Help Us Get Our Lives Back

By Andrea Giles, Guest Columnist

I am a 49-year old disabled nurse living in Wyoming. Since 2010, I have been diagnosed with ankylosing spondylitis, phantom limb pain and severe osteoarthritis with multiple major joint deformities.  My remaining knee is now bone on bone, requiring me to use a wheelchair. 

I lost my right leg and half of my pelvis after a total hip replacement due to the osteoarthritis, after which I developed a severe MRSA bacterial infection that resulted in the total hip disarticulation. I’ve had horrible phantom limb pain since the amputation. I also had 2 failed spinal fusions, leaving me with chronic back pain and nerve damage. Since 2010, I have had a total of 52 surgeries.

From 2010 to 2016, I was treated with opioid medication by a pain management physician, with a stable, safe, effective and legal regimen. I followed all of the requirements, such as urine drug tests, pill counts, using the same pharmacy, etc.

Then, at an appointment in 2016, my physician told me that because of the CDC guidelines, he would no longer prescribe opioid medication to me. I was forced off my high dose (120MME) cold turkey. I was lucky, as I didn’t experience withdrawal symptoms other than the reappearance of severe, intractable pain.

I tried to use NSAIDS for the pain and developed a severe, life threatening reaction to them called Stevens-Johnson Syndrome. I came very close to death and was in intensive care for 6 weeks. Because of that, I will be unable to take NSAIDs for the rest of my life.

Because of the MRSA infection, no physician will perform any further surgeries or steroid injections on me because of the risk of activating another infection.

I have tried acupuncture, massage, chiropractic therapy, mirror therapy, physical therapy, water therapy, many different herbal and nutritional supplements, aromatherapy, music therapy, psychotherapy, hypnotherapy and mindfulness. All without relief of the severe, intractable pain.

When I was forced off opioids, I also lost my career as a very good ER nurse. I went from a functional member of society to a home-bound, miserable person who hurts too badly to keep my house clean like I always prided myself on. Many days I’m in too much pain to even shower or complete daily activities of living.

My husband and children have lost the wife and mother they were able to interact with, go places with, share activities with, everything. I have gained 50 pounds because the pain has left me unable to exercise.

After I stopped taking opioids, I developed hypertension.  Before, my blood pressure had never been higher than 130/80. Now I take medication for high blood pressure and it is still usually around 150/90.

I also developed heart arrhythmia and last year suffered 2 sudden cardiac arrests. I only survived because both times they were witnessed by my husband, who is also an ER nurse, so he immediately started CPR. The cardiologist could find no underlying causes and told me that the arrhythmia and cardiac arrests were probably due to longstanding, untreated severe pain.

There is no physician that I can find that will accept me as a chronic pain patient and my primary care doctor refuses to prescribe opioids anymore. I have literally tried every pain management physician in Wyoming and in Montana, which would have required a 6 to 7-hour drive for each appointment.

I, along with many other intractable pain patients, are working feverishly contacting our congressional representatives, federal government and civil rights groups, begging for help -- for anyone in a position of power to hear our cries of medical abandonment and neglect.

Our pleas mostly fall on deaf ears, as the government has convinced the media and the public that pain patients are all addicts and use opioids only to get high. They site false overdose statistics and refuse to acknowledge that while opioid prescriptions have declined -- causing devastating effects on the pain community -- the overdose rate continues to climb because the clear majority of overdoses are due to heroin, illicit fentanyl or polypharmacy with multiple drugs.

Many intractable pain patients are committing suicide because untreated pain takes away their quality of life and the will to live – something they had with legally prescribed and effective doses of opioid medication.

We are desperate. We don’t want to get high. We just want to make informed decisions with our physicians about our own healthcare, to regain access to opioid medication, and to get our lives back!

Andrea Giles lives in Wyoming with her family.

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.

Opioid Prescriptions Plunge to 15-Year Low

By Pat Anson, Editor

The volume of opioid prescriptions in the United States has fallen sharply and now stand at their lowest levels since 2003, according to data released by the Food and Drug Administration.

Over 74 million metric tons of opioid analgesics were dispensed in the first six months of 2018, down more than 16 percent from the first half of 2017. Opioid prescriptions have been declining for several years, but the trend appears to be accelerating as many doctors lower doses, write fewer prescriptions or simply discharge pain patients.

“These trends seem to suggest that the policy efforts that we’ve taken are working as providers, payers and patients are collectively reducing some of their use of prescription opioid analgesic drugs,” said FDA commissioner Scott Gottlieb, MD, in a statement.

SOURCE: FDA AND IQVIA

"This graph confirms the perception that many of use have, that prescribing continues to decline," said Bob Twillman, PhD, Executive Director of Academy of Integrative Pain Management. "But, the question remains --what is the effect of this decreased prescribing on people with chronic pain?

"Measures of prescribing need to be matched with measures of patient function and quality of life, especially given evidence that decreased prescribing may actually be associated with increased suicide. All this measure really tells us is that the intense pressure from legislators, regulators, and payers has had its desired effect of driving down prescribing, even it there’s no evidence that it’s done anything else helpful."

While opioid prescriptions decline, overdoses continue to rise. According to preliminary data from the CDC, nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl and heroin, not prescription opioids.

“It isn’t necessarily the case that more people are suddenly switching from prescription opioids to these illicit drugs. The idea of people switching to illicit drugs isn’t new as an addiction expands, and some people have a harder time maintaining a supply of prescription drugs from doctors,” said Gottlieb. “What’s new is that more people are now switching to highly potent drugs that are far deadlier. That’s driven largely by the growing availability of the illicit fentanyls.”

Illicit fentanyl and its chemical cousins are synthetic opioids, 50 to 100 times more potent than morphine. They are produced largely by clandestine drug labs in China and then smuggled into the U.S., where they are often mixed with heroin, cocaine and counterfeit drugs.  A record 1,640 pounds of fentanyl and nearly 5,500 pounds of heroin have been seized by law enforcement so far this year; likely a small fraction of what’s available on the black market.

While the Trump administration has expanded efforts to stop the distribution and sale of illicit opioids, it also remains focused on reducing the supply of prescription opioids.  The FDA plans to develop new prescribing guidelines for treating short-term, acute pain that will likely set a cap on the number of pills that can be prescribed for certain medical conditions.

“No more 30-day prescriptions for a tooth extraction or an appendectomy,” said Gottlieb.

The Justice Department also recently announced plans to lower production quotas by 10% next year for six widely prescribed opioid medications. The goal of the administration is to reduce opioid prescriptions by a third in the next three years. 

“The number of opioid prescriptions is only one of many factors and may not be the most important factor contributing to the opioid crisis. In fact, the U.S. is at a 15-year low in the amount of opioid prescribed but continues to see a surge of drug overdoses,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.

“Much of the effort to curb the amount of prescription opioids has contributed to more suffering by people in chronic pain and possibly the increase in suicides.  It also hasn't done anything to curb the number of overdose deaths. Rather than being focused on number of pills or amount of opioid prescribed we need to focus on what is the best and most appropriate treatment for individual patients. When that is done properly, the right amount of opioids will be prescribed.”  

Genetic Variation Raises Risk of Post-Traumatic Pain

By Pat Anson, Editor

If you have chronic pain because of an accident, injury or assault, it could be because you have a genetic variation that makes you more likely to develop post-traumatic pain.

