The Death of Pain Management

By Janice Reynolds, Columnist

The art and science of pain management is more than just opioids.  It is knowing what pain is and how pain works, the harmful effects of pain, different reasons for pain, how individuals react differently to pain, which medications may work and how they work, what non-pharmacological interventions may be appropriate, the difference between “acute” and “chronic” pain, understanding that guidelines are not written in stone, and the importance of listening to the patient and treating the whole patient.

While many physicians, nurses and pharmacists may not know all of this, they should be willing to research it or ask for help from someone who is knowledgeable.  Above all, it requires compassion, belief and faith in the patient.  It’s complicated, but that is why I call it an art and a science.

There have always been those who are bigoted against people in pain, do not believe pain is all that important, and that people need to gut it out. They’d rather 1,000 people suffer in pain than be fooled by one. They see pain management as a money-making endeavor.

Others take the values of beneficence (doing good), non-maleficence (not doing harm), veracity (truth telling), and equable justice (all are treated fairly) seriously, and don’t try to warp these ethical values to support their own beliefs.

Unfortunately, the tide has turned against pain sufferers and pain management providers, and they are being overwhelmed with falsifications and even hate. Some would cite the so-called “opioid epidemic” as the cause, and while it has certainly acerbated the problem, the seeds were planted long ago.

What this “crisis” has done is escalate the terrorism of the DEA by driving providers out of pain management or punishing those who still treat pain. There has been a lack of due process, with providers found guilty until they can prove themselves innocent, damned by innuendo, and with no thought or care for the collateral damage to their patients.

The media and anti-opioid zealots have also made claims that pain management experts are all tools of the pharmaceutical industry and anyone who advocates for appropriate pain management is spreading lies.

The crisis in pain management can be traced back, in part, to the Joint Commission’s accreditation standards for pain.  Healthcare organizations were first held accountable to them in 2001.  My friend, Dr. June Dahl (a professor of pharmacology) and Dr. Patricia Berry (a nurse) wrote the initial standards.  Our belief was these standards would “make pain visible” and pain would no longer be ignored.

The standards essentially said that healthcare organizations should have a plan to assess the presence of pain, that pain should be treated, and that providers should be educated on pain and pain management. This turned out to be wishful thinking.  Negative comments we heard included variations of “If you ask them about pain they will have it” or “People will only exaggerate their pain.” My favorite one (asked by an emergency room doctor) was “Do you really think this pain thing is all that important?”

Dr. Andrew Kolodny and Physicians for Responsible Opioid Prescribing (PROP) have also had a huge impact on pain management. Seldom mentioned is the fact that PROP is a small group with only a handful of practicing physicians. Many, like Kolodny, have links to addiction treatment centers.

When the FDA wouldn’t go along with a PROP petition to change opioid warning labels, PROP found a home at the Centers for Disease Control and Prevention, where they helped draft the CDC’s opioid prescribing guideline. The guideline has severely damaged pain management by forcing providers to essentially ignore pain and commit malpractice. PROP has done more to murder pain management than any other entity.

Another large contributor to the death of pain management is the use of McCarthyism to spread fear and innuendo.  Doctors are afraid to provide appropriate pain management either because of the CDC guideline or a realistic fear of the DEA.  Providers are abandoning pain management or leaving practices entirely. Nor can they be faulted, as there is little support for them by politicians, the government or the media.  Even professional medical organizations, such as the American Pain Society, American Society of Anesthesiologists and American Academy of Neurology, have abandoned them.

Now we are seeing a bastardization of pain education, as well as a debasing of pain management itself. Education in medical schools and continuing education for providers should center on pain syndromes, pharmaceutical interventions, non-pharmaceutical therapy, and the consequences of poorly managed pain.  It should be evidence based, as well as ethical, and should not include the CDC guideline, which is neither. It should not just focus on addiction or the evils of opioids. 

There are now efforts to standardize pain management through the development of “best practices.”  President Trump’s opioid commission, the VA, Medicare, and other government agencies are creating them with input from addiction treatment advocates and insurance payers, without input from pain management experts or people in pain.

Will the art and science of pain management survive these assaults? I certainly want it to. But it will be difficult to re-educate providers and bring back into practice those who have been persecuted by the DEA and the media.

The narrative needs to change. We need to refocus on the harmful effects of inadequate pain management, the maltreatment of people in pain, and what forces are behind this butchery of adequate pain management.

Pain management, according to the World Health Organization, is a human right.  What kind of world and country do we live in when this right is blatantly ignored and the health of many placed in jeopardy by the death of pain management?  

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on pain management, and is co-author of several articles in peer reviewed medical journals. Janice has lived with persistent post craniotomy pain since 2009. 

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

FDA Issues New Kratom Warning

By Pat Anson, Editor

The Food and Drug Administration has issued a public health advisory about kratom, an herbal supplement used by millions of Americans to self-treat pain, anxiety, depression and addiction.

In a lengthy statement, FDA Commissioner Scott Gottlieb, MD, said the agency has “significant concerns” about the increasing use of kratom and its potential health risks – especially when it is used to treat opioid addiction.

“At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning. It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms,” Gottlieb wrote.

“There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. The leaves are usually ground up to make tea or turned into powder and used in capsules.

Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

In his statement, Gottlieb claimed that kratom was addictive and was being used recreationally for its euphoric effects. But he also acknowledged that the herb could have legitimate medical uses.   

“The FDA knows people are using kratom to treat conditions like pain, anxiety and depression, which are serious medical conditions that require proper diagnosis and oversight from a licensed health care provider,” he wrote. “I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence.”

The evidence is lacking, in large part, because kratom and its active ingredients are natural substances that cannot be patented and have less potential for profit. That discourages pharmaceutical companies from investing in research and clinical studies to prove kratom's safety and efficacy.

"To date, no marketer has sought to properly develop a drug that includes kratom," said Gottlieb. "We believe using the FDA’s proven drug review process would provide for a much-needed discussion among all stakeholders. Until then, I want to be clear on one fact: there are currently no FDA-approved therapeutic uses of kratom."

Last year, the Drug Enforcement Administration attempted to list kratom as a Schedule I controlled substance, which would have made it a felony to possess or sell. The DEA suspended its plan after an outcry and lobbying campaign by kratom supporters.

The DEA said at the time that kratom was linked to several deaths, as well as psychosis, seizures and an increased number of calls to poison control centers. Gottlieb renewed those claims today and said the FDA was “aware of reports” of 36 deaths associated with kratom. But he did not go into detail about where or when those deaths occurred.

The American Kratom Association (AKA) – a pro-kratom consumer group – has strongly disputed recent autopsy reports linking kratom to sudden deaths in Florida, Georgia and New York, calling them a "rush to judgement."

The AKA filed a dispute resolution petition challenging the "weak scientific basis" of the FDA advisory and asked that it be withdrawn.

“For years, the FDA has published scientifically inaccurate information on the health effects of consuming kratom, directly influencing regulatory actions by the DEA, states, and various local government entities.  AKA believes the FDA health advisory on kratom will lead to more state and local bans, all based on discredited, incomplete, and mischaracterized scientific claims," the AKA said in a statement.

In a survey of 6,150 kratom consumers by Pain News Network and the AKA, over 90% said the herb was “very effective” in treating their medical condition, whether it was pain, anxiety, depression or addiction. Many predicted that if kratom were classified as a controlled substance and made illegal, it would only increase the use of alcohol, marijuana, prescription opioids and illegal substances like heroin.

Senators Pressed DEA to Cut Rx Opioid Supply

By Pat Anson, Editor

A group of 16 U.S. senators played an influential role in getting the Drug Enforcement Administration to make further cuts in the supply of opioid pain medication, the latest example of how politicians have inserted themselves into the healthcare choices of Americans.

As PNN reported, the DEA published an order last week in the Federal Register that cut the 2018 production quotas for Schedule II opioid painkillers by 20 percent. It’s the second year in a row the DEA has ordered steep reductions in the supply of opioids. The move affects several commonly prescribed medications that millions of pain patients rely on for relief, such as oxycodone, hydrocodone, morphine and codeine.

The DEA acted even after drug makers and patients warned the agency that the cuts were so severe they could lead to shortages of pain medication. Under federal law, the DEA sets production quotas for manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more.

