The Rest of the Opioid Story

By Roger Chriss, Columnist

Media reports about the opioid crisis in the U.S. are often grim and sensational.

The Economist declares that “states are losing the battle against deadly drugs like heroin and fentanyl.” Vox describes the opioid epidemic as “America’s worst drug crisis ever.” And CBS News warns that “opioid dependence can start within just a few days.”

But all this ignores a key point: Opioids are the best pain reliever we have, and they relieve a lot of pain.

The Institute of Medicine estimates that 100 million Americans will be in chronic pain at some point in their lives. Associated Press reporter Matthew Perrone laughed at this number in an interview that recently appeared in The Huffington Post, saying “That’s a damn lot of pain.” And Anna Lembke suggested the number may be much lower in her book, Drug Dealer, MD.

Let Perrone have his little laugh and assume Lembke is right. Perhaps there are only 25 million people in chronic pain. That’s still a lot of people -- the population of many nations in the world. It’s a population that also includes some of the worst diagnoses imaginable. They include diseases and disorders that rarely get better and often get worse, requiring the patient to live for years or even decades in pain.

These journalists and authors may not realize what this pain represents. This is the pain that lands you in the emergency room only if someone else takes you there. You are simply not capable of getting there on your own.

This is the pain that keeps you awake for days at a stretch because the brain simply cannot disengage. This is the pain that ends careers, shatters families and destroys relationships. It is not an achy muscle or a tender joint. Chronic pain is to ordinary pain as a hurricane is to a rain shower.

Opioids make a huge difference in the life of such people. According to The Washington Post, “the vast majority of those who have used strong painkillers for a long period say they work.” Lembke may trivialize multiple sclerosis or complex regional pain syndrome in her book, but people with these and other disorders deserve the best modern medicine has to offer. For pain management, that is often opioid medication.

Moreover, opioids are essential to modern healthcare, a reality often ignored by journalists.  Trauma and battlefield injuries could not be managed without the analgesic effects of opioids. The same is true for tens of thousands of cancer surgeries, organ transplants and hip replacements. And for the neuropathic pain caused by chemotherapy or the pain of a sickle-cell crisis. The list goes on and on. Opioids are an invaluable medical resource.

Of course, they must be used wisely. Developing a safer opioid would be wonderful, but this has proven difficult. Clearly not Purdue Pharma with OxyContin, which contributed greatly to the current opioid crisis before it was reformulated into a pill that is harder to abuse. Endo’s Opana ER is under review by the FDA and may be removed from the market for safety reasons.

Nektar Therapeutics has a new opioid called NKTR-181 that is showing promise in clinical trials. But it remains to be seen if it will come to market or if it will actually be any safer. Non-opioids like NSAIDs and Lyrica also have their own non-trivial risks.

In other words, drug development is hard. And despite enthusiastic media coverage of new drugs, often labeled as promising alternatives for “deadly opioids,” we shouldn’t expect a medication with no risk of abuse or addiction to appear any time soon, assuming that is even possible. And none of this matters if you are facing a major surgery, chemotherapy, or life with a chronic medical disorder right now.

Opioid medications are already here. They work. Their risks have been amply described in the media with phrases like “highly addictive opioid” or “dangerous opioid,” but never with modifiers like “life-saving” or “function-preserving.”

Few people doubt the need for careful opioid prescribing, the importance of prescription drug monitoring programs, and the value of shutting down pill mills, but too many are ignoring the medical importance of opioids. 

Everyone recognizes the tragedy of overdose deaths. Nothing can express the significance of the loss of a family member or friend to addiction and overdose. But let’s also not understate the importance of preserving life, of restoring function, and minimizing suffering. In other words, let’s prevent both tragedies. Let opioid medications do what they can do, and make sure they do that and nothing else.

Roger Chriss suffers from 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.

Medicare Modifies Opioid Prescribing Plan

By Pat Anson, Editor

The Centers for Medicare and Medicaid Services (CMS) is moving ahead with plans to align its Medicare Advantage and Part D prescription drug plans with the CDC’s opioid prescribing guidelines.

However, the agency has modified a policy to ensure that high doses of opioids that are medically necessary can still be prescribed.

Like the CDC guideline, CMS is recommending a daily ceiling on opioid pain medication at 90 mgs of a morphine equivalent dose (MED).  If a dose exceeds that level, Medicare insurers are expected to impose a "soft edit" that would automatically block the prescription from being filled until the edit is overridden by a pharmacist. 

Under a previous proposal, insurance companies could also impose a “hard edit” that could not be overridden on prescriptions that exceed 200 mgs of MED. The modification allows a pharmacist to override the edit if the prescribing physician says the dose is medically needed.

“Point of sale edits are not intended to substitute physician judgment or dictate a prescribing limit. If a sponsor (insurer) chooses to implement a hard edit, CMS expects the sponsor to rely only on prescriber attestation that the MED is medically necessary to override the hard edit, and to not require additional clinical criteria,” a senior CMS official said in a news briefing.

“The edits are not to stop prescriptions. They’re to provide information to sponsors in real time as a preventative step, so that prescribers are aware of the amount of opioids that patients are receiving as well as that they may be receiving opioids from other doctors.  They are not prescriber limits and they are not to substitute for prescriber judgement.”

CMS said there was a “significant number of comments” from the public about its opioid prescribing proposal. Some doctors and patient advocacy groups expressed concern that pain patients who are medically stable on high opioids doses would be forced to taper to lower doses.

“My tentative judgement, based on quickly looking at the documents today, is that CMS carefully stepped back from the absolute requirement that would have caused patients at over 200 (MED) mgs to have a sudden crisis in their care,” said Stefan Kertesz, MD, a practicing physician and Associate Professor at the University of Alabama at Birmingham School of Medicine.

“That doesn’t mean that they have foresworn this course of action in the future, but they clearly registered that they heard concerns from patients, doctors and others, and to me that is a hopeful sign.”

CMS is still moving ahead with plans to implement an opioid Overutilization Monitoring System (OMS) to identify physicians who prescribe high doses and the patients who receive them. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged.

Insurers are expected to identify pharmacies, doctors and patients who do not follow CMS policies, and could potentially drop them from Medicare coverage and their insurance networks.

As PNN has reported, the insurance industry appears to have played a major role in drafting the OMS plan, which contains some of the same strategies suggested in a “white paper” prepared by the Healthcare Fraud Prevention Partnership, a coalition of insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper goes far beyond fraud prevention, however, by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed.  The white paper was drafted largely by insurance companies, including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation.

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

Why the CDC Needs to Recognize Palliative Care

By Barbara Nelson, PhD, Guest Columnist

A little over a year ago, the Centers for Disease Control and Prevention released its “Guideline for Prescribing Opioids for Chronic Pain.” Its goal is to help reduce the raging and heartbreaking overdose epidemic in the U.S.

Unexpectedly, the guideline has exposed the extraordinary need for palliative care for millions of patients who may live for decades with intractable pain. These patients now face enormous obstacles getting medically-needed opioids for effective pain control, especially when the dose exceeds the highest recommendation made in the guideline of 90 morphine milligram equivalents (MME) per day.

This unbending recommendation is too low to provide pain control that will keep many intractable pain patients out of agony.  In the last year, untold numbers of chronic pain patients requiring palliative care lost the correct opioid dose for their diseases -- making work, self-care, and family interactions harder or impossible.

I have seen this suffering, both personally and professionally.  I have an incurable and progressive neurological pain disease that, before diagnosis and some pain control, left me unable to read. My disorder profoundly changed my life as I previously knew it.