That’s the key finding behind a new study published in the Journal of Neuroscience. Researchers at the University of North Carolina studied over 1,500 people who were admitted to emergency rooms for trauma after a motor vehicle collision.

In addition to genotyping the patients, the researchers assessed their distress immediately after the accident, as well as their pain and post-traumatic stress symptoms six weeks later. Participants with a particular variant in the gene FKBP5 reported more severe pain and distress at follow up.

FKBP5 is a critical regulator of the stress response and affects how we respond to environmental stimuli. Previous studies have shown that certain variants of the gene play a role in the development of neuropsychiatric disorders such as post-traumatic stress disorder, depression, suicide risk and aggressive behavior.

UNC School of Medicine researchers were the first to show an association between FKBP5 and post-traumatic chronic pain. A 2013 study found that people with a particular variation of the gene are likely to experience more pain after exposure to trauma compared to people who don't have the variant.

The new study by the same research group builds on that discovery by showing that the variation inhibits the regulation of cortisol, a stress hormone that sensitizes peripheral nerves. People with high levels of cortisol are likely to experience more pain.

"In our current study, we showed that the reason this variant affects chronic pain outcomes is because it alters the ability of FKBP5 to be regulated by a microRNA called miR-320a," said lead author Sarah Linnstaedt, PhD, a professor of anesthesiology and an investigator in the UNC Institute for Trauma Recovery.

"In other words, it does not negatively regulate FKBP5, thus causing FKBP5 to be over-expressed. High levels of FKBP5 can be detrimental because it alters natural feedback mechanisms that control circulating cortisol levels."

Linnstaedt says the findings suggest there could be new therapeutic approaches to treating traumatic pain, such as medication that inhibits the activity of FKBP5 or gene editing that alters the variation.

Funding for the UNC study was provided by the National Institute of Arthritis, Musculoskeletal, and Skin Diseases, The Mayday Fund, a Future Leaders in Pain Grant from The American Pain Society, and the National Human Genome Research Institute.

‘Art Rx’ Museum Tours Relieve Chronic Pain

By Pat Anson, Editor

A small pilot study by researchers at the University of California, Davis has uncovered a novel way of temporarily relieving chronic pain: Visit an art museum.

The Crocker Art Museum in Sacramento hosted a series of “Art Rx” private tours for 56 patients with chronic pain. The one-hour tours were designed not to be physically challenging and to encourage participants to talk with each other about the artwork they were seeing --- not just silently view it.

Patients were surveyed about their pain before and immediately after the docent-led tour, as well as three weeks later.

The study findings, published in the journal Pain Medicine, found that over 57 percent of the patients reported a decrease in their pain levels during the tour.

“So we get there, and I’m already in pain, but truly we were having this discussion and I just wasn’t thinking about it. I was having a good time,” one patient said.

“(Art Rx) took my mind elsewhere,” said another. “Physically I still have pain, but I feel good mentally, and I think part of my pain lessens when I feel good mentally.”

CROCKER ART MUSEUM

For some, the pain relief lasted for weeks. Several patients noted that the tours made them more aware of how their pain made them socially and emotionally isolated, so they took steps to increase their social interaction. Some met socially with Art Rx participants they met during the tours or joined an art-based community group.

“If you’re involved and doing things with people, you’re not shut in; you’re not focused on the pain,” one participant said.

“If anything it drives home for me how important it was to make sure that I get out," said another. "In a way, it should be an aspect of my health regime.”

“(Participants) found Art Rx to be, among other things, inclusive, validating, and socially engaging. These qualities stood in stark contrast to the isolating nature of chronic pain described in their personal histories and the negative encounters many of them had with the health care system,” wrote lead author Ian Koebner, PhD, a professor at the School of Medicine, University of California, Davis.

“Socially based interventions for individuals with chronic pain supported by health care organizations, such as Art Rx, may help to mitigate not only the experience of isolation, but also the distressing associations that many individuals with chronic pain have with the health care system.”  

The UC Davis findings are similar to those reported recently in a large 10-year study of over 2,600 healthy older adults in England. Researchers found that participants who attended museums, concerts, art galleries and other cultural activities were significantly less likely to develop chronic pain as they grew older.

The "Art Rx" tours at the Crocker Art Museum began in 2014 and are held every other month at no cost to the public. For more information, click here.

A Zebra With the Heart of a Lion

By Dawn Tucker, Guest Columnist 

Ehlers-Danlos syndrome (EDS) sucks.  There, I said it.  I have EDS Type 3 hypermobility and it hurts. I cry every day, sometimes two and three times a day.

I have dislocated various parts of my body due to collagen deficiency.  I have what is called frequent subluxations. My neck, shoulders and wrists have sprained for no reason other than I turned too quickly or took a deep breath.  I never knew why. I just knew people judged me and were critical whenever I mentioned the severity of my pain. 

My whole life (and I am 50 years old now) has been spent listening to others tell me my pain is all in my head, or that I am lazy or crazy. So I stopped telling people about it because no one wants to listen to a constant complainer. 

Instead I isolate and spend most of my time -- when not working -- in bed trying to get my body to cooperate with me.  It doesn’t.

I have three children and five grandchildren.  One son and one grandson also have EDS, and I cry because I know they will be judged and criticized by people who don’t understand. 

I once heard someone tell my son, “Something is always wrong with you.’ And I thought to myself, they could be talking to me.  I am beset with migraines, insomnia, dental issues, allergies, fatigue, irritable bowels, sprains, pains and aches.

I too have been told, “Something is always wrong with you.”

DAWN TUCKER

And they are right.  Something is always wrong with me.  On bad days I want to give up.  Then I remember, I might be the only person my son or grandson knows, who truly understands their pain.  I cannot give up on them, even if at times I want to give up on myself.  

I try to be strong and do everything myself.  I hate to ask for help and I tire of arguing with people about my condition. Yet I know I will argue for my son and grandson.

In the last few years, I have made acquaintance with others who have EDS.  But I’ve met only two doctors that were familiar with EDS, so I took to learning more on the internet.  The internet offers a chance to get the word out about this condition. To let others know about EDS and the often painful associations because of this inherited disease. 

Medical students are sometimes told, “When you hear hoof beats behind you, don’t expect to see a zebra.” That’s why EDS is symbolized by a zebra. It is misdiagnosed, under-diagnosed or simply not considered.  

I am living proof that sometimes it really is a zebra.  I have no problem with being a zebra, but this zebra has the heart of a lion.  

Dawn Tucker lives in Ohio.

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.

90% of Massachusetts Overdoses Linked to Fentanyl

By Pat Anson, Editor

Nearly 90 percent of opioid-related overdose deaths in Massachusetts now involve fentanyl, according to a new report that documents the rapidly changing nature of the opioid crisis. Less than 20 percent of drug overdoses in the state were linked to prescription opioids.

In the second quarter of 2018, Massachusetts health officials say 498 people died from an opioid-related overdose – the third straight quarter that opioid deaths have declined.

But the good news was tempered by the rising toll taken by fentanyl -- the synthetic opioid that’s become a deadly scourge on the black market. Fentanyl is often mixed with heroin, cocaine and counterfeit drugs to increase their potency. 

Because Massachusetts was one of the first states to conduct blood toxicology tests in overdose cases, it’s quarterly reports on drug deaths are considered more accurate than federal estimates and more likely to spot emerging trends in drug use. 