The 16 senators – 15 Democrats and one independent – have been urging the DEA for months to go even further to reduce the risk of opioid painkillers being abused.

“As the gatekeeper for how many opioids are allowed to be sold legally every year in the United States, we commend DEA on taking initial steps last year to lower production quotas for the first time in a generation,” Democratic Sen. Dick Durbin of Illinois wrote in a letter to DEA Acting Administrator Chuck Rosenberg on July 11.

“However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.”

SEN. DICK DURBIN

Durbin’s letter was co-signed by 15 of his Senate colleagues: Sherrod Brown (D-OH), Amy Klobuchar (D-MN), Edward Markey (D-MA), Joe Manchin (D-WV), Dianne Feinstein (D-CA), Claire McCaskill (D-MO), Patrick Leahy (D-VT), Tammy Baldwin (D-WI), Jeanne Shaheen (D-NH), Kirsten Gillibrand (D-NY), Catherine Cortez Masto (D-NV), Maggie Hassan (D-NH), Richard Blumenthal (D-CT), Al Franken (D-MN) and Angus King (I-ME).

Durbin followed up with a personal meeting with Rosenberg at DEA headquarters on August 3. The meeting was also attended by Senators Brown, Shaheen, Manchin, Markey and Hassan.

“I commend Administrator Rosenberg for acknowledging that the DEA can do more to keep dangerous painkillers off our streets,” Durbin said in a statement after the meeting.  “In today’s meeting, I asked him to continue this effort and further lower the opioid quotas for 2018.  Fewer pills on the market means less addiction and, hopefully, fewer deaths.”   

The August 3 meeting is important, because the very next day the DEA announced it would publish a notice in the Federal Register that it was planning a 20% reduction in Schedule II opioids for 2018.

rosenberg (left) meeting with durbin and other senators

The notice opened up a 30-day public comment period on the DEA’s proposal. Over a hundred people wrote in, most of them pain sufferers who warned the DEA it was going too far.

“The quotas for 2017 caused some shortages at pharmacies. I do not understand the reasoning behind more aggressive production quotas for 2018. People I know who are long term chronic pain patients have gone to the pharmacy for their prescription and are told that it will be a week or 10 days to fill the prescription,” wrote Marjorie Zimdars-Orthman. “It is cruel to implement quotas that will cause pharmacy shortages.”

“This is just beyond insane. Far too many people are already suffering and committing suicide due to not being able to get proper pain management,” said Eric Busch. “Even those that find a doctor willing to actually treat the pain humanely and write a prescription, might not be able to fill said prescription if there are artificial quotas and shortages.”

“How can the government ensure that these quotas will not adversely affect pain patients?” asked Brian Teer, whose wife has suffered from chronic pain for nearly 20 years. “I implore you to consider the medical needs of unfortunate patients like my wife, who face the burden of untreated intractable pain. Please do not reduce the production of the very medications that she needs to continue living. Please do not take her life.”

The DEA said three unidentified drug makers also made comments, warning that the 2018 quotas for codeine, fentanyl, hydrocodone, methadone, morphine, oxycodone and oxymorphone “were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States.”   

The only comment left in support of the 2018 production quotas included a second letter from Durbin and his colleagues, warning that opioid supplies “remain far too high.”

“Given everything we now know about the threat posed by opioids and DEA’s downstream efforts to tackle this problem, there is no adequate justification for the volume of opioids approved for the market,” the letter said.

In the end, the DEA sided with the 16 senators, ruling that the 2018 opioid quotas were “sufficient” to meet the needs of patients. The agency dismissed the comments from pain sufferers as medical complaints that were “outside of the scope” of its final order.

“These one hundred and six comments did not provide new discrete data for consideration, and do not impact the original analysis involved in establishing the 2018 aggregate production quotas,” wrote Robert Patterson, who became acting head of the DEA after Rosenberg resigned unexpectedly in September.

Opioid Quotas Should ‘Continue to Come Down’

Sen. Durbin and his colleagues are apparently not done yet, and may seek to rein in the supply of opioids even further in 2019.

Durbin recently joined with Sen. Markey in introducing the Opioid QuOTA Act, a bill that seeks more transparency from the DEA in disclosing how it sets opioid production quotas. The legislation would require the agency to list on its website the production quota for each opioid manufacturer, information that the DEA now considers confidential.

“The public deserves the right to know which drug companies are manufacturing these opioids, how many they are producing each year, and their justification for asking the DEA to approve their ever-increasing quota requests,” Durbin said in a statement.

“Our work will not be done until these quotas continue to come down, doctors become more judicious in their prescribing, drug companies stop misleading the public about their products, and we do more to help those who are currently addicted get treatment.”

Along with Durbin and Markey, the legislation is co-sponsored by Senators Manchin, Brown, Shaheen and Hassan – the same group of senators that met with the DEA administrator in August and pressed him to make further cuts in the opioid supply.

Managing Emotions While Living with Chronic Pain

By Barby Ingle, Columnist

Before navigating through the minefield of the healthcare system, we need to get our own lives in order first.

It is important to learn the tools to manage chronic pain in a biological, psychological, social and spiritual approach. This can be quite tricky to do, if you don’t put effort into each area.

The one area most skipped over is the psychological challenge that comes with living in chronic pain. One of the things that negatively affected my healthcare was not having my emotions under control when going into a doctor’s office. I would go in expecting them to fix me and answer in broad sweeping terms that did not help them help me. I would typically cry, because I was in so much pain and trying to get someone else to understand was quite a challenge.

There were five major areas psychologically that I worked on: managing my conditions, avoiding peer pressure, figuring out tools that I was comfortable with, respecting the roles of everyone involved in my care, and setting expectations with my family and friends.

Once I became my own best advocate and learned to present my symptoms in ways that helped them understand, I finally started down the path to a team approach to managing my pain.

The first step was getting my emotions under control and taking responsibility for what happens between appointments. That meant making sure that I was organized, learned about my diseases and treatment options, and understood how my insurance worked. Getting organized really helped me get my emotions under control, let go of anxieties, and focus on maximizing my care and energy.

I also learned each provider has their own way of treating pain, and if that provider was not on board with me, I’d find a new one who was willing and able to help me accomplish my goals.

Avoid Peer Pressure

You may face some peer pressure from others in the pain community to try whatever they are doing. Remember to research and only do what you are ready to do for yourself. If it’s not right for you, then it’s not right for you. The stress of allowing others to pressure you into trying a treatment that you are not comfortable with can create a bad situation for you.

Don’t be misguided by the pressure to fit in with others who have the same disease as you. Be sure to stand up for yourself and the care you deserve.

Take Responsibility

We are taught from childhood that doctors fix sick people. Providers and parents make decisions for us about our medications and treatments. But as we age, it is important to learn that we are responsible for our own care, and to think through and develop our own solutions. This is an essential life skill for everyone, but when you are chronically ill it is even more important to develop.

Respect that pain takes a toll on us physically and emotionally, and that we must devote time, effort and energy to improve our living situation and be as mentally healthy as possible. So many times, I wanted to scream or have a tantrum. Can’t they hear me? Can’t they help me? Can’t they do something for me?

Finding more positive ways to say what I was going through and productive ways to communicate helped me get the best care possible in the worst of situations. No one helped me when I let my negative emotions lead me. I have learned to respect myself and others to get the care I need, know when to walk away, and when to find a better way.

Set Expectations Early

Most of my family understood that I was living with chronic pain and that it was not by choice. But not all of my husband’s family understood, and took the word of a nurse who said that I was acting up, looking for attention and nothing was wrong with me. Over the years most of them have come around, after I learned to be patient and stay consistent in my drive and determination.

I have only had to cut a few people out of my life and most of that happened because I was unable to set expectations. Now it is something I have learned to do at the start of any relationship. There is so much less frustration when I have to say sorry I can’t make it because of a pain flare or seizure. They know I want to be there, there just are times that my body doesn’t allow it.

Having chronic pain will challenge you in ways that you never imagined. Preparing for daily activities and pain flares becomes a must. So does searching for small ways to boost your own self-confidence.

Managing the emotional side of chronic pain can be done -- it just takes understanding, effort, and learning to choose your battles.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website. 

