The Magical Opioid Number

By Roger Chriss, Guest Columnist

Numbers can be impressive. They seem like powerful evidence or useful metrics in regulations and legislation.

In 2016, the Centers for Disease Control and Prevention issued its guidelines for opioid prescribing, setting a recommended daily limit on opioid doses at 90 morphine milligram equivalent (MME). Now the Centers for Medicare and Medicaid Services (CMS) is on the cusp of adopting that number as a requirement for Medicare recipients. Physicians around the country have already started using it and so has the Veterans Administration.

In addition, Maine has passed a state law with a maximum 100 MME allowed for opioid prescribing starting on July 1, 2017. New Jersey, Virginia and other states are also passing laws restricting opioid prescribing by dose or duration, often citing the CDC guidelines as justification. 

But this number is all but arbitrary. The CDC guidelines recognize that the 90 MME ceiling was based on limited evidence. Obviously, patients are not safe at either 80 MME or doomed at 100 MME.

Nor can this number be used to calculate the safe number of days or doses for an opioid prescription. It is a magical number. And magical numbers can lead to magical thinking.

In fact, the 90 MME from the CDC cannot even be reliably calculated. The CDC offers an app that allows physicians to calculate the 90 MME. Its basic methodology is described here. Web sites like Practical Pain Management also offer an opioid calculator, and third-party developers have created opioid conversion apps.

But it turns out that the results of these calculators are inconsistent. Dr. Jeffery Fudin and his students have shown that the various methods of calculating MME produce significantly different outcomes.

Thus, how much of a morphine equivalent dose an individual is actually allowed to receive depends on which method is used. This uncertainty makes the 90 MME level clinically less than meaningful and potentially dangerous.

Existing research does show an increased risk of addiction and overdose as the daily dose of an opioid medication rises. But this is exactly what we should see. Most substances are more dangerous in larger quantities, after all. But each patient is different: gender, age, health status, prior opioid exposure, and other factors all play a significant role in determining a safe and effective dose of an opioid medication.

A cutoff like 90 MME is at best arbitrary. At worst it leaves some patients undertreated, and may harm patients who are forced to taper to the 90 MME threshold from a higher dose that has been safe and effective for them.

In addition, it is not entirely clear how the magic number of 90 MME was determined. The CDC developed its guidelines in a largely closed-door process that involved outside consultants whose identity was not revealed at the time. Most magical numbers are like this: their justification is thin and often obscured.

Meanwhile, the CMS and states like New Jersey and Maine are ignoring more important numbers. A recent STAT News article reported that opioid prescriptions have been falling since 2012 and that the misuse of pain relievers bottomed out in 2014. In other words, opioid prescribing is no longer a driving factor in the opioid crisis -- street drugs are.

The magical number of 90 MME is simply not justified. The relative risk of prescription opioids, in particular for people with chronic or intractable pain, is quite low. This fact was ignored in the CDC guidelines and in state government regulation. But it should be obvious: Most Americans have taken opioids at some point in their lives, whether after trauma or surgery or as a part of dental care. And it is abundantly clear that the majority have not become addicted to opioids. Again, the magic number is not real.

On February 9, 1950, Senator Joe McCarthy gave a speech in Wheeling, West Virginia, claiming that the U.S. State Department was infested with Communists, specifically 205 of them. This number helped launch a wave of political repression, fear-mongering, and social paranoia that we now refer to as McCarthyism. Nothing good came of that era, except maybe a cautionary note about how magical numbers can contribute to tragic results.

We are facing a similar risk with opioids, a magical number motivated by magical thinking by regulators and policymakers -- none of which is likely to help address the opioid crisis or the tragedy of addiction.

Instead, millions of people who may benefit from short-term opioid therapy after trauma or surgery will be denied effective medication for pain management, and tens of thousands of people with chronic conditions for whom opioid therapy is a critical component in maintaining a reasonable quality of life will be harmed. These are real numbers that we really need to pain attention to.

Roger Chriss suffers from Ehlers Danlos syndrome. Roger is from Washington state, where he works as a technical consultant who specializes in mathematics and research.

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.

Signing a Pain Contract in the Age of Opioid Phobia

By Crystal Lindell, Columnist

I know, I know. Opioids seem to be all that pain patients talk about these days. Blah, blah, blah. We get it, you need drugs. Let’s move on already.

But I don’t have that luxury. Opioids are, for better and for (mostly) worse, a huge part of my life. And I recently decided that I was:

A. Going to need to continue taking at least a small dose of hydrocodone long-term

B. That I really needed a slighter larger, “small dose” to be able to function.

I have what’s called intercostal neuralgia on my right side and the best way I can think to describe it is that I always feel like I have three broken ribs. The pain is no joke. And although it seems to be more manageable these days, it lingers and it hurts like hell, and opioids are the only thing I have found that even kind of helps.

Without hydrocodone I am in too much pain to shower regularly, check email, do my makeup or even sit a restaurant and eat.  With hydrocodone I can pretty much do all those things, like a typical health person who’s just a bit high. 

And yes, I know they are addictive, I know how hard they are to get off of, and I know that withdrawal is hell. I’ve been through it. I took myself down to 5 mg a day from 60 mg day when my pain became more manageable. It wasn’t easy. It took about a year for my brain to deal with that, and the withdrawal issues sucked.

So, when I say I need to be on hydrocodone, I say it with all the wisdom and caution that comes from the personal experience of dealing with opioids — and their side effects. 

And honestly, I’m among the lucky ones. When I called my doctor to ask if I could up to 10 mg a day, he agreed and knew I wouldn’t be asking if I hadn’t given lots of thought to the pros and cons of that choice. 

But that doesn’t mean dealing with opioids doesn’t also suck. 

First, I had to drive two hours each way to see him, because that’s how far away the closest university hospital is to my house and my case is too complex for the local small town doctors. And, as a reminder, I live my daily life feeling like I have three broken ribs. Driving two hours each way sucks. 

Then, when I got there, I had to take a drug test. Some politician somewhere decided people on opioids shouldn’t be using pot. Okay. But peeing in a cup sucks when you’re a woman. It gets all over your hands. You miss the cup and don’t collect enough. It’s just messy. 

