Civil Rights Case Gives Hope to Pain Patients

By Richard Dobson, MD, Guest Columnist

People with chronic disabling pain frequently complain that doctors discharge them from their practice because of the medications they take. Sometimes doctors refuse to accept patients who are taking opioid pain medications, even though the medications treat a legitimate medical condition.

There may be hope that such actions will be considered violations of the civil rights of patients.

This week the Civil Rights Division of the Department of Justice (DOJ) signed a formal agreement with Selma Medical Associates, a large primary care practice in Virginia, that may open the door for people with chronic pain to regain their full access to medical care.

Selma Medical refused to schedule a new patient appointment for a man who was taking the addiction treatment drug Suboxone. He filed a civil rights complaint asserting that his rights were violated because has a disability.

According to the complaint, Selma Medical “regularly turns away prospective new patients who are treated with narcotic controlled substances such as Suboxone.”

The DOJ and Selma Medical settled the complaint out-of-court. The full agreement can be read here.

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In essence, Selma Medical agreed to stop discriminating on the basis of disability, including opioid use disorder (OUD). The settlement identifies several specific ways that Selma Medical was violating the civil rights of people with disabilities.

“By refusing to accept the Complainant for a new family practice appointment solely because he takes Suboxone, Selma Medical discriminated against him by denying him the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of Selma Medical.

By turning away the Complainant and other prospective patients who are treated with narcotic controlled substances, including Suboxone, Selma Medical imposed eligibility criteria that screen out or tend to screen out individuals with OUD.

Further, Selma Medical failed to make reasonable modifications to policies, practices, or procedures, when such modifications are necessary to afford such goods, services, facilities, privileges, advantages, or accommodations to individuals with disabilities.”

In the agreement, Selma Medical agreed to stop discriminating now and in the future. The staff and administration are also required to undergo intensive training on the implementation of the Americans With Disabilities Act (ADA).

Importantly for pain patients, the agreement applies to people taking “narcotic medications” for any reason and is not limited to people who are taking Suboxone for OUD. The agreement does seem to imply that people taking opioid medications also have their civil rights violated if they are refused medical care on the basis of their diagnosis and their use of opioids.

A former staff attorney in the DOJ’s Civil Rights Division agrees.  

“This formal settlement agreement from DOJ affirms that discrimination in access to medical treatment based solely on an individual’s use of a particular medication — in this case, a narcotic controlled substance — may violate the law,” says Kate Nicholson, a pain patient and civil rights attorney who helped draft federal regulations under the ADA.

Anyone who has chronic pain and who is discharged from a practice or refused admission to a medical practice should let the medical staff know that this is a violation of the ADA. Show them the agreement between Selma Medical and the DOJ. Then if the medical practice still refuses care, file a formal complaint with the Office of Civil Rights. Instructions on filing can be found here.

As part of the settlement agreement, Selma Medical had to pay $30,000 to the complainant for “the discrimination and the harm he has endured, including, but not limited to, emotional distress and pain and suffering.” Selma Medical also had to pay a civil penalty of $10,000.

It seems to me that the substance of this agreement gives real hope to the chronic pain community that discrimination based on disability, even if the disability is based on pain, is illegal and violates their civil rights.

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Richard Dobson, MD, worked as a physician in the Rochester, New York area for over 30 years, treating and rehabilitating people suffering from chronic pain, mostly as the result of work or motor vehicle accidents.  He is now retired.  

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.

What Should You ‘Tell Your Children’ About Marijuana?

By Roger Chriss, PNN Columnist

Depending on your point of view, the new book “Tell Your Children: The Truth About Marijuana, Mental Illness, and Violence” is either a welcome cautionary tale about cannabis or a reincarnation of the infamous movie Reefer Madness.

Author Alex Berenson, a novelist and former reporter for The New York Times, is clearly no fan of cannabis legalization and the growing hype over its medical use.  

“Marijuana is not medicine. Marijuana and THC-extract products — whether eaten or smoked — are intoxicants and mild pain relievers, like alcohol,” he writes. “Marijuana in the United States has become increasingly dangerous to mental health in the last fifteen years, as millions more people consume higher-potency cannabis more frequently.”

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Berenson argues that cannabis causes paranoia and psychosis, with more use leading to greater mental health issues and even violence.

He uses a combination of history and statistics as evidence, often with lurid reporting about cannabis and violent crime in the U.S. and Britain from over a century ago. Berenson describes incidents of psychotic breaks, murderous episodes, and heinous acts of violence that read a bit too much like true crime stories.

“Marijuana causes paranoia and psychosis. Psychosis causes violence. The obvious implication is that marijuana causes violence,” he writes, without offering any evidence linking the two.

Berenson then gives a brief history on the promotion of cannabis in the modern era by groups such as NORML, the Drug Policy Alliance and the magazine High Times. He emphasizes that the cannabis of the 1960s and ‘70s was “near beer” compared to the cannabis of today.

Berenson builds his case on the work of Swedish physician Sven Andréasson, who in the 1980s used data from the Swedish military draft to investigate the connection between cannabis and schizophrenia. Andréasson found that the use of cannabis was strongly correlated with schizophrenia and that the risk was dose-related.

To bolster his argument, Berenson draws on the work of Phil Silva in the Dunedin Multidisciplinary Health and Development Study; Robin Murray at the Institute of Psychiatry in London; and the 2017 National Academies report on cannabis.

The cannabis-schizophrenia connection has been overlooked, in part because of limited data. In Washington state, for example, where recreational cannabis was legalized in 2014, the state health department doesn’t even keep track of schizophrenia cases.

Berenson says legalizing cannabis for medical use is a cagey strategy to protect recreational users and gain public support for full legalization, because it “encourages voters to think of marijuana as something other than an intoxicant.”

“Medical marijuana is a way of protecting a subset of society from arrest,” he wrote, adding that “marijuana simply wasn’t a strong enough painkiller to be effective for most people who truly needed opiates.”

He even suggests cannabis legalization may be exacerbating the opioid crisis.

“What’s gone unnoticed in the discussion over state-by-state changes is the striking correlation between the opiate epidemic and cannabis use at the national level,” he said. “The direct economic benefits of legalization also appear to be vastly overrated.”

Berenson concludes with an ironic argument for more research: “The government should drop its barriers to researching cannabis for medical purposes. The reason is not that marijuana is likely to prove a miracle cure for cancer — or anything else. It’s precisely the opposite. Let’s put unfounded claims to rest, permanently.”

There are reasons to be skeptical of Berenson’s conclusions. He points to a lack of data on trends in serious mental illness as hiding the impact of cannabis on schizophrenia rates. But the lack of data means we don’t really know what is happening. Trends are further obscured by changes in diagnostic criteria, reporting requirements and treatment availability. All of this needs to be carefully teased out in regard to cannabis as a factor in schizophrenia.

Similarly, Berenson recognizes that no research proves cannabis causes psychosis and violence. He points out that such research is not ethically acceptable. But there are other ways to establish causation, including prospective longitudinal studies and natural social experiments such as Canadian legalization. In other words, Berenson may be able to claim he is right some day, but not yet.

Lastly, Berenson ignores the issue of scale. Even if the psychotic breaks and criminal acts he describes are attributable to cannabis, they are still very rare compared to the scale of cannabis use. He needs to establish a base rate and then show that increasing levels of cannabis use are associated with rising rates of psychosis and violent crime. That work remains to be done.

“Tell Your Children” is useful but could have been better. Berenson overreaches in his conclusions and omits important considerations. But he raises relevant questions about the potential mental health risks and social implications of cannabis. “Tell Your Children” may not be essential reading, but for people who are interested in the possible risks of cannabis, it is certainly worth reading.

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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.

Hormones & Pain Care: What Every Patient Should Know

By Forest Tennant, MD, Guest Columnist

As we start the year 2019, every chronic pain patient needs to know the status of hormones and pain care. Unfortunately, the recent hysteria over opioids has obscured the positive advances in the understanding and application of hormonal care to the relief and recovery of pain patients.

In fact, research and clinical experience is starting to revolutionize the way I personally think about pain care. Hormones are showing us the natural, biologic way the body deals with pain and injury. They are clearly the way forward.

Why the Excitement Over Hormones?

Hormones have recently been discovered to be made in the brain and spinal cord (central nervous system – CNS). Some hormones are made that have the specific job and function to protect (“neuroprotection”) CNS tissue from injury and to regrow the injured tissue (“neuroregeneration”). These hormones are collectively called “neurohormones.”

Intractable, chronic pain is actually a type of poisonous, electromagnetic energy that causes injury by producing inflammation (“neuroinflammation”) in the CNS and implanting the pain (e.g. “centralization”) so as to make it constantly (“24/7”) present.

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The process is similar to dropping acid on your skin which burns and causes inflammation to be followed by tissue destruction and scar formation. Fortunately, some neurohormones are made in the CNS to stop the pain, inflammation, tissue destruction and scarring process and rebuild the nerve cell network in the CNS.

Until recently, we physicians didn’t have a clue on how to enhance the natural, biologic hormonal system to help pain patients.

Excitement over neurohormones has really been enhanced by research in rats that had their spinal cords cut so that they walked around their cages dragging their hind legs. They were given some neurohormones which healed their spinal cords to the point that they could normally walk.

Other animal research studies using different test models with CNS tissue have also shown the power of specific hormones to heal and regrow brain and spinal cord nerve cells. This author can’t speak for others, but, in my opinion, these research studies are so compelling that hormone use in pain care has got to be fully investigated.

Are We Making Headway?

Absolutely, yes! First, eight specific hormones made in the CNS have been identified that produce healing effects in animals and show benefit in early clinical trials with chronic pain patients. These early trials indicate that some neurohormones can reduce pain and produce healing and curative neuroregeneration effects.

Six of these hormones are collectively known as “neurosteroids.” Don’t let the term “steroid” raise your eyebrows as it refers only to the chemical structure and not the complications of cortisone-type drugs. Some of the neurosteroids are known to the lay person such as estradiol, progesterone, and testosterone.

Two of the hormones produced in the CNS that control pain but are not classified as a “neurosteroid” are human chorionic gonadotropin (HCG) and oxytocin.