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

DEA Cutting Rx Opioid Supply in 2018

By Pat Anson, Editor

The U.S. Drug Enforcement Administration is going ahead with plans to reduce the supply of many opioid painkillers by 20 percent next year. That’s in addition to steep cuts in opioid production quotas the agency imposed in 2017.

In a notice quietly published this week in the Federal Register, the DEA said it would reduce the supply of many commonly prescribed Schedule II opioid painkillers, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, and fentanyl. The agency said demand for the medications had dropped.

In proceeding with the cuts, which were first proposed in August, the DEA dismissed warnings from three drug makers that the reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

The DEA received over 100 public comments on its proposal, most of them expressing concern that any further reduction in opioids would adversely impact the availability of prescription painkillers.

“I am 75 years old, have metastatic prostate cancer in my bones and have to take high doses of fentanyl patches and morphine tablets for the chronic, intractable pain. Please do not further reduce the supply of my critical medicine,” wrote Bill Daniel.

“Please stop this misguided attempt to save people from themselves. If demand is down, it's because you bullied physicians into prescribing less, not from a genuine market conditions,” wrote one anonymous poster.

“You want to cut my access to the medication I'm legally prescribed by my pain management doctors! Would you consider the same for people deemed disabled due to other illnesses? You are going to cause millions of us to either commit suicide due to unbearable pain or turn to street drugs,” said Christa Rood.

The DEA said comments such as these dealt with medical issues that were “outside of the scope” of its order and did not offer any new data for the agency to consider.

Under federal law, the DEA sets production quotas for all manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, was reduced by a third.

Those cuts were not sufficient to stop the opioid epidemic, according to two letters sent to the DEA by a group of U.S. senators. The first letter, sent in July, urged that "further reductions... are necessary to rein in this epidemic.”

A second letter, sent in September, said there was "no adequate justification for the volume of opioids approved for the market." The senators asked to DEA to make the 2018 cuts in the opioid supply at least as deep as they were in 2017. 

Opioid prescriptions have actually been in decline for several years.  According to the Centers for Disease Control and Prevention, opioid prescribing in the U.S. has fallen by 18 percent since 2010.  

In recent years, heroin and illicit fentanyl have emerged as the driving forces behind the overdose crisis, which killed an estimated 64,000 Americans in 2016. Despite that, federal efforts to prevent overdose deaths remain largely focused on reducing the use of prescription painkillers.

The CDC, for example, is spending $4.2 million on an Rx Awareness campaign in four states; running ads on billboards, radio, newspapers and online that warn about the risks of prescription painkillers. Although a recent CDC study found fentanyl was involved in over half the overdoses in ten states, the agency says it has no plans to include fentanyl or heroin in its awareness campaign.

“Our aim with this campaign is to prevent prescription opioid overdose deaths, since prescription opioids continue to be involved in more overdose deaths than any other drug. Based on studies of people entering treatment, the majority of people with opioid use disorder (including heroin use disorder) still start with prescription opioids,” CDC spokesperson Courtney Lenard said in an email.

Panic! At the Toilet: Dealing With a Panic Attack

By Crystal Lindell, Columnist

When I read the notes from the paramedics, I couldn’t help but laugh.

“Pt. was sitting on toilet. Began to hyperventilate,” they wrote.

I finally found a title for my future autobiography! Hey, it’s my panic attack. I can make jokes if I want to.

The whole thing happened about a week ago and, as you can tell by the notes from the EMTs, it happened while I was going to the bathroom. There aren’t a lot of good places to have a panic attack, but I can tell you from experience that the toilet is an especially bad one.

Nothing brought it on. I had literally just woken up. And I was in the middle of a text conversation with my best friend about how insanely expensive humidifiers are when it hit.

It’s not as though I was contemplating the meaning of life or freaking out about the idea of being single forever, or even thinking about our current president any more than usual. I was literally just trying to find the best way to wake up without dry sinuses.

For the lucky ones out there who aren’t aware of what happens during a panic attack, let me explain.

The first thing to know is that the whole thing is scary as hell. If you don’t know what’s happening, you might think you’re dying. As in, this is it. This is how it all ends. On the toilet. Like Elvis.

It starts with this weird urge to hyperventilate. For no reason. Literally. No. Reason. That, in turn, causes chaos.

I started screaming. Then, sweat suddenly drenched my entire body. And soon after that, things started to shut down, as my body rushed blood to the most important areas, like my heart, assuming extremities were expendable. So, my feet and then my calves went numb and then they started cramping. My hands curled under and stopped functioning. And eventually my tongue also went numb.  

Saying it’s really effing scary is an understatement. 

Thankfully, my brothers were both home and heard me screaming. When they came to check on me, I mumbled with my non-functioning tongue that I needed them to call 911. I live two doors down from the fire department, so the paramedics got to my house pretty quickly. That was helpful. 

And, I have to say, they were insanely good at dealing with the situation. 

One of them rushed in and knelt down in front of me, grabbed my hands, looked me in the eye and said, “Crystal, what’s happening to you is completely normal. I need you to try to breathe with me.” And then he guided my breaths while another paramedic got some oxygen ready. Once they put that on me, I was able to regain function in my limbs again. My hands slowly started to uncurl and I was able to kind of calm down. 

That’s about when I also regained the wherewithal to really understand exactly what was happening. Three young paramedic guys, in my bathroom, helping me breathe, while I sat on the toilet, in a T-shirt and hot pink underwear wrapped around my ankles. 

I’ve had better moments. 

I declined to go the hospital mostly because I knew that I would be ok after I calmed down. But it’s likely I had such a severe reaction because I was dehydrated, and IV fluids probably wouldn’t have hurt. Instead, I just drank some Gatorade.

Afterward, I was completely drained of energy and ended sleeping the rest of the day. I can tell you that I also have spent every day since genuinely concerned that I would have another panic attack any time I went to the bathroom. So that’s fun. 

And honestly, I have been struggling to process the emotional trauma of losing control of my body. Just writing this column, and remembering everything that happened, has been enough to make my heart race with fear. But I am seeing my psychiatrist in a couple days to talk about future coping strategies, so hopefully that will help.

I know this is the “Pain" News Network, and I struggled with whether I should write about a panic attack in this space. But panic attacks are really painful in lots of ways, and many people living with chronic pain also deal with anxiety. 

And I while I had one 7 years ago, I didn’t actually know that it had been a panic attack until I heard one of favorite YouTuber beauty bloggers describe something similar happening to her. I was like, “Oh, wow. That’s exactly what happened to me!”

And I can tell you that the most important thing to realize during a panic attack is that it is just that: a panic attack. Because a stroke or heart attack seem pretty similar. And thinking you’re going to die doesn’t help calm you down. So maybe this article will help someone else who unexpectedly finds themselves hyperventilating on the toilet someday. If nothing else, it’s a good reason to clean your bathroom. 

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.

A Pained Life: Help Us Help America

By Carol Levy, Columnist

I had a friend who was diagnosed with lung cancer. We were all afraid for her. Not only because we feared for her life, but because of all the horrors we hear surrounding treatment for cancer.

She had surgery and a part of one lung was removed. When I spoke with her after surgery, I hesitantly flirted around the edges of the question: chemotherapy, radiation, how awful will it be for you?

My worries were unwarranted. Her answer was completely unexpected.

"I don't need anything else,” was her reply. “My doctor said, ‘You had cancer. Now you don't.’”

Wow. What strides they have made against this horrendous disease.

There is no question how feared cancer is, how dreadful the disease is and the possible repercussions -- from the cancer itself or as a result of the terrible treatments used against it.

The federal government throws huge amounts of money at cancer research and new treatments. As they must. Cancer scares everyone. It must be eradicated, if at all possible.

Cancer also costs the economy. Treating cancer in the United States cost nearly $125 billion in 2010 and is projected to reach $156 billion in 2020. The government would be accused of malpractice if they ignored this life and money devouring monster. And they don't. That is one reason my friend had it and then she didn't.

 What is the economic impact of pain? Between $261 and $300 billion annually in healthcare costs alone. Add in lost works days and productivity, and the tab reaches $635 billion.

