FDA Takes a Bite Out of Nyloxin

By Pat Anson, PNN Editor

It’s fair to say that cobra venom isn’t high on the list of go-to analgesics for most chronic pain sufferers. But that hasn’t stopped Nutra Pharma from cashing in on the appeal of an exotic, non-opioid pain reliever.

The Florida company’s main product – Nyloxin – is a homeopathic-based medicine that contains a tiny amount of cobra venom, which supposedly contains compounds that block pain signals from reaching the brain. Like other homeopathic products, Nutra Pharma’s CEO says only a small amount of the active ingredient is needed to make Nyloxin sprays and gels effective.

“Our regular strength product is 70 micrograms per milliliter of cobra venom,” CEO Rik Deitsch told PNN. “Our product is based on over a hundred years of research utilizing cobra venom at these dilution levels.”

But a complaint filed last fall by the Securities and Exchange Commission raises doubts about Nutra Pharma claims that it had 1,300 cobra snakes on a Florida farm that it “milks” monthly for venom.

“Nutra Pharma never had a cobra farm, never had cobras, and indeed had never produced cobra venom,” the SEC said.

The only ones getting milked may be Nutra Pharma’s investors. The SEC complaint alleges Deitsch used manipulative insider stock trades and “a series of materially false or misleading press releases” to defraud investors out of nearly $1 million.

This week the U.S. Food and Drug Administration got into the act by sending a warning letter to Deitsch for illegally marketing unapproved products with false claims about their ability to treat chronic health conditions.  

“Today, we posted a warning letter to a company preying on patients who may be seeking alternative treatments for chronic pain, cancers, arthritis and autoimmune and neurological disorders. Health fraud scams like these are inexcusable,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

They may be inexcusable, but they’ve been going on for years with little government oversight. Nutra Pharma’s multi-level marketing touts Nyloxin as “clinically proven to treat moderate to severe chronic pain.” and its website has dozens of glowing reviews from customers.  In a video on its YouTube channel, one customer even claims Nyloxin helped him become the first rheumatoid arthritis sufferer to climb Mt. Everest.   

The FDA commissioner says its time for deceptive marketing claims to end.

“One of our most important obligations is to protect consumers from those who would prey on them with bogus claims and fraudulent products. We’ve dedicated new resources to our enforcement work and I consider these activities the cornerstone of our consumer protection mission,” said Gottlieb. “We’re especially focused on those who would exploit Americans harmed by the opioid crisis with the false promise of products that can treat pain or addiction, but that offer no such benefit.”

It’s good that Gottlieb wants to protect consumers, but he fails to recognize that many Americans are turning to products like Nyloxin because they’re losing access to opioid therapy.  Denied the pain medication that most have safely used for years, patients are experimenting with alternative treatments, including some that are dubious or even fraudulent, such as compounded pain creams and cannabis skin patches.

PNN’s recent survey of over 5,800 patients found that 20 percent had tried medical marijuana or kratom for pain relief. Even more (26%) had used alcohol and a small number (4%) had turned to illegal drugs such as heroin. One in ten said they were getting prescription opioids from family and friends or buying them on the black market — which is being flooded with “Mexican Oxy” and other counterfeit pills laced with fentanyl.

Is it any wonder that people are buying Nyloxin? Or that Nutra Pharma is touting it as a “non-narcotic” and “safe” homeopathic solution to the opioid crisis? In a sense, policymakers have done all the marketing for them.

“I can tell you we have hundreds, if not thousands of people that have reduced or gotten off their opiates with Nyloxin,” said Deitsch, who intends to comply with the FDA request and continue selling Nyloxin. “We are answering the FDA warning letter. We are making the changes to the website and the claims they have asked us to make. But it is a great product and we stand by it.”

Illicit Fentanyl Deaths Rising at ‘Exponential Rate’

By Martha Bebinger, Kaiser Health News

Men are dying after opioid overdoses at nearly three times the rate of women in the United States. Overdose deaths are increasing faster among black and Latino Americans than among whites. And there’s an especially steep rise in the number of young adults ages 25 to 34 whose death certificates include some version of the drug fentanyl.

These findings, published in a new report by the Centers for Disease Control and Prevention, highlight the start of the third wave of the nation’s opioid epidemic. The first was prescription pain medications, such as OxyContin; then heroin, which replaced pills when they became too expensive; and now illicit fentanyl, which is often mixed with heroin or used in the production of counterfeit pills

Fentanyl is a powerful synthetic opioid that can shut down breathing in less than a minute, and its popularity in the U.S. began to surge at the end of 2013. For each of the next three years, fatal overdoses involving fentanyl doubled, “rising at an exponential rate,” said Merianne Rose Spencer, a statistician at the CDC and one of the study’s authors.

Spencer’s research shows a 113 percent average annual increase from 2013 to 2016 (when adjusted for age). That total was first reported in late 2018, but Spencer looked deeper with this report into the demographic characteristics of those people dying from fentanyl overdoses.

FENTANYL DEATHS BY QUARTER (2011 TO 2016)

Increased trafficking of the drug and increased use are both fueling the spike in fentanyl deaths. For drug dealers, fentanyl is easier to produce than some other opioids. Unlike the poppies needed for heroin, which can be spoiled by weather or a bad harvest, fentanyl’s ingredients are easily supplied; it’s a synthetic combination of chemicals, often produced in China and packaged in Mexico, according to the U.S. Drug Enforcement Administration. And because fentanyl can be 50 times more powerful than heroin, smaller amounts translate to bigger profits.

Jon DeLena, assistant special agent in charge of the DEA’s New England Field Division, said 1 kilogram of fentanyl, driven across the southern U.S. border, can be mixed with fillers or other drugs to create 6 or 8 kilograms for sale.

“I mean, imagine that business model,” DeLena said. “If you went to any small-business owner and said, ‘Hey, I have a way to make your product eight times the product that you have now,’ there’s a tremendous windfall in there.”

For drug users, fentanyl is more likely to cause an overdose than heroin because it is so potent and because the high fades more quickly than with heroin. Drug users say they inject more frequently with fentanyl because the high doesn’t last as long — and more frequent injecting adds to the risk of overdose.

There are several ways fentanyl can wind up in a dose of some other drug. The mixing may be intentional, as a person seeks a more intense or different kind of high. It may happen as an accidental contamination, as dealers package their fentanyl and other drugs in the same place.

Or dealers may be adding fentanyl to cocaine, meth and counterfeit medication on purpose, in an effort to expand their clientele of users hooked on fentanyl.

“That’s something we have to consider,” said David Kelley, referring to the intentional addition of fentanyl to cocaine, heroin or other drugs by dealers. Kelley is deputy director of the New England High Intensity Drug Trafficking Area. “The fact that we’ve had instances where it’s been present with different drugs leads one to believe that could be a possibility.”

The picture gets more complicated, said Kelley, as dealers develop new forms of fentanyl that are even more deadly. The new CDC report shows dozens of varieties of the drug now on the streets.