"This quarterly report provides a new level of data revealing an unsettling correlation between high levels of synthetic fentanyl present in toxicology reports and overdose death rates. It is critically important that the Commonwealth understand and study this information so we can better respond to this disease and help more people,” Massachusetts Gov. Charlie Baker said in a statement.

Another trend documented in Massachusetts is the increasing role played by cocaine and benzodiazepines --- an anti-anxiety medication – in drug overdoses. In the first quarter of 2018, cocaine (43%) and benzodiazepines (42%) were involved in more overdoses than heroin (34%) and prescription opioids (19%). 

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

Drug experts say many cocaine users may not realize their drug has been spiked with fentanyl, while many people who buy Xanax or Valium on the black market don’t know they’re getting counterfeit medication laced with fentanyl.

“If you are using illicit drugs in Massachusetts, you really have to be aware that fentanyl is a risk no matter which drug you’re using,” Dr. Monica Bharel, Massachusetts public health commissioner told The Boston Globe. “The increased risk of death related to fentanyl is what’s driving this epidemic.”

Fentanyl is also involved in a growing number of fatal overdoses in Pennsylvania. According to the Drug Enforcement Administration, there were 5,456 overdose deaths in Pennsylvania last year. Of those, over 67% percent involved fentanyl. The presence of fentanyl or its chemical cousins in overdose deaths rose almost 400% in the state from 2015 to 2017.

Most overdoses involve multiple drugs and blood tests alone do not determine a cause of death -- only which drugs were present at the time of death.

Former CDC Director Arrested for Sexual Misconduct

By Pat Anson, Editor

Dr. Thomas Frieden, the former director of the Centers for Disease Control of Prevention, has been arrested on sexual misconduct charges in New York City.

Frieden turned himself in to police in Brooklyn Friday morning after being charged with forcible touching, harassment and third degree sex abuse, all misdemeanors. The charges stem from a complaint filed in July by a 55-year old unnamed woman who alleges the 57-year old doctor grabbed her buttocks without permission in his apartment last October. 

According to STAT, Frieden later apologized to the woman -- a longtime family friend -- and "tried to manipulate her into staying silent by citing his position and potential to save lives around the world."

Fried was arraigned Friday afternoon and released without bail, after a judge ordered him not to contact his accuser and to surrender his passport. He's due back in court October 11.

Frieden did not enter a plea. A spokesperson released a statement saying the incident "does not reflect Dr. Frieden’s public or private behavior or his values over a lifetime of service to improve health around the world.”

Frieden led the CDC from 2009 to 2017 and championed the agency’s controversial opioid prescribing guideline -- calling it an "excellent starting point" to prevent opioid abuse.

Although voluntary and only intended for primary care physicians, the guideline has been widely adopted by insurers, states and healthcare providers – resulting in many chronic pain patients losing access to opioid medication.

“This crisis was caused, in large part, by decades of prescribing too many opioids for too many conditions where they provide minimal benefit," Frieden wrote in a commentary published by Fox News.  “There are safer drugs and treatment approaches that can control pain as well or better than opioids for the vast majority of patients."

DR. THOMAS FRIEDEN

Frieden currently heads Resolve to Save Lives, a program of Vital Strategies, a non-profit health organization that is trying to improve public health worldwide.

Vital Strategies released a statement saying Frieden informed the organization in April about the misconduct allegation. His accuser does not work for Vital Strategies, but the organization hired an investigator to interview employees about Frieden. No inappropriate workplace behavior or harassment was found, according to Vital Strategies CEO Jose Castro.  

“I have known and worked closely with Dr. Frieden for nearly 30 years and have seen first-hand that he has the highest ethical standards both personally and professionally. Vital Strategies greatly values the work Dr. Frieden does to advance public health and he has my full confidence,” said Castro.

Frieden has an extensive background in epidemiology and infectious diseases, and his tenure at the CDC was marked by major efforts to combat the Ebola virus, fungal meningitis, influenza and the Zika virus.

Before his appointment as CDC director, Frieden was New York City’s health commissioner, where he led efforts to ban public smoking and remove unhealthy trans fats from restaurants. Frieden is married and has two children.

A Careful Reading of 'Dopesick'

By Roger Chriss, PNN Columnist

The new book “Dopesick: Dealers, Doctors, and the Drug Company That Addicted America” by Beth Macy describes the origins of the opioid crisis and the plight of people addicted to opioids, particularly in the Roanoke area of Virginia.

The book looks at the crisis from multiple perspectives, including local physicians and pharmacists, law enforcement and attorneys, community leaders and even drug dealers. Macy treats the story of opioids, addiction, and fatal overdose with sympathy and concern.

“Until we understand how we reached this place, America will remain a country where getting addicted is far easier than securing treatment,” she wrote.

Macy relies heavily on books like “Painkiller” by Barry Meier and “American Pain” by John Temple, asking questions these journalists explored but providing no new answers. In so doing, she perpetuates numerous media-driven myths about the crisis and misses opportunities to investigate important open questions.

Dopesick starts with the arrival of Purdue Pharma’s OxyContin and the rapid rise of addiction and overdose. Appalachia was among the first places where OxyContin gained a foothold in the mid-1990s, quickly ensnaring working class families:

“The town pharmacist on the other line was incredulous: ‘Man, we only got it a month or two ago. And you’re telling me it’s already on the street?’”

It is still not clear how OxyContin made it into the black market so deeply and quickly, but Macy concludes that overprescribing for chronic pain was a key factor in the crisis. She cites “recent studies” that the addiction rate for patients prescribed opioids was “as high as 56 percent."

Most studies actually put the addiction rate much lower, with the National Institute on Drug Abuse (NIDA) estimating it at 8 to 12 percent.

In the second part of Dopesick, Macy draws on the work of Stanford psychiatrist Dr. Anna Lembke in describing adolescent drug use:

“Across the country, OxyContin was becoming a staple of suburban teenage ‘pharm parties,’ or ‘farming,’ as the practice of passing random pills around in hats was known.”

But pharm parties were debunked years ago as an urban legend.  Slate’s Jack Shafer looked into their origin and concluded the “pharm party is just a new label the drug-abuse industrial complex has adopted."

Macy’s writing often echoes her source materials. On adolescent drug use, she writes:

“So it went that young people barely flinched at the thought of taking Adderall to get them going in the morning, an opioid painkiller for a sports injury in the afternoon, and a Xanax to help them sleep at night, many of the pills doctor prescribed."

Lembke herself wrote in the book ”Drug Dealer, M.D.” in 2015:

“Many of today’s youth think nothing of taking Adderall (a stimulant) in the morning to get themselves going, Vicodin (an opioid painkiller) after lunch to treat a sport’s injury, ‘medical’ marijuana in the evening to relax, and Xanax (a benzodiazepine) at night to put themselves to sleep, all prescribed by a doctor."

The similarities between Macy and Lembke (a board member of the anti-opioid group Physicians for Responsible Opioid Prescribing) are striking.  More importantly, the data on teenage drug use disagrees with both of them. According to NIDA, teen drug use has been in decline for most substances for the past 10 years. Which makes it hard to parse Macy’s and Lembke’s claims about high levels of medication misuse among the teenagers they describe.