Estimates vary, but according to the American Academy of Pain Medicine, 76.2 million Americans have chronic pain, compared to 20.8 million with diabetes, 18.7 million with coronary heart disease and stroke, and 1.4 million with cancer. In other words, chronic pain affects more Americans than diabetes, heart disease, stroke and cancer combined.

So why is chronic pain ignored? Why do we continually have to fight for the dollars to fund research and development of new treatments? The National Pain Care Act languished in the U.S. Senate for many years with no action taken. Under the Affordable Care Act (Obamacare), it was finally incorporated as an amendment that calls for more pain education of physicians, and more dollars for pain research and the development of new treatments.

So where are the dollars? Where is the research? Where are the new treatments?

So far, they seem nonexistent. Instead, the one option that many pain sufferers have – opioid medication -- is being taken away. We are the whipping boys of the “opioid epidemic.”

Many of us have been helped by opioid medication. Some are less disabled by pain. Some are helped enough to continue working and pay taxes, reducing our drain on the economy.

This should be celebrated and expanded, by giving us access to medications that provably help, at least until other treatments become available. But instead of assisting us in improving our lives, the government is giving us policies and “guidelines” antithetical to helping the chronic pain community. The consequences of these dreadful policies – higher healthcare costs, more disability, lost quality of life, and suicide -- are being ignored.

Is that because it makes for better headlines when politicians scream about the so-called opioid epidemic?

There is no doubt there is a big problem with the overuse, abuse and illegal use of narcotics. But we are not the bogeyman in this fight. Less than one percent of opioid medication that is legally prescribed falls into the wrong hands.

If they truly wanted to help the country, they would look seriously at the consequences of making us the bad guys. Many of us who were doing better as a result of opioids have been forced to reduce our dose or are no longer able to get a prescription. It’s not saving lives and it’s not preventing addiction. Look at how the overdose numbers keep rising. This is a benefit to no one. Not for us as individuals or to the country as a whole.

Our pain is invisible, but so too are cancer, diabetes, heart disease and many other conditions. Insulin is okay. Statins are okay. Chemotherapy is okay. Opioids are the devil.

The devil, as they say, is in the details. And the details are very clear. Opioids help pain patients. They allow us to help the country. We keep looking for a way in, to make our voices heard. Maybe we should make patriotism our rallying cry. When you hurt us, you hurt the country. Help us help America.

Until the government, DEA, CDC and politicians can find other ways to reduce or even eradicate chronic pain, take us off your list of opiate abusers.

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

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

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

Painkiller Study Conducted at Poorly Rated Hospital

By Pat Anson, Editor

Over-the-counter pain relievers are just as effective as opioid medication in treating short-term acute pain in a hospital emergency room, according to a widely touted study published in the Journal of the American Medical Association (JAMA).

The study was relatively small – only 416 patients participated – and it was conducted at a New York City hospital with a poor history of pain care. Still, it's getting a lot of media coverage. “Milder pill may be best for pain” is the front page headline in the Los Angeles Times. “Drugstore pain pills as effective as opioids” said STAT News. “Opioids Not the Only Answer for Pain Relief” reported HealthDay.  

Researchers said patients with moderate to severe acute pain in their arms or legs got just as much pain relief after being given a combination of acetaminophen and ibuprofen than those who took hydrocodone, oxycodone or codeine. The study only measured pain relief for two hours.

Patients with sickle cell disease, fibromyalgia, neuropathy or any type of pain that lasted more than seven days were excluded from the study because researchers only wanted to focus on short term pain.

"Although this study focused on treatment while in the emergency department, if we can successfully treat acute extremity pain with a non-opioid combination painkiller in there, then we might be able to send these patients home without an opioid prescription," said lead author Andrew Chang, MD, a professor of emergency medicine at Albany Medical Center.

"We know that some patients who are given an opioid prescription will become addicted, so if we can decrease the number of people being sent home with an opioid prescription, then we can prevent people from becoming addicted in the first place."

What Chang, JAMA and the news reports all fail to mention is that the study was conducted at one of the worst hospitals in the nation. In an annual survey of Medicare patients, Montefiore Medical Center in New York City was given only one star (out of five possible), placing it in the bottom 2.44% of hospitals nationwide.

Montefiore was rated poorly on a variety of quality measures, including pain care. Only 64 percent of the patients treated there said their pain was “always” well controlled, compared to the national average of 71 percent.

‘Worst Hospital in the Entire City’

Many of the online reviews of Montefiore’s emergency room are scathing.

“Please do not come to the ER unless you want to die or are used to unsympathetic health professionals,” warned Amanda G. on Yelp.  “I have severe abdominal pain and I'm walking home in tears right now. I came in told the nurse there my symptoms and she couldn't have made it clearer that she couldn't care less.”

“This has to be the worst hospital in the entire city. The nurses in the ER are rude and don't care about your well being. The ER is filthy. People stacked on top of each other,” wrote Robert in a Google review.

MONTEFIORE MEDICAL CENTER PHOTO

“The emergency room sucks. The doctors sit around on the computers gossiping. I even overheard a few doctors saying ‘why aren’t we picking up patients?’ Meanwhile there’s a room full of patients not being taken care of. There’s a patient screaming for help and no one hears him. All the staff members just walk by him,” wrote Zoe D. on Yelp.

“Somebody told me this place was the equivalent of going to a hospital in Manhattan. They lied! I went to the emergency room today for chest pains, I ended up sitting there for four hours never to be seen by a doctor. I ended up walking out and leaving still with my chest pains,” said Phonz R. on Yelp.

“Their ER department is horrible. I went to the ER with my mom via ambulance, we got there (a little) before 1pm. Fast forward 1:58 in the morning she still wasn't put in a room,” wrote J.L. Eaddy on Google. “This was the absolute worst ER I've ever encountered. And I NEVER want to come back again. I wish I had the option to give it negative stars.”

Unfortunately, complaints such as these are not unusual in busy, urban teaching hospitals like Montefiore.  And not all the reviews are poor. U.S. News and World Report gave high rankings to Montefiore in a number of areas, although it didn’t specifically rank its emergency department. Montefiore was recently given a lukewarm “C” rating by the Leapfrog group, a non-profit that grades hospitals on quality and safety.  

Many pain patients have poor experiences in hospitals. In a survey of nearly 1,300 patients by PNN and the International Pain Foundation, over half rated the quality of their pain care in hospitals as either poor or very poor. About two-thirds of the patients said non-opioid pain medications were ineffective.

Most Cannabidiol Oils Sold Online Mislabeled

By Pat Anson, Editor

With opioid medication increasingly harder to obtain and other types of pain relievers often ineffective, many chronic pain sufferers have turned to cannabidiol-based medication for relief.

But a new study published in JAMA has found that nearly 70 percent of all cannabidiol (CBD) products sold online are either over or under-labeled. Researchers say a number of CBD products that are used to treat pain, anxiety, epilepsy and other medical conditions also contain high-levels of tetrahydrocannabinol (THC), the substance in marijuana that makes people high.

“The biggest implication is that many of these patients may not be getting the proper dosage; they’re either not getting enough for it to be effective or they’re getting too much,” said lead author Marcel Bonn-Miller, PhD, an adjunct professor of psychology at the Perelman School of Medicine at the University of Pennsylvania

“This is a medication that is often used for children with epilepsy, so parents could be giving their child THC without even knowing it.”

Like THC, CBD is one of the active ingredients in marijuana, but it is not generally known to produce euphoria or make people high. CBD is currently classified as a Schedule I controlled substance by the federal government, even though it has been legalized for medicinal use in 29 states and the District of Columbia.

DRUG POLICY ALLIANCE

Bonn-Miller says the mislabeling and poor quality control of CBD products is a direct result of inadequate regulation.

“The big problem, with this being something that is not federally legal, is that the needed quality assurance oversight from the Food and Drug Administration is not available. There are currently no standards for producing, testing, or labeling these oils,” Bonn-Miller said. “There is no way to know what is actually in the bottle. It’s crazy to have less oversight and information about a product being widely used for medicinal purposes, especially in very ill children, than a Hershey bar.”

Bonn-Miller and his colleagues searched the Internet and purchased 84 CBD products from 31 different companies. They found that four out of ten products were under-labeled, meaning they contained a higher concentration of CBD than indicated. Another 26 percent of products purchased were over-labeled, meaning they contained a lower concentration of CBD than indicated.