CENTRAL NERVOUS SYSTEM HORMONES

  • ALLOPREGNANOLONE
  • ESTRADIOL
  • DEHYDROEPIANDROSTERONE (DHEA)
  • HUMAN CHORIONIC GONADOTROPIN (HCG)
  • OXYTOCIN
  • PREGNENOLONE
  • PROGESTERONE
  • TESTOSTERONE

Due to all the controversies surrounding opioids and pain treatment, one would never know we have, in the past couple of years, made serious headway with hormones and pain care. Medical science has discovered which hormones reduce chronic pain and how the hormones can be prescribed. The overall hormone advance in pain care can, however, be generally summarized in that one or more of the neurohormones can be administered to provide some curative and regenerative benefit in essentially every chronic pain patient.

Replenishment of Deficient Hormones

The production of hormones made in the CNS can be assessed by blood tests which are available in every commercial, community laboratory. The amount of hormone in your blood stream is a pooled amount of hormone made in the CNS and in the glands; adrenals, ovary, and gonads (ovary and testicles).

I recommend a hormone blood test panel of these 6 hormones: cortisol, DHEA, estradiol, pregnenolone, progesterone, and testosterone. If any are low, they should be replenished. Why? Severe chronic pain may overwhelm the production of one or more of these hormones.

If you take opioids and other symptomatic pain medications such as antidepressants and muscle relaxants, you may actually suppress the production of some hormones, particularly testosterone, DHEA, and pregnenolone.

I highly recommend that every chronic pain patient have a hormone blood panel test at least twice a year and replenish any hormone that is low in the blood stream.
— Dr. Forest Tennant

The reason you must replace any deficient hormone is because all 6 of them activate pain centers (“receptors”) in the CNS to reduce pain and produce a healing and curative effect. These hormones act as sort of a co-factor or “booster” of symptomatic pain relievers such as opioids and muscle relaxants. I highly recommend that every chronic pain patient have a hormone blood panel test at least twice a year and replenish any hormone that is low in the blood stream.

The Pregnancy Connection

A couple of years ago I was presenting a scientific poster at a medical meeting on some of my hormone research. An old friend came up and asked, “What took you so long?”

I initially thought he was insulting me. He wasn’t. He was lamenting, along with me, a sad fact. We should have long ago been studying the pregnancy hormones, HCG and oxytocin, for everyday pain care.

Why? HCG in pregnancy is the hormone that grows the CNS in the embryo and fetus. Oxytocin is the natural pain reliever in pregnancy that allows a big “tumor” to grow in the abdomen without death-dealing pain. Also, oxytocin surges at the time of delivery to make sure that pain doesn’t kill the expectant mother.

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With such obvious knowledge about natural pain relief in pregnancy, we should have tested these hormones for severe, chronic pain problems before now. Do they work? Yes. Long-term HCG use (over 60 days) is proving most effective in reducing pain and restoring function in some patients with adhesive arachnoiditis and other severe pain problems. Oxytocin is an effective short-term pain reliever that can be taken for pain flares. It can even be taken with symptomatic pain relievers like aspirin, acetaminophen, or a stimulant to help a patient avoid opioids.

Goodbye Symptomatic Treatments

Until the hormones came our way, you never heard much about “symptomatic” versus “curative” care. Why? Up until the discovery that hormones are made inside the CNS and produce curative effects, about all we could do was prescribe symptomatic pain relievers such as opioids, muscle relaxants, and anti-seizure (“neuropathic”) agents. There was no need or hope that we can permanently reduce severe chronic pain, much less hold out a hope for cure or near cure.

Chronic pain patients are beginning to use DHEA, pregnenolone, testosterone, estradiol, progesterone, and HCG on a long-term basis. Dosages are beginning to be determined. For example, DHEA requires a dosage of 200 mg or more each day. Pregnenolone requires 100 mg or more. Patients report reduced levels of pain, fatigue, and depression.

Although few controlled studies have yet been done, the open-label clinical trials are impressive and clearly call for chronic pain patients to get started with the neurohormones that are being found to be beneficial. Neurohormones have changed our thinking and old-hat beliefs.

Every severe chronic pain patient needs to know they can probably do a lot of mending with hormonal care. Be, however, clearly advised. Hormones can mend a lot of damaged nerve tissue, but they can’t fix scar tissue once it sets in.

So far at my clinic site, we have around 60 to 70 people on oxytocin. Early results look good so far. Many are also on DHEA and pregnenolone as well. The treatment seems to be working.
— Nurse practitioner

Unfortunately, millions of severe, chronic pain patients have had no option in the past couple of decades except to take symptomatic medication and use such devices as electrical stimulators.

Even long-standing severe chronic pain patients who are on opioids, however, can almost always benefit from one or more hormones. Most important, I am finding that hormone administration is the best way in most chronic pain patients to reduce opioid dosages but still get good pain relief.

Therapeutic Trials

One of my major purposes in writing this report is to encourage all chronic pain patients to embark upon a search for one or more hormonal treatments that will reduce their pain, need for opioids, and yield a better life. Don’t wait for your medical practitioner to offer hormone testing or treatment. To many overworked medical practitioners, such a request may be considered a real nuisance or even a threat.

Be prepared. Check with other patients in your social media group. Know what you need. Make it easy on your medic. Please share with your social media group this report and any materials you have about hormones and pain care. Most MD’s, NP’s, and PA’s will appreciate your preparation and desire to try something new on a short-term, trial basis.

Every chronic pain patient needs to know that all the hormonal agents described here can be safely tried for one month. This is known as a “therapeutic trial.” Specifically ask your medical practitioner for a one-month, therapeutic trial. In this manner you can find out if the hormone is right for you and whether you should continue with it past one month.

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Forest Tennant, MD, MPH, DrPH, recently retired from clinical practice but continues his groundbreaking research on the treatment of intractable pain and arachnoiditis. To download a complete copy of Dr. Tennant’s report on hormones and pain care, 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

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.

Why a Bad Night’s Sleep Causes More Pain

By Pat Anson, PNN Editor

It’s no secret that chronic pain makes sleeping difficult. And lack of sleep often makes pain worse.  But how exactly does poor sleep cause more pain?

For the first time, scientists at the University of California, Berkeley, have identified neural glitches in the sleep-deprived brain that can intensify and prolong pain. Their findings, published in the Journal of Neuroscience, help explain the self-perpetuating cycles that contribute to pain and sleep loss.

“Anyone who has had persistent back pain knows that they don’t sleep well when they are in pain. They also know that when they don’t sleep well, it hurts more the next day,” said senior author Matthew Walker, PhD, a UC Berkeley professor of neuroscience and psychology.

"If poor sleep intensifies our sensitivity to pain, as this study demonstrates, then sleep must be placed much closer to the center of patient care, especially in hospital wards.”

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In a small study involving 25 healthy young adults, Walker and his colleagues found that nerves that process pain signals and activate the body’s pain relief hormones are disrupted by insufficient sleep. Study participants were given MRI brain scans twice – once after a good night’s sleep and once after a night of no sleep – and then subjected to a thermal pain test in the laboratory  

“We found some surprising changes. The sleep-deprived brain seems to let more pain in,” Walker said.

Brain imaging showed increased activity in the brain's somatosensory cortex, but there was less activity in the nucleus accumbens, a region of the brain's reward circuitry that increases dopamine levels. Dopamine is a neurotransmitter that’s been called the “feel-good hormone” because it is associated with feelings of euphoria and happiness.

Another key brain region found to slow down in the sleep-deprived brain was the insula, which evaluates pain signals and prepares the body to respond.

"This is a critical neural system that assesses and categorizes the pain signals and allows the body's own natural painkillers to come to the rescue," said Adam Krause, lead author of the study and a doctoral student in Walker's Center for Human Sleep Science lab at UC Berkeley.

To further test the sleep-pain connection, researchers surveyed more than 230 adults of all ages nationwide. Respondents were asked to report their nightly hours of sleep, as well as their day-to-day pain levels. The results showed that even minor shifts in sleep patterns were correlated with changes in pain sensitivity.

"The results clearly show that even very subtle changes in nightly sleep -- reductions that many of us think little of in terms of consequences -- have a clear impact on your next-day pain burden," Krause said.

"The optimistic takeaway here is that sleep is a natural analgesic that can help manage and lower pain," said Walker. "Yet ironically, one environment where people are in the most pain is the worst place for sleep -- the noisy hospital ward."

Walker's goal is to work with hospitals to create more sleep-friendly patient facilities.

"Our findings suggest that patient care would be markedly improved, and hospital beds cleared sooner, if uninterrupted sleep were embraced as an integral component of healthcare management," he said.

Several previous studies have found that getting a good night’s sleep helps reduce sensitivity to pain. Researchers in Norway measured pain sensitivity in more than 10,000 adults and found a strong link between pain and insomnia.

Another study in Norway found that women who have trouble sleeping are at greater risk of developing fibromyalgia – although it’s not clear if there’s a cause and effect relationship between the two symptoms.

Memories, Medications and Hospital Horrors

By Tom Parker, Guest Columnist

Some things you never forget. Your mother’s love, your favorite teacher, your first home run (oh, that’s right, I’m 61 and that still hasn’t happened yet), your first date, your first kiss and your wedding.

Christmas to the Parker family is also memorable for many reasons. My delightful wife and I have always sought to make Christmas a precious time for our family. We listen to Christmas music off and on throughout the year, but nonstop in the fall and winter. Bing Crosby and Karen Carpenter mellifluously bless our home with the glorious sounds of Christmastime.

So why do I not remember a season of joy that just ended a month ago?

For several weeks, I had been experiencing pain and an inability to fully empty my bladder. I have quite a few health problems, so I just chalked this up as just another one and pretty much ignored it as it continued to get progressively worse.

My wife and son were on a long trip to take my youngest daughter back to college. I was home alone and finally felt the need to call my doctor about the urinary retention. My doctor’s sagacious nurse urged me to immediately go to the ER, so I called for an ambulance.

I was in St. Peter’s Hospital in Albany for almost a week while an interminable number of tests were conducted to determine what was wrong. I was not allowed any of my normal medications, pain or otherwise, or food or liquids while the initial tests were conducted. Nothing whatsoever passed my lips.

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TOM PARKER

When my normal medication regimen finally resumed, I found out very quickly that I had to specifically request an oxycodone tablet when meds were dispensed or I wouldn’t get one.