The highest rates of fentanyl-involved overdose deaths were found in New England, according to the study, followed by states in the Mid-Atlantic and Upper Midwest. But fentanyl deaths had barely increased in the West — including in Hawaii and Alaska — as of the end of 2016.

Researchers have no firm explanations for these geographic differences, but some experts watching the trends have theories. One is that it’s easier to mix a few white fentanyl crystals into the powdered form of heroin that is more common in Eastern states than into the black-tar heroin that is sold more routinely in the West. Another hypothesis holds that drug cartels used New England as a test market for fentanyl because the region has a strong, long-standing market for opioids.

Spencer, the study’s main author, hopes that some of the other characteristics of the wave of fentanyl highlighted in this report will help shape the public response. Why, for example, did the influx of fentanyl increase the overdose death rate among men to nearly three times the rate of overdose deaths among women?

Some research points to one factor: Men are more likely to use drugs alone. In the era of fentanyl, that increases a man’s chances of an overdose and death, said Ricky Bluthenthal, a professor of preventive medicine at the University of Southern California’s Keck School of Medicine.

“You have stigma around your drug use, so you hide it,” Bluthenthal said. “You use by yourself in an unsupervised setting. [If] there’s fentanyl in it, then you die.”

Traci Green, deputy director of Boston Medical Center’s Injury Prevention Center, offers some other reasons. Women are more likely to buy and use drugs with a partner, Green said. And women are more likely to call for help — including 911 — and to seek help, including treatment.

“Women go to the doctor more,” she said. “We have health issues that take us to the doctor more. So we have more opportunities to help.”

Green noted that every interaction with a health care provider is a chance to bring someone into treatment. So this finding should encourage more outreach, she said, and encourage health care providers to find more ways to connect with active drug users.

As to why fentanyl seems to be hitting blacks and Latinos disproportionately as compared with whites, Green points to the higher incarceration rates for blacks and Latinos. Those who formerly used opioids heavily face a particularly high risk of overdose when they leave jail or prison and inject fentanyl, she noted; they’ve lost their tolerance to high levels of the drugs.

There are also reports that African-Americans and Latinos are less likely to call 911 because they don’t trust first responders, and medication-based treatment may not be as available to racial minorities. Many Latinos said bilingual treatment programs are hard to find.

CDC researcher Spencer said the deaths attributed to fentanyl in her study should be seen as a minimum number — there are likely more that weren’t counted. Coroners in some states don’t test for the drug or don’t have equipment that can detect one of the dozens of new variations of fentanyl that would appear if sophisticated tests were more widely available.

There are signs the fentanyl surge continues. Kelley, with the New England High Intensity Drug Trafficking Area, notes that fentanyl seizures are rising. And in Massachusetts, one of the hardest-hit areas, state data show fentanyl present in more than 89 percent of fatal overdoses through October 2018.

Still, in one glimmer of hope, even as the number of overdoses in Massachusetts continues to rise, associated deaths dropped 4 percent last year. Many public health specialists attribute the decrease in deaths to the spreading availability of naloxone, a drug that can reverse an opioid overdose.

This story is part of a partnership that includes WBUR, NPR and Kaiser Health News.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Dawn Anderson’s Desperate Plea for Help

DAWN ANDERSON

(Editor’s note: Red Lawhern recently wrote a column about Dawn Anderson, a 52-year Indiana woman who died this month after a long battle with chronic pain and illness. Dawn was a double amputee and diabetic. We may never know the precise cause of her death, but as Red points out, Dawn died in “needless agony” because her pain was poorly treated.      

Last September, Dawn wrote a letter to her longtime primary care provider and shared a copy of it with PNN. Her letter is essentially a plea for help. Dawn asked the primary care doctor to take over her pain management because she was no longer able to get opioid medication from Dr. Paul Madison, a pain specialist who ran afoul of the law and stopped practicing medicine.    

Dawn wanted the letter published and her family has agreed because they want her story to be heard.)

A Letter to My PCP From His Chronic Pain Patient

Dear Doctor, 

You and I have been together, side by side for many years. You have been my doctor. I have been your patient.  You have cared for me during my most vulnerable times. You know my most precious secrets regarding my physical and mental capacities.  I have shared openly and honestly from my heart. You have saved my life not once, not twice, but numerous times. 

The pain I have endured has been stressful, exhausting, depressing and life changing.  You had tried your best to control my pain. Thank you for your referral to pain management.  This has been my experience.

I was promised by numerous pain management physicians my pain would resolve and I would be walking upright.  I knew it was puffing as no doctor could make such a promise.  Each time seeing a new pain management specialist, I went through numerous non-opiate medications.  Lyrica, Elavil, Cymbalta, Neurontin -- the list goes on and on. They tried numerous alternative treatments. Physical Therapy, Occupational Therapy, Acupuncture, Acupressure, epidural injections, trigger point injections, caudal injections, radiofrequency nerve ablations. Not only did these cost lots of money, it took lots of my time and energy.  Most did not work.  Some gave relief that was short lived. 

Many of the doctors I had seen tried opiate medications.  I was on high dose Methadone when you referred me to the pain specialists. The Methadone made me so drowsy. It allowed me to sleep but it did not relieve the pain.  I was forced from pain doctor to pain doctor.  When one could not fulfill the promise of relieving the pain and having me walking upright, I was discharged from the service with a letter saying my condition was too complex and they would no longer see me. Or I would get the famous, “I don't know what else to do for you.”

Many of the opiates I was prescribed did not relieve the stabbing intractable pain I was experiencing.  One pain center refused to see me because I was discharged from one service and scheduled the appointment 28 days later.  I was accused of drug seeking.  I was in no way seeking drugs, I was seeking relief from the pain that kept me thinking I would be better off dead.

After the second amputation and surviving septic shock, I had no hope. I was so tired of the pain, the hospitalizations, the medications, the embarrassment of crawling around like a dog, the quality of life that I no longer had.  I couldn't even wipe my own butt.  But there was something about that granddaughter who was recently born that I needed to hold onto some type of hope things would get better.

Midwest Pain Management was my last hope.  I explained everything I had endured as far as pain treatments, the type of pain I was having and all the locations my pain was affecting.  I was slowly weaned off Methadone.  Again, I had to go through all those previous alternatives, previous medications, previous treatments.

The last trigger point injection I received caused an abscess about the size of a grapefruit.  I had to get the abscess drained, get placed on antibiotics and the doctor refused to do any further injections for fear of more infections and septic shock. The only option at this point was again, the opiate based medications. 

Now understand when you agree to go on opiate medication, you sign a pain contract. Basically limiting you to one doctor prescribing opiates, one pharmacy to obtain the opiate, monthly urine drug screens, and occasional pill counts which means the office can call you any time and you must go in with your pill bottle. 

Although many of the opiates caused drowsiness, they did not control the pain.  After almost two and a half years of trying different drugs at different doses, this pain doctor was able to find the right drug at the right dose that relieved my pain and not cause extreme drowsiness.  I was able to start doing things I did prior to both legs being amputated.  I was able to live on a daily basis without being so drowsy and unable to focus.  I began to have hope as I was able to care for my family, take care of the house, start paying the bills again, look forward to going on vacation. 