Only 30 percent of CBD products purchased contained an actual CBD content that was within 10% of the amount listed on the product label. THC was detected in 21% of the samples.

“This is a wake up call for the CBD industry to standardize their products,” said co-author Jahan Marcu, PhD, Chief Science Officer for Americans for Safe Access (ASA).

“CBD product manufacturers need to adopt best practices and accept guidance from AHPA (American Herbal Products Association) and other groups to improve consistency and safety for consumers.”

ASA and AHPA supports the Patient Focused Certification (PFC) program, a non-profit, peer reviewed, third party certification program for the medical cannabis industry. Products that carry the PFC label have met their standards and been certified.

“I am constantly contacted for suggestions for a safe company that sells CBD - and it would be helpful to steer people in the right direction,” said Ellen Lenox Smith, a medical marijuana user, advocate and PNN columnist.

“Although less or more CBD won't hurt you, it makes sense to develop a method for people to know they are getting the correct product that is being claimed. If THC is found in the product, then someone out there is not abiding by the law and is using a form of cannabis, thus breaking the law.”

The problem isn’t limited to CBD oils and extracts. In a previous study, Bonn-Miller and his colleagues analyzed cannabinoid dose and label accuracy in edible marijuana products and found similar discrepancies. He hopes this and future studies will call attention to the impact of inconsistent cannabis product labelling.

“Future research should be focused on making sure people are paying attention to this issue and encouraging regulation in this rapidly expanding industry,” Bonn-Miller said.

Doctors Soak Up Profits With Urine Drug Tests

By Fred Schulte and Elizabeth Lucas, Kaiser Health News

The cups of urine travel by express mail to the Comprehensive Pain Specialists lab in an industrial park in Brentwood, Tenn., not far from Nashville. Most days bring more than 700 of the little sealed cups from clinics across 10 states, wrapped in red-tagged waste bags. The network treats about 48,000 people each month, and many will be tested for drugs.

Gloved lab techs keep busy inside the cavernous facility, piping smaller urine samples into tubes. First there are tests to detect opiates that patients have been prescribed by CPS doctors. A second set identifies a wide range of drugs, both legal and illegal, in the urine.

The doctors’ orders are displayed on computer screens and tracked by electronic medical records. Test results go back to the clinics in four to five days. The urine ends up stored for a month inside a massive walk-in refrigerator.

The high-tech testing lab’s raw material has become liquid gold for the doctors who own Comprehensive Pain Specialists. This testing process, driven by the nation’s epidemic of painkiller addiction, generates profits across the doctor-owned network of 54 clinics, the largest pain-treatment practice in the Southeast.

kaiser health news (Heidi de Marco)

Medicare paid the company at least $11 million for urine and related tests in 2014, when five of its professionals stood among the nation’s top billers. One nurse practitioner at the company’s clinic in Cleveland, Tenn., single-handedly generated $1.1 million in Medicare billings for urine tests that year, according to Medicare records.

Dr. Peter Kroll, one of the founders of CPS and its medical director, billed Medicare $1.8 million for these drug tests in 2015. He said the costly tests are medically justified to monitor patients on pain pills against risks of addiction or even selling of pills on the black market.

“I have to know the medicine is safe and you’re taking it,” Kroll, 46, said in an interview. Kroll said that several states in which CPS is active have high rates of opioid use, which requires more urine testing.

$8.5 Billion in Urine Tests

Kaiser Health News, with assistance from researchers at the Mayo Clinic, analyzed available billing data from Medicare and private insurance billing nationwide, and found that spending on urine screens and related genetic tests quadrupled from 2011 to 2014 to an estimated $8.5 billion a year — more than the entire budget of the Environmental Protection Agency. The federal government paid providers more to conduct urine drug tests in 2014 than it spent on the four most recommended cancer screenings combined.

Yet there are virtually no national standards regarding who gets tested, for which drugs and how often. Medicare has spent tens of millions of dollars on tests to detect drugs that presented minimal abuse danger for most patients, according to arguments made by government lawyers in court cases that challenge the standing orders to test patients for drugs. Payments have surged for urine tests for street drugs such as cocaine, PCP and ecstasy, which seldom have been detected in tests done on pain patients. In fact, court records show some of those tests showed up positive just 1 percent of the time.

Urine testing has become particularly lucrative for doctors who operate their own labs. In 2014 and 2015, Medicare paid $1 million or more for drug-related tests billed by health professionals at more than 50 pain management practices across the U.S. At a dozen practices, Medicare billings were twice that high.

Thirty-one pain practitioners received 80 percent or more of their Medicare income just from urine testing, which a federal official called a “red flag” that may signal overuse and could lead to a federal investigation.

“We’re focused on the fact that many physicians are making more money on testing than treating patients,” said Jason Mehta, an assistant U.S. attorney in Jacksonville, Fla. “It is troubling to see providers test everyone for every class of drugs every time they come in.”

 ‘Almost a License to Steal’

As alarm spread about opioid deaths and overdoses in the past decade, doctors who prescribed the pills were looking for ways to prevent abuse and avert liability. Entrepreneurs saw a lucrative business model: persuade doctors that testing would keep them out of trouble with licensing boards or law enforcement and protect their patients from harm. Some companies offered doctors technical help opening up their own labs.

A 2011 whistleblower lawsuit against one of the nation’s top billers for urine tests, a San Diego-based laboratory owned by Millennium Health LLC, underscores the potential for profit.

“Doctor,” one lab representative said during sales calls, according to an affidavit, “drug testing is not about medicine but about making money, and I am going to show you how to make a lot of money.”

Millennium Health, billing records show, took in more than $166 million from Medicare in 2014 despite being the target of at least eight whistleblower cases alleging fraud over the past decade. A Millennium sales manager involved in a 2012 case in Massachusetts reported earning $700,000 in salary and sales commissions in the previous year.

Millennium encouraged doctors to order more tests both as a way to lower patients’ risks and to shield the physicians against possible investigations by law enforcement or medical licensing boards, according to court filings. Millennium denied the allegations in the whistleblower suits and settled all of them with the Justice Department in 2015 by agreeing to pay $256 million; its parent company, Millennium Lab Holdings II, declared bankruptcy.

Tests to detect drugs in urine can be basic and cheap. Doctors have long used testing cups with strips that change color when drugs are present. The cups cost less than $10 each, and a strip can detect 10 types of drugs or more at once and display the results in minutes.

Tests to detect drugs in urine can be basic and cheap. Doctors have long used testing cups with strips that change color when drugs are present. The cups cost less than $10 each, and a strip can detect 10 types of drugs or more at once and display the results in minutes.

After noticing that some labs were levying huge charges for these simple urine screens, the Centers for Medicare & Medicaid Services moved in April 2010 to limit these billings. To circumvent the new rules, some doctors scrapped cup testing in favor of specialized — and much costlier — tests performed on machines they installed in their facilities. These machines had one major advantage over the cups: Each test for each drug could be billed individually under Medicare rules.

“It was almost a license to steal. You had such a lucrative possibility, it was very tempting to sell as many [tests] as you can,” said Charles Root, a longtime lab industry consultant whose company, CodeMap, has tracked the rise of testing labs in doctors’ offices.

Voluminous Drug Tests

The CPS testing lab in Tennessee opened in 2013, not long before a pain specialist named William Wagner moved from New Mexico to open a CPS clinic in Anderson, S.C. He was lured by the promise of $30,000 a month in salary, which would grow as the clinic added patients and revenue, along with other benefits. His contract said he could be on-site for as little as 20 percent of the clinic’s operating hours.

When the company recruited him, Wagner said, he was told the job offered “potential to earn a great deal of money” from bonuses he would receive from services he generated, including a share of collections from lab services for urine tests done at the new Tennessee facility.

That did not happen, according to Wagner. He is suing CPS, saying that it failed to collect bills for services he rendered and then closed the clinic. CPS refutes Wagner’s claims and says it fulfilled its obligations under the contract. In a counterclaim, CPS argues that Wagner owes it $190,000.

pain exhibit (Mark collen)

“All of their money was being made off of urine drug screens. They weren’t doing anything else properly,” Wagner said. The lawsuit is pending in federal court in Nashville.