The dosage recommendations in the CDC guideline show no compassion for those with intractable pain, who will probably need higher opioid doses for the rest of their lives. Only later, when faced with terminal illness and imminent death, will official support for adequate pain control be acknowledged.

How Did We Get Here?

The objective of the guideline was to reduce opioid addiction and overdoses by limiting the dose and duration of prescriptions written by primary care doctors.

The guideline begins with support for “appropriate and compassionate” pain control for those with chronic pain.  It pays special attention to the chronic pain care needed by those fighting cancer, needing palliative care, or facing terminal illness. These three categories of pain are excluded from the CDC’s suggested highest daily opioid dosages because of their well-researched requirements for higher than average pain control, 

There is a problem to this approach, however.

The differences between these three categories are unclear to many doctors and patients. Most frequently, palliative care is confused with end-of-life or hospice care for cancer.  But palliative care is different from end-of-life care, because in palliative care there is no assumption of imminent death, nor is there a decision to withhold medication that might curtail the disease itself.

Chronic obstructive pulmonary disease (COPD), multiple sclerosis and sickle cell anemia are routinely considered diseases that can require palliative care, and these patients may live decades after their diagnoses.

The CDC guideline defines palliative care “as care that provides relief from pain and other symptoms, supports quality of life, and is focused on patients with serious advanced illness. Palliative care can begin early in the course of any serious illness that requires excellent management of pain or other distressing symptoms.”

Not all diseases requiring palliative care also require opioids.  But those patients who require both palliative care and opioids are virtually invisible in the guideline.  Invisible patients get neither appropriate nor compassionate pain care.

The Need for a Palliative Care Appendix

The CDC should produce an appendix for all prescribers – not just primary care doctors – that would help them provide fully adequate pain relief to palliative care patients with life-long pain rather than near-death pain.  

The appendix could start by examining the legislative or regulatory language used in the 13 states that define intractable pain and that allow higher than typical opioid dosing.  The appendix also needs to emphasize research on the most painful long term diseases, which will offer physicians a wider variety and more specialized array of treatment options than is available from a focus on generalized chronic pain. 

The appendix could begin with the recognition that intractable pain patients needing palliative care do not get “high” or “euphoric.” Opioids are medicines that reduce pain and let them live closer to normal lives.

Helping physicians assist patients in organizing self-directed palliative care is another necessity, because most patients will not have access to a palliative care practice, let alone to one that is appropriate for their conditions. 

For patients with rare diseases, the CDC should emphasize the role of the doctor as learner as well as expert, as he or she must take the time to become familiar with a disease they may have never seen before. 

Yes, there may be some patients who attempt to scam the palliative care approach. However, I doubt that this kind of long-term pain is easily faked. The CDC guideline itself asks physicians to make dozens of new medical judgments. Acknowledging intractable chronic pain patients who require palliative care is just one more.

If the CDC does not add a palliative care appendix to the guideline, perhaps the American Academy of Pain Medicine, the American Medical Association or the American Academy of Hospice and Palliative Medicine could convene a group of all stakeholders to thoughtfully discuss the issues of pain treatment within palliative care.  Civil rights organizations that focus on inequality, including medical inequality, could contribute to this effort. 

Groups outside the CDC could also expand the mandate beyond training primary care physicians about opioid dosages, to include pain treatment for diseases requiring palliative care.

The conflict over opioid guidelines that are treated as laws or regulations, instead of recommendations, is not going away.  Several states, insurers and federal agencies have adopted versions of the CDC guideline, and others are sure to follow.  

Providing adequate pain control to palliative care patients would not make legislators, regulators or citizens any less committed to reducing misuse of opioid prescriptions.  In fact, drawing attention to palliative care would demonstrate a welcome dose of wisdom that millions of Americans would applaud.

Without an appendix to the CDC guideline or some other booklet that promotes correct palliative pain care, how will outstanding doctors be protected from unwarranted intrusions by insurance companies and drug enforcement organizations?  How will patients who deal correctly with pain that most people can’t imagine receive the palliative care that they deserve? They won’t.

The CDC’s “one-size-fits-all” guideline is bad medicine and bad policy. It ignores millions of intractable pain patients who require higher opioid doses.  

Everyone needs to recognize the importance of palliative care. You may need it someday. And unless changes are made, you won’t get appropriate medication either.

Barbara J. Nelson, PhD, is Dean Emerita of the UCLA Luskin School of Public Affairs and is Professor Emerita of UCLA’s Public Policy Department. She is the founder of The Concord Project, which builds social capital that allows people from divided communities to work together on projects of mutual benefit.

Barbara also directed The Leadership and Diversity Project, improving policy education and policy making through creative inclusion and enacted equality.  She served on the board of the Greater Los Angeles United Way.

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.

Lyrica, Cymbalta and Savella: Do They Work?

By Lana Barhum, Columnist

If you have fibromyalgia, chances are your doctor has prescribed one or more of the three drugs approved for fibromyalgia by the U.S. Food and Drug Administration (FDA).   It is also likely you have been disappointed when they didn’t work and by the side effects they caused.

I have tried Lyrica (pregabalin), Cymbalta (duloxetine) and Savella (milnacipran). My experience is they don’t work well and clinical research doesn’t offer up enough credible evidence that they do.

Patient feedback on these medications is actually more telling than recent studies.  Just check any fibromyalgia online forum and you will find your unpleasant experiences with these medications aren’t unique and shared by many.

Lyrica

Lyrica was developed by Pfizer as a treatment for epilepsy, but it is now widely prescribed for many different types of pain. Lyrica was approved by the FDA in 2007 as the first drug specifically for the treatment of fibromyalgia. Pfizer notes on its website that Lyrica “significantly relieves fibromyalgia pain and improves physical function” in fibromyalgia patients.  But does it really?

An initial study from 2005, with results published in Arthritis & Rheumatology, found Lyrica to be effective at relieving pain in only 29% of the 529 fibromyalgia patients in the study group. 

A major shortcoming of the study was that weight gain affected 10% of the study participants.

What was also interesting about the Arthritis & Rheumatology study is that a large number of participants dropped out due to Lyrica's side effects, which included edema, dry mouth, weight gain, infection, increased appetite and constipation.

A 2014 study of out of the University of Calgary, with results published in the journal Therapeutic Advances in Drug Safety,  also found that Lyrica causes edema and weight gain in some patients. 

Those side effects, especially the weight gain, aren’t worth it for a drug that doesn’t seem to work well for most people. You would get more benefit from dietary changes for fibromyalgia than with Lyrica - at least that was my experience. 

All I got from taking Lyrica was a 40 pound weight gain that took me two years to take off. I made the mistake of staying on it for too long, believing that it would one day work for me.

Cymbalta

Cymbalta was originally developed and marketed by Eli Lilly as a treatment for depression. You may even remember some of the commercials for it. In 2008, Cymbalta become the second drug approved by the FDA to treat fibromyalgia.

While Cymbalta doesn’t have stellar ratings amongst fibromyalgia patients, it does outperform Lyrica in my opinion. Initial trials, with results published in The Primary Care Companion to The Journal of Clinical Psychiatry, show that over a third (36%) of study participants reported at least a 50% reduction in pain, based on a dosage of 60 mg once or twice per day.

A report published in the journal Expert Review of Clinical Immunology found that many participants dropped out of Phase I, II, and III trials of Cymbalta due to side effects, including nausea, headache, and sleep issues. 

Cymbalta has given me some pain relief over the years, but I have also made changes to my diet and lifestyle which may have helped as well.  If Cymbalta has helped me with anything, it is managing the depressed feelings fibromyalgia often leaves in its wake.

