicines.”

The study was published online in the Proceedings of the National Academy of Sciences .

“Ibuprofen appears to be the preferred pharmaceutical analgesic for long-term chronic pain and arthritis. Therefore it is also of concern that men with compensated hypogonadism may eventually progress to overt primary hypogonadism, which is characterized by low circulating testosterone and prevalent symptoms including reduced libido, reduced muscle mass and strength, and depressed mood and fatigue,“ the researchers warned.

The same team of researchers reported in earlier studies that aspirin, acetaminophen and ibuprofen affected the testicles of male babies born to mothers who took the drugs during pregnancy.

Ibuprofen is a widely used over-the-counter pain reliever found in brand name products such as Motrin and Advil.   

Acetaminophen May Slow Language Development

By Pat Anson, Editor

Another study has linked acetaminophen to learning difficulties in young children born to mothers who used the over-the-counter pain reliever during pregnancy.

Researchers at the Icahn School of Medicine in New York City say toddlers exposed to acetaminophen in the womb had a slower rate of language development at 30 months. The findings are consistent with other studies reporting higher rates of autism, attention deficit disorder (ADHD) and behavioral problems in children born to mothers who used acetaminophen while pregnant.  

Acetaminophen (paracetamol) is one of the most widely used pain relievers in the world. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. Researchers say over half the pregnant women in the United States and European Union use the drug.

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“Given the prevalence of prenatal acetaminophen use and the importance of language development, our findings, if replicated, suggest that pregnant women should limit their use of this analgesic during pregnancy,” said senior author Shanna Swan, PhD, Professor of Environmental and Public Health at the Icahn School of Medicine at Mount Sinai.

“It’s important for us to look at language development because it has shown to be predictive of other neurodevelopmental problems in children.”

The study involved 754 women who enrolled in the Swedish Environmental Longitudinal, Mother and Child, Asthma and Allergy study (SELMA) during weeks 8-13 of their pregnancy. Researchers asked the women to report the number of acetaminophen tablets they took between conception and enrollment, and tested the acetaminophen concentration in their urine.

A delay in a child's language development, defined as the use of fewer than 50 words at 30 months of age, was measured by a nurse and a follow-up questionnaire filled out by the mothers.

Girls born to mothers with high exposure -- those who took acetaminophen more than six times in early pregnancy -- were nearly six times more likely to have language delay than girls born to mothers who did not take acetaminophen.

While the number of acetaminophen tablets and concentration in urine were associated with a significant increase in language delay in girls, there was only a slight increase in boys.  The findings suggest that acetaminophen use in pregnancy results in the loss of the well-recognized female advantage in language development in early childhood.

The study is published online in the journal European Psychiatry. Researchers will follow-up with the children and re-examine their language development at age seven.

A 2016 study of over 2,600 Spanish women linked acetaminophen to autism and attention deficit problems in their children. Studies in Denmark and New Zealand have also linked acetaminophen to a higher risk of ADHD.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. In the U.S. over 50,000 emergency room visits each year are caused by acetaminophen, including 25,000 hospitalizations and 450 deaths.

Stem Cells: Signs of Progress in a Rigged Game

By A. Rahman Ford, Columnist

The Wall Street Journal recently published an article on the use of stem cell therapies for knee problems, including arthritis.  Overall, the perspective of the piece was positive and it has several laudable aspects.  Physicians from large academic institutions, such as Harvard University and Stanford University, were interviewed to provide their opinions on the use of autologous stem cells derived from a patient’s own fat or bone marrow for certain painful orthopedic indications. 

The article rightly acknowledges the high patient demand for these autologous therapies. It also mentions how the U.S. lags behind other countries in offering them and the disturbing fact that this therapy is not covered by medical insurance.  The doctors who were interviewed also discussed how conventional approaches to osteoarthritis in knees – meniscus surgery, microfracture surgery, etc. – often fail to demonstrate long-term benefit.  These doctors, along with many others around the world, recognize that we need new therapies for orthopedic conditions.

Any positive portrayal of the clinical uses of stem cells should be welcomed. The unfortunate truth is that many potential patients are scared off by publications that focus their reporting on the alleged malfeasance of a few bad-actor stem cell clinics.  These same publications often neglect to cover the countless stem cell success stories from clinics in the U.S. and abroad. 