Which leads me to very distinct memories of my roommate for the rest of my stay. A very brawny young man of 30 or so, a massively-muscled professional bodybuilder, was wheeled into the room and into the next bed. He was just out of elective bilateral double knee replacement surgery. Forgive me for listening as his mother and wife conversed waiting for him to come out of anesthesia.

PNN readers are all too acutely aware of how pain medications are no longer properly given for serious conditions -- which would seemingly include bilateral double knee replacement. As my compatriot emerged from anesthesia, it was very audibly obvious that he was quite understandably in unimaginable agony. Multiple nurses and techs rushed in and out, and at one point a resident was summoned as the young man was having difficulty breathing.

There was serious conversation about rushing him back into surgery when I heard a loud thump. My roommate had hit his head against the headboard, knocking himself out. His relatives argued with the nurses and resident about what pain medicines should be administered during his recovery.

We live in an ungodly, strange and insidiously cruel perverse world!  When medical professionals seriously consider Tramadol as the most viable and appropriate medicine at such a time, we have reached a new low standard of medical barbarity in these United States of America.

Paging Dr. Sessions, paging Dr. Sessions….

Yes, Tramadol is a somewhat effective pain reliever for some people. But for an operation as critically complex as bilateral double knee replacement surgery?   It never was effective for me and it engendered extreme vomiting for several days.

The agonized screams of that young man over three days still haunt my sleep today -- hopefully, not again tonight.

All of us are familiar with the 1 to 10 pain scale and how it often seems wholly inadequate for describing the pain that many of us feel every day. When the young fellow awoke from his self-induced head to the headboard knockout, he was asked what his pain level was at that moment. Three numbers unmistakably rang out, loud, clear and true: “555! What the blank do you think?”

His anguish was finally lessened by multiple doses of Dilaudid, both orally and intravenously. He was also administered Celebrex for inflammation, and oxycodone. I was a very personally-interested witness to this for several days.

He and I left the hospital at almost the same time, me to go home with my beloved, and he to a rehabilitation facility nearby. His last pain attestation before leaving was “10 or 12.” I was utterly appalled to hear him say that “I will do it all over again” if he were unable to resume his bodybuilding career after rehabilitation.

Well, I have had my follow-up visit with my GP now. He renewed my oxycodone prescription without even asking me about it. For that, I am eternally grateful to God and to my kindhearted physician. He explained to me that he was very glad that I had listened to his nurse’s urging to go to the ER.

I asked him, “Why are my memories of Christmas just a month ago so very foggy?”

It was then my physician made it very clear to me, for the first time, that I had almost died from blood poisoning and kidney failure.

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Tom Parker was born in beautiful Charleston, South Carolina. He currently lives in the Albany region of frozen upstate New York with his wonderful Vermont wife of 30 years, Kelly Sue. They have four adult children. Tom has multiple spine problems, including severe cervical spinal stenosis, osteoarthritis, and was born with just one kidney.

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.

How Government Shutdowns Worsen the Opioid Crisis

By Lynn Webster, MD, Guest Columnist

On October 26, 2017— a little bit more than a year ago — President Donald Trump declared that the opioid crisis was a national Public Health Emergency. Most Americans seemed to back his initiative to stop opioid abuse, and to reduce drug supply and demand.

However, it seems the recent 35-day government shutdown and Trump's desire to build a border wall have been at cross-purposes with his concern about addressing the opioid crisis.

Two key aspects of Trump’s opioid plan were prevention and treatment of opioid use disorder. Prevention, in part, means reducing the supply. However, everything in the supply is not equally problematic.

Opioids fall into two major categories: those that are prescribed and those that are smuggled into the United States. The number of overdoses associated with prescription opioids has remained essentially unchanged since 2011, while the number of opioid overdoses due to illicit fentanyl and other synthetic opioids surged from 3,000 in 2013 to more than 29,000 in 2017. Most of these drugs originate in China.

One of Trump's major arguments for building a wall is that most drugs that kill Americans are coming over the southern border from Mexico. However, that conflicts with the final report of his opioid commission, which found that "we are losing this fight predominately through China."

Mexican cartels do smuggle illicit opioids across the southern border in passenger vehicles and tractor trailers, often at legal points of entry. Heroin and fentanyl are also smuggled into the U.S. by sea and air or through the mail. A physical barrier doesn’t block any of these types of entry.

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The U.S. Food and Drug Administration (FDA) is tasked with inspecting mail to prevent drug smuggling. Before the government shutdown, FDA Commissioner Scott Gottlieb was calling for more postal inspectors to intercept shipments of opioids. He wanted the government to be able to inspect 100,000 suspicious packages per year, but that would have required double the number of personnel that he had.

Government shutdowns handicap those efforts because it is difficult to hire during shutdowns. It can be challenging just to retain the employees you already have.

The Department of Homeland Security works with the U.S. Coast Guard and the U.S. Customs and Border Protection to patrol the South Pacific Ocean and the Caribbean Sea to stop drug smuggling. These efforts may have been impeded during the shutdown, because some of these "essential" employees had to decide whether to work without pay or call in sick. We can assume that some of them chose the latter course of action. Some government employees may be looking for other jobs because they want a reliable paycheck.

Ironically, due to increased scrutiny at the border, drug smugglers have gotten more creative, increasing their use of tunnels, boats, air and even catapults. These efforts may have been more successful due to the lack of personnel guarding trouble spots because of the shutdown.

Addiction Treatment Impacted

Government shutdowns increase the likelihood that opioids could find their way past our borders. And our ability to treat people with opioid addiction may also be compromised.

Providing treatment for addiction was the other important part of Trump's plan for addressing the opioid crisis. An estimated 2.1 million people had an opioid use disorder in 2016, yet only about 20% had access to treatment. One of the reasons so few people are treated is that not enough clinicians are trained and certified to treat opioid addiction. The president's initiative requires increasing the number of clinicians certified to treat addiction.

Buprenorphine (Subxone) is one of the tools physicians use to treat opioid use disorder. Doctors require special training and certification to prescribe the drug, as well as a waiver from the Drug Enforcement Agency. During the government shutdown, the DEA was still able to review doctors’ applications, but there were about 30% fewer certifications than there were before the shutdown. It is unclear if that was due to the shutdown or not.

Regardless of whether there will be a physical wall on our border with Mexico, we can see the potential damage that the recent government shutdown can have on curbing the opioid crisis. Congress will now discuss the merits of various options to secure the border, and President Trump is threatening another shutdown if a border wall isn’t funded.

But one thing we should take away from the recent experience is that there isn't much point in saving ourselves from illegal immigrants if we can't protect ourselves from the dangers posed by a government shutdown.

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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. Webster is the author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.”

You can find him 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.

A History Lesson of the War on Drugs

By Iris Erlingsdottir, Guest Columnist

One hundred years ago this month, the 18th Amendment to the U.S. Constitution was ratified, prohibiting the production, transport and sale of "intoxicating liquors.” It cleared the way for the Volstead Act, which declared that liquor, wine and beer all qualified as intoxicating liquors.

Prohibition – the first War on Drugs -- was on.

The U.S. government has never been above abusing its citizens in the name of fighting drug wars. Then, like now, government efforts to legislate the human condition were a losing, deadly battle. In today’s war against opioid addiction, it is patients on the receiving end. A century ago it was drinkers.

Alcohol deaths only increased during Prohibition, as Deborah Blum recounts in her 2010 book, “The Poisoner’s Handbook.”

Policymakers believed poisoning the alcohol supply was an acceptable way to stop people from drinking. Methanol was added to industrial alcohol to make it unfit for human consumption, but bootleggers found ways to distill the poisoned alcohol to make it drinkable.

The government responded by adding even more toxic chemicals, like gasoline and kerosene. And bootleggers kept stealing the increasingly dangerous alcohol and turning it into liquor.

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At the start of Prohibition, New York City’s Bellevue Hospital treated about twelve annual cases of moonshine and wood alcohol poisoning. About a fourth of those were fatal. By 1926, the hospital treated 716 people for blindness and paralysis due to poisoned alcohol. The holiday season that year was especially deadly. On Christmas Day alone, 60 people were treated at Bellevue for alcohol poisoning and eight died from it. By New Year’s Day 1927, 41 people were dead.

Prohibition-era statistics are notoriously unreliable, but according to some estimates over 10,000 Americans died during Prohibition from the effects of drinking poisoned liquor, courtesy of both government and organized crime chemists. Many more were blinded. Prohibition’s attempt to foster temperance instead fostered intemperance, along with violence and crime. The solution the government had concocted to address alcohol abuse had made the problem worse.

Act of Betrayal

“There is no Prohibition,” New York City medical examiner Charles Norris said in an angry report about the alcohol deaths. “All the people who drank before Prohibition are drinking now — provided they’re still alive.”

Norris and his staff considered the government’s deliberate poisoning of alcohol an “act of betrayal.” They weren’t accustomed to having their national government adopt a policy known to kill people.

Policymakers in the 21st century have few such qualms about the opioid crisis. Nor does the media, which continues to parrot the government’s blatantly misleading propaganda, blaming illicit fentanyl and heroin deaths on prescription opioids.  Just as thousands died from alcohol poisoning during Prohibition, opioid hysteria has had horrible consequences for millions of patients doomed to suffer torturous pain because of irresponsible journalism and the policy blunders it enables.

Many of the nation’s largest Prohibition-era newspapers, however, didn’t hesitate to condemn a government policy “gone haywire.”

“Prohibition in this area is a complete failure,” the New York Herald Tribune’s editorial page declared, “enforcement a travesty, the public a victim of poisonous liquor.”  The Evening World said no administration had been more successful in “undermining the health of its own people,” while The St. Paul Pioneer Press called the government an “accessory to murder.”

Perhaps the Chicago Tribune stated it best: “It is only in the curious fanaticism of Prohibition that any means, however barbarous, are considered justified.”

It’s a sentiment that applies just as aptly to today’s epidemic of opioid hysteria.

Íris Erlingsdóttir is an Icelandic journalist and writer who lives in Minnesota. Iris has a rare, untreatable arthritic condition that causes severe pain and progressive destruction of the joints. She became an advocate for pain patients’ rights after being denied continued opioid pain medication.

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.

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Spinal Fusions Ineffective for Osteoporosis Patients

By Pat Anson, PNN Editor

There is little evidence that two surgical procedures commonly used to treat spinal fractures caused by osteoporosis reduce pain for patients better than pharmaceutical drugs, according to a new report by an international task force of bone health experts published in the Journal of Bone and Mineral Research..

