Pain and Addiction Should Be Treated Separately

By Emily Ullrich, Columnist

Once again, the lack of humanity, honesty, and desire to provide quality pain care to patients on the part of doctors, hospitals, and medical and government organizations has astounded me.

Andrew Kolodny, MD, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), whose name seems to be six degrees of separation from all movements to thwart proper pain care, has submitted a petition asking Medicare to stop requiring hospitals to survey patients about the quality of their pain management.

A group of U.S. senators has gone even further, introducing the PROP Act in Congress, which would prevent Medicare by law from making "any assessments" of pain in hospitalized patients.

As I and others have written, pain is not merely discomfort. It is unhealthy and can even be life-threatening. If a patient is left in severe, unattended pain during a hospital stay, their acute pain can become chronic, triggering a host of other medical problems, such as high blood pressure, impaired immune function, ulcers, rashes, anxiety and depression. So, reporting one’s pain care while hospitalized is essential to the outcome of healing.

But, according to Kolodny and others who signed his petition, asking patients about their pain care leads to “dangerous pain control practices” and “aggressive opioid use.”

My question is, since patient surveys have contained pain evaluating questions for years, where is the evidence that doctors have over-medicated patients so their hospitals will have satisfactory survey ratings?

My guess is there is none. I have been hospitalized and suffered untreated or undertreated pain many times. I not only filled out surveys, but called hospital administrators, wrote the Joint Commission for hospital accreditation, and more, and STILL received sub-par pain care from doctors.

I am not alone. A recent survey of over 1,200 patients by Pain News Network and the International Pain Foundation found that over half rated the quality of their pain care in hospitals as either poor or very poor.

My next question is why doesn’t Kolodny want people to know about our pain? I suspect I know the answer.

As mentioned earlier, Kolodny can be traced back to nearly every movement to intervene in the proper medication of pain patients. In addition to running PROP, he is chief medical officer for the addiction treatment chain Phoenix House, and seemingly has an elaborate plan to have every patient on opioids be treated as an “addict.”  

This brings me to one final question. Why doesn’t any major American media outlet look into the conspicuous ulterior motives of Kolodny, PROP and Phoenix House? I am not much on conspiracy theories, but at this point I am compelled to say there might be something there, but our government and society are already so brainwashed to associate pain with addiction that no media outlet will touch it. Not to mention the political funding and special interest groups that also have a stake in this.

It all boils down to money. Healthcare in this country is treating pain on a financial hierarchy. The Obama administration has bought into the CDC guidelines on opioid prescribing, and the passing of the PROP Act will only further the notion that pain and addiction are one in the same.

Despite what we are being told, pain and addiction are two different issues, which need to be addressed separately. If this havoc wreaking discrimination continues, there will be no such thing as pain care left in this country.

Emily Ullrich suffers from Complex Regional Pain Syndrome (CRPS), Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, Endometriosis,  Interstitial Cystitis, migraines, fibromyalgia, osteoarthritis, anxiety, insomnia, bursitis, depression, multiple chemical sensitivity, and chronic pancreatitis

Emily is a writer, artist, filmmaker, and has even been an occasional stand-up comedian. She now focuses on patient advocacy for the International Pain Foundation, as she is able.

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.

Does Washing Your Hands Raise Risk of IBD?

By Pat Anson, Editor

Many of us were taught as children to always wash our hands before leaving the bathroom and before meals. But that basic sanitary practice may be contributing to an increase in inflammatory bowel diseases (IBD) such as Crohn’s disease and ulcerative colitis, according to a new study published in the journal Science.

Researchers at New York University’s Langone Medical Center tested the so-called “hygiene hypothesis” – the theory that some intestinal parasites and bacteria are beneficial because they help balance the immune system and reduce IBD rates. Sanitary practices have sharply reduced gut worm infections in developed nations, which now have some of the highest rates of Crohn’s disease and ulcerative colitis.

“Our findings are among the first to link parasites and bacteria to the origin of IBD, supporting the hygiene hypothesis,” says parasitologist P’ng Loke, PhD, an associate professor at NYU Langone.