Former CPS chief executive John Davis, in an interview, described the urine-testing lab as part of a “strategic expansion initiative” in which the company invested $6 million to $10 million in computerized equipment and swiftly acquired new clinics. Kroll, one of the owners of CPS, said the idea was to “take the company to the next level.”

Davis, who led the initiative before leaving the company in June, would not discuss the private company’s finances other than to say CPS is profitable and that lab profits “to a great degree” drove the expansion. “Urine screening isn’t the reason why we decided to grow our company. We wanted to help people in need,” Davis said.

Kroll acknowledged that urine tests are profit-makers, but stressed that verifying that patients aren’t abusing drugs gives him a “whole different level of confidence that I’m doing something right for the patients’ condition.”

He said his doctors try to be “judicious” in ordering urine tests. Kroll said some of his doctors and nurses treat “high-risk” patients who require more frequent testing. The company said that its Medicare billing practices, including urine screens, had withstood a “very in-depth” government audit.  The audit initially called for repayment of $25 million but was settled in 2016 for less than $7,000, according to the company. Medicare officials had no comment.

Kroll’s orthopedic career took a sharp turn more than a decade ago after watching his brother suffer through multiple surgeries for muscular dystrophy, along with bone fractures, stiffness and pain. His brother died at age 25, and Kroll decided to switch to anesthesiology and become a pain specialist.

“It sensitized me to the plight of people with chronic conditions that we have no medical answer for,” Kroll said. His brother “battled for his whole life.”

Kroll’s career change coincided with a national movement to establish pain management as a vital medical specialty, with its own accrediting societies and lobbying and political arm to advance its interests and those of patients.

Joined by three other doctors, he formed Comprehensive Pain Specialists at a storefront in suburban Hendersonville, Tenn. It quickly gained a foothold on referrals from local doctors unsure, or uneasy, about treating unyielding pain with heavy narcotics such as oxycodone, morphine and methadone.

In 2014, when CPS was among Medicare’s major urine-test billers, Tennessee led the nation in Medicare spending on urine drug tests run by doctors with in-house labs, according to federal billing records.

How Much Is Too Much?

There is wide disagreement among legislators, medical trade associations and the state boards that license doctors over the best approach to urine testing. One association of pain specialists argued in 2008 that urine testing could be done as often as weekly, while others have balked at that frequency.

Indiana’s medical board ordered mandatory urine tests for all pain patients in late 2013, only to face a lawsuit from the American Civil Liberties Union, which argued that the policy was unconstitutional and an unlawful search. Officials backed down the next year, and current policy states that testing can be done “at any time the physician determines that it is medically necessary.”

The federal Centers for Disease Control and Prevention, wary of both cost and privacy concerns, declined to set a definitive national standard despite years of debate. In long-awaited guidelines issued in March 2016, the CDC called for testing at the start of opioid therapy and once a year for long-term users. Beyond that, it said, testing should be “left up to the discretion” of the medical professional.

There is likewise little scientific justification for many of these new types of drug testing that have made their way onto doctors’ order sheets and laboratory menus.

Many pain patients on opioids are routinely tested for phencyclidine, an illegal, hallucinogenic drug also known as PCP, or angel dust, Medicare records show. Yet urine tests have rarely detected the drug. Millennium, the San Diego-based company that once topped Medicare billings for urine tests, found PCP in fewer than 1 percent of all patient samples, according to federal court filings.

In a tour of the CPS lab, Chief Operations Officer Jeff Hurst, who has more than two decades of experience working for commercial labs, rattled off a list of drugs ranging from cocaine to heroin and methamphetamine, which he said was “really big in East Tennessee.”

How often urine tests reveal serious drug abuse — or suggest patients might be selling some of their medications instead of taking them — is tough to pin down. Asked during a tour of the laboratory in Tennessee if CPS could provide such data, Hurst said he did not have it; Kroll said he didn’t either.

Hurst said the lab often ends up doing a “long list of tests” because CPS doctors are prescribing dangerous drugs that may be deadly if abused and “need to know what patients are taking.” Prescribed drugs, such as opiates and tranquilizers, are also measured at the CPS lab.

Government officials have criticized the explosive growth in testing for some prescription drugs, notably a class of tranquilizers known as tricyclic antidepressants. Medicare paid more than $45 million in 2014 for more than 200,000 people to be tested for tricyclic drugs, often multiple times. Medicare was billed for 644,495 tests for one tricyclic drug, amitriptyline, up from 6,173 tests five years earlier.

The Department of Justice argued in a 2012 whistleblower case that these tests often couldn’t be justified because of “low abuse potential” of the drugs and a “lack of abuse history for the vast majority of patients.”

Income Breakdown Raises ‘Red Flag’

When told that drug screens accounted for most of the Medicare income for dozens of pain doctors, federal officials said that was troubling.

“Doctors who receive the lion’s share of their Medicare funds from urine drug testing would certainly raise a red flag,” said Donald White, a spokesman for the Department of Health and Human Services’ Office of the Inspector General. “Confirmation of fraud would require federal investigation and a formal judicial proceeding.”

In a report released last fall, the watchdog office said some uptick in testing might be justified by the drug abuse epidemic, but noted that the situation also “could provide cover for labs that might seek to fraudulently bill Medicare for unnecessary drug testing.”

Medicare pays only for services it considers “medically necessary.” While that sometimes can be a judgment call, pain clinics that adopt a “one-size-fits-all” approach to urine testing may find themselves under suspicion, said Mehta, the assistant U.S. attorney in Florida.

Mehta’s office investigated a network of Florida clinics called Coastal Spine & Pain Center for alleged over-testing, including routinely billing for a second round of expensive tests simply to confirm earlier findings. In a press release in August 2016, the government argued that these tests were “medically unnecessary.” The company paid $7.4 million last year to settle the False Claims Act case. Coastal Spine & Pain, which did not admit fault, had no comment.

Four Coastal Spine & Pain doctors were among the top 50 Medicare billers during 2014, when they charged nearly $6 million for drug tests, according to Medicare billing data analyzed by KHN.

Starting in 2016, Medicare began to crack down on urine billings as part of a federal law that is supposed to reset lab fees for the first time in three decades. Now tougher scrutiny of urine testing, and cuts in reimbursements, may be threatening CPS — or at least its profits.

CPS closed nine clinics last year and told its doctors that urine-testing revenue had dropped off 32 percent in the first quarter of the year, according to a letter then-CEO Davis sent its physician partners.

Davis said the company had to “make some changes” because of cuts in Medicare reimbursements for urine tests and other medical services. A company spokeswoman told KHN that the drop in urine revenue worsened through 2016 but has bounced back somewhat this year.

Despite the cuts, privately held CPS plans to open new clinics this year. Urine testing will remain a key service — for keeping patients safe, it said. CPS is just playing by the rules of the game. “Tell us how often to test,” said Hurst, the operations officer, “and we’ll be happy to follow it.”

Kaiser Health News is national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

3 Reasons the Opioid Crisis is Getting Worse

By Roger Chriss, Columnist

The opioid crisis is now a public health emergency. The CDC reports increasing rates of fentanyl overdoses.  And The Economist warns the crisis is entering “a new and deadlier phase.”

The strategy to stop the overdose epidemic has largely focused on the supply side: limiting access to prescription opioids. History seems to support this idea. Two hundred years ago, a tincture of opium called laudanum was widely used to treat all kinds of ailments.  The “epidemic of laudanum” didn’t end until 1906, when the federal government got involved and started regulating opium-based medications.

So it seemed natural to curtail opioid prescribing. Washington State issued prescription opioid guidelines in 2010, Oregon in 2012, and the CDC in 2016. Other states followed with laws limiting the number of days opioids could be prescribed for short term, acute pain. Health insurers like Kaiser Permanente and Intermountain Healthcare have also reduced coverage of prescription opioids and drug store chains like CVS will be limiting prescription length and dose. 

In a narrow sense, this is working. Prescription opioid levels peaked in 2010, as a result of lower production quotas mandated by the DEA and reduced prescribing in a variety of clinical settings.

But in a broader sense, the focus on prescription opioid levels is failing. Opioid addiction and overdose rates continue to climb, despite the reduced availability of prescription opioids. There are three reasons for this.