This was 8 years ago. I have remained on the same drug and the same dose for those 8 years.

You have seen me at my most desperate times. You have seen me when all I could do was focus on all the pain I was having.  And you can attest for the last 8 years, my pain has been under control and has not been a topic in our office visits until now.

You and I have always spoken with honesty and sincerity.  You have always called my pain doctor my drug dealer.  Although I have always smirked when you say it, it hurts my heart because I feel if it wasn't for this pain doctor who never gave up trying old treatments, new treatments, questionable treatments, I would have killed myself many years ago. 

The quality of life I had on high dose opiate medication relieved that excruciating stabbing pains in my back, stumps and hips.  I may not be walking upright but I was walking with minimal pain.  Until recently, you and your office did not even know I had a wheelchair.  How do you think I was able to do that?  I was able to do that because I was taking the pain medication my so-called drug dealer prescribed for me.  I never once abused them, misused them, diverted them, overdosed on them. 

Since the decrease and removal of the long acting medication, my quality of life has greatly diminished.  It is so painful to walk with the prosthetics. It hurts to bend, it hurts to stand. The pain has returned and again, all I can focus on. Being in constant pain is exhausting, depressing, and taking my will to live. 

You may see this as being addicted to the medication.  I see this as being addicted to the quality of life I had when my pain was under control. The life where I could put on my prosthetics, go shopping, go out in the yard and rake my leaves. The life where I enjoyed being around others without having constant pain to focus on.  That life where I loved to plan and go on cruises to the Caribbean. That life that no longer exists.

I feel like there is nowhere to turn, no one to help. I know there is a life where all this pain I am experiencing can be relieved with one medication. I am desperate to get that life back.

Sincerely,

Dawn Anderson

(Editor’s note: How did Dawn’s doctor respond? “I brought him the letter and have not received any communication from him. Just sad. He has been my doctor for decades,” Dawn wrote in an email last October. “I'll fight until I can't fight any longer. I have lost over 40 pounds and my muscles keep getting weaker.”

Dawn died on March 11, 2019. She is survived by her husband, two daughters and three granddaughters.)

Pain Patient’s Death Was ‘State-Sanctioned Torture’

By Richard “Red” Lawhern, Guest Columnist

Dawn Anderson was 53 years old and a former registered nurse. Her family has granted permission to share the story of her last days. Dawn’s story is both horrifying and highly representative of many people in pain. These are patients who – in effect, if not from deliberate intent – have died in entirely avoidable agony because of the CDC’s 2016 opioid prescribing guideline. 

Dawn was diabetic.  She also suffered from kidney disease.  She had lost both legs and one eye, resulting in severe pain for many years, which until recently was managed with opioid pain relievers.  Her pain management physician – Dr. Paul Madison -- is no longer practicing medicine. Madison was recently convicted of healthcare fraud and awaits sentencing for billing insurance companies $3.5 million for services he didn’t deliver. Madison reportedly had “pill mills” in 11 states, from which he dispensed very high volumes of opioids. 

When Dr. Madison was barred from further treating patients, Dawn sought help from multiple pain management doctors in her area.  She found that many were no longer accepting new patients.  Among the few who would see her, none would treat her with opioids at the dose levels that had been effective for her in the past. Several were transitioning their patients to addiction treatment with Suboxone or recommending steroid shots. 

DAWN ANDERSON

Dawn’s most recent pain management doctor refused to prescribe above 90 morphine milligram equivalents (MME) per day, citing the CDC guideline as a de facto maximum allowable dose level.      

Like many patients with chronic pain, Dawn’s medical situation was complex and involved several interacting medical disorders and issues.  She had a history of MRSA – a highly aggressive antibiotic-resistant staph infection.  Dawn had also personally observed many patients in whom spinal injections had led to worsening pain.  She refused both Suboxone and the steroid shots

On March 4, 2019, a family friend spoke with Dawn.  She was very tired and not feeling well. Her husband was calling from work throughout the day.  When she did not answer, he called the police department and asked for a wellness check. When police arrived, they found Dawn had fallen out of her wheelchair and was unconscious on her living room floor. She was transported to a hospital.  When she regained consciousness, she was very confused.

Hospital physicians determined Dawn had a severe urinary tract infection and her kidneys were failing. She was admitted to ICU and a doctor ordered a dialysis tube. Staff also forcibly started her on Thorazine injections, as she was refusing dialysis.  They asserted that she was mentally incompetent.   Family members observed that she was covered in bruises due to the force used when pinning her down to administer the injections.

On March 10th, Dawn was moved from intensive care to a regular hospital room. Her daughter called a family friend so that Dawn could talk to someone she liked and trusted.  The conversation was very difficult.  The friend asked why Dawn was refusing dialysis.  Dawn replied, “I just can't take it anymore.”  She anticipated having new issues with the dialysis, but most important was her unbearable pain.  Hospital staff had again refused to provide adequate treatment with opioid pain relievers.  

Both Dawn and her friend were in tears, but Dawn was adamant: “Honey, I love you, but I can’t suffer any more. The pain is unbearable and I just can’t fight any more. If you keep begging me to, I will hang up.” 

Dawn’s friend and her family had talked with her about entering hospice care, where she would at least be treated for her pain.  She was released from the hospital that day to go home.  Her friend spoke with Dawn an hour later.  She was tired, but had at last been placed on comfort care.

Dawn died a day later, on March 11, 2019. 

What can we learn from this deeply disturbing narrative?  Would Dawn have lived longer if she had been treated adequately with opioid pain relievers?  That is impossible to say with confidence.  But what is clear is that this woman died in needless agony.  Dawn should never have been forced to see a pill mill doctor in the first place. And she should never have been forced to taper from effective dose levels because legitimate doctors were intimidated by CDC and state regulators into refusing effective — and largely safe — opioid therapy. 

By any other name, this was state-sanctioned torture.  

It is not accidental that the American Medical Association recently repudiated the CDC guideline.  But the government dinosaur’s bureaucratic brain is in its tail and it hasn’t gotten the message yet. CDC has merely doubled down on the mythology that doctor over-prescribing caused our “opioid crisis.” They are running away from their own overdose data, which demonstrates the falsity of their assertion.

There is very little relationship between physician prescribing and either opioid addiction or overdose deaths. But the only metric CDC seems willing to use to measure the success of the war against drugs is reduced prescribing to Dawn Anderson and other people in pain.

It is time for this madness to stop!  Opioid prescribing guidelines need to be taken away from the CDC and rewritten from the ground up by more competent agencies or by professional groups within medicine itself.  And this time, multiple patient advocates need to be voting members of the writers’ group.

Richard “Red” Lawhern, PhD, has for over 20 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  Red is co-founder and Director of Research for The Alliance for the Treatment of Intractable 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.