But fine. Whatever. 

I peed in a cup. Good news. I’m clean. Well, I mean, aside from the hydrocodone, I’m clean. 

Signing a Pain Contract

Then, I had to sign what is formally called the “Controlled Substances Medication Agreement” — basically an opioid pain contract. At first blush it doesn’t seem like a big deal. As long as I’m a good person, there shouldn’t be any issues, right?

But the thing is literally 21 bullet points long. And it feels like I signed away all of my rights. 

The contract includes things like bullet point number 8, which requires that I get my prescription filled at the same pharmacy every month.

This is annoying because I use my local small town pharmacy, which is closed on Sundays, holidays and every night at 7 p.m. And if I’m due for a refill on a Sunday or out of town for work when my prescription expires, I can’t get it filled early, as bullet point number 14 clearly explains. 

Bullet point 14 also says I have to keep all my drugs in a locked cabinet or safe, and if they’re ever stolen I can’t get an early refill. Guys, that’s just not practical. I take these meds as needed, and sometimes that means I’m at the grocery store or visiting a friend or eating at Taco Bell, and then suddenly they are needed. And at those times, they are in my purse, which doesn’t have a lock on it. 

Bullet point number 11 says I can’t go to the emergency room for opioids, which sucks because sometimes my pain spikes and the only thing that gets it under control is a shot of dilaudid, which I usually get at the ER. I guess now when my pain spikes, I’m supposed to drive two hours to my doctor and hope he’s available to deal with it. 

Oh, and if I’m ever too sick to make that drive, nobody is allowed to pick up my hydrocodone prescription unless I have pre-authorized them, as per bullet point number 13. Of course, it has to be a written prescription — doctors cannot legally call in or fax hydrocodone  prescriptions anymore. 

I also agreed to get random drug tests, allow pill counts. and basically just give up all of my dignity. 

Fine. Okay. I need these medications. So I signed on the dotted line. And I guess I just have to hope I never get robbed, have a flare up or need a refill on a Sunday. 

The thing about opioids is that everyone assumes that if they ever need these drugs they will be able to get them. That anyone who’s truly deserving doesn’t have anything to worry about. But I have to tell you something: I’m a good person. I’m in real pain. I need these drugs. And I’m barely able to get them.

I understand how powerful these drugs are. Going off morphine was literally hell for me. But you know what else is hell? Living every day of your life feeling like you have three broken ribs. 

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

Heroin Tops Painkillers as Leading Cause of Overdoses

By Pat Anson, Editor

One in four drug overdoses in the United States can now be blamed on heroin, according to a new report by the Centers for Disease Control and Prevention that shows deaths linked to prescription painkillers falling.

The report found that fatal drug overdoses have more than doubled in the U.S. since 1999, with overdose death rates growing the fastest among whites and middle aged Americans.

In 2015, the overdose death rate was 16.3 per 100,000 people, up from 6.1 deaths per 100,000 in 1999. Ten percent of the deaths in 2015 were classified as suicides, 84% were accidental and the remainder undetermined.

The report by the CDC’s National Center for Health Statistics further documents the changing nature of the nation’s drug problem. Overdose deaths involving natural and semisynthetic opioid painkillers – such as hydrocodone and oxycodone – remain high, but have fallen from 29% of all overdoses in 2010 to 24% in 2015.

At the same time, deaths involving heroin have tripled, from 8% of overdoses in 2010 to 25% in 2015 – making heroin the leading cause of drug overdoses.

Deaths involving synthetic opioids, a category that includes both fentanyl and tramadol, rose from 8% of overdoses in 2010 to 18% in 2015. The U.S. has seen a surge in illicit fentanyl being sold on the black market, where it is often mixed with heroin or used to make counterfeit painkillers. More recent data from some states, like Massachusetts and Ohio, show that deaths involving fentanyl now exceed those linked to heroin and painkillers.

PERCENTAGE OF OVERDOSE DEATHS BY DRUG CATEGORY (SOURCE: CDC)

Perhaps the only bright spot in the report is that overdose deaths involving methadone have declined from 12% of deaths in 2010 to 6% in 2015.

The CDC analysis is based on death certificate codes, a database that is not always considered reliable because of wide variability in reporting from state to state.

“At autopsy, the substances tested for and the circumstances under which the toxicology tests are performed vary by jurisdiction,” wrote lead author Holly Hedegaard, MD, a medical epidemiologist with the National Center for Health Statistics.

“Additionally, drug overdose deaths may involve multiple drugs; therefore, a single death might be included in more than one category when describing the percentage of drug overdose deaths involving specific drugs. For example, a death that involved both heroin and fentanyl would be included in both the percentage of drug overdose deaths involving heroin and the percentage of drug overdose deaths involving synthetic opioids excluding methadone.”

Other highlights from the report:

  • West Virginia, New Hampshire, Kentucky and Ohio had the highest overdose rates in 2015
  • Nebraska, South Dakota, North Dakota and Texas had the lowest overdose rates
  • The age-adjusted overdose death rate among whites in 2015 was 240% higher than in 1999
  • The overdose rate for whites was nearly double that of blacks and three times higher than Hispanics
  • Overdose deaths grew among all age groups, but surged over 500% for adults aged 55 to 64

The report helps document a disturbing increase in deaths among middle-aged white Americans, first reported by Princeton University researchers in 2015.

Anne Case and Angus Deaton estimated that a "lost generation" of nearly half a million Americans died from a quiet epidemic of chronic pain, suicide, alcohol abuse and drug overdoses from 1999 to 2013.  

“This change reversed decades of progress in mortality and was unique to the United States; no other rich country saw a similar turnaround,” Case and Deaton reported in the Proceedings of the National Academy of Sciences. “This increase for whites was largely accounted for by increasing death rates from drug and alcohol poisonings, suicide, and chronic liver diseases and cirrhosis.”

The rising death rate for middle-aged whites was accompanied by declines in physical health, mental health and employment, as well as increases in chronic joint pain, neck pain, sciatica and disability.