Savella

My Savella experience was far worse than my experiences with Lyrica and Cymbalta.  I could only stay on it for two weeks because the side effects were more than I could handle. Dizziness, vertigo, nausea, fatigue, and severe headache were a few of the side effects that stood out.  And I didn’t get any fibromyalgia pain or symptom relief.

Savella was developed by Forest Laboratories specifically for fibromyalgia and was approved by the FDA in 2009.

Like Lyrica and Cymbalta, studies confirm Savella’s poor performance. One double-blind study, reported in the journal Pharmacy & Therapeutics, found that only about one in four fibromyalgia patients (26%) were getting pain relief. 

The rate of discontinuation due to Savella’s side effects and treatment failure was also high -- nearly 43 percent.

In 2010, the consumer advocacy group Public Citizen petitioned the FDA to remove Savella from the market because it increased blood pressure in patients who didn’t have high blood pressure to start with. The group also argued Savella posed an increased risk for suicidal thoughts.

The FDA responded last year and denied Public Citizen’s petition, but said it would continue to monitor the safety of Savella.

My Thoughts

The only medication that I have seen that offers real improvement is Pfizer’s Neurontin (gabapentin), which is prescribed “off label” because it is not specifically approved to treat fibromyalgia by the FDA. Neurontin has helped my nerve pain and I also take muscle relaxers as needed, as I am frequent sufferer of muscle cramps and spasms. 

Studies have confirmed Neurontin’s effectiveness in treating fibromyalgia pain and improving sleep and fatigue. One double-blind study, with results published in Arthritis & Rheumatism, found that over half (51%) of fibromyalgia patients were finding relief with Neurontin.   

That’s not bad for a medication that was originally developed to manage seizures and whose formula has been the same since 1993. While it has helped me, I certainly understand Neurontin hasn’t helped everyone. There are even reports of Neurontin being abused by addicts. 

I am not sure why the makers of Lyrica, Cymbalta and Savella continue to market medications that don’t offer most people real results.  Yet, these medications remain available and doctors are still prescribing them to treat fibromyalgia. 

Let's just hope there are new fibromyalgia drugs on the horizon that actually work and give us real and reliable symptom and pain relief.

What has been your experience with Lyrica, Cymbalta and Savella?

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit 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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

CDC: Painkillers No Longer Driving Opioid Epidemic

By Pat Anson, Editor

A top official for the Centers for Disease Control and Prevention has acknowledged that prescription painkillers are no longer the driving force behind the nation’s so-called opioid epidemic.

In testimony last week at a congressional hearing, Debra Houry, MD, Director of the CDC’s National Center for Injury Prevention and Control, said that heroin and illicit fentanyl were primarily to blame for the soaring rate of drug overdoses.

“Although prescription opioids were driving the increase in overdose deaths for many years, more recently, the large increase in overdose deaths has been due mainly to increases in heroin and synthetic opioid overdose deaths, not prescription opioids. Importantly, the available data indicate these increases are largely due to illicitly manufactured fentanyl,” Houry said in her prepared testimony before the House Energy and Commerce Committee's Oversight and Investigations Subcommittee.

The CDC blamed over 33,000 deaths on opioids in 2015, less than half of which were linked to pain medication.  

While painkillers may be playing less of a role in the overdose epidemic, Houry believes pain medication is still a gateway drug for many abusers. She cited statistics from Ohio showing that nearly two-thirds of the people who overdosed on heroin or fentanyl received at least one opioid prescription in the seven years before their deaths.  

"The rise in fentanyl, heroin, and prescription drug involved overdoses are not unrelated,” Houry said. “While most people who misuse prescription opioids do not go on to use heroin, the small percentage (about four percent) who do account for a majority of people recently initiating heroin use.”

Houry also disputed reports that efforts to reduce opioid prescribing have led to increased use of illegal drugs. It was her office that oversaw the development of controversial CDC guidelines that discourage doctors from prescribing opioids for chronic pain. 

DEBRA HOURY, MD

“Some have suggested that policies meant to limit inappropriate opioid prescribing have led to an increase in heroin use by driving people who misuse opioids to heroin,” Houry testified.  “Recent research, however, has indicated otherwise. One study found that the shift to heroin use began before the recent uptick in these policies, but that other factors (such as heroin market forces, increased accessibility, reduced price, and high purity of heroin) appear to be major drivers of the recent increases in rates of heroin use.”

The “recent research” Houry cited was a report published in the New England Journal of Medicine in January, 2016 – a full two months before the CDC opioid guidelines were even released. She offered no evidence to support her claim that the guidelines were having no impact on heroin use.

Some Patients Turning to Illegal Drugs

According to a recent survey of over 3,100 patients by Pain News Network and the International Pain Foundation, the CDC guidelines have reduced access to pain care, harmed many patients and caused some to turn to illegal drugs for pain relief.

Over 70 percent said their opioid doses have been reduced or cutoff by their doctors in the past year. And one out of ten patients (11%) said they had obtained opioids illegally for pain relief since the guidelines came out. 

“The one person I know who says the recent guidelines have helped (is) my neighbor who is a heroin dealer. He says business has quadrupled since doctors have started becoming too afraid to help people in pain,” one patient wrote.

“This has caused me far more pain and suffering in my life, and increased my stress and anxiety, and depression, because nobody seems to care that I suffer like this,” said another patient. “This has also caused me to turn to using heroin, because I have nothing left now at this point and cannot suffer like this.”

“Because people are unable to get adequate pain relief from prescribed medications due to the fear instilled to doctors by these ‘guidelines,' most people, in my experience, are turning to heroin. This explains not only an increase in overdoses but also an increase in suicide from chronic pain patients,” wrote another.

“I found it easier to get medications through the black market than through my doctor. I spend about $1,000 per month in medications through the black market, but in the end that is less than the deductible on my insurance. And they deliver to my house!” a patient said.  

“My fear right now is that I've been using medications I buy from a dealer. They appear to be real and thus far I've been OK, but I'm afraid that I may eventually hit a bad batch laced with fentanyl,” said a patient. 

Houry’s testimony came on the same day the Drug Enforcement Administration warned that counterfeit painkillers made with fentanyl have killed dozens of people in the Phoenix area.

The DEA said at least 32 deaths in the last 18 months in Maricopa County, Arizona have been linked to fake pills laced with fentanyl that were disguised to look like oxycodone tablets. In nearly 75% of the overdoses, examiners also found dipyrone (Metamizole), a painkiller banned for use in the U.S. since 1977. 

Fentanyl is a synthetic opioid 100 times more potent that morphine. It is sold legally in sprays, patches and lozenges to treat severe chronic pain.

counterfeit oxycodone (dea photo)

The DEA says illicit batches of fentanyl are being made in China and exported to Mexico, where drug dealers mix it with heroin or turn it into counterfeit medication before smuggling it into the U.S.

The DEA released detailed demographic information on the age, sex and ethnicity of the people who overdosed in Arizona. It did not say how many of the dead were patients looking for pain relief.    

New Saliva Drug Test for Pain Patients

By Pat Anson, Editor

A Denver-based drug testing company has developed a new saliva test to help doctors determine if their pain patients are taking opioid medications appropriately.

Cordant Health Solutions says its Comprehensive Oral fluid Rx Evaluation (CORE) test is more accurate than the point-of-care (POC) urine tests that are widely used by doctors to test patients for prescribed medications, as well as illegal drugs.