“The prevalence of IBD is much less in regions of the world which have heavy worm infection. In fact, I got interested in the question of how worms can be beneficial when I was contacted by an individual who had deliberately infected himself with worms to treat his symptoms of IBD and was able to put his disease into remission.”

Loke and his colleagues found that laboratory mice infected with intestinal worms experienced a thousand-fold decrease in Bacteroides — a type of bacteria linked to people with higher risk of IBD. At the same time, the number of Clostridia, a bacterium known to counter inflammation, increased tenfold in the mice.

RESEARCHERS P'ng Loke and Ken Cadwell, NYU Langone Medical Center

Researchers believe the immune response to the worms triggers the growth of Clostridia, which then either outcompete Bacteroides for nutrients or release toxins that are harmful to them.

In a second phase of the study, researchers gave mice an infusion of Clostridia – without the use of parasites – and found that it reduced the presence of Bacteroides.

“That gives us a lot of hope in terms of IBD therapy because maybe we don’t need to give people parasitic worms, which can be harmful and cause disease, and instead target the harmful bacteria by replacing them with healthy bacteria,” says microbiologist Ken Cadwell, PhD, an assistant professor at NYU Langone and the Skirball Institute of Biomolecular Medicine. “Our study could change how scientists and physicians think about treating IBD.”

Researchers say the hygiene hypothesis may also apply to other autoimmune diseases, including multiple sclerosis, rheumatoid arthritis, and type 1 diabetes, in which processes meant to attack foreign invaders instead become oversensitive and trigger an immune response to the body’s own cells.

IBD is a chronic or recurring immune response and a painful inflammation of the gastrointestinal tract. Inflammation affects the entire digestive tract in Crohn’s disease, but only the large intestine in ulcerative colitis.

According to the Crohn's and Colitis Foundation of America, IBD affects about 1.6 million Americans and tends to run in families. Caucasians are more likely than other ethnic groups to have IBD. The diseases are especially prevalent in Jews of European descent (Ashkenazi Jews). African Americans and Hispanics in the United States are also increasingly affected.

Pain Clinic Settles Discrimination Case

By Pat Anson, Editor

An Indiana pain management clinic has agreed to pay $30,000 to settle a federal claim that it discriminated against a pain patient by refusing to treat him.

In an unusual twist, the discrimination case filed by the U.S. Justice Department against Pain Management Care of South Bend was not based on the man’s rights as a pain patient – but because of his HIV status. The Americans with Disabilities Act (ADA) is intended to protect all people from being discriminated against because of physical or mental disability.

According to the Justice Department, the patient was referred to Pain Management Care (PMC) in November, 2014 after the closure of another pain clinic where he had been treated. The patient sought bi-monthly cortisone injections, which he had been receiving for pain management from his previous doctor.

After sending the results of an MRI exam and other medical records to PMC, the patient received a voicemail message from a clinic employee stating that Dr. Joseph Glazier would not treat him “due to the risks involved with needles and blood due to (his) condition of being HIV positive.”    

The patient asked PMC to change its position but was still refused treatment. He was not able to find another pain management doctor willing to treat him until several months later.

“PMC’s discriminatory denial caused (the patient) to endure six months without needed pain management care and to experience emotional distress,” federal prosecutors said.

The case against PMC was filed on April 7th and quickly settled out-of-court, with Dr. Glazier agreeing to pay the patient $20,000 and a $10,000 civil penalty. PMC must also develop a non-discrimination policy, provide ADA training to its staff, and submit annual reports to the government. The consent decree still needs a judge’s approval.

PMC’s website now contains this notice: “Pain Management Care, P.C., does not discriminate on the basis of disability, including HIV. All individuals, including persons with HIV, have an equal opportunity to treatment from Pain Management Care, P.C.”

“The Justice Department is committed to eradicating discrimination resulting from the unfounded fear and dangerous stereotype that someone with HIV would pose a threat to a medical provider,” said Principal Deputy Assistant Attorney General Vanita Gupta, head of the Justice Department’s Civil Rights Division.  “Discrimination by those in the medical profession breaks a trust critical to ensuring access to appropriate treatment for all.”