What Doctors Say About CDC Opioid Guideline

By Pat Anson, PNN Editor

Over two-thirds of healthcare providers are worried about being prosecuted for prescribing opioid medication and many have stopped treating chronic pain, according to a new survey by Pain News Network on the impact of the CDC’s opioid prescribing guideline. One in four providers say they’ve lost a pain patient to suicide since the guideline was released in 2016.

A total of 68 doctors and 89 healthcare providers participated in the online survey. While that’s a relatively small sample size in comparison to the nearly 6,000 patients who took the survey, the providers come from a broad spectrum of healthcare, including pain management, primary care, palliative care, surgery, pharmacy, nursing and addiction treatment.

The CDC guideline discourages the prescribing of opioids for chronic pain and cautions doctors not to exceed a daily dose of 90 morphine milligram equivalents (MME) because of the risk of addiction and overdose. Although voluntary and only intended for primary care physicians, the guideline has been widely implemented as mandatory throughout the U.S. healthcare system.

Many doctors believe the guideline limits their ability to treat patients and has not improved the quality of pain care in the United States.  

“There are reasonable elements to the guidelines which should be preserved. However, setting an upper dose limit, especially one so low, severely interferes with titrating the opioids to their most effective doses, which is often much higher than 90 MME,” said a pain management doctor.

“The guidelines became hard rules for many insurance companies and pharmacies. Patients with pain have suffered in consequence,” said a palliative care doctor. 

“I see chronic pain patients all day that do not have their pain well controlled. It is heart breaking,” said another provider.

HAS CDC GUIDELINE IMPROVED QUALITY OF PAIN CARE?

“They are horribly ill-conceived. If we thought our previous approach to pain management was flawed, we surely will soon realize that these guidelines are worse,” said a pain management physician. “A patient told me two weeks ago that his friend needs repeated (coronary bypass) surgery, but now the hospital system treats post-surgical pain with Tylenol. This is barbaric.” 

An addiction treatment doctor summed up his feelings about the guideline with two words: “Misguided and draconian.”

Pain Contracts and Drug Tests

Nearly two-thirds of providers surveyed require patients to sign a “pain contract” before they get opioids. Over half have discharged a patient for failing a drug test or not following the rules. And nearly one in five mistakenly believe the guideline is mandatory.

• 64% require patients to sign a pain contract or take drug tests

• 52% have discharged patients for failing drug test or not following rules

• 45% use more non-opioid therapies

• 18% believe CDC guideline is mandatory

• 17% refer more patients to addiction treatment

• 10% stopped treating chronic pain patients

•   7% closed practice or retired due to concerns about opioids

“I feel like the blow-back to the CDC guideline is just as misplaced as the misuse of it. The recommendations are good science,” said a pharmacy provider. “There are lots of people - prescribers, pharmacists, insurance companies, law enforcement - who have misapplied the guidelines and are practicing poorly with them as an excuse. That is not the fault of the guidelines themselves, but the fault of poor education and dissemination.”

“These guidelines came from people that do not serve as clinicians to patients,” said one provider. “I have witnessed patients being abruptly cut off from medications they've been on for years and without any notice. Some have gone through extreme withdrawal to the point of death from the complications of withdrawal.”

Disparity in Prescribing

The survey found a wide disparity in how providers have adjusted to the guideline’s recommendations.

Nearly half still prescribe opioids above 90 MME when they feel it’s appropriate, while 20 percent only prescribe at or below the 90 MME threshold. Fourteen percent have stopped prescribing opioids altogether.

“We are getting dumped on by all the PCP’s (primary care providers). They no longer want anything to do with patients on opioids,” said a pain management doctor. “What is medicine coming to that the number of opioids is more important than a patient’s well-being?”

“Acute pain is now being undertreated, as well as many who have been denied pain control with opiates. These patients are being harmed. All of us prescribers know that the majority of overdoses are from illegal opiates from other countries. We are not stupid,” wrote a provider who works in urgent care.

HOW HAS CDC GUIDELINE AFFECTED YOUR OPIOID PRESCRIBING?

Chilling Effect

Doctors are well aware they are under scrutiny. The Drug Enforcement Administration and other law enforcement agencies monitor prescription drug databases (PDMPs) to track opioid prescriptions. While PDMPs were initially promoted as a way to protect physicians from “doctor shopping” patients, they are now routinely used by the DEA to identify, threaten and raid the offices of doctors who prescribe high doses – even when there is no evidence of a patient being harmed by the drugs.       

“PDMPs are tracking prescribing based upon CDC guidelines. That has an adverse effect upon prescribers who end up being profiled and in jeopardy of arrest and prosecution,” a doctor wrote.

“They have weaponized the political and legal manifestations of appropriately treating chronic pain,“ said a pain management doctor.

“They have shamed high dose long term opioid patients and treat the prescriber like a bad guy. They are clueless to the fact that majority of deaths have always been street addicts and not legit pain patients. The guidelines embolden medical regulators to come after doctors, resulting in chilling effect on prescribers,” said an addiction treatment doctor.

The crackdown has also had a chilling effect on pharmacies and insurers, who are just as eager to stay out of trouble. Nearly three out of four providers (73%) say they’ve had a pharmacy refuse to fill an opioid prescription and 70 percent say an insurer has refused to pay for a pain treatment.

“Why does CVS, a drug store that sells NSAIDs without restriction, have control of how I treat my patient?” asked one provider.

“The insurance companies are acting beyond the CDC guidelines with their hard limits on dosing, even sending threatening letters to doctors,” said a physician. 

“Pharmacies and insurances are dictating how we treat our patients without the medical ability or authority to make diagnosis or treatment plans. Each patient is different,” wrote one provider. 

“The guideline is extremely narrow-minded and reactionary. Yes, opioid addiction has become a huge problem, and yes, some physicians are partially to blame because of inappropriate prescribing, but plenty more physicians prescribe opioids appropriately. Now many of those doctors are scared to do their job, leaving patients in unnecessary pain,” said a doctor.

Biased CDC Advisors

Many providers believe the guideline advisors assembled by the CDC were biased and unqualified to make recommendations for pain management. Their initial meetings were closed to the public and the agency refused to disclose who the advisors were. Later it was revealed that five board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group, were involved in developing the guideline, including two that belonged to a key committee that helped draft it.

“They are an abomination that has been foisted on the world by PROP via the CDC and have no real clinical or evidence based background, yet are carried forward by political and bureaucratic purveyors of untruth,” said a pain management doctor.

“I believe this guideline was made by a panel without any pain doctors. How can they know what is best? They have contributed to stigma, and now patients instead of safely being monitored by pain clinics are turning to the streets and dying from illegal opioids. The CDC then uses that data to inflate the so-called epidemic,” said another provider.

“The CDC never weighed the information from the pain treating community. The consequences were predictable. Poor quality of life for the pain patients and continuation of the opiate epidemic from imported fentanyl. The guidelines were a travesty,” a pain management doctor wrote.

“The CDC did not have the legal authority to issue the guidelines in the first place. They should be declared unconstitutional and burned. Dosing should be following the FDA published guidelines for a particular medication,” said a pharmacy provider.