Macy also perpetuates ideas about race in the crisis: “Doctors didn’t trust people of color not to abuse opioids, so they prescribed them painkillers at far lower rates than they did whites.”

“It’s a case where racial stereotypes actually seem to be having a protective effect,” she quotes PROP founder and Executive Director Andrew Kolodny, MD.

In fact, rates of addiction and overdose have been rising rapidly among African Americans for years and recent CDC data on ethnicity in overdoses shows no significant difference among black, white, and Hispanic populations. The crisis has long since evolved beyond omitting a particular minority group.

Why did it take so long to recognize the opioid crisis and work to stop it?  Macy assigns blame to the political unimportance of regions like Appalachia, the failure in many states to expand Medicaid under the Affordable Care Act, and addiction treatment that’s based on 12-step or abstinence-only programs. She writes about the treatment industry with almost righteous anger:

“An annual $35 billion lie -- according to a New York Times exposé of a recovery industry it found to be unevenly regulated, rapacious, and largely abstinence-focused when multiple studies show outpatient MAT (medication assisted therapy) is the best way to prevent overdose deaths.”

“The battle lines over MAT persist in today’s treatment landscape -- from AA rooms where people on Suboxone are perceived as unclean and therefore unable to work its program, to the debate between pro-MAT public health professionals and most of Virginia’s drug-court prosecutors and judges, who staunchly prohibit its use.”

But Macy doesn’t look at the full story that heroin addiction represents. She omits the shattered childhoods and serious mental illness often seen in heroin users, and ignores the complicated trajectory of substance abuse. She also skips the fact that heroin addiction frequently starts without prior use of any opioids.

Throughout the book, Macy follows the standard media narrative of the crisis, focusing on addiction as a result of pain management gone wrong. But most people who become addicted to opioids start with alcohol, marijuana and other recreational drugs.

What Dopesick may lack in depth and rigor, it makes up for in compassion and intensity. Unfortunately, Macy accepts at face value claims from experts when she should have fact-checked them.  Perhaps the errors will be corrected in a second edition, which could turn an interesting book into essential reading.

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.

How Low Dose Naltrexone Relieved My Chronic Pain

By Marelle Reid, Guest Columnist

For the past eight years I've been dealing with Interstitial Cystitis (IC), a chronic pain condition that feels like a bladder infection that never ends. No one really knows what causes IC and there is no cure.

I've tried everything from surgery and homeopathy to narcotics and antidepressants, but nothing seemed to work until I discovered Low Dose Naltrexone (LDN). A hormone specialist suggested I use LDN as a way to combat the nerve pain that had plagued me for years. I figured I might as well try it since the only side effects from LDN are trouble sleeping and vivid dreams.

MARELLE REID

After a couple of weeks I found the strange dreams stopped, and a few months later I realized I was able to eat foods I normally would avoid because they made my IC pain worse. In fact, I was able to resume a completely normal diet, including foods and drinks that would have previously sent me into terrible flare.

For the past year I've been taking 4.5mg naltrexone at night just before bed. Although it has not cured me, I've been thrilled to find that it has reduced my pain to the point where I no longer feel held back from doing anything I would have done before I was diagnosed with IC. 

Naltrexone is the same drug used to treat alcoholism and opioid addiction. In larger doses (50mg) it blocks opioid receptors in the brain and decreases the desire to take opiates or alcohol.  It's believed that taking naltrexone in smaller doses stimulates the immune system and the production of endorphins, the body's natural painkiller.

LDN is prescribed "off label" for many conditions, but it isn't well known as a treatment for chronic pain because it's not marketed by any drug company for that purpose. The patent on naltrexone expired years ago and there's little money to be made from it or to conduct clinical trials.

However, a review of anecdotal information online and in social media suggests many people suffering from Crohn's disease, multiple sclerosis, fibromyalgia and other chronic illnesses believe they have benefited from taking LDN. (See "Naltrexone Changed Life of Fibromyalgia Patient").

I hope others can find the same relief that I have. 

Marelle Reid lives in Vancouver, British Columbia.

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.

FDA to Develop Acute Pain Guidelines

By Pat Anson, Editor

The head of the U.S. Food and Drug Administration is following up on a promise to develop new federal prescribing guidelines for treating short-term, acute pain. But don't expect an overhaul of the CDC's controversial opioid guideline.

FDA commissioner Scott Gottlieb, MD, announced today that his agency has awarded a contract  to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help develop guidelines for prescribing opioids for acute pain that results from specific medical conditions or procedures, such as wisdom tooth removal or post-operative pain.  

The CDC guideline takes a one-size-fits-all approach to chronic pain -- pain that lasts longer than three months -- and doesn't distinguish between pain from fibromyalgia, arthritis, neuropathy or any other medical condition.  

"We’ve contracted with NASEM to conduct a consensus study and issue a report on its findings. This work will begin with an identification and prioritization of procedures and conditions associated with acute pain for which opioid analgesics are commonly prescribed and where evidence-based clinical practice guidelines would help inform prescribing practices," Gottlieb said in a statement.

"We acknowledge the work of our colleagues at the U.S. Centers for Disease Control and Prevention (CDC) who have taken an initial step in developing federal guidelines on pain management and the use of opioids which are based on expert opinion. Our work seeks to build on that work by generating evidence-based guidelines where needed. The guidelines we generate would be distinct from this corresponding effort by the CDC, in that our effort would be indication-specific." 

Importantly, Gottlieb says NASEM will hold a series of public meetings and workshops, and seek input from "a broad range of stakeholders" from different medical specialties. The CDC guideline was initially developed with no public hearings and with little input from pain management experts.

While Gottlieb clearly wants more transparency brought to the guideline development process, he also clings to the notion that opioid medication is overprescribed and is primarily responsible for the nation's opioid crisis.

"Many people who become addicted to opioids will first be exposed to these drugs through a lawfully prescribed medication. Unfortunately, the fact remains that there are still too many prescriptions being written for opioids," Gottlieb said.

"Our analyses suggest that the first prescription for many common, acute indications could typically be for many fewer pills – maybe just a day or two of medication rather than a 30-day supply, which is typically prescribed. In some cases, the excess pills that aren’t used by patients may end up being diverted to illicit markets or misused or abused by friends or family members. In other cases, patients who are prescribed more medication than necessary may find themselves at increased risks for misuse, abuse and addiction."

But studies show that long-term opioid use by patients recovering from surgery is rare and less than one percent of legally prescribed opioids are diverted.

In 2016, the American Pain Society released guidelines that encourage physicians to limit the use of opioids and offer “multimodal therapies” to patients suffering from postoperative pain. Among the treatments suggested are pregabalin, gabapentin, NSAIDs and acetaminophen.

The University of Michigan has also developed prescribing guidelines for over a dozen common surgeries, ranging from hernia repair to hysterectomies. The recommendations list the suggested dose of opioids and number of pills for each procedure.      

Several states have already adopted their own guidelines for acute pain, limiting opioids to a few days' supply -- regardless of whether the pain is from a broken leg, a tonsillectomy or gunshot wound.  It's not clear how federal guidelines for acute pain would impact state regulations.