More than 10 million Americans suffer from osteoporosis, a loss of calcium and bone density that worsens over time and significantly raises the risk of bone fractures, especially among the elderly. About 750,000 spinal fractures occur each year in the United States alone.

The task force looked at two types of spinal fusions: vertebroplasty, where medical grade cement is injected into the broken vertebrae to fuse bone fragments together; and balloon kyphoplasty, where a balloon is inserted into the compressed area of the spine to lift it and allow the cement to be inserted. Metal plates, screws and rods can also be used in spinal fusions, but were not the focus of the study.

The researchers found little to no evidence that vertebroplasty or kyphoplasty relieve pain effectively. In five clinical studies, vertebroplasty provided no significant benefit in pain control over placebo or sham procedures. There were no placebo-controlled trials for balloon kyphoplasty, leaving doctors to rely on anecdotal, low-quality evidence.

"The message for doctors and their patients suffering from painful spinal fractures is that procedures to stabilize spinal fractures should not be a first choice for treatment," said lead author Peter Ebeling, MD, Head of the Department of Medicine in the School of Clinical Sciences at Monash University in Australia.

"While patients who had these surgeries may have had a short-term reduction in pain, we found that there was no significant benefit over the long-term in improving pain, back-related disability, and quality of life when compared with those who did not have the procedures."

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The task force report comes as spine surgeons increasingly market vertebroplasty and kyphoplasty as “minimally invasive" procedures that offer immediate relief from back pain without the risks of opioid medication. But there are still risks of infection, cement leakage and complications associated with elderly patients undergoing anesthesia.

Some 300,000 Medicare patients underwent vertebral augmentation between 2006-2014, with most getting the more expensive balloon kyphoplasty. The procedures have become so common they are recognized as a standard of care. The video below calls them "the most effective pain relieving treatments for elderly patients.”

"These procedures are not a magic bullet," says Bart Clarke, MD, President of the American Society for Bone and Mineral Health and a Professor of Medicine at the Mayo Clinic. “Until now, doctors have been left to sift through the data on their own to determine whether these procedures can benefit their patients. This report coalesces all that information concisely and provides recommendations to guide them."

Clarke said Mayo Clinic doctors do not typically perform vertebral augmentation procedures unless a patient's pain is unmanageable for more than 4-6 weeks. "We've seen that with analgesics and other pain relief, our patients often get better within about 6 weeks," he said.

The task force also focused on the need for osteoporosis prevention. About 25% of older men and women who have a hip fracture will have a second fracture within one year, as will around 20% of older patients who have a spinal fracture. Breaking a bone in your spine or hip may be so traumatic – especially for the elderly -- that it often leads to disability and chronic widespread body pain.

Recent studies have shown that many patients at high risk of fractures are not being diagnosed or treated for osteoporosis, even though hormones and bisphosphonate drugs can help strengthen their bones. Bisphosphonates such as Fosamax have been found to be effective at slowing the loss of bone mass and reducing fractures, but concerns about side effects made some patients reluctant to take bisphosphonates and doctors less likely to prescribe them.  

"Overall, prevention is critical. and we need to get these high-risk patients on anti-osteoporosis drugs that have proven to reduce future fractures by as much as 70 percent," Clarke said.

The Marijuana Ad You Won’t See During the Super Bowl

By Pat Anson, PNN Editor

The hype over Super Bowl LIII between the Los Angeles Rams and New England Patriots took a back seat this week to a debate over the benefits of medical marijuana.

The February 3 game is being broadcast by CBS, which rejected a 30-second Super Bowl ad by Acreage Holdings -- the cannabis company that recently hired former House speaker John Boehner as a spokesman. Along with the other broadcast networks, CBS currently does not accept any cannabis related advertising.

The Acreage ad features 3 cannabis users -- a boy who suffers from epilepsy, a man who took opioid medication for 15 years for back pain, and a military veteran who suffers from phantom limb pain after losing a leg in the service. The ad doesn’t promote Acreage products, but urges viewers to call their congressional representatives and advocate for medical marijuana.

“We’re disappointed by the news but somewhat unsurprised,” Acreage President George Allen told CNN Business. “Still, we developed the ad in the spirit of a public service announcement. We feel it’s our responsibility to advocate on behalf of our patients.”

The chief marketing officer for Acreage was less diplomatic.

“You will see countless ads (during the Super Bowl) for beer and erectile dysfunction medications but our ad with an educational goal to help people who are suffering is rejected. That is the irony we are looking to highlight,” Harris Damashek told the Green Entrepreneur.

A 30-second ad during the Super Bowl would have cost Acreage over $5 million, but the company is getting a lot of free publicity over the controversy.  A 60-second version of the ad was posted on YouTube.

Medical marijuana is legal in 33 states and Washington DC, but remains illegal under federal law. Although cannabis is a banned substance in the NFL, many current and former players use it for pain relief.

“When you compare it to what the alternative is in their training rooms; pills, pills, pills, that are being put into these guys’ hands and turning them into addicts,” former NFL player Nate Jackson told PNN. “I was never big on those pills. I medicated with marijuana and it helped me and I think it helped save my brain.”

Although the NFL has a reputation as a league that closely monitors and disciplines players for illegal drug use,  Jackson estimates over half its players currently use marijuana to relieve pain and stress after games.

Doctors Call Probe of Opioid Deaths a ‘Witch Hunt’

By Cheryl Clark, Kaiser Health News

The Medical Board of California has launched investigations into doctors who prescribed opioids to patients who, perhaps months or years later, fatally overdosed.

The effort, dubbed “the Death Certificate Project,” has sparked a conflict with physicians in California and beyond, in part because the doctors being investigated did not necessarily write the prescriptions leading to a death. The project is one of a kind nationally, although a much more limited program is operated by North Carolina’s board.

So far, the board has launched investigations into the practices of about 450 physicians and referred the names of 72 nurse practitioners, physician assistants and osteopathic physicians to their respective licensing boards.

To date, the regulators have formally accused at least 23 doctors of negligent prescribing, and more accusations are expected. Some of the accusations, like one 63-page document filed against Dr. Frank Gilman, a San Diego internist, detail hundreds of prescriptions for one patient over four years, most of them by him. Gilman did not respond to a request for comment.

The project, first reported by MedPage Today, has struck a nerve among medical associations. Dr. Barbara McAneny, the American Medical Association president and an Albuquerque, N.M., oncologist whose cancer patients sometimes need treatment for acute pain, called the project “terrifying.” She said “it will only discourage doctors from taking care of patients with pain.”

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Using terms such as “witch hunt” and “inquisition,” many doctors said the project is leading them or their peers to refuse patients’ requests for painkiller prescriptions — no matter how well documented the need — out of fear their practices will come under disciplinary review.

The influential California Health Care Foundation also has pushed back against the project, saying it could harm patients.

Unusually aggressive for the board, the program is a reaction to the by now well-known phenomenon of physicians overprescribing opioids. Nationally, a host of policy changes and educational efforts have driven down the rate of opioid prescriptions in recent years.

The goal of California’s program, quietly launched four years ago, is not necessarily to link a doctor’s specific prescription to a specific patient’s death — although many of the cases do — but to find doctors whose patterns of prescribing are so dangerous they may lead to patients’ ultimately fatal addictions.

Sometimes a doctor was earmarked for investigation even though the cause of death included multiple drugs prescribed by many physicians, or suicide by overdose, board documents indicate.

Kimberly Kirchmeyer, executive director of the Medical Board of California, defended the project. She said the effort has found patterns of “gross negligence,” incompetence and excessive prescribing.

“I understand their frustrations,” she said of the complaining doctors, “but we do have to continue our role with consumer protection.”

She noted that part of the point of the project is to educate doctors and, through probation requirements, change the behavior of those who prescribe excessively.

“That’s education that could potentially save patients in the future,” said Kirchmeyer, whose agency licenses some 141,000 doctors.

Some consumer groups consider the board’s bold effort to find overprescribing doctors not aggressive enough.

“It’s long overdue,” said Carmen Balber, executive director of the nonprofit Consumer Watchdog. The board should investigate opioid-related deaths that occurred more recently, she said: “They need to get their act together and speed things up.”

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The agency thus far has looked at deaths only in 2012 and 2013 in which opioids were confirmed as a cause or contributing cause. It matched the names of the dead with the prescription drugs they filled, which are listed in the state’s prescription database. The database also shows the names of the doctors who prescribed to them. Physician experts reviewed those doctors’ prescribing history and selected those who appeared to prescribe drugs heavily.

Some doctors said they were especially angered that the letters they received concerned prescriptions they wrote as long as nine years ago.

McAneny, of the AMA, noted that prescribing practices now deemed unacceptable came out of public policies years ago that “compelled doctors to treat pain more aggressively for the comfort of our patients.” Also, payers have measured quality of care by whether their patients answered surveys about whether their pain was well-controlled.

“We’re [already] doing a lot of education to undo the damage” from those policies, she said.

Similarly, Dr. David Aizuss, a Los Angeles ophthalmologist who is president of the California Medical Association, said state and federal guidelines that took effect in 2014 and 2016 impose much more stringent prescribing precautions than “what was going on six or seven years ago.”

Many insurance plans and pharmacies in recent years have restricted dosages and durations of certain painkillers a physician may prescribe at one time.

Afraid to Prescribe

The crackdown on doctors has created fear, said Dr. Robert Wailes, a pain medicine specialist in Encinitas and chair of the California Medical Association’s Board of Trustees.

“What we’re finding is that more and more primary care doctors are afraid to prescribe and more of those patients are showing up on our doorsteps,” he said.

Officially, the CMA stops short of saying the medical board should stop the project, perhaps to avoid any perception that the association condones overprescribing. But it has asked the board to hire an independent reviewer to assess the criteria the board is using to decide which physicians to investigate, and whether physicians in certain specialties or regions of the state are being targeted more than others.

Dr. Ako Jacintho, a San Francisco addiction medicine specialist, was notified by the board that he was in trouble over a year ago. A patient for whom he had prescribed methadone fatally overdosed in 2012. The letter said “a complaint” had been filed against him, and asked him to respond to the allegations or, if he delayed, face a citation or fine of $1,000 per day. (The medical board can file its own complaints against a doctor.)