Study: Suboxone Usually Fails To Stop Opioid Use

By Pat Anson, Editor

A drug widely prescribed to treat opioid addiction fails so often that two-thirds of the pain patients who took it during addiction treatment wound up getting opioid prescriptions again, according to a large new study by the Johns Hopkins Bloomberg School of Public Health.

Researchers analyzed pharmacy claims for over 38,000 people who were prescribed Suboxone (buprenorphine) between 2006 and 2013, and found that 67 percent of them filled a prescription for an opioid painkiller in the year after Suboxone treatment.

Nearly half of the patients – 43 percent -- filled an opioid prescription during treatment. Most patients continued to receive similar amounts of opioids before and after Suboxone treatment.

Suboxone is a combination of two different medications: buprenorphine, a short-acting opioid similar to methadone, and naloxone, an anti-overdose drug.

During most of the years analyzed in the study, Suboxone was the only combination of buprenorphine and naloxone that was available. It is now sold under several different brand names.

The Johns Hopkins study, which was funded by Centers for Disease Control and Prevention, found that about two-thirds of the patients who received Suboxone stopped filling prescriptions for it after just three months.

The findings, published in the journal Addiction, raise questions about the effectiveness of Suboxone and addiction treatment in general, at a time when the federal government is spending hundreds of millions of dollars to subsidize the addiction treatment industry.

"The statistics are startling," said lead author G. Caleb Alexander, MD, "but are consistent with studies of patients treated with methadone showing that many patients resume opioid use after treatment."

Researchers say the continued use of pain medication during and after addiction treatment suggests that many patients did not have well-coordinated treatment for their addiction or their chronic pain.

“There are high rates of chronic pain among patients receiving opioid agonist therapy, and thus concomitant use of buprenorphine and other opioids may be justified clinically. This is especially true as the absence of pain management among patients with opioid use disorders may result in problematic behaviors such as illicit drug use and misuse of other prescription medications,” Alexander wrote.

Prescriptions for Suboxone and other brands of buprenorphine have soared in recent years as the U.S. grapples with an “opioid epidemic” that was initially fueled by painkillers, but is now increasingly caused by heroin and illicit fentanyl. Sales of buprenorphine now exceed $2 billion annually and are likely to keep growing.

Last year the federal government nearly tripled the number patients that can be treated with buprenorphine by an eligible physician. Raising the limit from 100 to 275 patients was intended to give addicts greater access to treatment, especially in rural areas where few doctors are certified to prescribe buprenoprhine.

An additional $1 billion in funding for addiction treatment was approved by Congress last year under the 21st Century Cures Act. Much of that money will be used to pay for buprenorphine prescriptions.

Addicts long ago discovered that buprenorphine can be used to get high or to ease their withdrawal pains from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked it as the third most diverted opioid medication in the U.S. in 2014. 

Tougher Opioid Guidelines for U.S. Military and Veterans

By Pat Anson, Editor

It’s going to be even harder for U.S. military service members and veterans – especially younger ones -- to obtain opioid pain medication.

The Department of Veterans Affairs and the Department of Defense have released a new clinical practice guideline for VA and military doctors that strongly recommends against prescribing opioids for long-term chronic pain – pain that lasts longer than 90 days.

The new guideline is even more stringent than the one released last year by the Centers for Disease Control and Prevention (CDC).

It specifically recommends against long-term opioid therapy for patients under the age of 30.  And it urges VA and military doctors to taper or discontinue opioids for patients currently receiving high doses.

The 192-page guideline (which you can download by clicking here) is careful to note that the recommendations are voluntary and “not intended as a standard of care” that physicians are required to follow.

But critics worry they will be implemented and rigidly followed by military and VA doctors, just as the CDC guidelines were by many civilian doctors.

“I am concerned that many of these veterans with moderate to severe pain who may be well-maintained on long-term opioid therapy as part of a multidisciplinary approach or whom have already tried non-pharmacological and non-opioid therapies and found them insufficient will be tapered off their medication for no good reason except that their physicians will be fearful to run afoul of these new guidelines,” says Cindy Steinberg, National Director of Policy and Advocacy for the U.S. Pain Foundation, a patient advocacy group.

Although much of the research and clinical evidence used to support the new guideline was considered “low or very low” quality, a panel of experts found “mounting evidence” that the risk of harm from opioids -- such as addiction and overdose – “far outweighed the potential benefits.”

“There is a lack of high-quality evidence that LOT (long term opioid therapy) improves pain, function, and/or quality of life. The literature review conducted for this CPG (clinical practice guideline) identified no studies evaluating the effectiveness of LOT for outcomes lasting longer than 16 weeks. Given the lack of evidence showing sustained functional benefit of LOT and moderate evidence outlining harms, non-opioid treatments are preferred for chronic pain.”

The panel of experts was comprised of a diverse group of doctors, nurses and pharmacists within the Departments of Defense and Veterans Affairs, including specialists in pain management and addiction treatment. 

“We recommend against initiation of long-term opioid therapy for chronic pain,” reads the first of 18 recommendations of the expert panel, which said that only “a rare subset of individuals” should be prescribed opioids long term.

Instead of opioids, the panel recommends exercises such as yoga and psychological therapies such as cognitive behavioral therapy to treat chronic pain, along with non-opioid drugs such as gabapentin (Neurontin).

“In light of the low harms associated with exercise and psychological therapies when compared with LOT these treatments are preferred over LOT, and should be offered to all patients with chronic pain including those currently receiving LOT.”

Another strong recommendation of the panel is that opioids not be prescribed long-term to anyone under the age of 30, because of the damage opioids can cause to developing brains. 

“Some may interpret the recommendation to limit opioid use by age as arbitrary and potentially discriminatory when taken out of context; however, there is good neurophysiologic rationale explaining the relationship between age and OUD (opioid use disorder) and overdose.”

Of the seven studies used to support this claim, four were rated as “fair quality” and three were considered “poor quality.”

“That strikes me as an extremely weak evidence base for such a sweeping recommendation,” said Steinberg. “There is no mention of severity of pain condition which is extremely relevant in this population, many of whom sustained devastating and gruesome battlefield injuries such as blown off limbs.”