This settlement is part of the department’s Barrier-Free Health Care Initiative, a partnership of the Civil Rights Division and U.S. Attorney’s Offices to target enforcement efforts on access to healthcare for individuals with disabilities. 

The Americans with Disabilities Act was signed into law by President H. W. Bush in 1990. It is intended to protect against discrimination based on “physical or mental impairment that substantially limits one or more major life activities.”

For more information on the obligations of healthcare providers under the ADA, you can call the Justice Department’s toll-free hotline at 800-514-0301. ADA complaints may be filed by email to ada.complaint@usdoj.gov or by clicking here.

U.N. Report: War on Drugs a Failure

By Pat Anson, Editor

The international war on drugs has been a costly failure that has created a “public health and human rights crisis,” according to a new report commissioned by the United Nations, which is meeting in special session this week to discuss global drug policy.

The 54-page report by the Johns Hopkins–Lancet Commission on Drug Policy and Health found that many drug policies are based on ideas about drug use and dependence that “are not scientifically grounded” and have been particularly harmful to pain patients.

The commission estimates that about 5.5 billion people worldwide do not have adequate access to controlled drugs for the management of pain. 

“Inequity of access to controlled drugs for pain management and other clinical uses is now a public health and human rights crisis,” the report found. “Yet the obligation to prevent abuse of controlled substances has received far more attention than the obligation to ensure their adequate availability for medical and scientific purposes, and this has resulted in countries adopting laws and regulations that consistently and severely impede accessibility of controlled medicines.”

The commission said there were many “myths and exaggerations” about opioid use that have stigmatized people who use the drugs. And rather than lowering the risk of abuse and addiction, drug prohibition was making the problem worse by forcing some people to turn to the streets for opioids.

“Prohibition creates unregulated illegal markets in which it is impossible to control the presence of adulterants in street drugs, which add to overdose risk,” the commission said. “The idea that all drug use is dangerous and evil has led to enforcement-heavy policies and has made it difficult to see potentially dangerous drugs in the same light as potentially dangerous foods, tobacco, and alcohol.”

Four mothers who lost their children to drugs have been invited by the Canadian government to attend the U.N. assembly on drug policy. One of them is Jennifer Woodside of Vancouver, whose 21-year son Dylan died of an overdose two years ago after he took a pill he thought was oxycodone, but was actually laced with illicit fentanyl.

 “This is a big epidemic,” Woodside told The Globe and Mail. “I think we’ve got our head in the sand if you think it can’t affect you.”

“The war on drugs has been a war on our families,” said Lorna Thomas, who also lost a son to an overdose of oxycodone and will attend the U.N. conference. “The starting point for it, that we were going to punish people out of using drugs has failed. People will continue to use drugs and we need to acknowledge that reality and keep people safe.”

As Pain News Network has reported, counterfeit pain medications laced with fentanyl began appearing in the U.S. this year and are blamed for a dozen overdose deaths in California and Florida. Coincidentally, the fake pain pills appeared just as the Centers for Disease Control and Prevention (CDC) finalized new guidelines that discourage primary care physicians from prescribing opioids for chronic pain.  Many patients fear losing access to opioids because of the guidelines.

“These CDC guidelines are brand spanking new. I think it’s hard to draw any sort of conclusions from that,” said Rusty Payne, a spokesman for the Drug Enforcement Administration. “I don’t think the Mexican cartels are paying one lick of attention to what the CDC guidelines are. What they see are thousands and thousands of addicts that they can push a product on, whether it be heroin or now fentanyl. And introducing it in pill form is just another way to make a lot of money."

The U.N. report on drug policy recommends decriminalizing nonviolent drug offenses and phasing out the use of military forces to enforce drug laws.

“Policies meant to prohibit or greatly suppress drugs present a paradox. They are portrayed and defended vigorously by many policy makers as necessary to preserve public health and safety, and yet the evidence suggests that they have contributed directly and indirectly to lethal violence, communicable disease transmission, discrimination, forced displacement, unnecessary physical pain, and the undermining of people’s right to health,” the report concludes.