Urine tests only tell a doctor if a drug is present, not if the patient is taking the right amount of medication. As PNN has reported, studies have also shown the urine tests often give false results for drugs like marijuana, oxycodone and methadone.

“Urine screening methods are subject to false positive and false negatives. If somebody for instance is taking a cold medication, they could very easily test positive for amphetamines,” said Richard Stripp, PhD, Chief Scientific Officer for Cordant. “The CORE test is specific for the drug that’s in the blood at the time the oral fluid (saliva) is collected.

“And not only will it tell you whether the drug is there or not, it will tell you whether it’s there at a level that consistent with what was prescribed.”

If a prescribed drug is found in saliva, the CORE test will tell whether it’s within an expected range, or at a level that’s above or below it – an indication the patient is taking too much or too little medication. Stripp admits the test is not foolproof. About 25 percent of the time, he says drug levels detected in saliva don’t match what is found in the patient’s blood.

“There are always things that you have to consider when you are interpreting results. I often say this does not replace the clinical judgement of the physician. This is a tool to help them make better decisions,” Stripp told PNN.

“If a doctor says (a patient is) out of range, I’m kicking them out of my practice, we would never, ever suggest that should be the case. Basically, it’s time to have a conversation with a patient and maybe it requires further monitoring.”

Unlike urine samples, which are usually collected privately in a bathroom and can be swapped or altered with “clean” urine from someone else, a saliva sample for the CORE test can be collected directly from a patient’s mouth with a simple swab.  

One disadvantage of the CORE test is that the results are not immediately available, as they are with POC tests that utilize color-coded “dipsticks” that quickly change color when a drug is detected.

The saliva samples need to be shipped to a Cordant laboratory for testing and the results generally won’t be available for 48 to 72 hours. Currently the CORE test can be used to detect levels of oxycodone, hydrocodone, morphine, oxymorphone, hydromorphone, tramadol and fentanyl.

Patients Penalized After Failed Test

Laboratory testing is far more accurate than POC tests, but some doctors don’t bother ordering confirmatory lab tests if something suspicious is found in a patient’s urine. We hear regularly from readers who say their doctor became suspicious or even “fired” them after a POC test turned up something unexpected.

“Last week they had me come in to take a urine sample. A week later they called and said I failed because they found no drugs in my sample,” said one man who has been taking hydrocodone for nearly 30 years.

“The doctor now tells me they can't approve any more refills. I thought they were joking. They also told me that no one in the area could either. It's crazy and I don't know what to do. I tried not taking pain meds and nearly went insane from the sleepless nights.”

A woman who takes Percocet for her fibromyalgia pain wrote to us saying two urine tests failed to detect any opiates in her system.

“My physician of 14 years immediately interrogated me about compliance and asked if I was giving it away,” she said. “Based on the negative findings, he said he could not prescribe me any further narcotic pain relief.

“I have no idea how I will manage my pain now. This has turned into an insane circus. I feel betrayed by my physician, and the doctor-patient relationship has had its trust destroyed.”

Stripp says he cautions doctors not to jump to conclusions after a failed test.

“If you don’t do the laboratory confirmation test, from a legal perspective you can’t say with reasonable certainty that the test actually contains or doesn’t contain the material it was tested for,” he said.

“You never want to accuse a patient of aberrant behavior if you have an inconsistent result, because there are other reasons why you could have inconsistent results. It could be there are differences in metabolism or they could have a health issue that may be causing the problem. Or there may be a drug interaction.”

Another reader who is on probation was given a urine test that showed he was positive for fentanyl.

"After a nightmare trying to keep myself out of jail, they allowed me to go to a hospital for another urine and blood tests. Both came back 100% negative! The second tests were taken an hour after the first," he wrote. "The judge accepted the hospitals tests and I am free, but this should not be happening."

The CDC’s opioid prescribing guidelines encourage doctors to conduct urine tests on patients before starting opioid therapy and at least once a year afterward. But they explicitly warn against dropping a patient after a failed test.

 "Clinicians should not dismiss patients from care based on a urine drug test result because this could constitute patient abandonment and could have adverse consequences for patient safety, potentially including the patient obtaining opioids from alternative sources," the guidelines state.

How common is patient abandonment? In a recent survey by Pain News Network and the International Pain Foundation, 20 percent of doctors and healthcare providers said they had discharged a patient who failed a drug test in the past year.  And about 4 percent of the patients surveyed said they had been fired by a doctor over a failed test.

Doctors Oppose 'Perverse' Limit on Opioid Painkillers

By Pat Anson, Editor

A group of 80 doctors, pharmacists, academics and health researchers have signed a joint letter opposing “perverse” new guidelines being proposed to limit high doses of opioid pain medication.

The National Committee for Quality Assurance (NCQA) is a little known non-profit organization that accredits healthcare organizations and ranks their performance against a set of standards known as the Healthcare Effectiveness Data and Information Set (HEDIS).

In a proposed new HEDIS standard for opioid prescribing, NCQA would set a daily ceiling at a 120 milligram morphine equivalent dose (MME) when opioids are prescribed for 90 consecutive days or longer. Any insurer or provider in violation of that standard would be red flagged, and if too many violations are found they risk losing their accreditation.

The proposed standard “will pose a serious risk to some patients currently receiving opioids,” according to the letter drafted by Stefan Kertesz, MD, a primary care physician and Associate Professor at the University of Alabama at Birmingham School of Medicine. 

The letter was signed by a diverse group of healthcare providers, including some who helped develop the CDC’s opioid prescribing guidelines. Those guidelines are voluntary and intended only for primary care physicians, but are being widely adopted and made mandatory throughout the U.S. healthcare system.

Ironically, the NCQA's limit of 120 MMEs is actually higher than the CDC's recommended limit of 90 MMEs.

“We must distinguish between the language of the CDC Guideline itself, and the perverse care decisions that the NCQA ‘Opioid High Dosage’ binary measure will incentivize,” the letter states.

Kertesz and his colleagues say the proposed standard would force many doctors to taper patients off high opioid doses “despite the lack of any evidence to assess its impact on risk to patients, and the reality that the CDC Guideline did not endorse this approach.”

“Put simply, the ‘Opioid High Dosage’ measure will accelerate a reconfiguration of care that has never been tested in prospective trials and that could actually increase risk to individual patients, as illustrated by scholarly and popular reports of acute withdrawal (with death), protracted abstinence syndrome, and suicide associated with incautious unilateral opioid discontinuation or unrelenting pain,” they wrote.

The letter concludes by urging the NCQA to abandon its high opioid standard until evidence is available to assess the potential harm to patients.

In a statement explaining its proposal, NCQA said “there is limited evidence for the long-term beneficial effects of opioid use” and suggested opioids were only appropriate for acute pain and chronic pain conditions “such as sickle cell disease or late stage cancer.”

The NCQA just ended a public comment period on its opioid proposal. Several PNN readers have complained they were unable to post comments on the NCQA website.

Lyrica Fails in Sciatica Pain Study

By Pat Anson, Editor

A small study in Australia has found that pregabalin – a drug more widely known under the brand name Lyrica -- works no better than a placebo at relieving leg pain caused by sciatica.

Researchers enrolled 209 sciatica patients in the study and assigned them to groups that received either pregabalin or placebo for a year. The findings, published in the New England Journal of Medicine, not only showed that pregabalin was no more effective than a placebo, but that it caused unwanted side effects such as dizziness.    

“Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica and did not significantly improve other outcomes, as compared with placebo, over the course of 8 weeks. The incidence of adverse events was significantly higher in the pregabalin group than in the placebo group,” researchers concluded.