‘Where Are the Followup Studies?’

When it released the guideline in 2016, CDC said it was “committed to evaluating the guideline” and would make revisions if there were unintended consequences. A CDC spokesperson recently told PNN several studies are underway evaluating the guideline, but gave no indication that any changes are imminent.

“Where are the followup studies to monitor the incidence of patients committing suicide, looking for illicit drugs on the streets, overuse of NSAIDs, (acetaminophen) with organ damage and death, increased disability, loss of quality of life, overuse of alcohol and tobacco, worsening of co-morbid conditions due to weight gain, inability to exercise or sleep, adverse effects on relationships?” asked a pain management doctor. “The guidelines are effective at saving money for the payors. That, I fear, is why there is no serious effort to revise the guidelines.”

For a breakdown of some of the other key findings from our survey, click here. To see what patients had to say about the guideline, click here. Our sincere thanks to everyone who took the time to participate.

What Pain Patients Say About CDC Opioid Guideline

By Pat Anson, PNN Editor

Are there better and safer alternatives than opioids for chronic pain?

That’s one of the questions posed in PNN’s latest survey on the CDC’s opioid prescribing guideline. The guideline states that “no evidence shows a long-term benefit of opioids” and recommends physical therapy, cognitive behavioral therapy, massage and a number of non-opioid medications as safer and more effective treatments.

People in pain disagree. Nearly 7 out of 10 patients tell us there are no better or safer treatments for chronic pain than opioids.

But the numbers tell only part of the story. Most of the 5,885 patients who responded to our survey left detailed comments on how the CDC guideline has affected them.  

Many have lost access to opioid medications after using them responsibly for years. They feel abandoned by the healthcare system.

Some are bedridden due to physical pain, but also live with the emotional suffering that comes from losing jobs, financial security, marriages and friends.

Many are suicidal. And a few have turned to street drugs.

ARE THERE BETTER AND SAFER ALTERNATIVES THAN OPIOIDS FOR CHRONIC PAIN?

We thought the comments below were important for you to see. They are representative of the thousands that we received. The comments are edited for clarity and to protect the patients’ identities.  

‘I Have Lost So Much’

“I am now only able to use Tylenol for my multiple, severe chronic pain conditions. In two years, I have had to quit working, I am homebound, mostly bedridden. I am severely depressed, think about suicide daily as my only remaining option for pain management. I have severe insomnia due to the pain. I have developed severe hypertension and cardiac arrhythmia due to the constant severe pain and twice have suffered sudden cardiac arrest. The cardiologist said there is no underlying cardiac conditions, it is due to long term, unmanaged, severe pain.”

“I have been diagnosed with over 30 different conditions and a rare muscular disease. I spent thousands on doctors and natural treatments. Now, I have to suffer until I die. I have missed out on so much and lost so much. In bankruptcy, lost my business, could not go to Thanksgiving or Christmas, but the worst was I could not go to my daughter’s wedding. My life has become PAIN and my bed. As Americans we are supposed to have freedom. The right to choose what’s best for our pain. Each individual is different. The government should not choose what medication we should not take or how much.”

“You have no idea what it feels like to hurt, every single day. To be accused of being a drug addict for needing opioids. I have tried physical therapy. I have tried essential oils and Epsom salt baths. I have tried acupuncture and going to a chiropractor. I have tried every single alternative, but nothing helps the debilitating bone pain. I think of suicide, often. The opioids don't even get us high, it barely helps with the pain. At least with them, we can lead somewhat of a life. Right now I can barely work, let alone live. Your guidelines help no one but yourselves. People will always find a way to abuse something. But you guidelines are not hurting them. They are hurting us. You, are hurting us.”

“People with chronic/intractable pain just want to have some form of quality life. We want to live our lives. We want to be able to work, run errands like grocery shopping, clean our homes, cook food and take care of our families. I don't mention a social life as that is even difficult with good pain management. These guidelines are stripping people of their dignity, self worth and will to live, not to forget the shame and humiliation for needing narcotic pain medication in order to live.”

‘American Genocide’

"I am ashamed that my chosen career in Public Health has actively created a campaign based on false data.  The fact that the ‘prescription’ drug epidemic was based on both the legal and illegal drug statistics was openly stated at every public health presentation I attended. That more accurate breakdowns have now been published has not altered the campaign, since grant monies have been awarded to organizations based on the inaccurate info, and those organizations must follow-through with the original requirements to get their money. Although they knew that data on suicides and the impact on pain patient quality of life would need to be measured, information systems to gather this information were not put into place.” 

“A prescription opioid was the only medication that worked for me. I went through every non-narcotic drug before my doctor would even prescribe opioids. These guidelines have made doctors scared to write pain med prescriptions.  Never in my life did I think I would live in a country that has legalized the torture of millions of American citizens by withholding necessary pain medication. This is beginning to look like the start of an American genocide of chronic pain/ill people.”

“I believe everyone has a right to be pain free. Every person has a different pain tolerance and to deny them medication for their pain should be absolutely illegal. People who are denied pain medication WILL find another way to handle their pain, and WILL be more likely to overdose and possibly die. Denying prescription pain medication will not stop people from finding it somewhere else, it will only increase their desperation to find another way to get it.”  

I'm scared. I am a senior citizen. I cannot afford to go on like this. I am now afraid to see a physician because I am using Heroin for pain. I do not have a addictive personality. It is the only substance I use and only enough to barely function. I am frightened. I am ashamed. The one thing the CDC was attempting to halt has sent numerous pain patients down the road of underpasses and scary encounters to try and keep functioning as we used to before we were treated like addicts.”

“I have lost good friends because of the CDC guidelines. I have had 4 friends commit suicide because they could not deal with their day to day pain levels. I had a friend who broke his ankle bad enough that the bone was sticking out and he had to have surgery and they told him to take Advil and Tylenol afterwards. This is starting to be barbaric and inhumane.” 

‘Living on Borrowed Time’

“I have been fortunate. My doctor continues to treat me, prescribe my meds, and help when there is a problem getting prescriptions filled. However, many of my friends have had problems ranging from doctors discharging them to pharmacists refusing to fill their prescriptions and more. One of my friends committed suicide when her pain meds were taken from her and she could no longer live with her pain. I feel so fortunate that I'm not having these problems, but then I wonder if I'm living on borrowed time.” 

“My spine specialist informed me one year ago he would no longer be doing pain management due to the DEA. I have not been able to find another pain doctor.  I am 55 years old. I spend 75% of my days in bed suffering. Even taking a shower puts me in tears. My house is a mess. I only go to the grocery store and my primary care provider when I have to. I have had multiple injections in my back, have tried every OTC med but nothing helps. When I was on opioids I passed my urine screens, my medication was never off count. I took them as prescribed. WHY AM I BEING NEGLECTED? DON'T I HAVE THE RIGHT TO BE TREATED FOR MY PAIN?”