The president of Columbia, which has long been on the front lines of the war on drugs, will urge the U.N. to radically change drug policies.

"Vested with the moral authority of leading the nation that has carried the heaviest burden in the global war on drugs, I can tell you without hesitation that the time has come for the world to transit into a different approach in its drug policy," President Juan Manuel Santos wrote in a column published in The Guardian.       

"No other nation has had to endure the terrible effects of the world drug problem in such magnitude and over such extended period of time as Colombia. The international community can rest assured that, when we call for a new approach, we are not giving up on confronting the problem; we are moved by the aim of finding a more effective, lasting and human solution."

Fake Oxycodone Seized at US-Mexican Border

By Pat Anson, Editor

Federal prosecutors this week filed charges against an alleged smuggler caught at the California-Mexico border with nearly 1,200 fake oxycodone pills, the latest sign that Mexican drug cartels are targeting pain patients in the U.S.

The pills were made with illicit fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. Counterfeit fentanyl pills are blamed for 11 deaths and dozens of overdoses in recent weeks in the Sacramento area, where they were disguised to look like Norco pain medication. Some of the victims were patients who sought painkillers on the street because they couldn’t obtain them legally.

Fake oxycodone, Percocet and Xanax pills have also been appearing in Florida, where they are blamed for at least one death.

19-year old Sergio Linyuntang Mendoza Bohon of Tijuana, Mexico was arrested at the Otay Mesa port of entry on February 10. Border patrol agents became suspicious when they saw “an unnatural looking bulge” in his underwear.

A search turned up 1,183 tablets labeled as oxycodone and 5.4 grams of powdered fentanyl. Laboratory tests later determined the pills were made with fentanyl, not oxycodone.

“This investigation involves the first interdiction of counterfeit oxycodone pills containing fentanyl that were smuggled from Mexico into the U.S. at the local ports of entry,” said Dave Shaw, special agent in charge for Homeland Security in San Diego.

FILE PHOTO of otay mesa border crossing

“While this time we’ve successfully prevented a potentially deadly drug from reaching the streets, we face an uphill battle stemming from the rapidly growing demand for pharmaceutical painkillers on the black market.”

Last year, the DEA issued a nationwide public health alert for acetyl fentanyl, a synthetic opioid produced by illegal drug labs in China and Mexico. Acetyl fentanyl is virtually identical to fentanyl, a Schedule II controlled substance that is often used in patches to treat more severe forms of chronic pain.

Acetyl fentanyl has been blamed for thousands of overdose deaths in the U.S. and Canada. It typically is mixed with heroin and cocaine to make the drugs more potent, but is now showing up in pill form – sometimes disguised as pain medication.

“These criminals are putting fentanyl into fake pills and passing them off as legitimate prescription medications.  Fentanyl is extremely powerful and can very easily lead to overdose deaths,” said William Sherman, DEA Special Agent in Charge.

“Unsuspecting individuals who illegally purchase oxycodone could potentially die from the ingestion of what turns out to be fentanyl tablets,” said U.S. Attorney Laura Duffy. “We are very concerned that these counterfeit pills could cause serious harm to users. Even miniscule amounts of fentanyl can have devastating consequences for those who abuse it or literally even touch it.”

Bohon faces up to 20 years in prison if convicted of unlawfully importing a controlled substance. His next court appearance is scheduled for May 2.

Public Health Emergency in Canada

British Columbia this week became the first province in Canada to declare a public health emergency due to a spike in fentanyl overdoses. Health officials say 201 overdose deaths were recorded in the first three months of 2016. 

Counterfeit fentanyl pills disguised as oxycodone started appearing in Canada about two years ago, where they are often called “greenies” when sold on the street.

ROYAL CANADIAN MOUNTED POLICE photo

“When it's mixed into these tablets it's highly variable from one to the next. So an individual who uses a pill they bought off the street that contains fentanyl may crush up a tablet, inject it and be fine but with the next one they do they may overdose.” Dr. Matthew Young, a substance abuse epidemiologist in Ottowa, told Vancouver Metro.