In all, 227 side effects were reported by the 108 patients who received pregabalin.

"Until now there has been no high quality evidence to help patients and doctors know whether pregabalin works for treating sciatica. Our results have shown pregabalin treatment did not relieve pain, but did cause side effects such as dizziness," said lead author Dr. Christine Lin, an associate professor at the George Institute for Global Health and the University of Sydney Medical School.

The placebo effect appeared to play a strong role in the study. Participants started out with an average score of about 6 on a zero to 10 pain scale. After one year, the pain levels dropped to 3.4 for those taking pregabalin and 3.0 for those taking placebo.

“It seems people associate a drop in pain being due to taking a capsule, rather than something which would happen naturally over time,” said Lin. "Unfortunately there are no drugs proven to work for people with sciatica and even epidural injections only provide a small benefit in the short term. What we do know is that most people with sciatica do eventually recover with time. It's also important to avoid bed rest and to stay as active as possible."

Sciatica originates in the lower back and travels down the sciatic nerve to each leg, causing pain, tingling and numbness. 

Pregabalin was originally developed as a treatment for epilepsy, but drug maker Pfizer was very successful in turning Lyrica into a multi-purpose pain drug that generates worldwide sales of $5 billion a year.

The U.S. Food and Drug Administration has approved Lyrica to treat chronic nerve pain caused by diabetes, fibromyalgia, epilepsy, spinal cord injury and post-herpetic neuralgia caused by shingles. The drug is also prescribed “off label” to treat a variety of other conditions, including sciatica and spinal stenosis.

According to ClinicalTrials.gov, dozens of studies are underway to test the effectiveness of pregabalin on conditions such as cirrhosis of the liver, anxiety, chronic cough, post-operative pain, pediatric seizures, and neuropathic pain caused by chemotherapy.

Common side effects of Lyrica are dizziness, blurred vision, nausea, headache, weight gain and fatigue.  Lyrica may cause suicidal thoughts in about 1 in 500 patients who use it. Pfizer also warns patients to talk to their doctor before they stop taking Lyrica. Suddenly stopping the medication may result in withdrawal symptoms such as headaches, nausea, diarrhea, trouble sleeping, increased sweating, and anxiety.

Little Evidence That Pain Contracts Work

By Roger Chriss, Columnist

Pain contracts are common. The Centers for Disease Control and Prevention recommends their use and many states all but require them. The contracts can be long, detailed and sometimes oddly demanding, as Crystal Lindell described in her recent column, "Signing a Pain Contract in the Age of Opioid Phobia."

In 2001, pain contracts and opioid use agreements were being promoted as “A Tool for Safely Treating Chronic Pain” by the American Academy of Family Physicians.

By 2011, Kaiser Health News was reporting that doctors were increasingly using contracts to protect themselves and to spell out the rules patients had to follow to reduce the risk of abuse and addiction.  

Some patients may end up signing multiple contracts with various providers, sometimes even watching video presentations about the content and intent of the contract.

So it seems reasonable to assume that pain contracts work, that research supports their use and establishes their benefits. Unfortunately, that is not the case.

The American Medical Association’s Journal of Ethics reported in 2013 that a review of opiate treatment agreements found “only weak evidence of a reduction in opiate misuse” in studies that were described as “methodologically poor.” The article also warned that “perhaps the greatest potential harm in the use of narcotics contracts is the inherent message to the patient that he or she can’t be trusted.”

Similarly, in 2010 the Annals of Internal Medicine published a review of a handful of observational studies rated as poor or fair quality, which found that opioid misuse was only modestly reduced in patients who signed contracts. In some of the studies, no benefit could be demonstrated.

In 2011, MD Magazine reported that “there is little evidence that these documents help reduce opioid misuse.” Steven King, MD, agreed with that assessment in the Psychiatric Times, writing that “there does not appear to be any firm evidence that these tools reduce the likelihood that opioids will be used in unintended ways.”

And as far back as 2002, the Clinical Journal of Pain published a study that stated “efficacy is not well established” for opioid contracts.

Thus, pain contracts have been researched for well over a decade with consistent results: they do little to reduce opioid misuse or abuse in any form.

Moreover, there is research and expert opinion suggesting that contracts can be harmful. For instance, in 2011 the Partnership for Drug-Free Kids reported that opioid contracts may damage patient trust and should not be used as a way to “fire” patients who violate the terms of the agreement.

In 2016, STAT reported on the unintended consequences of federal legislation promoting the use of such contracts, in particular how they could stigmatize and endanger patients who are struggling with substance abuse and addiction.

So why are pain contracts becoming more common and more complicated? And why is there a perception that they work?

Perhaps because chronic pain patients are in general compliant about pain medication, rarely share or sell their pills, and tend not to develop problems with abuse or addiction. In other words, pain contracts work because there is nothing for them to do.

The Johns Hopkins Arthritis Center tells us that patients who develop an opioid problem almost always have a prior history of substance abuse, and that stealing or forging prescriptions rarely occurs among patients. Another study found an opioid addiction rate of only about 3% in chronic pain patients.

Much like airport security scanners, pain contracts seem like a form of theater, a solution in search of a problem. But they are not just a benign if pointless exercise in paperwork.

Pain contracts unnecessarily lump together chronic pain patients and people suffering from drug addiction, and thus risk stigmatizing and misunderstanding two distinct groups. Chronic pain patients are not potential addicts or abusers-in-training, and substance abuse is a separate medical condition that requires a distinct approach from pain.

Perhaps there is a way to create pain contracts that actually help patients and clinicians. But until the evidence to support them is found, resources could be better used to improve treatments for chronic pain, as well as substance abuse.

Roger Chriss suffers from 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.

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.

Anti-Anxiety Meds Raise Risk of Opioid Overdose

By Pat Anson, Editor

Taking opioid painkillers with benzodiazepines – a class of anti-anxiety medication that includes Xanax and Valium – significantly raises the risk of an emergency room visit or hospital admission for an overdose, according to a large new study.

Opioids and benzodiazepines are both central nervous system depressants that can cause sleepiness, respiratory depression, coma and death. Nearly 30% of fatal overdoses in the U.S. linked to opioids also involve benzodiazepines.

Researchers at Stanford University School of Medicine analyzed private insurance claims for over 315,000 people prescribed opioids from 2001 to 2013.

In 2001, they found that 9 percent of opioid users also received a prescription for a benzodiazepine. By 2013, the co-prescribing rate nearly doubled to 17 percent.

Their study, published in The BMJ, found that use of both drugs was associated with a substantially higher risk of an emergency room visit or inpatient admission for opioid overdose.

“We found that opioid users who concurrently used benzodiazepines were at an increased risk of opioid overdose and that eliminating concurrent benzodiazepine/opioid use could reduce the risk of opioid overdose by 15%,” wrote lead author Eric Sun, MD, an assistant professor at Stanford University School of Medicine.

“Providers should exercise caution in prescribing opioids for patients who are already using benzodiazepines (or vice versa), even in a non-chronic setting. Indeed, we note that the association between concurrent benzodiazepine/opioid use and the risk of opioid overdose was broadly similar for both intermittent and chronic opioid users.”

The Food and Drug Administration recently expanded the warning labels on opioids and sedatives because of the risk of overdose. Insurance companies are also actively discouraging doctors from prescribing the two together..

A recent study by the Centers for Disease Control and Prevention ranked Xanax (alprazolam) as the fourth deadliest drug in the United States, while Valium (diazepam) was ranked tenth. Xanax was involved in about a quarter of the overdoses involving opioid pain medication.  