“I have chronic pain due to multiple spine surgeries and fibromyalgia. I am on Medicaid and unable to work. I was on the same dose of opioids through a pain management physician for over 10 years with no issues whatsoever. I was able to work, raise my children (single mom) and have a life. I now have been cut back so far that I have to choose whether or not I want a good night’s sleep. The CDC guidelines have completely left the chronic pain community out to dry.”

‘Doctors Have a Responsibility’

“Please please please tell doctors they have a responsibility to provide pain medication to patients whose lives are being destroyed by chronic pain. I've lost everything because I got hurt at work. I used to run marathons and triathlons. Now my my blood pressure has skyrocketed, I gained 30 pounds, I lost my independence, I have no social life, I lost my sex life, and as a result of all these things I finally lost my wife of ten years. The guidelines needs to emphasize the need for people like me to have access to pain meds because so far, every doctor I have come into contact with since my injury has ignored that part of the guidelines. If you want to see a doctor's eyes glaze over and watch them stop listening to you, just mention pain medication.”

“My doctor was placed under investigation by the DEA for overprescribing. His practice was for high risk pain patients (many receiving end of life care), so he was red-flagged for a high volume of opioid Rx’s. As a result multiple chain pharmacies refuse to fill his scripts, Medicare & Medicaid patients were dropped with only 30 days notice, and he had to start tapering all other patients no matter our diagnosis. My insurance has refused to reimburse my prescriptions and half my disability check now goes to pay for them. I have no quality of life, it hurts to do everything, even basic self-care. I was openly mocked by doctor at a recent visit to the emergency room when I said I had a pain level of 7. He told me I wouldn’t get my fix from him. I had fractured my back in a rollover car accident.”

“Four years ago I was diagnosed with a B cell Lymphoma cancer. At that time my cancer doc prescribed pain meds for the broken vertebrae the cancer caused and the pain that the chemo caused. I came out of remission recently and started another round of treatment. My cancer doctor will no longer prescribe pain meds for me because I now see a pain doctor. The pain doctor doesn't understand the new cancer drug I'm on and that the side effects of this drug are pain, so he is very reluctant to manage my cancer pain. Many days I wonder if it would just be better to let the cancer take its course than to be scrutinized and treated like a criminal.”

“I am 88 years old and the dosage of medication I was given before these guidelines went into effect gave me a decent quality of life and I was able to endure the severe chronic pain I have had for years. I am now in a nursing home with a 38-year-old doctor who refuses to treat my pain. I feel helpless and fear I am going to remain in this nursing home much longer than I would like. I am also angry, in pain and have become depressed due to my situation. I have thought of suicide, often. I recall our lawmakers and others stating they did not want to do anything to keep the elderly from suffering due to these changes. I am here to tell you that they missed that goal by a long shot. As an elderly man, I should have the right to take what I need to live out my last bit of time on this earth as comfortable as possible. These guidelines have made that impossible.”

For a breakdown of some of the key findings from our survey, click here.  To see what doctors and other healthcare providers are saying about the guideline, click here.

Survey: CDC Guideline Having ‘Horrendous’ Impact on Pain Patients

By Pat Anson, PNN Editor

The CDC opioid prescribing guideline has harmed pain patients, significantly reduced their access to pain care, and forced many patients to turn to alcohol and other drugs for pain relief, according to a large new survey of over 6,000 patients and healthcare providers by Pain News Network. 

Today marks the third anniversary of the CDC guideline, which discourages the prescribing of opioid medication for chronic pain. Although voluntary and only intended for primary care physicians, the guideline has been implemented as mandatory policy by many states, insurers, pharmacies and throughout the U.S. healthcare system. The survey found many unintended consequences for both patients and providers.

Over 85 percent of patients say the guideline has made their pain and quality of life worse. And nearly half say they have considered suicide because their pain is poorly treated.

“The guidelines are affecting legitimate patients in a horrendous way while the actual addicts are just turning to street drugs,” said one pain sufferer.  “My quality of life has been so drastically reduced I attempted to take my life last year. Fortunately, I was found before I could bleed out but every single day has been an absolute struggle.”

Over two-thirds of healthcare providers are worried about being sanctioned or prosecuted for prescribing opioids. Rather than risk going to prison, many have stopped treating pain, closed their practice or retired.

“Many of those doctors are scared to do their job, leaving patients in unnecessary pain, both acute and chronic. Tapering patients on chronic stable doses of opioids because some people abuse opioids is not just unjustified, it’s cruel and harmful,” a doctor wrote.

The PNN survey was conducted online and through social media from February 17 to March 15.  A total of 5,856 patients and 157 doctors and other healthcare providers in the U.S. participated.

Asked if the guideline is helpful or harmful, 96 percent of respondents said it has harmed pain patients — a startling verdict for an agency with a mission statement that says “CDC saves live and protects people from health threats.”

“Cannot understand or know why the CDC will not speak out on the harm done to undertreated, denied and abandoned patients,” one patient said.

“It was a criminal act. The outcome was foreseen, the guidelines were written in secret, and the carnage that we predicted has come to pass,” said an emergency medicine physician.

“They should be revoked. People are suffering and committing suicide due to inability to tolerate suffering. This is inhumane,” another provider wrote. “It blemishes CDC’s reputation.”

HAS CDC GUIDELINE BEEN HELPFUL OR HARMFUL TO PAIN PATIENTS?

Opioid Prescriptions Declining

Opioid prescriptions in the U.S. have been declining for several years and now stand at their lowest level since 2003. The drop in prescriptions appears to have accelerated since the CDC guideline was released in 2016.

Eight out of ten patients said they are being prescribed a lower dose or that their opioid prescriptions were stopped. Many indicated they were forcibly tapered off opioids without an effective alternative.

“I had my pain under control until my doctor told me he was cutting my pain meds by half,” a patient said. “He lied to me, he cut them by 85% and now I am home ridden! The CDC guidelines are a disaster to the chronic/intractable pain patients.”

“I have lost all quality of life and many days I no longer want to live with this pain,” another patient wrote. “I've never abused my meds, yet I'm being treated like a drug addict.”

“VA doctors are afraid to prescribe any opioids or narcotics, because of mandatory education courses given to all VA doctors,” a nurse with the Veterans Administration said. “The veterans are not being treated for chronic pain. Suicides have increased!”

“Our doctors should not have to choose between treating their patients in a safe meaningful way or feeling like they could lose their licenses to practice,” another patient said.

HOW HAS CDC GUIDELINE AFFECTED YOUR OPIOID PRESCRIPTIONS?

Patient Abandonment

It’s not just opioids that patients are losing access to. Nearly 9 out 10 pain patients report problems finding a doctor that’s willing to treat them. Many say they’ve been discharged or abandoned by a doctor or had problems with a pharmacy or insurer. Only a small percentage of patients have been referred to addiction treatment.

• 73% of patients say it is harder to find a doctor

• 15% unable to find a doctor

• 34% abandoned or discharged by a doctor

• 27% insurer refused to pay for a pain treatment

• 27% pharmacy refused to fill an opioid prescription

• 5% given a referral for addiction treatment

“As an RN in pain management I have seen decreased quality of life, increased pain and anxiety for patients. Providers fear for their license and livelihood. My staff spends HOURS on the phone trying to authorize scripts,” a nurse wrote.