A Pained Life: Hold On Hope

By Carol Levy, PNN Columnist

If I didn’t know better, I would think the lyrics from Peter Allen’s 1976 song “Taught by Experts” were specifically for the chronic pain community:

I've been taught by experts in the art of cruelty
Now I'm giving lessons free
All it takes is three
I'll teach you to make friends with pain
Lesson number one
No it's not much fun
Never was much fun

That song feels like the story of my life, at least my life since the pain started.

After my last surgery, the doctor took photos of my shaved head and of the scars remaining from the 12 other neurosurgeries I’ve had for trigeminal neuralgia. Every one of them left visible scars, at least until my hair grew back.

Surgeries also leave invisible scars in our minds and souls. I would venture to say that, in one way or another, many of us have some level of post-traumatic stress disorder that will continue for as long as we have pain.

Recently I finished reading a book on chronic pain. The author gave many exercises and suggestions for ways to deal with pain. The exercises were geared towards ways to change how we think.  Many of the suggestions seemed to be variants of “Don't worry. Be happy.”

There must be a middle ground between “My life is cruel because of pain and I am consumed by it.” -- a thought that is hurtful and soul crushing -- and “I'll pretend it isn’t there and smile.” -- a falsehood that is equally destructive.

What is it that tethers us?

I think it is hope. Hope that the pain will get better, hope that a better, newer, easier treatment will be found. Or better yet, a cure.

And hope that in the interim we will still have access to the treatments and providers that helped us. 

Maybe these lyrics from “Hold on Hope” by Guided by Voices expresses it better than I can.

Every street is dark and folding out mysteriously
Well that’s the chance we take
To be always working, reaching out

For a hand that we can't see
Everybody's got to hold on hope
It's the last thing that's holding me

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

Studies Warn of Pregabalin Deaths

By Pat Anson, Editor

Two new studies – one in Canada and one in Australia – should give pause to patients who use opioids and pregabalin (Lyrica), an anticonvulsant medication increasingly prescribed for fibromyalgia, neuropathy and other chronic pain conditions. Both studies found a number of overdose deaths that involve – but were not necessarily caused -- by pregabalin.

The Canadian study, published in the Annals of Internal Medicine, looked at over 1,400 patients in Ontario on opioid medication from 1997 to 2016 who died from opioid-related causes. Another group of over 5,000 surviving opioid patients was used as a control group.

Researchers found that patients who were co-prescribed opioids and pregabalin had a significantly higher risk of an overdose.

The risk of death was over two times higher for patients receiving opioids and a high dose of pregabalin (over 300mg) compared to those who took opioids alone.

Patients on a low or moderate dose of pregabalin also had a heightened risk, although not as large.

Researchers say pregabalin has a sedative effect and may interact with opioids in ways that increase respiratory depression. Few doctors and patients are aware of the risk, even though over half of Ontario residents who begin pregabalin therapy are also prescribed an opioid.

"There is an important drug interaction between opioids and pregabalin that can lead to increased risk of fatal overdose, particularly at high doses of pregabalin," lead author Tara Gomes, PhD, of the Institute for Clinical Evaluative Sciences (ICES) and St. Michael's Hospital in Toronto, told MedPage Today.

"Clinicians should consider carefully whether to prescribe opioids and pregabalin together. If they decide that both medications are clinically appropriate, they should start with low doses and monitor their patients closely."

Lyrica (pregabalin) and Neurontin (gabapentin) are both made by Pfizer and belong to a class of anticonvulsant nerve medication called gabapentinoids. Sales of gabapentinoids have tripled in recent years, in part because of CDC prescribing guidelines that recommend the drugs as alternatives to opioid medication.  

U.S. health officials have only recently started looking into the misuse and abuse of gabapentinoids, which are increasingly used by addicts to enhance the euphoric effects of heroin and other illicit opioids. While gabapentin  has a warning label cautioning users who take the drug with opioids, there is no similar warning for pregabalin.

“Although current product monographs for gabapentin contain warnings about serious adverse events when this agent is combined with opioids, those for pregabalin do not. The importance of our finding warrants a revision of the pregabalin product monographs,” wrote Gomes.

Pregabalin Abuse in Australia

Health officials in Australia are also concerned about the growing use of pregabalin.  Researchers at the NSW Poisons Information Centre say poisoning cases involving pregabalin rose from zero in 2005 to 376 cases in 2016.

“Our study shows a clear correlation between the rapid and continuous rise of pregabalin dispensing and an increase in intentional poisonings and deaths associated with pregabalin,” said lead author Dr. Rose Cairns, a specialist at the NSW Poisons Information Centre.

According to the Australian Journal of Pharmacy (AJP), there have been 88 recorded deaths associated with pregabalin in recent years. Most of the deaths involved young, unemployed males who had a history of substance abuse, particularly with opioids, benzodiazepines, alcohol and illicit drugs.

“We believe that Australian doctors may not be aware of the abuse potential of pregabalin,” Cairns said. “Most patients who are prescribed this medication are in the older population but the group who are at high risk of overdosing are much younger. These people are likely to have been prescribed pregabalin despite having a history of substance abuse.”

According to researchers, up to two-thirds of people who intentionally misused pregabalin had a prior documented substance abuse history. “Prescribers need to consider this growing body of evidence that pregabalin has abuse potential before prescribing, especially to patients with substance abuse history,” said Cairns.

Pfizer did not respond to a request for comment on the Canadian and Australian studies.

Study Finds Racial Bias in Drug Testing

By Pat Anson, Editor

African-American patients on long-term opioid therapy are more likely to be drug tested by their doctors and significantly more likely to have their opioid prescriptions stopped if an illicit drug is detected, according to a new study.

Yale researchers analyzed the health records of more than 15,000 patients who received opioids from the Veterans Administration between 2000 and 2010. About half of the VA patients were white and half black.

Over 25 percent of the black patients had a urine drug test within the first six months of opioid treatment, compared to nearly 16% of whites.

When patients tested positive for either marijuana or cocaine, the vast majority – 90 percent -- continued to receive their opioid prescriptions. But there were significant differences in how patients were treated depending on their race.

Black patients that tested positive for marijuana were twice as likely as whites to have opioid therapy stopped and three times more likely to have opioids discontinued if cocaine was detected in their urine.

The findings, published in the journal Drug and Alcohol Dependence, are consistent with previous research showing disparities in how blacks and whites are treated by the healthcare system in general, and particularly when opioids are involved.

“There is no mandate to immediately stop a patient from taking prescription opioids if they test positive for illicit drugs,” said first author Julie Gaither, PhD, a pediatrics instructor at the Yale School of Medicine.

“It’s our feeling that without clear guidance, physicians are falling back on ingrained stereotypes, including racial stereotyping. When faced with evidence of illicit drug use, clinicians are more likely to discontinue opioids when a patient is black, even though research has shown that whites are the group at highest risk for overdose and death.”

A 2016 study of emergency room patients found that blacks were significantly less likely to get an opioid for abdominal pain than whites. Another study of white medical students and residents found that half had at least one false belief about black patients. Those that did were more likely to report lower pain ratings for black patients.

Drug Testing for Marijuana Not Recommended

The 2016 CDC opioid guideline encourages doctors to conduct urine drug tests before starting opioid therapy and at least annually after patients start taking the drugs. But the guideline also urges physicians not to test opioid patients for tetrahyrdocannabinol (THC), the psychoactive ingredient in marijuana that makes people high.