First, the main drivers in the crisis are now heroin and illicit fentanyl. Importantly, heroin is increasingly the first opioid of abuse.

“As the most commonly prescribed opioids - hydrocodone and oxycodone - became less accessible due to supply-side interventions, the use of heroin as an initiating opioid has grown at an alarming rate,” researchers recently reported in the journal of Addictive Behaviors.

Second, according to the National Survey on Drug Use and Health, approximately 75% of all opioid misuse starts with people taking medication that was not prescribed to them. These pills are sourced from friends, stolen from other people’s prescription bottles, or purchased online illegally.

Contrary to common belief, opioid therapy for chronic pain conditions rarely leads to misuse or addiction. Most addictive behaviors start during adolescence, usually with substances like alcohol or tobacco, long before anyone gets their hands on opioid medication.

Third, nearly 10% of drug overdoses are intentional.

"Hidden behind the terrible epidemic of opioid overdose deaths looms the fact that many of these deaths are far from accidental. They are suicides,” wrote Dr. Maria Oquendo, President of the American Psychiatric Association, in a blog for the National Institute on Drug Abuse.

In other words, the crisis may have started with prescription opioids, but it has evolved. We are now facing a crisis driven primarily by heroin, illicit fentanyl, and other street drugs, as well as social and economic conditions that have led to an "epidemic of despair."

Therefore, the current intense focus on prescription opioids -- from the CDC’s Rx Awareness campaign to the recommendations of the President Trump’s opioid commission -- is woefully off target. Reducing access to prescription opioids has not decreased addiction and overdose rates, and may actually be making them worse.

Exactly what will be required to end the crisis is not clear. But an essential step is to understand the nature of the crisis as it stands today so as to end the opioid disconnect.

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.

China Denies Responsiblity for Fentanyl Crisis

By Pat Anson, Editor

China is disputing claims that most of the illicit fentanyl and related chemicals that are being smuggled into the U.S. and killing thousand of Americans originated in China. President Trump has said he would ask Chinese President Xi Jinping to “hold back the flood of cheap and deadly fentanyl” when he visits Beijing this week.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. It is prescribed legally to treat severe pain, but illicit fentanyl and its chemical analogues have become a scourge on the black market, where they are often mixed with heroin or turned into counterfeit prescription drugs.

“The evidence isn't sufficient to say that the majority of fentanyl or other new psychoactive substances come from China," said Wei Xiaojun, deputy director-general of China’s Narcotics Control Bureau of the Ministry of Public Security.

Wei spoke at a joint news conference Friday with the U.S. Drug Enforcement Administration. China and the DEA have stepped up their cooperation on drug control problems in recent months, with Beijing putting dozens of fentanyl related chemicals on its list of controlled substances.

“Once China controls a substance it has a dramatic effect on the United States in terms of lives saved,” said Lance Ho, who heads a new DEA office in Beijing.

DEA PHOTO OF counterfeit FENTANYL PILLS

"We did this even when there is no widespread fentanyl abuse in China," Wei said. "We were aware of the crisis in the U.S. and took the U.S. concern into consideration."

But an editorial in a Korean newspaper disputed the level of Chinese cooperation, claiming that China was using fentanyl in a “chemical war” against the U.S.

“Fentanyl is the nuclear narcotic that is killing thousands of Americans today and another example of China’s two-faced approach. The chemical, known as ‘China Girl’ or ‘China White’ on the street, may have some Chinese victims, but its true value is as a profitable opiate export that also destroys American communities and roils the U.S. political landscape,” said The Korea Herald. 

“Drug exports have allowed for the establishment of new Chinese-run drug cartels and distributors within the United States while untimely and tragic American deaths are recorded daily.”

According to the CDC, illicit fentanyl killed 20,000 Americans in 2016. A recent CDC study found that over half the opioid overdoses in ten states involved fentanyl.

Son of Fox News Anchor Overdosed on Fentanyl

The son of a former Fox News anchor overdosed and died after taking counterfeit prescription drugs made with fentanyl, according to reports.

19-year old Eric Bolling Jr. was found dead in his Boulder, Colorado apartment September 3. He is the son of Eric Bolling, who was recently fired by Fox News for allegedly sending lewd texts to several women.

The Boulder County coroner recently reported the younger Bolling had high levels of fentanyl, cocaine, marijuana and the anti-anxiety drug Xanax in his system when he died.

According to police, Bolling and a friend had gone to Denver the day before his death to buy cocaine and other drugs. They bought five pills that appeared to look like Percocet, a branded version of the painkiller oxycodone. Bolling, who had a history of drug abuse, took one of the pills and quickly realized it wasn’t Percocet.

ERIC BOLLING AND SON ERIC JR.

“Eric took half of a percocet and the cocaine dealer took half of a percocet. Within a few minutes Eric and the percocet dealer started ‘panicking’ because they had a different reaction to the percocet than they normally do. Eric made the comment that he thought the percocet may have contained fentanyl,” investigators said in a police report obtained by TheBlast.com.

Bolling’s body was found by a girlfriend the next day. His death has been ruled accidental.

The DEA recently added three more fentanyl analogues -- ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl  -- to its list of Schedule I Controlled Substances, chemicals that are considered highly dangerous and addictive.

At least 17 confirmed overdose deaths have been linked to the three drugs in Georgia, North Carolina, Texas, New Jersey, Wisconsin and Pennsylvania. The drugs have also been found in California, Florida, Ohio and Missouri.

The Justice Department recently indicted two major Chinese drug traffickers accused of manufacturing fentanyl in drug labs in China and selling it to U.S. customers over the Internet.

FDA May Require Opioids Be Packaged in ‘Blister Packs’

By Pat Anson, Editor

The Food and Drug Administration may soon require some opioid pain medications to be packaged in “blister packs” to limit the number of pills that can be prescribed and dispensed at one time.

“This is something we’ve been looking at for some time. And it is gaining some traction inside the agency as a potential solution to instigate different kinds of prescribing patterns around opioids. Something like this could move potentially quickly. We’re invested in it and taking a hard look at this,” FDA commissioner Scott Gottlieb told CNBC.

In May, Gottlieb appointed an Opioid Policy Steering Committee to study ways that the supply of opioids for short-term acute pain could be limited through packaging. Next month the FDA will hold a two-day public workshop with health experts and drug makers to discuss packaging options.

“One of the things that we can do is look at blister packs as an alternative to how opioids are dispensed. And perhaps package opioids in blister packs where it might come in a 2, 4, 6 or 8 day supply.  That would potentially encourage more doctors to prescribe smaller durations of use for patients,” said Gottlieb.

“This would be especially relevant to immediate release formulations of the drugs, which are the most widely prescribed formulations. And where most people form an addiction.”

Gottlieb said if doctors wanted to prescribe more opioids – such as a 30-day supply – the FDA could require that they “jump through additional hoops” such as a mandatory prescriber education course.

"We're at a point in this crisis that we're going to have to think of ideas and taking actions that are going to be more disruptive and are going to be uncomfortable to some parties," he said.

Several states have already adopted regulations that limit the supply of opioids for acute pain to seven days or less. CVS recently announced that its pharmacists would limit new opioid prescriptions to 7 days’ supply, starting in February for customers enrolled in its pharmacy benefit management program.

I Am a Casualty of the War on Drugs

By Lorelei Bryan, Guest Columnist

I am a 51 year old wife, mother, grandmother and businesswoman, among other things.  Along with all of those other titles and roles, I am a person who lives with chronic pain.

I do not like the label “chronic pain patient,” as it carries with it more stigma and derogatory implications than ever. 

In 2010, I began to experience extreme pain near my left ear.  Suspecting an ear infection, I went to my primary care physician. After examining me and asking a lot of questions, he said I had no infection and that he suspected this was related to the temporomandibular joint (TMJ) in my jaw. Like most people, I had heard of TMJ and thought it was the result of grinding or clenching my teeth. A visit to my dentist confirmed that there was no evidence of grinding or clenching.  He was at a loss. 

Thus began my two year journey of one oral surgeon after another, one therapy after another, and one failed surgery after another, trying to get this condition resolved. All the while, I battled between the primary care doctor and the surgeons on which of them was going to write the pain medication prescriptions I needed to keep functioning throughout this ordeal.