“Most doctors in our area are refusing to prescribe any opioids, even the pain management doctors. This is forcing some patients to buy street drugs,” a primary care physician said.

Desperate Measures

The widespread denial of care has many patients taking desperate measures for pain relief. One in five are hoarding opioid medication because they fear losing access to the drugs. Many others are using alcohol, marijuana or the herbal supplement kratom for pain relief. A small percentage are using illicit drugs. Few have found medical treatments that work as well as prescription opioids.

• 22% of patients hoarding opioid medication

• 11% obtained opioid medication from family, friends or black market

• 26% used medical marijuana for pain relief

• 20% used alcohol for pain relief

• 20% used kratom for pain relief

• 4% used illegal drugs (heroin, illicit fentanyl, etc.) for pain relief

• 2% found other treatments that work just as well or better than Rx opioids

“I know seven people personally that have gone to the streets to get pain relief. Four of them died because it was mixed with fentanyl. Two committed suicide,” one patient said.

“Since my doctor stopped prescribing even my small amount of opioids, I deal with days where I can’t even get out of bed because I hurt so much and I’m stuck turning to alcohol, excessive amounts of acetaminophen and NSAIDs,” another patient wrote. “Kratom has been the omly thing that has helped my pain.”

“I have been without a prescription for two years and have been getting medication on the street. I cannot afford this and I have no criminal history whatsoever. I have tried heroin for the first time in my life, out of desperation and thank God, did not like it. It was stronger than anything I need to help with pain,” wrote another patient.

Addiction and Overdoses Still Rising

While the guideline appears to have significantly reduced the dose and quantity of opioid prescriptions, patients and providers overwhelmingly believe it has failed to reduce opioid addiction and overdoses. Nearly 49,000 Americans died from opioid overdoses in 2017, but over half of the deaths involved illicit fentanyl or heroin, not prescription opioids.

“They are attacking the wrong problem. Pain patients are under strict scrutiny by their doctors and therefore have an addiction rate lower than the general population. The large numbers of deaths are among those who are using heroin and other illegal drugs,” one patient wrote.

“As a retired substance abuse counselor, these new guidelines do nothing to stop the real addict. It only hurts those of us in chronic pain,” said another patient.

“What happened to care for the elderly, disabled and sick?” asked one patient. “We are not the problem. The amount of prescription pain medicine has significantly gone down but the overdoses are continuing to rise. This is targeting the wrong people!”

HAS CDC GUIDELINE REDUCED OPIOID ADDICTION AND OVERDOSES?

Guideline Revisions Needed

An overwhelming majority (97%) of patients and healthcare providers believe the CDC guideline should be revised. When it released its recommendations in 2016, the agency said it was “committed to evaluating the guideline” and would make future updates “when warranted.” A CDC spokesperson recently told PNN there are several studies underway evaluating the impact of the guideline, but gave no indication that any changes are imminent.

Patients and providers say the the guideline is misunderstood, based on faulty evidence and needs revision.

“It is a falsified document created only to satisfy political pressure which demanded such a report. There is no medical/scientific evidence to support the conclusions made in the document,” a patient wrote.

“The CDC needs to correct their glaring error. They need to make sure that every doctor in America is re-educated and reassured that they can treat people with serious pain disorders without being jailed,” said another patient. “The CDC needs to stand up and admit their mistake, they need to correct the damage.”

“While the guidelines are useful, they should not have been made into mandatory rules followed by states and insurers. The patients with chronic pain issues are suffering. Can we revisit them?” asked a palliative care doctor.

SHOULD CDC GUIDELINE BE REVISED?

For more survey results and comments on the guideline, see “What Pain Patients Say About CDC Opioid Guideline” and “What Doctors Say About the CDC Opioid Guideline.”

Over 6,200 people responded to PNN’s survey. In tabulating the results, we did not include the responses of caretakers, spouses and friends of patients or those who live outside the U.S. We greatly appreciate everyone who participated and will be releasing more survey results in coming days.

Oregon’s Opioid Tapering Plan Delayed

By Pat Anson, PNN Editor

A controversial plan that could force thousands of Medicaid patients in Oregon off opioid pain medication has been put on hold because of a medical expert’s potential conflict of interest.

Oregon Health Authority (OHA) Director Patrick Allen asked the Health Evidence Review Commission (HERC) to table a final vote on changes in opioid policy until his agency could get an independent review of the recommendations.

At issue is a task force plan to limit Medicaid coverage of opioids to just 90-days for fibromyalgia and lower back pain. Patients currently on opioids longer than 90 days would be required to taper off the medications and switch to alternative therapies such as acupuncture and physical therapy that would be covered by Medicaid.

The plan has drawn nationwide criticism from chronic pain patients, advocates and pain management experts who say forced tapering would “exacerbate suffering for thousands of patients.”

Allen said he learned this week that Dr. Catherine Livingston, a family medicine physician who serves as a contracted medical consultant to HERC, is also a paid consultant to the Kaiser Center for Health Research and the National Institute of Drug Abuse. Livingston helped draft the opioid coverage proposal.

“I have requested the HERC to remove a chronic pain management proposal from today’s agenda to allow OHA time to seek independent review to ensure no potential conflicts of interest compromised the way the chronic pain benefit proposal was developed for the HERC’s consideration,” Allen said in a statement.

“It is vital for the Oregon Health Plan to cover safe and effective therapies to help people reduce and manage chronic pain. Yet it is also vital that Oregonians have full confidence in the decisions the HERC makes to assess the effectiveness of health care procedures.”

No timetable was set for the independent review. At a HERC hearing earlier this week, The Bend Bulletin reported that state officials defended the opioid policy change.

“I think the potential harms associated with opioids have become clear,” said Dr. Dana Hargunani, chief medical officer for the Oregon Health Authority. “Harms shown by the evidence about tapering are less clear.”

But in a joint letter signed by over 100 pain management experts, Dr. Sean Mackey, chief of pain medicine at Stanford University, urged the commission not to mandate “non-consensual forced tapering.”

“We fear the HERC’s proposal is, in essence, a large-scale experiment on medically, psychologically and economically vulnerable Oregonians, at a moment when Oregon has already seen a significant reduction in opioid prescribing and prescription opioid-related deaths,” Mackey wrote. “The evidence supports that this proposal represents an alarming step backward in the delivery of patient-centered pain care for the state of Oregon.”

Other members of the task force questioned the distinction between forced and voluntary tapers.

“I can’t tell you whether the tapers I do in my practice are voluntary or involuntary,” said Dr. Roger Chou, a professor of medicine at Oregon Health & Science University who was one of the co-authors of the controversial CDC opioid prescribing guideline.  “I explain why I think that’s important, that it’s a safety issue, and I guide them through the process. I try to be empathetic, but they don’t want to taper.