Like the United States, Canada has a serious problem with opioid abuse and addiction. Young says efforts to reduce opioid prescribing may have contributed to the current wave of fentanyl overdoses.

“That also created a market where organized crime stepped in and started selling these counterfeit tablets containing fentanyl,” he said.

Joint Commission Defends Hospital Pain Standards

(Editor’s Note: As Pain News Network has been reporting, an intense lobbying effort is underway to stop requiring U.S. hospitals to ask patients about the quality of their pain care. Critics contend the practice creates a financial incentive for hospitals to treat pain and leads to “aggressive opioid use.”  The Joint Commission, which accredits hospitals and sets pain management standards, released this statement about the controversy, which we thought you should see in its entirety.)

By David Baker, MD

In the environment of today’s prescription opioid epidemic, everyone is looking for someone to blame. Often, The Joint Commission’s pain standards take that blame.  We are encouraging our critics to look at our exact standards, along with the historical context of our standards, to fully understand what our accredited organizations are required to do with regard to pain.

The Joint Commission’s standards require that patients be assessed for pain, and if they are experiencing pain, then it should be managed. The standards DO NOT require the use of drugs to manage a patient’s pain; and when a drug is appropriate, the standards do not specify which drug should be prescribed.

Our foundational standards are quite simple. They are: 

DAVID BAKER, MD

• The hospital educates all licensed independent practitioners on assessing and managing pain.
• The hospital respects the patient's right to pain management.
• The hospital assesses and manages the patient's pain. (Requirements for this standard follow)
  1. The hospital conducts a comprehensive pain assessment that is consistent with its scope of care, treatment, and services and the patient's condition.
  2. The hospital uses methods to assess pain that are consistent with the patient's age, condition, and ability to understand.
  3. The hospital reassesses and responds to the patient's pain, based on its reassessment criteria.
  4. The hospital either treats the patient's pain or refers the patient for treatment. Note: Treatment strategies for pain may include pharmacologic and nonpharmacologic approaches. Strategies should reflect a patient-centered approach and consider the patient's current presentation, the health care providers' clinical judgment, and the risks and benefits associated with the strategies, including potential risk of dependency, addiction, and abuse.

Despite the stability and simplicity of our standards, misconceptions persist, and I would like to take this opportunity to address the most common ones:

Misconception #1: The Joint Commission endorses pain as a vital sign

The Joint Commission does not endorse pain as a vital sign, and this is not part of our standards. Starting in 1990, pain experts started calling for pain to be “made visible.” Some organizations implemented programs to try to achieve this by making pain a vital sign. The original 2001 Joint Commission standards did not state that pain needed to be treated like a vital sign. The only time that The Joint Commission referenced the fifth vital sign was when The Joint Commission provided examples of what some organizations were doing to assess patient pain. In 2002, The Joint Commission addressed the problems in the use of the 5th vital sign concept by describing the unintended consequences of this approach to pain management and described how organizations had subsequently modified their processes. 

Misconception #2: The Joint Commission requires pain assessment for all patients

This requirement was eliminated in 2009.

Misconception #3: The Joint Commission requires that pain be treated until the pain score reaches zero.

There are several variations of this misconception, including that The Joint Commission requires that patients are treated by an algorithm according to their pain score. In fact, throughout our history we have advocated for an individualized patient-centric approach that does not require zero pain. The introduction to the “Care of Patients Functional Chapter” in 2001 started by saying that the goal of care is “to provide individualized care in settings responsive to specific patient needs.”

Misconception #4: The Joint Commission standards push doctors to prescribe opioids

As stated above, the current standards do not push clinicians to prescribe opioids. We do not mention opioids at all:
The note to the standard says: Treatment strategies for pain may include pharmacologic and nonpharmacologic approaches. Strategies should reflect a patient-centered approach and consider the patient's current presentation, the health care providers' clinical judgment, and the risks and benefits associated with the strategies, including potential risk of dependency, addiction, and abuse.

Misconception #5: The Joint Commission pain standards caused a sharp rise in opioid prescriptions.

This claim is completely contradicted by data from the National Institute on Drug Abuse (Figure 1).