Finally, after two years and seven surgeries of various types, I was referred to an oral surgeon who specialized in TMJ patients with advanced and rare conditions.  A cat scan revealed that arthritis had destroyed almost all of the bone structure in my jaw.  I had to have two more major surgeries; one to remove what was left of the diseased bone and the second to install custom made titanium jaw parts.  

LORELEI BRYAN

The surgeon warned me that the procedures would restore function to my jaw (I could not open my mouth more than a few millimeters), but that I may be left with chronic pain.  He was right on both counts. The combination of the multiple surgeries, scar tissue, damage to the surrounding structure, and permanent nerve damage left me with severe chronic pain from trigeminal neuralgia that will never improve. 

During the final two surgeries, I was working with a pain management specialist who knew my surgeon.  All was well, as they communicated regularly and I was receiving pain medication that allowed me to manage my pain to the point of having a relatively normal life, although not completely pain free. 

In 2014, 18 months post replacement surgery. I received a letter from my pain management doctor explaining that he was no longer treating pain patients. No additional prescriptions would be given to any patient and no referrals to other doctors or pain clinics would be provided.  Just like that, everyone he treated for pain was dropped. Of course, I panicked, as I’m sure many of his other patients did. Being dropped by a doctor for no reason and with no support for transitioning to another provider feels like betrayal.

I sought help from my primary care provider and, fortunately, he said he could treat my pain himself. I was very relieved and grateful to him.  For three years he and I worked together to manage my chronic pain, including the trigeminal neuralgia that the surgeries caused. We were able to use a combination of Tegretol and oxycodone that reduced my need for oxycodone by 20mg per day, as compared to the dose I was on with the pain management specialist.

Never before had my pain been managed to the point it was.  He and my pharmacist know each other well, and the three of us worked together to manage my pain.   

The War on Drugs Targets the Wrong People

Fast forward to June 2017.  I go in for my every other month appointment with my primary care provider. He does his exam, we talk about my other medical issues, and then he gets a grave look on his face.  “I can’t write the oxycodone for you anymore,” he says. 

I am thrown.  He explains that the state has instituted strict limits on who can be prescribed narcotic pain medication and very strict limits on the amounts. I couldn’t breathe. Thoughts of what life would be like without having my pain effectively managed ran through my head -- reduced job performance, reduced job attendance, possible job loss, checking out of the lives of my children and grandchildren, suffering and crying all day like I used to. 

When I gained a little composure, I said, “We are talking about my quality of life here. I know why this is happening. This so called ‘war on drugs’ is creating a war on the wrong people.” 

My doctor agreed that I am a model pain management patient, a “poster child” for the appropriate use of narcotic pain medication. I see only him. I use only one pharmacy and he knows the pharmacist personally. I take the medication according to directions. I do not doctor shop. I do not ask for early refills.  I follow all the rules and still I have to suffer, so that a bunch of bureaucrats who have no right getting involved in what my healthcare provider deems appropriate for me, so they can pat each other on the back and congratulate each other for “striking a blow in the opioid crisis.”  

When I put it that way, the doctor agreed that I was a prime example of a responsible patient who needs this medication and is not a high risk. He agreed to continue writing the narcotic pain medication prescriptions, but explained that new state laws meant we had to almost cut my dose in half. 

I am now trying to manage on much less medication. The increased pain level makes it difficult to concentrate at work. It has made me withdraw from my husband. And it has impacted my ability to be the mother and grandmother I should be.

These bureaucrats and politicians are causing needless suffering for thousands of people in pain, while doing virtually nothing to stem the heroin overdoses that are the prevailing reason for the opioid crisis in the first place.

Is there a serious issue with abuse and addiction to narcotic pain medication?  Of course there is, and something should absolutely be done to address it.  But taking away medication needed by people in chronic pain is not the answer.  Limiting or denying medication to legitimate patients who need it to live and function with any quality of life only creates another crisis. More and more people turn to illegal drugs or, worse yet, commit suicide because their medication has been taken from them and they cannot endure without it.

My question is this: where is our voice?  For all of the politicians and celebrities speaking out on the war on drugs, who is speaking out on the other side of this?  If someone of consequence and influence does not speak out for people in pain, these new laws and limits will create just another silent epidemic and the war on drugs will take more lives than ever.

Lorelei Bryan lives in Virginia.

The Virginia Board of Medicine recently adopted emergency regulations that require doctors who prescribe more than 120mg morphine equivalent (MME/day) to a patient to document the justification for the dose or to refer or consult with a pain management specialist. It does not expressly forbid doctors from prescribing more than 120 MME/day.

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.

Trump Commission Seeks More Limits on Rx Opioids

By Pat Anson, Editor

President Trump’s opioid commission released its final report Wednesday, an ambitious list of over four dozen recommendations aimed at treating addiction, preventing overdoses, and further restrictions on opioid prescribing.   

“This crisis can be fought with effective medical education, voluntary or involuntary changes in prescribing practices, and a strong regulatory and enforcement environment,” the commission said in its report.

The president established the commission in March to give him a list of recommendations to combat drug addiction and the overdose crisis. 

“Our people are dying. One hundred seventy-five people a day, every day, are dying in the United States from this epidemic,” said commission chairman Gov. Chris Christie of New Jersey, one of five politicians who served on the six member panel.

“If a terrorist organization was killing 175 Americans every day on American soil, what would you be willing to pay to make it stop? I think we’d be willing to do anything and everything to make it stop. And that’s the way we now need to see this, because this is an attack from within. We are killing ourselves.”

The commission’s 131-page report did not spell out how much money would be needed to implement the panel’s wish list of 56 recommendations.

Chief among them was to get drug makers and the National Institutes of Health to work together developing new non-opioid painkillers and addiction treatment medications.

“It is inexcusable that the major pharmaceutical companies in this country have stood on the sidelines during this crisis. And they have,” said Christie.

New Prescribing Guideline to Supplement CDC's

The commission is also recommending that a new set of guidelines for opioid prescribing be developed to “supplement” the guideline released last year by the Centers for Disease Control and Prevention.  It was not immediately clear if the new guidelines would replace, weaken or strengthen the CDC’s recommendations, or simply expand their use throughout the healthcare system.

“An updated set of guidelines for prescription pain medications should be established by an expert committee composed of various specialty practices to supplement the CDC guideline that are specifically targeted to primary care physicians,” the report says.

The commission recommended that federal regulators require patients to give informed consent about the risks and alternatives to opioid painkillers before the medication is prescribed to them. The panel also called for a new “national curriculum and standard of care” for opioid prescribers, and that pharmacists be trained to recognize and deny “inappropriate prescriptions.”

The commission urged the federal government to work with states to improve the toxicology data on overdose deaths by developing uniform forensic drug testing. Critics say the current data now being used by federal agencies is flawed or cherry-picked. 

“We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths,” the report says.

No Limit on Opioid Supply for Acute Pain

The commission did not recommend that supply limits be placed on opioid prescriptions for short term pain, as many expected. Several states have already enacted 5 or 7-day limits on opioids for acute pain. The panel also did not endorse the development of marijuana-based medications, which many pain sufferers are now using as an alternative to opioids.

Most of the commission’s other recommendations deal with cracking down on drug traffickers and the illicit drug market, expanding the drug court system, and increasing access to addiction treatment.

Gov. Christie refuted criticism of President Trump for declaring the overdose crisis a public health emergency, instead of a national emergency. Only $57,000 in federal funding is currently set aside to deal with a public health emergency.

“The president did exactly what I asked him to. I wanted this to be a public health emergency because I wanted HHS (Department of Health and Human Services) to administer the funds, not FEMA (Federal Emergency Management Agency). No offense to FEMA. They’re busy with some other things and it’s not there area of expertise,” Christie said.

“Now it’s incumbent upon Congress to step up and put money in the public health emergency fund, so the president can utilize that. And that should happen without delay in the view of the commission.”

In addition to Christie, commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Florida Attorney General Pam Bondi, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman.

In its fifth and final hearing, the commission heard testimony from several people who lost loved ones to opioid addiction and overdose. The panel never asked for or received testimony from pain sufferers, patient advocates or pain management physicians.