The letter said the patient had died of “acute combined methadone and diphenhydramine intoxication.” Jacintho had refilled the patient’s prescription for methadone the day before but said a 10-milligram pill was not a toxic dose. And he said he never prescribed diphenhydramine, the antihistamine sold as Benadryl.

“The only way he would have died was if he had not taken it as directed, or had mixed it with a medication that was not prescribed,” Jacintho said.

As of Dec. 21, Jacintho was still waiting to hear if he would face a formal accusation.

Last year, the board rewrote those letters in a less accusatory tone — describing the “review” as routine — although it still threatens doctors with $1,000 fines.

In a much smaller subset of cases, it finds problems that result in formal accusations that can result in discipline, such as public reprimands or restrictions on a physician’s ability to practice.

You can’t even begin to understand how disrupting and upsetting this is. It’s not just a threat on your license; it’s a threat that you’ve not been a good physician.
— Dr. Paul Speckart

Despite its designation as a “Death Certificate Project,” the California effort has not focused only on doctors whose patients died. In an unknown number of overdose cases, the board has sent letters to living patients asking them to authorize their doctors to relinquish their medical records to the board, adding that those documents would otherwise be subpoenaed.

Dr. Paul Speckart, a San Diego internist, said three of his patients last year received board letters that seemed to question his quality of care when all he did was try to relieve their well-documented pain. The board has not filed any accusations against him.

“You can’t even begin to understand how disrupting and upsetting this is,” Speckart said. “It’s not just a threat on your license; it’s a threat that you’ve not been a good physician.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.

 

FDA Pushing for Over-The-Counter Sales of Naloxone

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has launched an “unprecedented” effort to support over-the-counter sales of naloxone, an overdose recovery drug credited with saving thousands of lives. The FDA has developed new drug labeling — at taxpayer expense — to encourage drug makers to start selling naloxone without a prescription.

“This is the first time the FDA has proactively developed and tested a DFL (drug facts label) for a drug to support development of an OTC product. We proactively designed, tested and validated the key labeling requirements necessary to approve an OTC version of naloxone and make it available to patients,” FDA commissioner Scott Gottlieb, MD, said in a statement.

“I personally urge companies to take notice of this pathway that the FDA has opened for them and come to the Agency with applications as soon as possible.”

FDA proposed label for evzio

FDA proposed label for evzio

Curiously, one of the labels the FDA developed would support sales of Evzio, a controversial naloxone auto-injector that sells for about $3,700.

A recent U.S. Senate report accused Kaleo – the company that makes Evzio – of inflating its price by 600% to “capitalize on the opportunity” of a “well established public health crisis.” The report estimates Medicare and Medicaid paid over $142 million in excess costs to Kaleo for its Evzio injectors.

Kaleo has since announced plans for a generic version of Evzio to be available in mid-2019 at a reduced price of $178.

The FDA has also developed an OTC label for Narcan, a naloxone nasal spray that sells for about $135.

Last month, federal health officials called naloxone an “essential element” of government efforts to reduce deaths from opioid overdoses, and urged doctors to co-prescribe naloxone to pain patients talking relatively modest doses of 50 morphine milligram equivalents (MME) or more per day.

The drumbeat for naloxone comes at a time when sales are already booming. According to the healthcare data firm IQVIA, naloxone sales grew from $21 million in 2011 to over $274 million in 2016, and are projected to reach $500 million by 2020. Many of these purchases are made through Medicare or Medicaid, or government funded grants that supply naloxone at no cost to first responders, hospitals and addiction treatment clinics. 

According to one estimate by the CDC, naloxone reversed over 26,000 opioid overdoses from 1996 to 2014, and advocates say the drug has likely prevented thousands of deaths since then.

Earlier this month, naloxone was credited with saving a dozen lives at a suspected fentanyl mass overdose that left one man dead in Chico, California.

“Without that, I’m convinced that we would have had certainly four or five, if not more, additional fatalities,” Chico Police Chief Michael O’Brien told The Los Angeles Times. “There’s no doubt it saved lives.”

Is Naloxone Increasing Opioid Abuse?

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There’s no doubt naloxone saves lives, but some researchers say the drug has had little effect on the opioid epidemic and may in fact be making it worse.

In a study recently published by SSRN, an open access online journal, two economics professors said naloxone may raise the risk of an overdose by providing a “safety net” to opioid abusers -- in effect giving them a second chance to abuse more drugs. In an anlaysis of Google search results, they found anecdotal evidence that drug crimes and overdoses increased in states where there was easy access to naloxone.

“Expanding naloxone access increases opioid abuse and opioid-related crime, and does not reduce opioid-related mortality. In fact, in some areas, particularly the Midwest, expanding naloxone access has increased opioid-related mortality. Opioid-related mortality also appears to have increased in the South and most of the Northeast as a result of expanding naloxone access,” wrote Jennifer Doleac, PhD, Texas A&M University, and co-author Anita Mukherjee, PhD, University of Wisconsin.

“Our results show that broad naloxone access may be limited in its ability to reduce the epidemic’s death toll because not only does it not address the root causes of addiction, but it may exacerbate them.”

Doleac and Mukherjee say naloxone may give drug abusers a false sense of security, encouraging them to seek “a higher high” with more dangerous drugs like illicit fentanyl. The researchers said public health officials should prepare for these unintended consequences by offering addiction treatment along with naloxone.

Government-supported efforts to increase naloxone sales are not confined to the federal government. As PNN has reported, a new state law in California requires doctors to “offer” naloxone prescriptions to pain patients deemed at high risk of an opioid overdose. Nothing in the law requires patients to obtain naloxone, yet some pain sufferers say they are being “blackmailed” by pharmacists who refuse to fill their opioid scripts unless naloxone is also purchased. Patients around the country report similar experiences.   

Study Finds Naltrexone Has No Serious Side Effects

By Pat Anson, PNN Editor

A generic drug increasingly used off-label to treat fibromyalgia and other chronic pain conditions is safe to use and more clinical studies are needed on its potential uses, according to British researchers.

Naltrexone is primarily used to treat alcoholism and opioid addiction, but many patients have discovered that low doses of naltrexone (LDN) are effective in relieving pain and other symptoms.

Many doctors won’t prescribe naltrexone, often citing liver toxicity as a reason. But when researchers at The University of Manchester reviewed 89 placebo-controlled studies of naltrexone involving over 11,000 patients, they found no evidence of any serious side effects.

"Though naltrexone is licensed for the treatment of alcohol addiction, it remains underutilized,” says lead author Monica Bolton, PhD, who reported her findings in the journal BMC Medicine. "And that has devastating consequences for individuals, health and social services in the UK and around the world.

"It is cost effective and could reduce deaths."

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“Our review also shows that fears over side-effects are unfounded," said co-author Alex Hodkinson, Phd. "Like all drugs for alcohol addiction, the chaotic nature of being an addict means this drug is simply not prescribed as much as it should be,”

Naltrexone does cause minor side effects in some patients, such as nausea and dizziness, and because it is an opioid antagonist the drug should not be taken with opioid medication.

The fact that naltrexone is generic and inexpensive is one reason the drug is not more widely prescribed. There is little incentive for pharmaceutical companies to market naltrexone or to conduct expensive clinical trials to prove its effectiveness in treating pain.

"As it is safe, cheap and long out of patent, naltrexone would seem an excellent candidate for repurposing for a whole range of conditions,” says Bolton. "That is why it is imperative to find ways to fund clinical trials to test if it might one day be possible to license it.

"The problem is, it is extremely difficult to repurpose existing drugs - and naltrexone is just one example of many wasted opportunities to treat people and save the NHS money."

Of the 89 naltrexone trials included in the Manchester University study, only 3 dealt with chronic pain conditions.

Anecdotal evidence suggests that at very low doses of 5 mg or less, naltrexone may be able to treat a range of immune-modulated conditions including Crohn's disease, HIV, multiple sclerosis, fibromyalgia and Chronic Fatigue Syndrome (ME/CFS).

In a PNN guest column, Marelle Reid shared her experience using LDN to treat Interstitial Cystitis, while Janice Hollander said LDN “completely changed my life” when she started taking it for fibromyalgia.

Patients interested in trying LDN often encounter doctors who refuse to prescribe it. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website.

 

How Hollywood Romanticizes Addiction

By Lynn Webster, MD, Guest Columnist

We all love good storytelling. Cinema can mirror the real world or create a universe of its own. Movies can transport us to another world, beyond ordinary consciousness and emotions. They can be an agent for positive cultural change, or they can spread false narratives that are largely adopted by society. They can help solve our problems, or they can exacerbate them.

Two films that were released this past year -- "Ben Is Back" and "Beautiful Boy" -- are examples of movies that tell heart-wrenching stories, but fail to provide solutions. Instead, they reinforce unhelpful narratives that we glean from the news media and politicians.

Both are mainstream films with wide distribution and built-in audiences due to their talented casts and subject matter. They both tackle a theme that often works well for Hollywood: a child in life-threatening danger.

Each of these films focuses on the drama of a troubled young person who struggles with addiction. In both cases, the addiction creates a tragedy that feeds a romantic thread.

As a frequent film goer, I appreciate both movies' artistic delivery. However, their messages don’t necessarily reflect the realities of addiction in America. The movies perpetuate stereotypes and demonstrate that the color (pun intended) of addiction matters.

Through both of these films, Hollywood provides viewers with romantic views of addiction that are played out as love stories between parents and their children.

Josephine Livingstone, culture staff writer at The New Republic, recently wrote, “To make a movie about drugs almost guarantees that you romanticize them, because otherwise there would be no narrative at all -- just long nights, empty bank accounts, and a feeling like cold hunger.” 

COURTESY ROADSIDE ATTRACTIONS

COURTESY ROADSIDE ATTRACTIONS

"Ben is Back" stars Julie Roberts as the loving but frightened mother and Lucas Hedges (Ben) as a young man in an upper middle-class white family.

Ben is polite and likeable. His only apparent flaws are the behaviors associated with his addiction to opioids. The audience is primed to wonder how this could happen to an All-American boy. This young man and his family surely couldn't be responsible for the problem. 

The film poignantly blames a senile physician for initiating the boy’s addiction years earlier by prescribing Ben an opioid following a painful injury. The doctor is portrayed as the villain who pushes Ben toward a path of destruction. 