The panel recommends alternatives to opioids for mild-to-moderate acute pain. If opioids are prescribed temporarily for acute short-term pain, immediate release opioids are preferred.

Risk of Suicide Discounted

Pain is a serious problem for both active duty service members and veterans. A study found that nearly half the service members returning from Afghanistan have chronic pain and 15 percent reported using opioids – rates much higher than the civilian population.

The incidence of pain is even higher among veterans being treated at VA facilities. Over half suffer from chronic pain, as well as other conditions that contribute to it, such as depression and post-traumatic stress disorder. Even more alarming is a recent VA study that found an average of 22 veterans committing suicide each day.

The new guideline recommends that patients be monitored for suicide risk before and during opioid therapy, but curiously there is no mention that undertreated or untreated pain is also a risk for suicide. For patients being tapered or taken off opioids, doctors are advised not to take a threat of suicide too seriously.

“Some patients on LOT who suffer from chronic pain and co-occurring OUD, depression, and/or personality disorders may threaten suicide when providers recommend discontinuation of opioids. However, continuing LOT to ‘prevent suicide’ in someone with chronic pain is not recommended as an appropriate response if suicide risk is high or increases. In such cases, it is essential to involve behavioral health to assess, monitor, and treat a patient who becomes destabilized as a result of a medically appropriate decision to taper or cease LOT.”

Many patients could find themselves being tapered or taken off opioids if the guideline is taken literally by their doctors. The expert panel strongly recommends against opioid doses greater than a 90 mg morphine equivalent (MME) daily dose and urges caution for doses as low as 20 MME. 

“This again fails to recognize that patients differ widely in severity of pain, individual response to medication, body size and weight and tolerance for pain,” says Steinberg.

“I worry that, as we have seen with the CDC guidelines, clinicians will begin tapering patients who may be well-maintained on stable does of medication for fear of running afoul of sanctioned limitations rather than being guided by what is best for their patients. These limitations are in direct conflict with FDA approved labeling which is based on safety and efficacy trials and does not include dose thresholds.”

The VA and Department of Defense opioid guideline will affect millions of service members, veterans and their families. Nearly 1.5 million Americans currently serve in the armed forces and over 800,000 in the National Guard and Reserves.  The Veterans Administration provides health services to another 6 million veterans and their families.

The guideline is the second major initiative by the federal government so far this year aimed at reducing opioid prescribing. As Pain News Network has reported, the Centers for Medicare and Medicaid Services (CMS) has announced plans to fully implement the CDC’s opioid prescribing guidelines.

CMS is taking those voluntary guidelines a step further by mandating them as official Medicare policy and taking punitive action against doctors and patients who don’t follow them. CMS provides health insurance to about 54 million Americans through Medicare and nearly 70 million through Medicaid.

China Agrees to Crackdown on Fentanyl

By Pat Anson, Editor

China is finally taking steps to stop the production of illicit fentanyl, a synthetic opioid blamed for thousands of drug overdoses in the U.S. and Canada.

China’s National Narcotics Control Commission announced this week that it is “scheduling controls” against four fentanyl-class substances – carfentanil, furanyl fentanyl, valeryl fentanyl, and acryl fentanyl, starting on March 1, 2017.  The announcement came after several months of talks between the Chinese government and the U.S. Drug Enforcement Administration.

"Fentanyl-related compounds represent a significant and deadly component of the current opioid crisis.  These actions will undoubtedly save American lives and I would like to thank my Chinese counterparts for their actions on this important issue," said Acting DEA Administrator Chuck Rosenberg in a news release.

"It shows China's attitude as a responsible big country," Yu Haibin, the director of the Office of the National Narcotics Control Committee, told the Associated Press. "It will be a strong deterrent."

DEA officials say China’s move is a potential “game-changer” in the opioid epidemic, because it will close a loophole that allowed Chinese laboratories to manufacture fentanyl and its chemical cousins legally.

DEA PHOTO

The substances were then shipped to Mexico before being smuggled into the U.S. and Canada, where they were often mixed with heroin or used in the manufacture of counterfeit oxycodone and other painkillers. Traffickers also purchased pill presses from China, according to the DEA.

COUNTERFEIT OXYCODONE

“The counterfeit pills often closely resemble the authentic medications they were designed to mimic, and the presence of fentanyls is only detected upon laboratory analysis,” the DEA warned in a report last summer.

Fentanyl is up to 100 times more potent than morphine. It is legally prescribed in lozenges and patches to treat severe pain. Carfentanil is so potent it is used by veterinarians as an anesthetic on elephants.

Illicit fentanyl is mixed with heroin to increase its potency, but dealers and buyers may not know exactly what they are selling or ingesting. Massachusetts, Rhode Island, Ohio and other states have reported an “alarming surge” in fentanyl related deaths. In some states, the number of deaths from illicit fentanyl now exceeds those from prescription opioids.

Two public health researchers have speculated that a “malicious actor” could be behind some of those deaths.

“These highly potent pills could have been created by a malicious actor to intentionally poison consumers or attract the attention of law enforcement to redistributors,” wrote Traci Green, PhD, Boston University School of Medicine, and Michael Gilbert, MPH, Epidemico Inc., in a research letter published in JAMA Internal Medicine.

Waiting for My Pain Medication to Be Stripped Away

By Sheryl Donnell, Guest Columnist

Up until recently, I thought I was coming through this opioid crisis unscathed. My pain management doctor has been with a top clinic for many years and is highly respected and generally above reproach.

We did not have that dreaded conversation virtually everyone else with chronic pain I know has had -- until September 13th, 2016.

That night, I fell and broke 5 bones in my foot, which was already affected with Chronic Regional Pain Syndrome (CRPS). The pain was so incredibly severe.

I laid on the floor from 2 am to 10 am before I could stay alert enough, and not pass out from shock and pain, to get to a phone to call my husband upstairs for help (he is deaf in one ear). It took 4 paramedics to get me off the floor and into an ambulance.