A focus on these promising results may help allay those fears and convince some of those fearful patients that stem cells are, in fact, a viable medical option for their chronic orthopedic pain. 

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Less fear can lead to self-education and increased awareness of the safety and potential of stem cells.  Patients may even try stem cell therapy and become advocates.  In this sense, the WSJ piece is good public relations for stem cell therapies overall.

However, there is an unsettling undertone in the WSJ piece and media coverage in general of stem cells, which places too much emphasis on the opinions of clinicians from certain large institutions.  That diminishes the value of work being done in smaller stem cell clinics, which have been safely and effectively treating patients with orthopedic conditions for years. 

The unintended implication is that Harvard and Stanford physicians’ assessments are more legitimate because of the perceived prestige of their employers, and because they follow the guidelines that the FDA set forth for pursuing such treatments.  Of course, these institutions have millions of dollars in capital that it takes to conduct clinical studies and comply with these guidelines, while smaller clinics often do not.  We must take care to avoid creating or reinforcing illegitimate hierarchies that give some physicians more scientific authority than others, based solely on money, perceived prestige, or the ability to adhere to an unfair set of rules.

The sad truth is that the stem cell game is rigged.  The FDA’s rules regarding the use of autologous stem cell therapies favor those with more financial resources because they can afford expensive clinical trials.  Medical innovation cannot be strictly the domain of wealthy institutions with the finances to play on a tilted field.  The FDA’s “minimal manipulation” and “homologous use” regulatory standards for using stem cells are unduly burdensome and need to be relaxed for autologous stem cell uses. 

Recently, the FDA issued a warning letter to American Cryostem, a company involved in the manufacture of adipose stem cell products derived from a patient’s body fat.  In addition to manufacturing violations, the company was accused of violating the FDA’s “minimal manipulation” and “homologous use” standards. 

Setting the merits of the case aside, it is emblematic of the FDA’s crackdown on clinics that are much smaller than Harvard and Stanford, but which have been relieving patients’ pain with autologous therapies for years.  Their scientific contributions must not be subordinated or dismissed as illegitimate or inconsequential.

Stories of how stem cells are entering mainstream medicine can help us realize the goal of available, affordable stem cell therapy for all Americans.  However, valorization of those institutions with the means to “play within the rules” must not come at the expense of sounding the alarm that the rules themselves are patently unfair.

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A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

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

Little Evidence Cannabis Can Treat Chronic Pain

By Roger Chriss, Columnist

There is an abundance of research on medical cannabis. Everything from basic science to clinical trials and even major reviews have been conducted on the effectiveness of cannabis in treating chronic pain and other conditions. But the results don’t necessarily say what people want to hear.

As Leafly shows in a comprehensive list, most states in the U.S. that have legalized medical cannabis include chronic pain or painful conditions among the accepted indications for use. But these same states also note that research supporting medical cannabis for chronic pain is thin.

Minnesota, for example, accepts “intractable pain” but then says that “the literature assessing the effects of medical cannabis treatments for non-cancer chronic pain is sparse and patchy.”

Similarly, the California Medical Association’s “Physician Recommendation of Medical Cannabis” states that the approved list of 12 serious medical conditions that cannabis can be used for “is broad, and in most cases not supported by solid clinical research.”

In other words, medical cannabis has been approved for use, despite having not been rigorously demonstrated to be useful.

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The existing research supports this view. A recent systematic review of two dozen clinical trials published in the journal Pain Physician found that “the majority of studies did not show an effect.” The review concludes that cannabis-based medications “might be effective for chronic pain treatment, based on limited evidence, primarily for neuropathic pain (NP) patients.”

Another recent review of randomized placebo-controlled studies of smoked cannabis published in the journal Pharmacotherapy found that “cannabis did not outperform placebo on experimentally evoked pain.”

And a systematic review of the efficacy of cannabis in patients with neuropathic pain, multiple sclerosis or receiving  chemotherapy concluded that “there is incomplete evidence of the efficacy and safety of medical use of cannabis” and that “confidence in the estimate of the effect was again low or very low.”

Even reviews of medical cannabis for disorders that involve a chronic pain component are lackluster. A 2017 systematic review looked at randomized controlled trials of cannabis and its derivatives in treating psychiatric, movement, and neuro-degenerative disorders. The review found that "definitive conclusion on its efficacy could not be drawn” because the trials were low quality and had methodological limitations.