This works because the characters in "Ben Is Back" are of the same demographic and ethnicity as most of the viewers who would watch the movie. The film reinforces the clichés the audience has come to believe about addiction and its etiology. 

History tells us that poor inner-city minority members, by contrast, are usually blamed for their addictions. If the film starred a black or brown young man, the plot would have likely focused on the criminal activity and character flaws of the drug abuser. 

Julia Roberts told USA Today that she was able to relate to the problem of watching a family member suffer from addiction because, in real life, her older brother had suffered from the disease. However, Roberts acknowledges, "The position of the mother in this film is very different from a sister," reinforcing the parent/child love theme.  

The other film, "Beautiful Boy," is based on a true story. In contrast to "Ben Is Back," the movie is about a relationship between a father and his son. Steve Carell and Timothée Chalamet (Nic) play the father and son. As Rolling Stone says, "It’s the two leads who, thanks to their astonishing, ripped-from-the-guts performances, make this movie a standout." 

Nic has a great relationship with his father. The father introduces his son to marijuana, which the movie inaccurately suggests is the seed to Nic's eventual use of methamphetamine.  

The story is told from the father's point of view. The father blames himself because he buys into the myth that marijuana is a gateway drug. Unfortunately, many movie goers probably also inaccurately believe that using marijuana could lead to meth addiction. 

Meth is not an opioid. However, the story line is similar to that of "Ben Is Back." Nic is a good white kid from a loving home, but he, too, is caught in a web of addiction. 

While Nic's story is emotionally riveting, we know that he lives a privileged life. Like Ben, Nic is a sympathetic character.   

COURTESY AMAZON STUDIOS

COURTESY AMAZON STUDIOS

These two movies blame outside causes for addiction. The movies fail to explore the real motivators to using drugs. Both characters acknowledge, in a discreet and almost offhand way, that they use drugs to feel alive. This subtlety is a huge statement. It describes the reason for their drug use that most viewers probably miss. 

Why should these two movies matter so much to us?  

These films may be entertaining, but they fail to tell the true story of addiction. Addiction is not sentimental. It is a tragedy, regardless of color. There are no tidy endings in real life. Propagating misleading narratives about addiction has made it more difficult for people in pain to be treated. 

If Hollywood producers are going to make films about addiction that don’t feed false narratives, they will have to stop romanticizing addiction.  

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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. Webster is the author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.” You can find him 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.

Some California Pain Patients Forced to Buy Naloxone

By Pat Anson, PNN Editor

A new state law that mandates new prescription pads isn’t the only headache faced by doctors and pain patients in California.

Over a dozen bills passed by the state legislature and signed into law by former Gov. Jerry Brown are aimed at addressing the opioid crisis. One of them -- AB 2760 -- requires doctors to “offer” a prescription for naloxone to any patient deemed at high risk of an opioid overdose.  Naloxone (Narcan) rapidly reverses the effects of an opioid overdose and has been credited with saving thousands of lives.

The naloxone law does not require patients to fill the prescription, but some pain sufferers are being forced by pharmacists to buy naloxone if they want to get their opioid medications filled. For one patient, it was a choice between pain relief and putting food on the table.

“A medication I don't want, don't need, and didn't ask for, is being forced on me. As in holding my other medication hostage. And each dose of Narcan is $75 for the uninsured. Which I am, because my insurance company won't pay for it,” one reader wrote on PNN’s Facebook page.

“I had to go without groceries to purchase a medication I didn't want, need or ask for. Nine years of never ever breaking a rule, having any adverse effects EVER, and never failing all those ‘gotcha’ tests they inflict on pain patients. So now, in addition to being in pain, I'm hungry. This cannot be.”

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Another pain sufferer said she felt treated like a drug addict when a pharmacist forced her to buy Narcan, a nasal spray that contain naloxone.

“Blackmailed by Kaiser to pay $50 for Narcan before they would give me my pain meds. I am retired, disabled, and on fixed income,” wrote a woman who lives with severe arthritis. “I was an RN who worked holidays, weekends, nights, etc. Now this ‘greatest’ country treats me like some scum addict who shoots up illegal drugs.”

The requirement that doctors offer a naloxone prescription applies to so-called “high-risk” patients taking over 90 MME (morphine milligram equivalents) of opioids a day or those who are co-prescribed benzodiazepines, an anti-anxiety medication. Patients who have previously overdosed or have a history of substance abuse are also considered high risk.

But whether high-risk or low-risk, nothing in the law requires a patient to buy naloxone or empowers a pharmacist to withhold medications.

“The law does not make it mandatory for the patient to accept a prescription for naloxone or to fill it but only for the patient and physician to have a thoughtful conversation about whether it would be in the best interest of the patient,” Assemblyman Jim Wood, the bill’s sponsor, said in a statement to PNN.

The law does not make it mandatory for the patient to accept a prescription for naloxone or to fill it.
— CA Assemblyman Jim Wood

“We are beginning to hear circumstances where patients are being required to fill the naloxone prescription, and will investigate the circumstances where this is happening because that is not what the law states.”

Naloxone costs only pennies to make and syringes containing generic versions of the drug typically cost about $15 each. Branded and formulated versions such as Narcan are more expensive.

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Evzio, a kit that contains two auto-injectors of naloxone, retails for about $3,700 and its manufacturer has been accused of price gouging.  The company reportedly raised Evzio’s price by over 600% to “capitalize on the opportunity” of a “well established public health crisis.”

Whether it comes in a spray, injector or syringe, its impractical to expect anyone to give themselves a dose of naloxone.

“What the state and others fail to realize is many pain patients live alone. Even if one were to accidentally overdose and lose consciousness how are they supposed to administer the Narcan?” asks PNN columnist Rochelle Odell, who lives in California. “No one clearly thinks these grandiose ideas through.”

Law enforcement groups, pharmacists and the Medical Board of California supported passage of AB 2760, but the bill was opposed by the Academy of Family Physicians, American College of Emergency Physicians and the California Medical Association (CMA).

“Mandating that a specific medication be prescribed in a variety of situations, regardless of the individual patient characteristics, is inappropriate and places the government between a patient and his or her physician,” the CMA said.

Despite that warning, AB 2760 was passed unanimously by the state Assembly and Senate, signed by the governor, and became law on January 1st.

Prescription Pad Chaos

As PNN has reported, the law of unintended consequences also applies to AB 1753, which requires California doctors to use customized prescription pads for opioids that have uniquely serialized identification numbers.

The idea was to prevent counterfeiting and get more prescriptions filed electronically, but instead the early weeks of the law’s implementation have been marked by chaos. Many doctors were unaware of the new law or unable to get new prescription pads ordered before January 1st. As a result, pharmacists have refused to fill prescriptions written on old pads and patients have been sent away empty-handed.

“I just got my new prescription pads (Monday) at a cost of several hundred dollars, and the change is trivial,” Dr. Richard Buss, a family practice physician in Jackson, told the Sacramento Bee. “At the hospital here, I was next to a doctor who was trying to send a patient home after knee surgery, and the pharmacy wouldn’t honor his prescription because they were old forms.” 

Buss said this is the second year in a row that California doctors were not given proper notification of changes in their prescription pads. 

“They’re just changing prescription requirements, and then the doctors have to jump through the hoops suddenly, and I’m left with thousands of prescription blanks that are unusable, and that’s probably true for a lot of other doctors,” he said. 

Assemblyman Evan Low, who sponsored AB 1753, was unavailable to comment to PNN. In a January 7 letter to California’s Attorney General, Low blamed state regulators for the “unanticipated” confusion caused by his legislation. 

“I have been informed that numerous pharmacies have already turned away individuals holding prescriptions written on unserialized forms that are otherwise valid; in the face of possible discipline, dispensers are forced to decide between denying care to their patients and risking action against their license,” Low wrote. 

The California Medical Association is drafting new legislation to ensure a smoother transition to the new prescription pads, a process that usually takes weeks or months.

How to Check Out a Charity Before You Donate

By Stefanie Lee Berardi, Guest Columnist

Many of us have been following PNN’s reporting on the misuse of donated funds by the former CEO of the U.S. Pain Foundation. Paul Gileno allegedly misappropriated about $2 million for his own personal use from the non-profit from 2015 to 2017.

The acting CEO and chair of U.S. Pain’s board of directors has admitted that a lack of financial oversight enabled Gileno to commit his misdeeds. Nicole Hemmenway says the board has instituted “a robust system of checks and balances” to make sure it doesn’t happen again.

As the story continues to unfold, U.S. Pain has attempted to refocus the public’s view of this fraudulent activity by claiming that 2018 was “its most successful year of programs and services,” while also indicating that additional financial irregularities may be reported on its 2018 tax return.

Arguably, their claim of success does not comport with the facts and does not enumerate the numerous failings of the board and senior staff that enabled the fraud to continue for years. Until there is full disclosure of what happened and people are held accountable, the public cannot be sure that U.S. Pain’s resources are being utilized effectively going forward.

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Choosing to support a non-profit organization is an investment. And those of us who give our limited time and money to a charity must protect that investment by learning all that we can about what the organization does, what senior staff they employ, where they get their money and how they spend it.

It is not always easy to find reliable information about a non-profit, but if you know where to look, a short online search can give you a wealth of information. Here are some tips that donors and volunteers may want to explore.

Search Their Website

Consider an organization’s website as the front door to its operations and core mission. A disease-related organization’s mission, for example, might be to provide support for those affected, education about the disease, and research to find a cure.

An organization must be accountable and transparent to its investors. Their website should provide an annual report of its accomplishments from the previous year and goals for the next. You will need to review several annual reports to evaluate if the organization is making progress on the previous years’ goals.

Look at Their Tax Returns

Examine the organization’s tax returns to learn about how they operate, where they get their funding, and what proportion of their money is spent on programs that actually help people versus overhead costs like administration, salaries and fundraising.

There are a few exceptions, but most non-profit organizations’ tax returns are public information, meaning anyone can inspect them. When you compare two or three years of the organization’s tax returns, you can get a sense of the organization’s financial stability over time.

I find ProPublica to be the easiest place to find these documents. You can also search an IRS database to see if an organization’s tax-exempt status is in good standing. If a non-profit misses a tax return filing deadline, as was the case with U.S. Pain, that could be a sign of trouble.