New Opioid Relieves Pain Without the ‘High’

By Pat Anson, Editor

Nektar Therapeutics has announced positive results from Phase III study showing that a new opioid medication significantly reduces pain without the high levels of euphoria that can lead to abuse and addiction.

The company also said the Food and Drug Administration has given the medication – known as NKTR-181 – “fast track” designation for the treatment of moderate to severe chronic pain, a status that allows for an expedited review of the drug.

Many pain sufferers say they do not get "high" or experience euphoria from opioid pain medication. But drug makers and government regulators are seeking to develop painkillers with less risk of abuse and addiction.  

"The data from this efficacy study are extremely important because they demonstrate that NKTR-181 produces strong analgesia in patients suffering from chronic pain while NKTR-181 has also demonstrated significantly lower abuse potential than oxycodone in a human abuse potential study," said clinical investigator Martin Hale, MD, medical director of Gold Coast Research.

"While standard opioid analgesics, including abuse-deterrent formulations, have been the most effective way to treat chronic pain, they are associated with serious safety concerns and many opioid-naïve patients fear taking them because of the potential for abuse and addiction.  The data for NKTR-181 suggest that it is a transformational pain medicine that could fundamentally change how we treat patients with chronic pain conditions."

The placebo controlled study involved 610 patients with moderate to severe chronic low back pain who had not taken opioids before. During the open-label phase of the study, pain scores dropped by an average of 65% in patients taking NKTR-181 twice daily.

The company said over half the patients (51.5%) on NKTR-181 reported their general overall status and quality of life "improved" or "very much improved" compared to patients taking a placebo. 

They also reported better overall quality of sleep, with less sleep disturbance and fewer sleep problems. There were no differences in daytime sleepiness on NKTR-181 versus placebo. The drug was generally well-tolerated, although some patients reported nausea, constipation and somnolence.

Nektar is currently conducting another Phase III study to evaluate the safety and tolerability of NKTR-181 in 638 patients with chronic low back pain or chronic non-cancer pain.

The company says NKTR-181 is the first opioid molecule to provide pain relief without high levels of euphoria and sedation. The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier in order to slow its rate of entry into the brain.

Nektar is a research-based biopharmaceutical company that discovers and develops new drugs for which there is a high unmet medical need. It has a pipeline of new investigational drugs to treat cancer, auto-immune disease and chronic pain.

Should CDC’s Opioid Guidelines Be Revised?

By Pat Anson, Editor

Suicidal patients. Illegal drug use. Hoarding of pain pills. Pharmacists refusing to fill prescriptions. Doctors worried about going to jail. Chronic pain going untreated.

Those are some of the many problems uncovered in a PNN survey of nearly 3,400 pain patients, doctors and healthcare providers, one year after the release of opioid prescribing guidelines by the Centers for Disease Control and Prevention (see "Survey Finds CDC Opioid Guidelines Harming Patients"). The guidelines were meant to be voluntary and are only intended for primary care doctors, but they're being widely implemented throughout the U.S. healthcare system – often with negative consequences for the patients they were intended to help.

Over 70 percent of patients say doctors have either reduced or stopped their opioid medication. Eight out of ten say their pain and quality of life are worse. Nearly half are having suicidal thoughts and some are hoarding opioids or turning to the black market for pain relief.

And hardly anyone believes the guideline has been successful in reducing opioid abuse and overdoses.

“This is astounding, but not surprising,” says Lynn Webster, MD, a leading expert in pain management and a longtime critic of the CDC guideline. “It may be time for the CDC to consider inviting the pain community to help revise the guideline to more align with a public health policy that finds a better balance of avoiding opioid related problems, while also allowing opioids to be used in a responsible way.  

“The CDC should not have issued the guideline without a plan to measure its possible benefits and unintended consequences.”

Does the CDC even have such a plan? PNN asked the agency if one exists and also for a comment on the survey findings. We have yet to get a response. 

The founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid group that helped draft the guidelines, also declined to comment on the survey findings.

“I’m not going to want to comment either way,” said Andrew Kolodny, MD, before launching into a defense of the guideline.

“Since the CDC guideline came out, the bad news on opioids for chronic pain continues to increase. The evidence keeps getting stronger and stronger that opioids are lousy drugs for most people with chronic pain,” said Kolodny, who is Co-Director of the Opioid Policy Research Collaborative at Brandeis University.

“Opioids for chronic pain should be a rare treatment. And unfortunately the practice is widespread. Millions of people like your readers are victims of this aggressive prescribing,” he told PNN.

CDC Pledged to Revise Guideline if Needed

The closing words of the CDC guideline say the agency is “committed” to revising it if evidence is found that it's not helping patients or doctors.

“CDC will revisit this guideline as new evidence becomes available,” the agency pledged last year. “CDC is committed to evaluating the guideline to identify the impact of the recommendations on clinician and patient outcomes, both intended and unintended, and revising the recommendations in future updates when warranted.”

Some critics are skeptical that CDC has any intention to revise the guideline.

“I am not aware of any actions which would demonstrate that the CDC is actually open to revising their guideline, especially when they knew of the problems in advance of its release,” said Stephen Ziegler, PhD, a Professor Emeritus of Public Policy at Indiana University-Purdue University.

“Instead of revising, did they instead opt to hire a PR firm? The negative outcomes, while unintended, were nevertheless foreseeable.”

Ziegler is referring to a contract the CDC signed last year with PRR – a Seattle-based public relations firm – to provide research and analysis for the agency. The research wasn’t focused on the “intended and unintended” impact of the guidelines, but on why they were received so poorly in the pain community.   

“They’ve heard a lot of outrage about this,” a source at PRR told us. “And so they hired our firm to gauge those perceptions and talk to people and come back to them with an analysis of what those perceptions are.”

Lynn Webster thinks the CDC needs to do more than hire a public relations consultant.

“I think it is time for Congress to ask the CDC to provide them a detailed report on the impact the opioid prescribing guideline has had on access to appropriate pain management, quality of care for people in pain, access to insurance coverage of alternative and complementary therapies recommended by the guideline, impact on the number of opioid related overdoses, rate of change reported in treatment for opioid use disorder, and change in possible suicide rate with people in pain due to inadequately treated pain,” said Webster, a former President of the American Academy of Pain Medicine.

Voluntary Recommendations Become Mandatory

Some believe the problem isn’t so much the wording of the guideline as the way it is being implemented by physicians, states, insurers and other federal agencies like the Department of Veterans Affairs (VA) and the Centers for Medicare and Medicaid Services (CMS). They’ve turned the CDC’s voluntary recommendations for primary care doctors into mandatory rules that all prescribers have to follow. 

“I've said about both the CDC guideline and the Washington state guidelines from years ago, that what they actually say isn't so bad. I can live with most of it. The problem is that people take what is there and turn it into something it shouldn't be,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“With respect to the CDC guideline, the problem is that everyone is trying to turn it into laws, rules, and criteria for prior authorization for payment, and those things absolutely shouldn't be done. If everyone treated it as what it is -- a series of expert-drafted suggestions -- we'd be doing OK. It might even have helped a lot of people.”

Millions of veterans and Medicare beneficiaries are about to learn what Twillman means about the guideline being turned “into something it shouldn’t be.”  

CMS is planning to adopt new rules to “better align” its policies with the CDC’s.  Medicare’s “Opioid Misuse Strategy” not only makes the guidelines mandatory, it allows insurance companies to take punitive action against doctors, pharmacists and patients who don’t follow them.