These results run contrary to the public perception of cannabis efficacy and the exuberance of media coverage about marijuana in any form. This has not escaped the notice of researchers. A 2017 study from Europe found that “public perception of the efficacy, tolerability, and safety of cannabis-based medicines in pain management and palliative medicine conflicts with the findings of systematic reviews and prospective observational studies conducted according to the standards of evidence-based medicine.”

Moreover, the Pain Physician study notes another significant trend: More recent studies tend to report more favorable results. It is not clear why this is happening, though a shift in cultural attitudes, ongoing advocacy in favor or cannabis legalization, and changes in the available strains of cannabis have been suggested. In particular, an increasingly positive attitude toward cannabis among study participants may be augmenting the placebo effect.

There are other limitations to the existing research -- from problems with blinding, lack of a good placebo and small study size – that make it open to criticism. Much of the commentary on cannabis research seems to have less to do with a close reading of the literature than with a desire for cannabis to gain widespread acceptance.

There is, of course, growing evidence for the use of cannabis in the treatment of some disorders, such as epilepsy and chronic neuropathic pain.  Medical cannabis may also have some value for people who are not benefiting from or cannot tolerate pharmaceutical drugs and other established therapies. So cannabis should remain an option -- intractable pain is sufficiently horrible that we need as many options as possible.

Medical research is about accumulating evidence through clinical trials and laboratory study. One trial is rarely ever enough to demonstrate efficacy. Even one major review is not sufficient. But an abundance of reviews all pointing in one direction should not go ignored.

Medical cannabis certainly merits further study. But the above reviews clearly show that efficacy is limited in many cases. Cannabis may well prove useful in treating certain disorders, but it is not a panacea and not likely to outperform existing treatments.

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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.

5 Steps to Successful Advocacy for Pain Community

By Barby Ingle, Columnist

When it comes to advocating for the pain community, there are many roles to fill and many ways to go about doing it. There are patient advocates, legislative activists, social media activists and self-advocates.

I do a little of each and see that the most common mistake in activism is when patients join an organization without fully understanding the legislative process, how long it takes, and that there’s no guarantee that the desired outcome will be reached.

This is a topic I have seen on many of the upcoming pain conference agendas for 2018. I have been asked to speak at a conference about it, and while preparing my talk I realized that patients need more information on what it takes to build a pain organization into a successful change maker in public policy and legislation.

There is a 5-step process that I use to insure that a message is heard, supported, and goes from being an idea to actual legislation at the federal or state level. It takes a never-give-up attitude, with a big influx of time, effort, follow-up and social media support.

First, when crafting legislation to improve patient care or some other goal, you need to start by creating an implementation plan. This plan should outline a budget, strategies, leadership responsibility and timelines for goals to be met.

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Second, the team leader must clarify the roles of the advocacy team and communicate that role to the rest of the leadership team, staff and volunteers. There are many personalities and challenges that will come up, so having the right people in place working together is very important.

Third, confirm that all team leaders express support for the initiative in meetings with legislators and their staffs. Allow additional time for the implementation of each step. Things tend to take longer than they should when working with teams and with government officials. The leadership should organize volunteers, create training resources, reach out to the media (and have patient stories ready for them), and provide effective speakers for hearings and press conferences. Be sure to include healthcare professionals and patients on your team.

Fourth, monitor the progress of the legislation closely. There are usually a lot of “hurry up and wait” situations and it could take years before a bill gets out of committee or comes up for a vote.  Sometimes mid-course corrections and negotiations are needed with legislators to gain their support and to keep a bill from dying, especially if a mandate or money is involved. 

Fifth and finally, carry out your strategies to achieve your goals. Your leadership team and volunteers should understand the bill and the legislative process, and be using marketing and social media tools to gain public support and awareness about why the legislation is needed. Staying motivated is critical to success. Keep your staff and volunteers involved and committed to making a difference in their own lives and the lives of others.

If you are a chronic pain patient and want to get involved, understand that this type of work takes physical action, but it doesn’t have to be all encompassing. Volunteer with advocacy groups or non-profits that are already working on legislative issues that interest you. See what fits you and volunteer to be a team leader or social media supporter. Share your story and why the bill is important to you, or even testify in person at a legislative hearing.

Be the change agent that we all need in getting proper and timely healthcare for the chronically ill.

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Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) 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.