Identify Their Funding Sources

In order for a non-profit to remain financially healthy and compliant with IRS regulations, it must seek funding from different types of revenue streams, such as grants and corporate or individual donations. For example, an organization may accept donations from pharmaceutical companies or charge membership dues or fees to attend their events.

Investors need to know where the organization gets its money. If the organization is growing and thriving, you will see a steady increase in the money they bring in (revenue); the money they spend (expenses) will remain proportional to their revenue; and their bottom line (net assets) will remain stable from year to year.

Learn Where They Are Spending Their Money

There are well-established benchmarks for how much of a non-profit’s budget should be spent on programs versus administration and fundraising. Organizations should be spending at least 75% of their revenue on programs that raise awareness or directly benefit a cause and less than 25% of their revenue on overhead.

As a reference, Charity Navigator publishes an annual report on CEO pay that finds mid-sized non-profits pay their CEO’s in the low $100,000’s. And the Better Business Bureau’s accountability standards indicate that fundraising expenses should not exceed 10 to 25 cents of every dollar raised.

As an investor, we want to see these figures as low as possible and to ensure they are aligned with organizations of similar size and type.

Engage with a Non-Profit at All Levels

If an organization is worthy of receiving your financial support, it should also be worthy of receiving your time and talent. Volunteering for the organization is an important way for you to increase the value of your investment. Most non-profits depend on volunteers to help them run programs, raise funds and promote awareness.

When you find the right organization, consider pledging a monthly, rather than a one-time annual donation. Large foundations that offer grants to non-profits want to see repeat donations because it is an indication of a healthy, growing organization that is capable of using their grant money effectively. Staying involved with an organization helps ensure your investment is used to its fullest potential.

There is simply too little time and money to waste on an organization that lacks oversight and is not using its resources effectively. Many of us have made donations to organizations simply because they asked and believed they were doing good things. In the future, we must raise that benchmark.

When nonprofit organizations solicit for financial support, they are in a position of public trust. That money is not theirs to misuse and they should be held accountable if they lose that trust.

Each of us has the responsibility to learn everything we can about an organization before we offer our time, talent and money. We must advocate for each other and contribute to the body of knowledge about the organizations that we support. 

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Stefanie Lee Berardi worked as an advancement and communications professional, grant writer and principal investigator of several multi-agency grant programs at Illinois State University. She has a graduate degree specializing in the management and administration of non-profit organizations.

Stefanie is an avid volunteer in her local community and has volunteered for organizations supporting individuals with Complex Regional Pain Syndrome, a disease she developed in 2008.

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.

Climbing Mountains Together

By Mia Maysack, PNN Columnist

Just about every time I'm in the bathtub, I contemplate slipping my head under water for a tad bit too long.  I do not consider myself suicidal, nor do I really want to die in the literal sense. But sometimes I reach a point when I'd do almost anything to kill this pain.   

Current situation: At least 30 cluster headache attacks thus far this week. Constant migraine going strong for about two weeks. Ongoing fibromyalgia flares. Working to pass kidney stones induced by stress and dehydration. Nausea, dizziness, fatigue and exhaustion have latched onto my soul like draining parasites. None of my go-to treatments have eased any of the discomfort.   

Despite my own battles, I consistently make myself available to others in the thick of their own private storms. The world needs more light and I can always use a distraction from my own body self-destructing. Win/win.  

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Recently I did what I could to talk a loved one off the ledge. This person is also unwell but in a very different way. Their infliction is not physical, but boils down to their own personal choices.  

You might imagine the frustration I feel when surrounded by others who could save themselves from drowning simply by standing up.

All the while, I've been standing strong for years but consistently get swept away by overwhelming undercurrents that are entirely out of my control. 

It can be difficult to encourage others to live when you're barely hanging onto a shred of hope for yourself. But I consider myself honored for the opportunity to try.  

I cannot keep track of how many times I've had to “die" in a figurative sense so that I could grieve the losses of countless aspirations, ideas, goals and dreams.  I've always been known as a positive person and that's most definitely who I am.  It is not an act, but people tend to think it’s easy for me and they couldn't be more wrong. 

It takes absolutely everything I have to lay my head down at night, knowing I'll awaken to the same demons I spent the previous day slaying. And that it'll likely remain this way, forever.  

My positivity began out of necessity and is a method of survival. Relentless pain every single day for 20 years straight is enough for anyone to question their sanity or possibly even lose it. As a matter of fact, we're currently mourning the medically assisted suicide of a fellow Pain Warrior, who endured similar pain for the same amount of time.   

I felt the need to write this so that others do not think they are crazy. Under our circumstances, it's understandable we might fantasize about no longer feeling this way. The mantras, positive quotes and clichés can only get us so far, and it can be downright devastating to not have adequate support, acknowledgment, validation or pain relief.  

I also had to write this because I want to convey that you are all the main reason why I still hold on. Knowing there's a community of others who truly get it, provides me with a purpose and reason to get myself out of bed in the morning.

It has become my mission to demonstrate that these mountains of misfortune aren't meant to be carried, but they can be climbed. They might even be moved if we all work together.   

No one can give us quality of life or the will to live outside of ourselves, but we can lean on one another during our deepest and darkest moments of despair. It's okay to have bad days, to be in a negative headspace, to question the purpose of all this, to feel angry, hurt or sad.  

As I envision the water calming my ailments and swirling its way down the drain, I think about the possibility of someone reading this at a time they needed it most. That thought gives me the strength I need. 

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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.

Experimental Stem Cell Therapy Reverses MS

By Steve Weakley

A small but promising study has shown that an experimental stem cell therapy can dramatically slow the progression of multiple sclerosis. Some MS patients treated with their own stem cells even experienced a reversal of their symptoms that has lasted for years.

MS is a chronic, incurable and progressive disease that attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain. The disease affects over 2 million people around the world.

An international team of researchers enrolled 110 patients in the study with relapsing-remitting MS, a version of the disease where symptoms appear for a few days or weeks, followed by periods of remission.

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Half of the patients were treated with standard MS medications as a control group, while the other half went through a four-step experimental procedure.

The experimental group was given chemotherapy to stimulate the production of hematopoietic stem cells that recharge the immune system. Those stem cells were then removed from the patients’ blood and frozen.  After that, a more powerful round of chemotherapy was used to wipe out the patients’ damaged immune systems, and the thawed stem cells were put back into their bodies by transfusion.

Over half of the 55 patients in the control group continued to see their disease progress, while only three patients got worse in the experimental stem cell group. The other 52 had fewer symptoms and a better quality of life. The findings were reported in the journal JAMA.

“It’s the best evidence comparing stem cell transplants to standard therapy,” Harry Atkins, MD, a stem cell scientist at Ottawa Hospital in Canada told Vox . “This is one of the first pieces of proof that, yes, patients who have aggressive MS do better after a transplant than with the standard therapy.”

“The stem cell therapy gets patients off lifelong treatments and gives them results that have never been seen before with this disease,” said lead author Richard Burt, MD, a stem cell researcher and physician at Northwestern University.

One of Burt’s patients who benefited from the stem cell transplant is 28-year old Amanda Loy, who told Vox that prior to treatment she needed a cane to walk and was unable to work.  Within a year of treatment her symptoms had disappeared.

“It sounds so dramatic, but (the treatment) gave me my life back,” said Loy, who now works as a full-time teacher, runs half marathons and plays soccer with her 10-year-old son. She no longer takes MS medication.

Researchers still don’t know if the stem cell therapy will work with other forms of MS or how long the benefits will last. But it’s the first treatment that has shown the potential to actually reverse the disease.

“I do think it’s going to change the natural history of MS,” says Burt. “When you use it in the right group of patients with MS, you get these really gratifying results.”

A recent study by Australian researchers found that another experimental stem cell therapy shows promise in treating patients with progressive multiple MS, the most difficult-to-treat form of the disease.

Scientists at the University of Queensland extracted immune cells from patients who had either primary or secondary progressive MS. The cells – known as T-cells – were then “trained” in a laboratory to target and kill cells infected with the Epstein Barr virus, which has long been associated with MS.

When the altered T-cells were injected back into the bloodstream of 10 patients, seven said their symptoms improved. They had more energy, improved concentration, slept better, and had improved vision and balance. There were no serious side effects.

National Safety Council's Misleading Report on Opioids

By Roger Chriss, PNN Columnist

This week the National Safety Council released a report claiming that “for the first time on record, your odds of dying from an accidental opioid overdose are greater than dying in a motor vehicle crash.”

Media outlets from The New York Times to NPR were quick to repeat that claim.

“The opioid crisis in the United States has become so grim that Americans are now likelier to die of an overdose than in a vehicle crash,” The Times reported.

This is incorrect. The average American is vastly more likely to die in a car crash than of an opioid overdose. The reason is simple: the typical American does not have any opioids to overdose on.

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Good practice in epidemiology and public health research is to look at the “population at risk.” This population represents those people who would be counted if they are affected by whatever risk is being studied.

The population at risk for opioid overdose consists of people exposed to opioids, intentionally or otherwise. Within this population are people with varying degrees of risk, from low-risk in the form of a single dose of opioid medication in a hospital to high-risk in the form of heroin injection.

By contrast, the population at risk for car crash death is people who are exposed to car rides, whether as drivers or passengers. Needless to say, this is a very broad population that includes most Americans.

These two populations are not the same. There is some overlap between the two, but that does not mean they can be lumped together for the purpose of a generalized conclusion. Instead, epidemiological investigations look at a target population, that is to say the group of people about which conclusions will be drawn.

Again, these are distinct populations. The target population for reducing car crash fatalities is not the same as the target population for reducing opioid overdose fatalities.

As a result, a general comparison between the odds of dying of an opioid overdose versus a car crash is not statistically meaningful. Moreover, such comparisons misconstrue risk management and may lead to poor allocation of resources.

For instance, in 2017 there were 2,008 fatal overdoses with Benadryl and 1,250 with tramadol, according to the CDC. But this does not mean that Benadryl is more dangerous than tramadol. Far more people use Benadryl than tramadol, and usually without a prescription or monitoring. Ranking one as inherently more dangerous than the other would not lead to good public health policy.