The VA and Pentagon have also released new guidelines that take the CDC’s recommendations a big step further. They strongly recommend against prescribing opioids long-term to anyone under the age of 30, and urge VA and military doctors to taper or discontinue opioids for any patients currently receiving high doses.

“You should take a look at the VA guideline that just came out, if you don’t like the CDC guideline,” says Andrew Kolodny. “The VA guideline is even stronger. It says don’t give opioids. Opioids are not preferred. Don’t do it.”

Lost in the shuffle of all these new rules and regulations is the voice of pain patients. Many who responded to our survey are fearful of becoming disabled or bedridden if opioids are taken away from them. And some believe the government has an ulterior motive.

“This is a silent genocide aimed squarely at Baby Boomers. An expedited way to avoid paying Social Security benefits to those who are approaching retirement or are receiving benefits. I am ashamed of our country,” wrote one patient.

“Completely wrong approach which will, I believe, result in more addiction as patients experiencing intolerable suffering are forced to look outside the medical system for relief,” said another.

“This is going to backfire on the CDC, Medicare, Medicaid, etc. The CDC is punishing every single person on pain medications,” wrote another patient. “People will die because of this, but they don't seem to care about any of the consequences of these guidelines. Being in pain is a terrible thing, I know from experience. I wouldn't even be able to work if it weren't for my pain medication. This is all very stressing, and I only see bad results coming out of this.”

The online survey of 3,108 pain patients, 43 doctors and 235 other healthcare providers was conducted between February 15 and March 11 by Pain News Network and the International Pain Foundation (iPain).

To see the complete survey results, click here.

Survey Shows Doctors Shunning Chronic Pain Patients

By Pat Anson, Editor

Chronic pain patients are not only having problems getting opioid medication, most are finding it hard just finding a doctor willing to treat their pain, according to a new survey.

Nearly 3,400 patients, doctors and healthcare providers responded to the online survey by Pain News Network and the International Pain Foundation, which was designed to assess the impact of the CDC’s opioid prescribing guidelines after one year.

The guidelines are voluntary and only intended for primary care physicians, but are being implemented throughout the U.S. healthcare system, often with negative consequences for patients. Over 70 percent of patients said they are no longer being prescribed opioid medication or are getting a lower dose. 

Asked if it has become easier or harder to find a doctor willing to treat their chronic pain, nearly half of patients said it was harder and 11% said they were not able to find a doctor. 

“I have been unable to find a doctor to treat my pain. I was going to a pain doctor but she suddenly dropped all her chronic pain patients to focus on surgery,” said a patient who added that he is now buying pain medication on the black market.

“I have found a new primary care doctor that is OK with prescribing Valium but stated she won't treat chronic pain because ‘the DEA is watching all of us,’” wrote another patient.

"I have been told by more than one doctor that they cannot legally prescribe over the guidelines. They are very concerned about being investigated and as a result refuse to treat pain with an appropriate dose of opioids," said another patient.

HAS IT BECOME EASIER OR HARDER TO FIND A DOCTOR TO TREAT YOUR CHRONIC PAIN?

"I was weaned off opiates last summer," said a patient. "My lower back and head are now in constant pain. I tried to hang myself last December but failed and spent a few days in hospital. Everyone thinks it was bad fall. Next time I won't fail."

"You have taken away my life. I am no longer a member of society, but more importantly, I can no longer function as a mother to two disabled children. I have exhausted all alternative methods of treatment. What do I do now? Illicit drugs or suicide?" asked one mother.

Doctors and healthcare providers are well aware that pain patients are losing access to treatment. Over two-thirds (67%) acknowledge that it is harder for patients to find a doctor.  A small number (9%) admit they’ve stopped treating chronic pain patients.

“I feel a standard of care for pain management has been needed, but the chronic pain patient is being lost in the process,” wrote a pain management provider. “For the first time in 5 years, I had to tell a patient I did not know what to do to help them. Pain management needs regulations, but should not cause the quality of life of chronic pain patients to suffer.”

"The manner in which (the guideline) was issued and received seemed to cause a response in which patients were basically titrated off all medication. Over half of my patients were treated this way," said a psychologist.

"Further, there appeared to be little or no assistance or cooperation in this process of removing a patient's analgesic medication. Overall, I believe that the response to CDC guidelines has harmed legitimate pain patients."

Doctors Worried About Prosecution

Why are some doctors shunning pain patients? They’re not worth the risk or hassle may be the simplest way to explain it. Consider some of the problems healthcare providers say they've dealt with in the past year:

• 59% say a pharmacy refused to fill an opioid prescription for a patient
• 57% say insurance refused to pay for a pain treatment they thought necessary
• 36% are worried about being prosecuted or sanctioned for prescribing opioids
• 20% have discharged a patient for failing a drug test
• 15% are referring more patients to addiction treatment
• 10% have lost a pain patient to suicide

Only 12 percent said their patients were better off without opioids and just 16% said their patients were getting safer and more effective treatment since the guidelines were released. Over a third (38%) believe their patients have more pain and a reduced quality of life.

The survey also found a sizeable number of doctors and providers who mistakenly believe the CDC guidelines are mandatory for everyone. While 70% correctly recognize them as voluntary, 20% think they are mandatory and 10% of healthcare professionals admit they simply don’t know.

"When a government agency suggests treatment guidelines, they will become the law. That is currently happening. We have reduced the number of pain patients and are no longer accepting new pain patients. The fear of prosecution is very real," wrote one pain management doctor.

"They are being interpreted as mandates and creating fear about ever using opioids to treat pain appropriately," said a provider who treats geriatric patients.

“(They) need to make it even more clear that these guidelines are geared for primary care and not experienced board certified pain doctors. Creating hysteria is what this is doing,” said a pain management doctor.

“While well meaning, the guidelines are incredibly biased and my colleagues are using them as an excuse to arbitrarily exclude patients from opioids when they clearly need them,” wrote an emergency room doctor.

ARE THE CDC GUIDELINES VOLUNTARY OR MANDATORY RULES EVERYONE HAS TO FOLLOW?

There is a strong divergence between patients and providers about the safety and effectiveness of opioids. Nearly two-thirds of doctors and providers (64%) think there are safer and better alternatives than opioids, while only about 7 percent of patients think so.    

Another area of disagreement is whether the guidelines are causing more harm than good. The vast majority of patients -- over 95 percent -- believe they have been harmful, while only 40 percent of doctors and providers think so. Nearly one in four healthcare professionals (22%) believe the guidelines have been helpful to patients, while only about 1% of patients think so.

"We have two problems in the U.S. A drug addiction problem and a chronic pain problem. We should not be attempting to treat one problem if that will also create a worsening problem in those that suffer from the other," wrote a primary care doctor. "We need to work on a solution to the addiction problem while still allowing those with chronic pain that need the opioids in order to sustain an acceptable quality of life."

The online survey of 3,108 pain patients, 43 doctors and 235 other healthcare providers was conducted between February 15 and March 11. For more on how the guidelines are affecting patients, click here.

To see the complete survey results, click here.

Survey Finds CDC Opioid Guidelines Harming Patients

By Pat Anson, Editor

The CDC’s opioid prescribing guidelines have harmed chronic pain patients, reduced access to pain care, and failed to reduce drug abuse and overdoses, according to a large new survey of patients, doctors and healthcare providers. The survey also found signs of a dramatic shift away from opioid prescribing over the past year.

Today marks the one-year anniversary of the guidelines, which discourage the prescribing of opioid medication for chronic pain. The guidelines are meant to be voluntary and only intended for primary care physicians, but are being widely implemented throughout the U.S. healthcare system and having many unintended consequences.