Once at the hospital, even though I was writhing in agony and still passing out literally from pain, the doctor never examined me or my foot. She didn't care I had been on an ice cold floor for 6 hours. All she heard was "chronic pain patient" and she was done with me.

SHERYL DONNELL

I begged her to call the pain experts my doctor worked with so she could get some guidelines for treating me, but she didn't see a reason. I asked if she was familiar with CRPS, and she proudly said no and it didn't matter. She sent me for x-rays. No sooner did I get back in my room from another horrifyingly painful experience did she announce nothing was broken and to go home.

I sat there stunned. I had heard the bones break. I knew there were fractures. I begged the nurses to do something. I had not even been given a single Tylenol. This doctor firmly believed I was a drug seeker and wanted to bounce me.

The nurse started reading my discharge papers, which said, "Come back if you have any of these symptoms." I started crying harder. I said I have every one of those right now! She was practically in tears herself.

Then my husband asked, “What will he do when we get home? We can't even get her into the house!” The nurse told him to call the paramedics again to help get me back inside my home, which we did.

My husband called in 24-hour care workers to help me so I could manage a bit. It was agony going to the bathroom, even with a bedside commode my mother brought.

The following morning, the paramedics came back and helped me into the car. We went downtown for a pain injection to try to stop a progression of my CRPS. While there I insisted on new x-rays, which my pain doctor of 9 years grudgingly agreed to -- mostly to shut me up. He said come back in a week for another shot.

I asked for an increase in my pain medication. My biggest shock that day was his response. He said there was no reason for an increase! What? We went home to 24-hour care and instructions to start weight bearing exercises asap!

A full week later with not a single call, we returned to my pain management doctor for my second injection. He casually mentioned the results of my x-rays, which showed that I had 5 broken bones in my foot. No call for an entire week. I was left to think I was nuts and was trying to bear weight on a severely fractured foot!

I was not offered, nor were my requests for additional pain medication granted. I was told to come in every week for four more weeks (in great agony and great difficulty) for pain injections which did very little. However, I did not have a spread of my CRPS.

I did lose about 8 weeks of my life again. My pain levels were so extreme I did nothing but sit in my recliner and do a lot of crying. And realize how lucky I was to have family support, the ability to pay for 24-hour caregivers, and to be believed I was in the kind of pain I said I was in. My adult daughter moved home for a month to help me and my husband with caregiving duties.

What do other people do?

Even after my 6 weeks of pain injections, when I requested a short term increase in pain medication to help me rehab my still very painful foot once I was cleared by my orthopedist, I was again turned down by my pain management doctor.

It is now 5 months after I broke my foot and I cannot complete my rehabilitation because my pain is still so intense. I know if this had happened 5 years ago, I would not be suffering like this.

Even though my pain has worsened and I need to rehabilitate my injury, the CDC has arbitrarily changed the rules and I must suffer. My doctor's hands are tied.

I lose more and more days spent doing things I enjoy or need to do because the CDC’s “experts” sat in a room and made decisions based on flawed data and street drugs; not real patients who follow the rules of their pain contracts and don't seek out multiple doctors or illegal methods to get medication. I follow all the rules, just like 99.5% of my peers.

We are suffering and living in fear that we will be next to have our medication stripped away from us, through no fault of our own. And then the real terror begins.

Sheryl Donnell lives in Illinois. She suffers from CRPS and fibromyalgia.

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

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

How Have the CDC Opioid Guidelines Affected You?

By Pat Anson, Editor

Next month will mark the one year anniversary of opioid guidelines released by the Centers for Disease Control and Prevention – guidelines that discourage primary care physicians from prescribing opioids for chronic non-cancer pain.

At the time of their release, the CDC estimated that as many as 11.5 million Americans were using opioid medication daily for pain relief. Many of those patients now say their doses have been abruptly lowered or they are unable to obtain opioids at all.

That could be a good thing, depending on your point of view about the nation’s so-called “opioid epidemic.” Former CDC director Thomas Frieden, MD, has called the guidelines an “excellent starting point” to stop an epidemic fueled by “decades of prescribing too many opioids for too many conditions where they provide minimal benefit.”

Many pain patients disagree, saying they’ve used opioids safely and effectively for years. They say the guidelines have had a chilling effect on many of their doctors and are being implemented in ways that go far beyond what the CDC intended.  

“Last year, when the CDC ‘recommendations’ came out, the entire building of the only doctor's office I can go to decided they were rules, and cut me from 210 mg/day morphine to 90 mg. Now they say they can only give me 60 mg/day,” wrote Eli, one of hundreds of patients we’ve heard from in the past year.

“I'm in so much pain I can't properly care for myself, nor get to town for supplies when I need them. I've become increasingly more disabled and dependent on others.”

“My pain management doctor told me that the CDC required that all morphine be taken away from all Americans,” wrote a California woman who suffers from severe back pain. “He even stated that surgeons were sending home their post-surgery patients with Motrin, nothing else.

“What are you people in the CDC doing? Don't you realize how paranoid doctors can get? You may think using the term ‘guideline’ will help them understand what you are trying to do, but you have created a bunch of neurotic paranoids. Stop it. Do something before you kill all of us.”

“I am a 76 year old intelligent woman who is not an addict or an abuser, yet I am denied relief from unremitting pain even after 20 years of trying every drug and treatment modality available,” wrote Roberta Glick. “I am at a total loss as to what to do, how to fight, etc.  My physician is a strong supporter.  He is not the problem. He also is a victim of misguided CDC attempts to curb drug addiction.”

Are the CDC guidelines voluntary or mandatory? Have they improved the quality of pain care? Are patients being treated with safer and better alternatives? Most importantly, are soaring rates of opioid abuse and addiction finally being brought under control?

Those are some of the questions Pain News Network and the International Pain Foundation (iPain) are asking in an online survey of patients, doctors and other healthcare providers.

“I strongly believe that as these guidelines are implemented by doctors and hospitals around the country there are important lessons to learn from those who are affected by them,” says Barby Ingle, president of iPain and a PNN columnist.