Further, the risk of opioid overdose rises when people use other substances like alcohol, benzodiazepines or cocaine. Similarly, the risk of fatal car crashes rises when driving under the influence or other risky driving behaviors are involved. Because most people do not do these things, they are at the low end of the range of risk in the population at risk.

State laws like California’s AB 2760 requiring naloxone co-prescribing may help reduce opioid overdoses, but only if they reach people at greater risk. And resources committed to people at low risk may be taking resources away from people at high risk.

So although the National Safety Council’s report may be technically accurate, it is flawed and misleading. Most people are much more likely to die in a car crash because they are exposed to that risk on a regular basis. Only a small number of people are more likely to die of an opioid overdose, and risk reduction strategies need to be directed to them.

The NSC is a nonprofit that promotes itself as a "data-driven organization," but this is not the first time it has provided misleading information about opioids.  As PNN has reported, an NSC memorial to opioid victims that toured the country last year overestimated the number of Americans who overdosed on prescription opioids by about 25 percent.

Good public health policy involves assessing the relative risks for the population at risk and adopting effective harm reduction policies. Sweeping statements that confuse a population at risk with the population at large can only lead to bad policies. And we’ve seen enough of those.  

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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.

California’s New Prescription Law Causing Chaos

By Jeffrey Grolig, MD, Guest Columnist

Like many other states, California has enacted a series of laws to more tightly regulate the prescribing of opioid medication.  One such law that took effect January 1 is AB 1753, which requires doctors to use new prescription pads for controlled substances that have uniquely serialized identification numbers. The idea is to prevent counterfeiting and to get more prescriptions filed electronically.

The serial numbers begin with three letters, followed by six numbers, followed by one letter, and end with five more numbers. There are 46-thousand trillion potentially different combinations of numbers and letters – making California’s prescription pads more complicated than the serial numbers on U.S. currency.

Only publishers who are fingerprinted, pass a security check, and approved by the Department of Justice (DOJ) are authorized to print these new pads.

What could possibly go wrong? A lot.

Shortly before Christmas, the California Medical Association (CMA) expressed concern that doctors would not be able to get the new prescription pads before the new year:

“Physicians were finally notified this week that the updated forms were available for purchase... with less than two weeks to go before the compliance date. The CMA is very concerned that this does not provide enough time for physicians to re-order forms... and could be a serious barrier to patients who must access necessary medications in a timely manner.”  

And a serious barrier it has become.  

Up to a million old prescriptions for controlled substances became technically invalid in California at the stroke of midnight on New Year’s Eve, potentially leaving hundreds of thousands of patients with medication delays and denials, including some who need emergency room treatment.  

On January 2, I was barraged with telephone call interruptions while I tried to see my patients. Dozens of messages were left by pharmacists stating that my prescriptions were invalid and that I needed to phone them immediately.

When I returned the calls, I was informed about the new law and told to order new scripts immediately as the old ones would not be honored. The pharmacists told me all I needed to do was write a note that I was aware of the new law and was ordering the new pads. Fortunately, in each case the pharmacist made an exception.

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But the following week, the problem worsened. A colleague told me he fielded some 40 telephone calls dealing with the new law and invalid scripts. Not all his patients were lucky. One woman, just discharged from abdominal surgery, went an entire weekend without pain medication as her pharmacist could not get through on the telephone to her surgeon. 

Then last Friday, a pharmacist telephoned me about a patient I had on methadone. “I cannot fill this script, because it is written on the old form,” she said. 

“But I wrote on the top that I was aware of the new law,” I replied.

“Yes, I noted that. However, my board has told me that I need your purchase order number, or else I cannot fill the prescription,” she answered.

I informed her I had not been given any information on which printers might be able to produce the new prescription pads with their complicated 15-character serial numbers. She provided me with a telephone number to the DOJ. I called and learned about a website which had recently posted the compliant printers. It was 5:00 p.m. Friday before the weekend, and many of the approved printers were located back east and had already closed.

I asked the pharmacist if an exception could be made, and she stated it could not. She required a valid purchase order number and I needed to scramble. I had patients waiting over an hour in the examination rooms while I telephoned printing companies on the west coast. Mostly I got recorded messages. I received website and fax information. But what I could not get was a purchase order number. They were all too busy to take an order over the telephone.   

I went back to seeing patients, my main priority. Then I stayed late, copied my DEA and medical license certificates and a voided prescription like they had requested, and I placed my order via fax. I still had no purchase order number. I called my methadone patient over the weekend and fortunately her methadone script had been honored. She would not go through withdrawal or end up at the ER.  

A public healthcare crisis emerged in California the first day of the new year due to this new law. Pharmacists who fill a prescription on an old pad risk losing their licenses and there is no grace period to allow doctors time to order the new script pads.   

The pharmacists have been told by the Board of Pharmacy “to exercise their best judgement in handling these situations” and to refuse to fill a prescription if they’re not comfortable with it. If they do fill one, they are required to telephone the prescriber and get their purchase order number for the new pads in every case. This represents hundreds of thousands of telephone calls between pharmacists and physicians. And millions of dollars in new prescription pad orders.   

Because of the new law, patients are being subjected to numerous delays and denials of pain medication.  And physicians and pharmacists are losing countless hours on the telephone.  One physician texted me:   

“This whole fiasco has been nothing short of a delusional nightmare, construed as improved patient safety, although California already requires at least two different types of security features that have worked flawlessly for many years.”  

Meanwhile, insurance companies are saving millions of dollars in unfilled prescriptions. Is the government really worried about mathematical-genius counterfeiters working feverishly in their basements to make fake Norco scripts? Or is the true reason because insurance companies no longer wish to fund the annual $500 billion price tag of chronic pain treatments?

Is the serial number law a sincere attempt to reign in prescription theft or is it yet another transparent effort to further limit pain patients' access to opioids?

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Jeffrey W. Grolig, MD, JD, is a board-certified specialist in Physical Medicine & Rehabilitation. He has taught at UC Davis Medical Center in both the departments of Family Practice and Physical Medicine & Rehabilitation. Dr. Grolig has formerly worked as a licensed attorney and has authored 6 books, including “The Physician Primer: Prescribe Like a Lawyer.

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.

Limiting Rx Opioids Is Making Opioid Epidemic Worse

By David Hanscom, MD, Guest Columnist

I am an orthopedic spine surgeon who specializes in complex problems in all areas of the spinal column.

Over the last five years, a significant percent of my practice has been addressing spine infections, most of them in patients addicted to intravenous drugs. Bacteria can enter the blood stream from a contaminated needle and lodge in the discs between the vertebrae, which have a limited blood supply. It’s an ideal environment for bacterial growth and it destroys the neighboring discs and vertebra. Often they weaken to the point where they break.

Corrective surgery entails draining the infection and then stabilizing the broken spine with a fusion. These operations are complex, expensive and risky. After surgery there is a minimum of six weeks of IV antibiotics.  Occasionally, a patient ends up paralyzed because the infection cuts off the blood supply to the spinal cord.

One typical case was that of middle-aged carpenter with low back pain, who had been able to work for years by taking a stable low dose of opioid medication. He needed to keep working, so when the local pain clinic shut down, he felt he had no other choice but to use IV heroin. His spine became infected and the infection spread deeply into his pelvis. I met him in the hospital when he was extremely ill, and it took three operations to drain and stabilize his spine.

My experience from this and other cases tells me the opioid epidemic is rapidly getting worse. In addition to the medical problems created from IV drug abuse, there were nearly 49,000 overdose deaths from opioids – both legal and illegal -- in 2017. Unfortunately, there doesn’t appear to be a viable solution in sight. In fact, current efforts to reduce opioid prescribing are exacerbating the problem. Although I agree with more careful prescribing practices, it isn’t the answer to the epidemic.

This CDC graphic tells why. As deaths from prescription opioids leveled off over the past several years, mortality from heroin and synthetic opioids like illicit fentanyl have spiked higher. Although the medical system is decreasing the supply of prescription opioids, it’s pushing people to these illicit sources.  

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Chronic Pain and Anxiety

Nearly 90 percent of patients on opioids have chronic pain, while the rest mostly suffer from acute pain. But the mental pain is a far greater problem than the physical pain. Any physical or mental threat causes your body to secrete stress hormones, such as cortisol, adrenaline and histamines to improve your chances of survival.

The sensation created by these chemicals is anxiety. Humans have a major problem when they can’t escape from negative thoughts. Anxiety triggers a sustained chemical assault that we will try almost anything to escape from. This unconscious and automatic survival response is over a million times stronger than the conscious brain.

Research has documented that when you are upset for any reason, your pain will increase. It isn’t psychological or “all in your head.” There’s a direct linkage between pain circuits and stress. You will experience an increased speed of nerve conduction from stress chemicals, causing your pain levels to increase.

Many Treatments Don’t Work

Another problem is that modern medicine isn’t providing viable solutions to chronic pain. A recent survey found that only about 1% of physicians enjoy and are comfortable treating chronic pain.

Modern medicine is only pretending to treat your pain. You go to the doctor trusting him or her to help you and you’re repeatedly disappointed. As your frustration grows, your stress hormones remain elevated and your pain physically worsens.

Even worse, many “mainstream” interventions such as surgery have been demonstrated to be ineffective and often cause harm, while effective treatments are not readily available because they are not covered by insurance. A significant percent of a medical system’s revenue is driven by these expensive and risky interventions.

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Instead of exploring ways to implement effective treatments for pain, the government and medical establishment are focusing their efforts on restricting access to pain medications -- with most of the focus being on the providers. Physicians are now afraid to prescribe long-term opioids, even though most of us have had patients thrive on a stable opioid regimen.

This is the worst step that could be taken because patients immediately experience increased anxiety, frustration and eventually anger when they are cutoff or have their doses reduced.

What can we do to solve the opioid epidemic?

First, solve chronic pain! Recent medical research has revealed possible solutions but mainstream medicine isn’t implementing them.

Second, recognize that what drives most people to use opioids is mental pain. Physical pain is often secondary.

Third, environmental factors, especially family dynamics may be exacerbating chronic pain. Allow physicians to take the time to listen to patients and focus on their real problems, rather than just randomly treat their symptoms.

Finally, since the problem is so pervasive, the answers must be widely available and implemented by anyone. 

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Dr. David Hanscom is a spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

In his book Back in ControlHanscom shares the latest developments in neuroscience research and his own personal history with pain.

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.