“Clinicians should not test for substances for which results would not affect patient management or for which implications for patient management are unclear. For example, experts noted that there might be uncertainty about the clinical implications of a positive urine drug test for tetrahyrdocannabinol (THC).” the guideline states.

"Clinicians should not dismiss patients from care based on a urine drug test result because this could constitute patient abandonment and could have adverse consequences for patient safety, potentially including the patient obtaining opioids from alternative sources and the clinician missing opportunities to facilitate treatment for substance use disorder."

Another factor to consider is the unreliability of urine drug tests. As PNN has reported, “point-of care” (POC) urine drug tests, the kind widely used in doctor’s offices, frequently giving false positive or false negative results for marijuana, cocaine and other drugs. 

A 2015 study found that 21% of POC tests for marijuana and 12% of those for cocaine produced a false positive result.

The Man Who Sold America on Vitamin D

By Liz Szabo, Kaiser Health News

Dr. Michael Holick’s enthusiasm for vitamin D can be fairly described as extreme.

The Boston University endocrinologist, who perhaps more than anyone else is responsible for creating a billion-dollar vitamin D sales and testing juggernaut, elevates his own levels of the stuff with supplements and fortified milk. When he bikes outdoors, he won’t put sunscreen on his limbs. He has written book-length odes to vitamin D, and has warned in multiple scholarly articles about a “vitamin D deficiency pandemic” that explains disease and suboptimal health across the world.

His fixation is so intense that it extends to the dinosaurs. What if the real problem with that asteroid 65 million years ago wasn’t a lack of food, but the weak bones that follow a lack of sunlight? “I sometimes wonder,” Holick has written, “did the dinosaurs die of rickets and osteomalacia?”

Holick’s role in drafting national vitamin D guidelines, and the embrace of his message by mainstream doctors and wellness gurus alike, have helped push supplement sales to $936 million in 2017. That’s a ninefold increase over the previous decade. Lab tests for vitamin D deficiency have spiked, too: Doctors ordered more than 10 million for Medicare patients in 2016, up 547 percent since 2007, at a cost of $365 million. About 1 in 4 adults 60 and older now take vitamin D supplements.

But few of the Americans swept up in the vitamin D craze are likely aware that the industry has sent a lot of money Holick’s way.

A Kaiser Health News investigation found that he has used his prominent position in the medical community to promote practices that financially benefit corporations that have given him hundreds of thousands of dollars — including drugmakers, the indoor-tanning industry and one of the country’s largest commercial labs.

In an interview, Holick acknowledged he has worked as a consultant to Quest Diagnostics, which performs vitamin D tests, since 1979.

Holick, who is 72, said that industry funding “doesn’t influence me in terms of talking about the health benefits of vitamin D.”

DR. MICHAEL HOLICK

There is no question that the hormone is important. Without enough of it, bones can become thin, brittle and misshapen, causing a condition called rickets in children and osteomalacia in adults. The issue is how much vitamin D is healthy, and what level constitutes deficiency.

Windfall for Vitamin D Industry

Holick’s crucial role in shaping that debate occurred in 2011. Late the previous year, the prestigious National Academy of Medicine (then known as the Institute of Medicine), a group of independent scientific experts, issued a comprehensive, 1,132-page report on vitamin D deficiency. It concluded that the vast majority of Americans get plenty of the hormone through diet and sunlight, and advised doctors to test only patients at high risk of vitamin D-related disorders, such as osteoporosis.

A few months later, in June 2011, Holick oversaw the publication of a report that took a starkly different view. The paper, in the peer-reviewed Journal of Clinical Endocrinology & Metabolism, was on behalf of the Endocrine Society, the field’s foremost professional group, whose guidelines are widely used by hospitals, physicians and commercial labs nationwide, including Quest. The society adopted Holick’s position that “vitamin D deficiency is very common in all age groups” and advocated a huge expansion of vitamin D testing, targeting more than half the United States population, including those who are black, Hispanic or obese — groups that tend to have lower vitamin D levels than others.

The recommendations were a financial windfall for the vitamin D industry. By advocating such widespread testing, the Endocrine Society directed more business to Quest and other commercial labs. Vitamin D tests are now the fifth-most-common lab test covered by Medicare.

The guidelines benefited the vitamin D industry in another important way. Unlike the National Academy, which concluded that patients have sufficient vitamin D when their blood levels are at or above 20 nanograms per milliliter, the Endocrine Society said vitamin D levels need to be much higher — at least 30 nanograms per milliliter. Many commercial labs, including Quest and LabCorp, adopted the higher standard.

Yet there’s no evidence that people with the higher level are any healthier than those with the lower level, said Dr. Clifford Rosen, a senior scientist at the Maine Medical Center Research Institute and co-author of the National Academy report. Using the Endocrine Society’s higher standard creates the appearance of an epidemic, he said, because it labels 80 percent of Americans as having inadequate vitamin D.

“We see people being tested all the time and being treated based on a lot of wishful thinking, that you can take a supplement to be healthier,” Rosen said.

Patients with low vitamin D levels are often prescribed supplements and instructed to get checked again in a few months, said Dr. Alex Krist, a family physician and vice chairman of the U.S. Preventive Services Task Force, an expert panel that issues health advice. Many physicians then repeat the test once a year. For labs, “it’s in their financial interest” to label patients with low vitamin D levels, Krist said.

In a 2010 book, “The Vitamin D Solution,” Holick gave readers tips to encourage them to get their blood tested. For readers worried about potential out-of-pocket costs for vitamin D tests — they range from $40 to $225 — Holick listed the precise reimbursement codes that doctors should use when requesting insurance coverage.

“If they use the wrong coding when submitting the claim to the insurance company, they won’t get reimbursed and you will wind up having to pay for the test,” Holick wrote.

Holick acknowledged financial ties with Quest and other companies in the financial disclosure statement published with the Endocrine Society guidelines. In an interview, he said that working for Quest for four decades — he is currently paid $1,000 a month — hasn’t affected his medical advice. “I don’t get any additional money if they sell one test or 1 billion,” Holick said.

A Quest spokeswoman, Wendy Bost, said the company seeks the advice of a number of expert consultants. “We feel strongly that being able to work with the top experts in the field, whether it’s vitamin D or another area, translates to better quality and better information, both for our patients and physicians,” Bost said.

Since 2011, Holick’s advocacy has been embraced by the wellness-industrial complex. Gwyneth Paltrow’s website, Goop, cites his writing. Dr. Mehmet Oz has described vitamin D as “the No. 1 thing you need more of,” telling his audience that it can help them avoid heart disease, depression, weight gain, memory loss and cancer. And Oprah Winfrey’s website tells readers that “knowing your vitamin D levels might save your life.” Mainstream doctors have pushed the hormone, including Dr. Walter Willett, a widely respected professor at Harvard Medical School.

Today, seven years after the dueling academic findings, the leaders of the National Academy report are struggling to be heard above the clamor for more sunshine pills.

“There isn’t a ‘pandemic,’” A. Catharine Ross, a professor at Penn State and chair of the committee that wrote the report, said in an interview. “There isn’t a widespread problem.”

Ties to Drugmakers and Tanning Salons

In “The Vitamin D Solution,” Holick describes his promotion of vitamin D as a lonely crusade. “Drug companies can sell fear,” he writes, “but they can’t sell sunlight, so there’s no promotion of the sun’s health benefits.”