“I hope that pain patients and providers participate in this survey so that we can begin to show how deep the impact actually is to the chronic pain community one year later.” 

The online survey consists of less than a dozen multiple choice questions, which should take only a few minutes to complete. Please take time out of your busy day and complete the survey by clicking here.

The survey findings will be released on March 15th, the first anniversary of the CDC guidelines. By taking the survey, you can also sign up to have the results emailed to you.

A Deadly Mix: Opioids and Alcohol

By Pat Anson, Editor

Taking one oxycodone tablet together with alcohol significantly raises the risk of respiratory depression and possible death, according to a new study by Dutch researchers. Elderly people were more likely to experience this complication, researchers found.

The study, published in the journal Anesthesiology, is one of the first to address the effect of alcohol and opioids on respiratory depression, which causes breathing to become extremely shallow or stop altogether.

"Unfortunately, we're seeing more fatalities and people in emergency rooms after having misused or abused legally prescribed opioids, like oxycodone, while having consumed alcohol," said lead author Albert Dahan, MD, a professor of anesthesiology at Leiden University Medical Center in the Netherlands.

"Respiratory depression is a potentially fatal complication of opioid use. We found alcohol exacerbated the already harmful respiratory effects of opioids."

Dahan and his colleagues studied the effects of oxycodone and alcohol on breathing in 12 healthy young volunteers (ages 21 to 28) and 12 elderly volunteers (ages 66 to 77). On three separate occasions, the volunteers were given one 20 mg oxycodone tablet combined with an intravenous infusion of ethanol (alcohol).

The amount of alcohol was increased until blood-alcohol levels reached 0.5 g/L on the second visit and 1.0 g/L on the third visit, as measured through the volunteers' breath. A man would need to consume about 5 alcoholic drinks to reach the latter level.

Taken alone, one oxycodone tablet reduced respiratory ventilation – the amount of air the volunteers breathed per minute -- by 28 percent. Adding 1.0 g/L of alcohol caused ventilation to further decrease by another 19 percent - a total decrease of 47 percent.

The combination of alcohol and oxycodone also caused a significant increase in the number of times volunteers temporarily stopped breathing. This was especially true in the elderly volunteers, who were more likely to experience repeated episodes where they temporarily stopped breathing.

"We hope to increase awareness regarding the dangers of prescription opioids, the increased danger of the simultaneous use of opioids and alcohol, and that elderly people are at an even greater increased risk of this potentially life-threatening side effect," said Dahan. "Ultimately, people should know that it is never a good idea to drink alcohol with opioids."

Although warning labels for oxycodone and other opioids caution against using them with alcohol, it’s common for the two to be mixed. A recent study by the Centers for Disease Control and Prevention found that alcohol was involved in about 15 percent of drug overdoses, including deaths associated with oxycodone, hydrocodone, morphine and fentanyl. 

New Guidelines Offer Little Relief for Back Pain

By Pat Anson, Editor

“Take two aspirin and call me in the morning” doesn’t cut it anymore for low back pain. In fact, very little does.

One in four adults will experience low back pain in the next three months, making it one of the most common reasons for Americans to visit a doctor. But when it comes to treating low back pain, the American College of Physicians (ACP) says the evidence is weak for many pharmaceutical and non-drug therapies.

In fact, the best treatment for acute low back pain may be none at all.

"Physicians should reassure their patients that acute and subacute low back pain usually improves over time regardless of treatment," said Nitin Damle, MD, president of ACP. "Physicians should avoid prescribing unnecessary tests and costly and potentially harmful drugs, especially narcotics, for these patients."

An ACP review committee analyzed dozens of clinical studies to arrive at new guidelines for treating acute back pain (pain lasting less than 4 weeks), subacute back pain (pain lasting 4 to 12 weeks) and chronic back pain (pain lasting more than 12 weeks).  

The ACP recommends that doctors start with non-drug therapies, such as exercise and superficial heat with a heating pad, along with massage, acupuncture, spinal manipulation (chiropractic), tai chi, and yoga. The evidence for the effectiveness of exercise and superficial heat was considered moderate, while the evidence for the other non-drug treatments was considered low quality.

Only when non-drug treatments have failed does the ACP recommend medication for chronic low back pain, starting with non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and aspirin. Tramadol (a mild acting opioid) and duloxetine (Cymbalta) are recommended as second line therapies. The ACP says physicians should only consider stronger opioids as a third line therapy when all other treatments have failed.

The evidence for the effectiveness of NSAIDs and opioids was classified as moderate, while the evidence for acetaminophen, benzodiazepines and systemic steroids was considered low-quality.

"For the treatment of chronic low back pain, physicians should select therapies that have the fewest harms and costs, since there were no clear comparative advantages for most treatments compared to one another," Damle said.

The ACP guidelines say surprisingly little about the documented risks associated with NSAIDs, such as cardiovascular and gastrointestinal problems. The guidelines refer only vaguely to “moderate quality evidence” that NSAIDs have “adverse effects.”

Short-term use of opioids for low back pain was linked to increased nausea, dizziness, constipation, vomiting, somnolence and dry mouth. Interestingly, addiction and overdose were not listed as potential risks because they were not studied.

“Studies assessing opioids for the treatment of chronic low back pain did not address the risk for addiction, abuse, or overdose, although observational studies have shown a dose-dependent relationship between opioid use for chronic pain and serious harms,” the guideline states.

The ACP guidelines were released one week after Australian researchers released their own evaluation of NSAIDs in treating back pain. Their study found that NSAIDs reduced pain and disability somewhat better than a placebo, but the results were not statistically important (see “Ibuprofen No Better Than Placebo for Back Pain”).

The ACP calls itself the largest medical specialty organization in the United States. ACP members include 148,000 internal medicine physicians (internists), related sub-specialists and medical students.

The new guidelines are published in the Annals of Internal Medicine.

Sex, Poverty and Education Linked to Chronic Pain

By Pat Anson, Editor

If you are female, poor and never finished high school, you are much more likely to suffer from chronic pain than other Americans, according to a new study published in the journal Pain.