“I don’t think there’s anything compassionate about leaving people on drugs that could potentially harm them.”

Steep Decline in New Opioid Prescriptions

By Pat Anson, PNN Editor

The number of doctors writing new prescriptions for opioid pain medication has fallen by nearly a third in recent years, according to a large but limited study that documents a dramatic shift in opioid prescribing patterns in the U.S.

Researchers at Harvard Medical School studied health data for over 86 million patients insured by Blue Cross Blue Shield from 2012 to 2017, and found that first-time prescriptions for patients new to opioids – known as “opioid naïve” patients -- declined by 54 percent.

At the start of the study, 1.63% of Blue Cross Blue Shield patients were being treated with new opioid prescriptions. Five years later, only 0.75% were.

The study also found a shrinking pool of doctors willing to start opioid treatment. The number of doctors who prescribed opioids for opioid naive patients decreased by nearly 30 percent, from 114,043 to 80,462 providers.

The research findings, published in The New England Journal of Medicine, do not provide any context on the patients’ health conditions or the severity of their pain and injuries. As such, it is a data-mining study that provides no real information on the harms or benefits of opioids.

"The challenge we have in front of us is nothing short of intricate: Curbing the opioid epidemic while ensuring that we appropriately treat pain," lead investigator Nicole Maestas, PhD, an associate professor of health care policy at Harvard Medical School, said in a statement. "It's a question of balancing the justified use of potent pain medications against the risk for opioid misuse and abuse."

First-time prescriptions for opioids are usually used to treat short-term acute pain caused by trauma, accidents or surgery. They rarely result in long-term opioid use or addiction, but have become a major target for healthcare policymakers and anti-opioid activists. Several states have adopted regulations that limit the initial supply of opioids to 7 days or less.

While the number of doctors starting opioid therapy has fallen dramatically, Harvard researchers say many are still engaged in “high-risk prescribing” – which they defined as new prescriptions for more than 3 days’ supply or a daily dose that exceeds 50 morphine milligram equivalent (MME).

More than 115,000 of these “high-risk prescriptions” were written monthly for Blue Cross Blue Shield patients. Over 7,700 of the prescriptions exceeded 90 MME per day, a dose that researchers say puts patients at a substantially higher risk of an overdose. The study did not identify whether any of those high-dose patients experienced an overdose.

Opioid prescriptions in the U.S. have fallen sharply since their peak in 2010, but have yet to slow the rising tide of overdoses. Nearly 49,000 Americans died from opioid overdoses in 2017, over half of them due to illicit fentanyl and heroin, not prescription opioids.

The Complexity of Rx Opioid Misuse

By Roger Chriss, PNN Columnist

The misuse of prescription opioids is a complex phenomenon. Recent research has found that non-medical opioid use almost always involves a variety of other substances -- not just exposure in the course of routine medical care.

The risks of non-medical prescription opioid use developing into addiction need to be better understood to develop more effective measures to prevent misuse and to ensure that patients who use opioids responsibly are not wrongly targeted.

A new study in The American Journal on Addictions looked closely at the 2016 National Survey on Drug Use and Health, which found that that about 2.5% of respondents had misused prescription opioids in the previous 30 days. Almost half (43.9%) obtained opioid analgesics from a friend or relative for free and most were using other substances, such as cigarettes, alcohol, marijuana or street drugs.

“So much of the public discussion focuses on the opioid epidemic as though it is happening in a vacuum when, in fact, so many people misusing prescription opioids are also engaging in other substance use,” says lead author Timothy Grigsby, PhD, an assistant professor at The University of Texas at San Antonio.

“If we want to end the opioid epidemic, and stop another similar one from taking its place, then we need to consider the entire clinical picture of the patient including their use of other substances.”

Grigsby and his colleagues found that prescription opioid and polydrug users were also more likely to engage in stealing, selling drugs, have suicidal thoughts, suffer from major depression and need substance use treatment.

A similar study recently published in the journal Pediatrics examined non-medical prescription opioid use by parents and teenagers. The study found that parental misuse of opioid analgesics was associated with teenagers doing the same, with mothers’ use having a stronger association than fathers’ use.

Parental smoking, low parental monitoring and parent-adolescent conflict were also associated with teenage prescription opioid misuse, as were adolescent smoking, marijuana use, depression, delinquency and schoolmates’ drug use.

Despite what you may have heard, non-medical prescription opioid use does not usually lead to heroin. The National Institute on Drug Abuse reports that only 4 to 6 percent of people who misuse prescription opioids transition to heroin.

But trends in this transition have been shifting. A new study in PLOS One found that people who injected illicit drugs who were born after 1980 were more likely to initiate drug use with prescription opioids and non-opioids, and had higher levels of polydrug use. This study was limited to Baltimore, but similar findings have been reported for other parts of the U.S.

Importantly, most non-medical prescription opioid use occurs in the context of more general substance use. U.S. News recently reported that most patients treated in emergency rooms for misuse of prescription medications get into trouble because they mixed different substances.

"Most of the time there may have been only one pharmaceutical involved, but there were other non-pharmaceutical substances or psychoactive drugs or alcohol involved as well. When people get into trouble with misusing medicines, they're usually taking more than one substance," Dr. Andrew Geller of the CDC told U.S. News.

This is a long-standing trend in the opioid crisis. The 2014 Overdose Fatality Report in Kentucky found that the top five drugs in drug-related deaths were morphine, cannabis, heroin, alcohol and alprazolam (Xanax), with more than one drug present in many overdoses.

Moreover, a new study in the Journal of Substance Abuse Treatment compared 2013 and 2017 data on patients seeking opioid addiction treatment. Researchers found that many patients had employment, psychiatric, alcohol and drug problems, and were more likely to have depression, anxiety, hallucinations and suicidal thoughts. In other words, the overdose crisis is far more complex and dangerous than just opioids alone.

Fortunately, these long-standing trends are now starting to be appreciated. Public and private health officials in Ohio have started looking at data from multiple sources to better address mental health and substance abuse. 

The overdose crisis is a fast-moving target that is rapidly evolving. Overdoses now more than ever involve multiple drugs, and may not even occur among people who use opioids non-medically or people who have a substance use disorder. Understanding these features of the crisis is essential for developing better responses.

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.

Are Sit-Stand Desks Overrated?

By Pat Anson, PNN Editor

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

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

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

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

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

Minimal Health Benefits

Just how reliable is this industry-promoted research?

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

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

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

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

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

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

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

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

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

Risky Combination: Opioids and Gabapentin

By Pat Anson, PNN Editor

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

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

KAISER HEALTH NEWS

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

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

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

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

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

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

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

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

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

My Daily Persistent Headache

By Warren Cereghino, Guest Columnist

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

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

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

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

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

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

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

WARREN CEREGHINO

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

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

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

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

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

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

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

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

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

Study: Alcohol Relieves Fibromyalgia Pain

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Menopause Linked to Chronic Pain

By Pat Anson, PNN Editor

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

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

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

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

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

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

The study findings are published in the journal Menopause.

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