Yet Holick also has extensive financial ties to the pharmaceutical industry. He received nearly $163,000 from 2013 to 2017 from pharmaceutical companies, according to Medicare’s Open Payments database, which tracks payments from drug and device manufacturers. The companies paying him included Sanofi-Aventis, which markets vitamin D supplements; Shire, which makes drugs for hormonal disorders that are given with vitamin D; Amgen, which makes an osteoporosis treatment; and Roche Diagnostics and Quidel Corp., which both make vitamin D tests.

The database includes only payments made since 2013, but Holick’s record of being compensated by drug companies started before that. In his 2010 book, he describes visiting South Africa to give “talks for a pharmaceutical company,” whose president and chief executive were in the audience.

Holick’s ties to the tanning industry also have drawn scrutiny. Although Holick said he doesn’t advocate tanning, he has described tanning beds as a “recommended source” of vitamin D “when used in moderation.”

Holick has acknowledged accepting research money from the UV Foundation — a nonprofit arm of the now-defunct Indoor Tanning Association — which gave $150,000 to Boston University from 2004 to 2006, earmarked for Holick’s research. The International Agency for Research on Cancer classified tanning beds as carcinogenic in 2009.

In 2004, the tanning-industry associations led Dr. Barbara Gilchrest, who then was head of Boston University’s dermatology department, to ask Holick to resign from the department. He did so, but remains a professor at the medical school’s department of endocrinology, diabetes and nutrition and weight management.

In “The Vitamin D Solution,” Holick wrote that he was “forced” to give up his position due to his “stalwart support of sensible sun exposure.” He added, “Shame on me for challenging one of the dogmas of dermatology.”

Although Holick’s website lists him as a member of the American Academy of Dermatology, an academy spokeswoman, Amanda Jacobs, said he was not a current member.

Dr. Christopher McCartney, chairman of the Endocrine Society’s clinical guidelines subcommittee, said the society has put in place stricter policies on conflict of interest since its vitamin D guidelines were released. The society’s current policies would not allow the chairman of the guideline-writing committee to have financial conflicts.

A Miracle Pill Loses Its Luster

Enthusiasm for vitamin D among medical experts has dimmed in recent years, as rigorous clinical trials have failed to confirm the benefits suggested by early, preliminary studies. A string of trials found no evidence that vitamin D reduces the risk of cancer, heart disease or falls in the elderly. And most scientists say there isn’t enough evidence to know if vitamin D can prevent chronic diseases that aren’t related to bones.

Although the amount of vitamin D in a typical daily supplement is generally considered safe, it is possible to take too much. In 2015, an article in the American Journal of Medicine linked blood levels as low as 50 nanograms per milliliter with an increased risk of death.

Some researchers say vitamin D may never have been the miracle pill that it appeared to be. Sick people who stay indoors tend to have low vitamin D levels; their poor health is likely the cause of their low vitamin D levels, not the other way around, said Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women’s Hospital in Boston.

Only really rigorous studies, which randomly assign some patients to take vitamin D and others to take placebos, can provide definitive answers about vitamin D and health. Manson is leading one such study, involving 26,000 adults, expected to be published in November.

A number of insurers and health experts have begun to view widespread vitamin D testing as unnecessary and expensive. In 2014, the U.S. Preventive Services Task Force said there wasn’t enough evidence to recommend for or against routine vitamin D screening. In April, the task force explicitly recommended that older adults outside of nursing homes avoid taking vitamin D supplements to prevent falls.

In 2015, Excellus BlueCross BlueShield published an analysis highlighting the overuse of vitamin D tests. In 2014, the insurer spent $33 million on 641,000 vitamin D tests. “That’s an astronomical amount of money,” said Dr. Richard Lockwood, Excellus’ vice president and chief medical officer for utilization management. More than 40 percent of Excellus patients tested had no medical reason to be screened.

In spite of Excellus’ efforts to rein in the tests, vitamin D usage has remained high, Lockwood said. “It’s very hard to change habits,” he said, adding: “The medical community is not much different than the rest of the world, and we get into fads.”

Kaiser Health News coverage related to aging and improving care of older adults is supported in part by The John A. Hartford Foundation. KHN is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Message to CDC: Tear Down Your Walls of Silence!

By Richard Lawhern, PhD, Guest Columnist

In March 2016, the Centers for Disease Control and Prevention published its guideline for primary care physicians on prescribing opioid medication for chronic non-cancer pain.

Three months before its publication, Congress and President Obama made the guideline mandatory for the Veterans Health Administration, leading to revised practice standards at the VA that sharply restrict opioid medication for all veterans, regardless of risk or benefit. These unjustified restrictions were again written into federal law by the Veterans Administration Mission Act and recently signed into law by President Trump.

In civilian practice -- and despite being phrased as voluntary and only for general practitioners -- the CDC guideline was immediately and widely interpreted as a mandatory standard of practice for all doctors. 

Many insurers and healthcare providers adopted the CDC’s 90mg morphine equivalent dose (MME) as the maximum safe level of treatment, and some states have limited opioids to 7 days' supply or less for initial prescriptions, even after major surgery. 

More recently, Oregon’s Medicaid program has proposed rule changes that would forcibly taper many chronic pain patients currently on opioid therapy to zero. 

Major changes are also coming next year for Medicare patients nationwide that will sharply restrict high-dose opioid therapy for hundreds of thousands of older and disabled patients, by allowing insurers to require prior authorization for prescriptions in excess of 200 MMEs.

Almost immediately -- and despite wording in the CDC guideline discouraging such action -- doctors began coercing patients to eliminate or reduce opioids that were effective in managing their pain for years. State and federal law enforcement agencies like the Drug Enforcement Administration also ramped up the investigation and prosecution of doctors who prescribe high doses. 

Fearing loss of their livelihoods, many doctors refused to prescribe opioids or discharged patients who asked for them.  Some physicians left pain practice altogether.  As a result, tens of thousands of patients can no longer find effective pain treatment. There are widespread stories in social media, acknowledged in professional medical literature, of patients deserted by doctors who spiral down into agony, disability, and in some cases suicide. 

Where is CDC’s Guideline Evaluation?

One would think that federal agencies that caused such a public health disaster would be concerned with correcting course.  But that is not the case. 

Practice standards published by medical associations usually include a follow-up program to measure their safety and effectiveness. However, CDC has failed to conduct a full assessment of the opioid guideline in the nearly two and a half years since its release – even though the agency pledged in the guideline to conduct one:

“CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

It is obvious why the CDC has maintained a wall of silence in the face of widespread criticism of the guideline by both patients and doctors. The agency is desperately wrong on three central assumptions about the opioid crisis:

1. The crisis was caused by “over-prescribing” medical opioids to patients in pain. Doctors were careless, greedy or deceived by evil pharmaceutical companies into ignoring risks of drug addiction.
2. There is no evidence that opioid analgesics are effective for pain when used over long periods.
3. Alternative pain therapies and non-opioid medications are safer and more effective than opioids and should be preferred over them.

All three of these assumptions are wrong.  Patient experience and published data from healthcare researchers demonstrate they are wrong. Let’s look at these three false assumptions.

Do Opioid Prescriptions Cause Overdose Deaths? 

Very rarely.  If prescribing increases the risk of opioid overdose deaths, then we would expect to see more overdoses in states and patient demographic groups where prescribing rates are highest.  But we do not. 