“Women, the less educated, and the less wealthy experience not only more pain, but also more severe pain, as well as greater disability, said Hanna Grol-Prokopczyk, an assistant professor of sociology at the University of Buffalo.

Grol-Prokopczyk studied over 12 years of data from nearly 20,000 Americans aged 51 and over, who participated in the national Health and Retirement Study from 1998 to 2010.

Her research uncovered some unexpected findings about chronic pain in the United States.

She found that the severity and frequency of pain is increasing in older adults. People who were in their 60’s in 2010 reported more pain than people who were in their 60’s in 1998.

“There are a lot of pressures right now to reduce opioid prescription,” says Grol-Prokopczyk. “In part, this study should be a reminder that many people are legitimately suffering from pain. Health care providers shouldn’t assume that someone who shows up in their office complaining of pain is just trying to get an opioid prescription.

“We have to remember that pain is a legitimate and widespread problem,” she added.

The study is among the first to measure chronic pain by degree. Participants were asked whether their pain was mild, moderate or severe, and if they were “often troubled with pain.” Participants were followed for over 12 years, as opposed to most studies that follow patients over a much shorter period.

“I found that people with lower levels of education and wealth don’t just have more pain, they also have more severe pain,” she says. “I also looked at pain-related disability, meaning that pain is interfering with the ability to do normal work or household activities.  And again, people with less wealth and education are more likely to experience this disability.”

About one out of every four people who didn’t finish high school said their pain was severe, while only 10 percent of those with college graduate degrees did so.

About 8 percent of African Americans and Hispanics said their pain was severe, compared to about 5 percent of whites.

“If you’re looking at all pain – mild, moderate and severe combined – you do see a difference across socioeconomic groups. And other studies have shown that.  But if you look at the most severe pain, which happens to be the pain most associated with disability and death, then the socioeconomically disadvantaged are much, much more likely to experience it,” said Grol-Prokopczyk.

More research needs to be done to understand why pain is so unequally distributed in the population, and Grol-Prokopczyk says it’s critical to keep the high burden of pain in mind as the nation grapples with an overdose epidemic.

“We don’t have particularly good treatments for chronic pain. If opioids are to some extent being taken off the table, it becomes even more important to find other ways of addressing this big public health problem,” she said. “If we as a society decide that opioid analgesics are often too high risk as a treatment for chronic pain, then we need to invest in other effective treatments for chronic pain, and/or figure out how to prevent it in the first place.”

How We Can Stop Medicare’s ‘Big Brother’ Opioid Policy

By Rick Martin, Guest Columnist

How many readers who leave comments on PNN are doing more than just commenting?

Change takes work if the pain community is going to stop the Centers for Medicare and Medicaid Services (CMS) from making the CDC’s opioid prescribing guidelines mandatory for millions of Medicare patients, including a ban on daily doses higher than 90 mg morphine equivalent (see “Medicare Planning to Adopt CDC Opioid Guidelines”).

We don’t need CMS and the insurance industry dictating what medication a physician can prescribe for pain or the appropriate amount of medication needed (see "Insurers Behind Medicare's 'Big Brother' Opioid Policy").

In my opinion, this is what needs to be done:

We have to start a chain letter.

I propose a form letter that everyone can copy and paste, forward, fax and mail to friends, family, caregivers, bloggers, Facebook, Twitter, and any other viable means of communication.  

You have to send it to at least 10 people. And ask them to send it to 10 people they know.

The letter also needs to be sent to patient advocacy groups like the U.S. Pain Foundation, American Chronic Pain Association, International Pain Foundation and the Alliance for Balanced Pain Management, a coalition of advocacy groups. They can post it in their newsletters and alert their members to what CMS is doing. This is the only way to reach a huge amount of people in a short amount of time. 

Here are their email addresses:

We need to rein in CMS from dictating how we should live and the ability of our physicians to treat us. It won’t be easy. It took me 27 letters to the CDC to get a response from Dr. Debra Houry, who helped draft the agency’s guidelines.  

CMS is only accepting emailed public comments to their proposal until March 3, 2017. They will publish the final rules on April 3, so there is not much time. We must all act NOW.

Here is what I am emailing to CMS at this email address: AdvanceNotice2018@cms.hhs.gov

To Whom It May Concern:

I oppose the Centers for Medicare and Medicaid Services’ plan to align its policies with the CDC Guideline for Prescribing Opioids for Chronic Pain.

The CDC guideline is voluntary and gives physicians discretion in determining what is right for their patients. However, your policy as presently drafted will make the guidelines mandatory for all doctors, patients and pharmacists, and impose a ceiling on the highest dose of opioids that can be prescribed. That was never the CDC’s intent. 

On June 1, 2016, Dr. Debra Houry, Director of the CDC’s National Center for Injury Prevention
and Control, wrote the following:

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain. Specifically, the Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

The following are additional quotes from the CDC Guideline itself:

"Clinicians should consider the circumstances and unique needs of each patient when providing
care.”

"Clinical decision making should be based on a relationship between the clinician and patient,
and an understanding of the patient's clinical situation, functioning, and life context."

"The Guideline provides recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care and end-of-life-care."

Your policy does not provide an exception for palliative care, only patients receiving cancer treatment or end-of-life care. In my opinion, that is a blatant omission.

The facts are also available showing there has been collusion between the insurance industry and CMS in drafting your new “Opioid Misuse Strategy.”

For all of these reasons and more, CMS should not adopt or align your agency’s policies with the CDC Guideline, as it is apparent you have misinterpreted them.

Sincerely,

Rick Martin

Feel free to copy my letter or make changes to express your own views. It also might be helpful to attach a copy of Dr. Houry’s letter in your email. If anyone wants a copy of her letter, click here to download it.

Time is running out if we want to put a stop to this.

Rick Martin is a retired pharmacist in Nevada who was disabled by chronic back pain.

Pain News Network invites other readers to share their opinions and stories with us.  Send them to:  editor@PainNewsNetwork.org

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

Ibuprofen No Better Than Placebo for Back Pain

By Pat Anson, Editor

When it comes to treating back pain, anti-inflammatory drugs such as ibuprofen work no better than a placebo, according to new Australian study.