According to the survey, over 70 percent of pain patients say they are no longer prescribed opioid medication or are getting a lower dose. While reducing opioid prescriptions may have been the ultimate goal of the guidelines, it came with a heavy price: Eight out of ten patients say their pain and quality of life are worse. Many are having suicidal thoughts, and some are hoarding opioids or turning to illegal drugs for pain relief.

“I had a doctor pull me off methadone cold turkey after taking it successfully for 15 years for no reason other than the CDC's guidelines. I was in the worst pain of my life,” said one patient.

"The CDC needs to stop practicing medicine without a license. They are hurting more chronic pain patients than they are helping," said another.

"These guidelines are so incredibly wrong. People are already suffering, myself included. And it's going to get so much worse," predicted one patient.

“The ‘War on Drugs’ has devolved into a war on patients,” wrote a primary care doctor. “The government should spend its time, effort, and money on research to find a pain treatment with fewer harmful effects than narcotics and butt out of the doctor-patient relationship.”

HOW HAVE THE CDC GUIDELINES AFFECTED YOUR OPIOID PRESCRIPTIONS?

The online survey of 3,108 pain patients, 43 doctors and 235 other healthcare providers was conducted between February 15 and March 11 by Pain News Network and the International Pain Foundation (iPain).

“This survey shows that patients and providers are in agreement about the harm the guidelines have caused since their release last year,” said Barby Ingle, president of iPain. “When we have government agencies or insurance companies impose poor practices on the pain community, we see failure. A failure to stop abuse and overdoses, hoarding behaviors by well-intentioned patients, increased use of illegal drugs and, worst of all, suicides increase.”

There was broad agreement between patients, doctors and healthcare providers that the guidelines have been harmful to patients. When asked if the guidelines had improved the quality of pain care in the United States, over 90 percent said no.

"I have been on a high dose of opioids for twenty years. I was having a quality of life and enjoyed living. Now I want to die every day. I am in excruciating pain and have no quality of life. I am on more drugs than ever and all I want is to die," said a patient..

“Not only do I have less pain relief but I am not able to be as active and am sad and frustrated about that. Something has to change, what’s happening is not sane or humane,” wrote a fibromyalgia sufferer.

HAVE THE CDC GUIDELINES IMPROVED THE QUALITY OF PAIN CARE?

Eight out of ten respondents said the guidelines have not been successful in reducing opioid abuse and overdoses. That view is supported by recent reports showing that opioid overdoses are soaring around the country, and are now being driven primarily by heroin and illicit fentanyl, not prescription painkillers. 

Some patients admit they are turning to the black market for pain relief.

"Eleven of the 36 people in my support group have admitted using illegally obtained pain medication. Three of those have resorted to heroin because it is cheaper," one patient said.

“I was able to find illegal sources of medication. However, the prices are high. I have been trying to avoid heroin but I may have to make a switch in the future if I don't find another doctor to manage my pain,” said another patient.

"My pain clinic sent a letter to all of their patients stating they would no longer prescribe opiates,” said a patient. “No other practice would accept me in the area so I have been able to obtain my former meds through the black market. The prices are high and I am tempted to move to heroin as it's much less expensive.”

HAVE THE CDC GUIDELINES BEEN SUCCESSFUL IN REDUCING OPIOID ABUSE AND OVERDOSES?

"I have found a source of illegal hydrocodone that I have been testing (making sure not laced with fentanyl) in extremely small does. If that turns out clean I will move to the black market for my drugs since it will end up cheaper," another patient wrote.

Over the past year, patients reported many negative consequences from the guidelines, with very few positive outcomes – such as finding safer and more effective treatments.

• 84% say they have more pain and worse quality of life
• 42% have considered suicide because their pain is poorly treated
• 22% are hoarding opioids because they’re not sure of future access
• 20% say insurance refused to pay for a pain treatment they needed
• 19% say a pharmacy refused to fill their opioid prescription
• 11% have obtained opioids illegally for pain relief
•   4% found better and safer treatment than opioids
•   4% were given a referral for addiction treatment
•   4% were discharged by a doctor for failing a drug test
•   1% found that they don’t really need opioids

Suicidal thoughts and an increasing sense of desperation were common in many of the patient’s answers.

“My neighbor poured gasoline over her head and set herself on fire and died because she could not get any pain relief. To me it’s the same as taking chemo and radiation away from a cancer patient," said one patient.

"Should be very careful who they kick off meds. A friend hung himself in the bathroom, another lost his job and went homeless. I live in fear," said another.

"People are killing themselves because their chronic pain isn't being treated, and I become closer and closer to being one of those people," wrote another patient.

"So far I have lost three friends with chronic pain to suicide. I bet the CDC sees that as a win. Three less people to deal with. Bullets are cheaper than dealing with their chronic pain. It’s become a joke," a patient said.

To see a story on the impact the guidelines are having on doctors, providers and the availability of pain care, click here.

To see the complete survey results, click here.

Doctors and Pain Patients Often Disagree on Goals

By Pat Anson, Editor

If you’ve ever felt that you and your doctor are not on the same page when it comes to treating your chronic pain, you’re not alone.

A small study published in The Clinical Journal of Pain found that disagreements between primary care physicians and patients over priorities in pain management are common. Patients generally hope to reduce pain intensity and identify the pain’s cause, while physicians aim to improve physical function and reduce the side effects of opioid pain medication, such as dependency.

"We wanted to understand why discussions about pain between patients and doctors are often contentious and unproductive," said lead author Stephen Henry, MD, an assistant professor of internal medicine at University of California Davis.

"Primary care physicians treat the majority of patients with chronic pain, but they aren't always equipped to establish clear, shared treatment goals with their patients."

The study involved 87 patients receiving opioid prescriptions for chronic musculoskeletal pain and 49 internal or family medicine physicians at two UC Davis Medical Center clinics in Sacramento, California. In most cases, the patients were seeing their regular physicians. Patients receiving pain treatment as part of cancer or palliative care were excluded from the study.

Immediately following clinic visits between November 2014 and January 2016, the patients completed questionnaires to rate their experiences and rank their goals for pain management. The physicians also completed questionnaires about the level of visit difficulty, along with their own rankings of goals for the patient's pain management.

Nearly half of patients (48%) ranked reducing pain intensity as their top priority, while 22% said finding a diagnosis was most important to them. In contrast, physicians ranked improving physical function as the top priority for 41% of patients, while reducing medication side effects was most important for 26 percent of them.

Physicians also rated 41% of the visits with pain patients as "difficult" -- meaning their interactions were challenging or emotionally taxing. Primary care physicians usually rate about 15% of patient visits as difficult.

One surprise finding was that patients rated their office visits as fairly positive, even when their doctor did not. That may reflect the fact that patients tend to have positive relationships with their regular physicians, even though they don't always agree with them..

“Another possibility is that patients and physicians may not have realized that they prioritized different goals, because goals were not explicitly discussed during the visit. Some patients may assume that their treatment priority and their physicians’ treatment priority are the same, even when they are not,” Henry wrote. “Disagreements about goals may only become relevant during visits where patients and physicians disagree about treatment plans (e.g., whether to prescribe opioids).”

Henry says primary care physicians may have adapted to recommendations such as the CDC opioid guidelines, which emphasize functional goals and avoidance of long-term opioid therapy. Patients have yet to adapt to the guidelines and are still primarily interested in pain relief.

What can be done to help doctors communicate more effectively with their pain patients?

Henry recommends communication training for primary care physicians to ensure that patients are more aware of their goals. "It is critical for doctors and patients to be on the same page and not working at cross purposes," he said.