The following graphic compares overdose mortality rates from legal and illegal opioids to rates of opioid prescribing in all 50 states and Washington, DC in 2016.

SOURCE: CDC DATABASE

It might be difficult for a layman to make much sense of this graphic.  And that is precisely the point.  If there was a clear cause and effect relationship between prescribing and overdose deaths, then we would see higher death rates on the right side of the chart, with most data clumped closely around a rising central trend line.  But we don’t see that. 

The contribution of medically prescribed opioids to overdose deaths is so small that it gets lost in the noise of illegal street drugs.  Contrary to the screaming headlines in the media, prescription drugs aren’t killing people in large numbers. Illegal street drugs are.

This is not to say prescription drugs played no role in worsening the opioid crisis.  But in recent years, their role in opioid mortality has become small.  Even when they are found in the bloodstream of an overdose victim, opioid prescriptions are almost never found alone.  In Massachusetts, illicit fentanyl was found last year in 85% of blood toxicology screens of overdose victims, while heroin and/or cocaine were detected in about 45% of them.  Prescription opioids were found in only 15% of overdose victims.

Those numbers obviously don’t add up to 100 percent.  That is because the great majority of overdose victims had taken more than one illegal drug plus alcohol and/or benzodiazepine drugs.  We don’t really know which drug or combination of drugs caused the overdose.   

Overdose data also suggest that death is not a predictable outcome of opioid prescribing, nor is it common in groups that use the most opioid prescriptions. 

Basic trends in the chart below stand out.  First, rates of overdose deaths among people over age 50 have been stable for the last 17 years, while death rates among young people have risen sharply. In 2016, they were six times higher than in seniors.

We know that rates of opioid prescribing for seniors are at least 250% higher than for kids under 21. Thus, the group that benefited the most from liberalized prescribing policies of a decade ago – older adults -- has shown no higher risk of overdose deaths, even as kids who receive fewer opioid prescriptions are now dying in record numbers.

The asserted demographics of “over-prescribing” are plainly wrong. They don’t work and never have.  Exposure to medically managed opioids does not cause increased opioid mortality, at least not directly. 

Brief exposure to prescription opioids contributes very little to addiction or long term use. In two recent large-scale studies, opioid abuse and prolonged prescribing of opioids were evaluated for over 650,000 patients given opioids for the first time to control pain after surgery.  Fewer than 0.6% of these patients were diagnosed with opioid abuse 2.5 years later. 

This means that opioid treatment for acute pain is safe, effective and usually free of bad outcomes for over 99% of opioid-naive post-surgical patients.

Do Opioid Medications Relieve Chronic Pain?

Of course they do!

We hear a lot of noise that there is no evidence or proof that opioids work for long periods.  But “no proof” is not the same as “proof of no effect”. 

There are very few double blind clinical trials for opioids longer than 90 days -- and this reality is entirely understandable.  When people with severe pain are given placebos, they lapse into agony and drop out of trials.  Long term studies of any pain treatment can easily rise to the level of being inhumane – which is why so few have been conducted.

It isn’t rocket science, and the writers of the CDC guideline knew it.  Instead of comparing shorter trials of opioid analgesics against behavioral therapies and non-opioid medications, the guideline writers stacked the deck against opioids.  And they got caught at it by their medical peers. 

If trials of all three therapies had been limited to studies of at least a year -- as opioids were but alternative therapies were not -- none of the three could have provided “evidence” of useful effect.

We must also acknowledge that not all patients do well on opioids.  Some develop persistent nausea, sedation, constipation, suppression of sexual libido and depression. Some patients also become drug tolerant, requiring ever-increasing doses of opioids to achieve the same pain-relieving effects.  It has been theorized that a condition called “opioid induced hyperalgesia” may alter the action of opioid receptors in the brain.  But there is no medical consensus on how to measure such an effect in human beings, or even whether hyperalgesia exists. 

Many of the perceived failures of opioid therapy might be laid at the feet of ill-trained physicians.  Some doctors titrate their patients from zero to a therapeutic dose too fast.  Others fail to recognize factors in liver metabolism which make some patients poor metabolizers or hyper-metabolizers of opioids. Variation in metabolism means that there can be no one-size-fits-all pain treatment. Opioid therapy can be safe and effective for a small minority of patients at doses well above 1,000 MME.

Are Safe Substitutes for Opioids Widely Available?

For millions of patients, not yet.

We hear a lot of noise about tapering pain patients out of opioid therapy and into “alternative” or “integrative medicine.”  Indeed, it seems appropriate to first try less powerful medications such as NSAIDs or anticonvulsants before proceeding to opioids.  Exercise and massage therapy are also useful as palliative therapies.  But for millions of people, less powerful medications don’t work well enough -- or at all.  Tylenol or ibuprofen at high doses might also put you in a hospital with liver toxicity or major gastrointestinal problems.

What about “non-pharmacological” and “non-invasive” therapies?  Do they work well enough to be substituted for opioids?  Unfortunately, the answer is no. The state of science for alternatives like cognitive behavioral therapy, acupuncture, chiropractic, or various talk therapies is simply abysmal. 

At most, these alternative treatments are experimental.  They might be useful as supportive therapies in coordination with a well managed program of pain relieving medications.  But pending a more rigorous evaluation, we simply cannot offer such experimental techniques as substitutes for opioids. 

What Are Federal Agencies Doing to Correct Course?

In two words, “nothing apparent.”

The CDC, Food and Drug Administration, Health and Human Services (HHS), and the National Institutes of Health seem to be collectively dragging their feet in a campaign of deliberate inaction, refusing to respond to criticism or examine their own medical evidence of error.

This author and others have been trying for years to get healthcare agencies to reevaluate the relationship between opioid prescribing and overdose mortality. These efforts have included recent testimony to the FDA Opioid Policy Steering Committee and to the HHS Inter Agency Task Force on Best Practice in Pain Management.

In addition, copies of our analysis have been sent to the following authorities.  Most have been silent and none have responded in substance.

• Dr. Scott Gottlieb, FDA Commissioner and senior analytics staff
• Dr. Sharon Hertz, Director, Division of Anesthesia, Analgesia, and Addiction Products, FDA
• Dr. Mary Kremzner, Director, Division of Drug Information, FDA. (Dr. Kremzner responded with a courteous letter referring to a press release from Scott Gottlieb). 
• Alicia Richmond Scott, Designated Federal Officer, and Dr. Vanilla Singh, Chair of the HHS Inter Agency Task Force on Best Practices in Pain Management  
• Dr. Nora Volkow, Director of the National Institute on Drug Abuse
• The Whistleblower gateway of the House Subcommittee on Government Oversight

An inquiry was also filed online with the CDC. A dismissive response was received from the CDC Center for Injury Prevention – which oversaw development of the opioid guideline -- claiming to have read my analysis and asserting their previous positions.  This response was clearly a brush-off adapted from previous form letters.

A request is now in preparation to the HHS Office of the Inspector General, asking for investigation of CDC for malfeasance and possible fraud.

Richard Lawhern, PhD, has for 21 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  He is co-founder and corresponding secretary of the Alliance for the Treatment of Intractable Pain.

Graphics in this article originally published by The Crime Report on January 21, 2018, in "The Phony War Against Opioids - Some Inconvenient Truths."

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.