Researchers at the University of Sydney conducted a meta-analysis (a study of studies) of 35 clinical trials involving over 6,000 people with back pain, and found that non-steroidal anti-inflammatory drugs (NSAIDs) provide little benefit. The study was published in the Annals of the Rheumatic Diseases.

NSAIDs are effective for spinal pain, but the magnitude of the difference in outcomes between the intervention and placebo groups is not clinically important. At present, there are no simple analgesics that provide clinically important effects for spinal pain over placebo,” wrote lead author Gustavo Machado, PhD, of The George Institute for Global Health. “There is an urgent need to develop new drug therapies for this condition.”

Back pain is the world’s leading cause of disability, with about 80 percent of adults experiencing back pain at some point in their lives.

Opioids are usually not prescribed for simple back pain, leaving patients little alternative but over-the-counter pain relievers such as NSAIDs, a class of drugs that includes both aspirin and ibuprofen. NSAIDs are known to raise the risk of gastrointestinal and cardiovascular problems.

The Australian study found that NSAIDs reduced pain and disability somewhat better than a placebo or dummy medication, but the results were not statistically important.

"NSAIDs do not provide a clinically important effect on spinal pain, and six patients must be treated with NSAIDs for one patient to achieve a clinically important benefit in the short-term," wrote Machado. “When this result is taken together with those from recent reviews on paracetamol (acetaminophen) and opioids, it is now clear that the three most widely used, and guideline-recommended medicines for spinal pain do not provide clinically important effects over placebo.”

The study did not evaluate non-pharmacological treatments for back pain, such as exercise, physical therapy or chiropractic care.

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are found in so many different products -- such as ibuprofen, Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

Misuse of Opioid Medication a Worldwide Problem

By Pat Anson, Editor

We hear often about the recreational or “non-medical” use of prescription drugs, particularly opioids, in the United States and Canada. But a new study published in the journal World Psychiatry suggests the abuse and misuse of opioids is a problem around the world.

Researchers at Columbia University's Mailman School of Public Health studied surveys of teenagers and young adults in Europe, Latin America, Asia, Middle East and the U.S.  They found that from 2000 to 2014, there was a 200 percent increase worldwide in overdose deaths due to opioids.

“Data on high school or university students from the Middle East or Arab world indicate that nonmedical use of prescription drugs warrants closer attention,” said lead author Silvia Martins, MD, associate professor of Epidemiology at Columbia University's Mailman School of Public Health.

“In Beirut, Lebanon, past-year nonmedical use of any prescription drugs was 21.6% among private university students and 10% among high school students. In both populations, prescription opioids were the drugs most commonly used nonmedically. In Saudi Arabia, a recent school-based survey showed a lifetime prevalence of 7.2% for the nonmedical use of any prescription drug.”

The growing misuse of opioid medication in some countries comes at a time when there is less misuse in the United States. A recent large survey found that 4.8% of American high school seniors had misused an opioid pain reliever in the past year, down from a peak of 9.5% in 2004. In the past five years, misuse of opioid pain medication by American 12th graders has declined by 45 percent.

Martins and her co-author say the availability of prescription opioids can vary widely from one country to another. Societal attitudes about medications and the misconception that they are “safe” can also contribute to misuse.

“The biggest challenge is balancing a country’s need to make available prescription drugs to those in need (i.e., those with chronic pain), while simultaneously curbing diversion and nonmedical use,” Martins wrote. “Another challenge is controlling the top most reported sources of supply, including parents, doctors and friends.”

A recent DEA report said the diversion of prescription opioids in the U.S. has fallen dramatically in the last few years, with less than one percent of legally prescribed opioids being diverted. The prescribing and abuse of opioid medication is also declining, along with the number of admissions to treatment centers for painkiller addiction. Despite these trends, which are rarely reported in the mass media, overdoses from heroin and other illegal opioids are soaring.

The DEA is planning to cut the supply of opioids even further in 2017, by reducing the supply of hydrocodone and other Schedule II opioids by 25 percent or more.

Trump Administration Promises Relief to Patients

By Pat Anson, Editor

A spokesman for the Trump administration pledged this week that the Department of Health and Human Services (HHS) would provide relief to patients who are "being harmed by the status quo.”

Matt Lloyd, a former top aide to Vice President Mike Pence, recently assumed the job of chief spokesman for HHS, the federal department that oversees the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services (CMS).

Lloyd made his comment in an unusual statement emailed to reporters after CMS released a report Friday that showed the number of Americans who signed up for insurance during Obamacare’s annual enrollment period had fallen to 9.2 million. That’s down from 9.6 million the year before.  

“Obamacare has failed the American people, with one broken promise after another. As noted in the report today from CMS, premiums in the ACA marketplace have increased 25 percent while the number of insurers has declined 28 percent over the past year,” Lloyd said.

MATT LLOYD

“We look forward to providing relief to those who are being harmed by the status quo and pursuing patient-centered solutions that will work for the American people.”  

Ironically, Lloyd made his statement two days after CMS invited public comment on the agency’s plans to have Medicare adopt the CDC’s opioid prescribing guidelines – a move that could affect thousands of patients who use opioids for pain relief. The CDC guidelines are voluntary and only intended for primary care physicians, but CMS wants to apply them to all doctors who prescribe opioids for non-cancer pain. A strict daily limit on opioids would also be set at 90 mg of a morphine equivalent dose.

Doctors and patients who don’t follow the proposed CMS policy could face punitive action, such as being dropped from Medicare coverage and insurance networks. CMS has estimated that over 15,000 Medicare beneficiaries who receive high doses of opioids for pain relief could be impacted  

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare.

The agency’s “Opioid Misuse Strategy” was developed during the final months of the Obama administration, but could be quickly adopted by the new administration.  CMS is only accepting public comments on its proposals until March 3 and plans to publish the final rules by Monday, April 3, 2017.

Comments on the CMS rule change should be mailed to:  AdvanceNotice2018@cms.hhs.gov.

Comments can be emailed to Matt Lloyd at: Matt.Lloyd@hhs.gov.