The number of opioid prescriptions filled at commercial pharmacies in the United States from 1991 to 2013 shows the rate had been steadily increasing for ten years prior to the standards’ release in 2001. It is likely that the increase in opioid prescriptions began in response to the growing concerns in the U.S. about under treatment of pain and efforts by pain management experts to allay physicians’ concerns about using opioids for non-malignant pain. Moreover, the standards do not appear to have accelerated the trend in opioid prescribing. If there was an uptick in the rate of increase in opioid use, it appears to have occurred around 1997-1998, two years prior to release of the standards.

The Joint Commission pain standards were designed to address a serious, intractable problem in patient care that affected millions of people, including inadequate pain control for both acute and chronic conditions. The standards were designed to be part of the solution. We believe that our standards, when read thoroughly and correctly interpreted, continue to encourage organizations to establish education programs, training, policies, and procedures that improve the assessment and treatment of pain without promoting the unnecessary or inappropriate use of opioids. 

The Joint Commission is committed to working to dispel these misunderstandings and welcomes dialogue with the dedicated individuals who are caring for patients in our accredited organizations.

David Baker, MD, is Executive Vice President of Healthcare Quality Evaluation at The Joint Commission

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.

Significant Decline in U.S. Opioid Prescribing

By Pat Anson, Editor

Nearly 17 million fewer prescriptions were filled for opioid pain medications in the U.S. in 2015, driven largely by a significant decline in prescriptions for hydrocodone, according to a new report by IMS Health.

The report adds further evidence that the so-called “epidemic” of opioid abuse and addiction is increasingly being fueled by illegal opioids such as heroin and illicit fentanyl, not by prescription pain medication intended for patients.

Hydrocodone was reclassified by the Drug Enforcement Administration as a Schedule II controlled substance in October, 2014 – making 2015 the first full year that more restrictive prescribing rules for the pain medication were in effect. But hydrocodone prescriptions were falling even before the rescheduling. They peaked in 2011 at 137 million and fell to 97 million in 2015, a 30% decline.

Hydrocodone is typically combined with acetaminophen to make Vicodin, Lortab, Lorcet, Norco, and other brand name hydrocodone products. The rescheduling of hydrocodone limits pain patients to an initial 90-day supply and then requires them to see a doctor for a new 30-day prescription each time they need a refill.

“It is not surprising that we have seen a dramatic drop in hydrocodone prescribing,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences. “Patients are being told they are not going to be prescribed opioids in general by many physicians. Since hydrocodone has been the most prescribed, it is the most affected. Schedule II opioids are more of a hassle so prescribers shun away from them.

“What is most striking is that the number of unintentional overdoses are still climbing despite fewer pills being prescribed.  Obviously this is a reflection that the goal to reduce harm from reduced prescribing is not working.  We have to wait to see if that trend continues.”

The Centers for Disease Control and Prevention recently adopted new guidelines that discourage primary care physicians from prescribing opioids for chronic pain. The agency also reported that 28,647 Americans died from opioid overdoses in 2014 and attributed about 19,000 of those deaths to prescription opioids. However, the CDC admits the data is flawed. Some overdoses may have been counted twice and some deaths blamed on prescription medications may have been caused by illegal opioids.

Hydrocodone Falls to #3

For several years hydrocodone was the #1 most widely filled prescription in the U.S. It now ranks third behind levothyroxine (Synthroid), which is used to treat thyroid deficiency, and lisinopril (Zestril), which is used to treat high blood pressure.

“Over 16.6 million fewer prescriptions were filled for narcotic analgesics, driven mainly by a sharp decrease in prescriptions for acetaminophen-hydrocodone, whereas prescriptions for oxymorphone, another controlled substance, increased 5.3%,” the IMS report said.

Oxymorphone is the generic name for Opana, a semisynthetic opioid that is also abused by drug addicts.  

The IMS report also found an increasing number of prescriptions being written for gabapentin (Neurontin), a medication originally developed to treat seizures that is now widely prescribed for neuropathy and other chronic pain conditions.  About 57 million prescriptions were written for gabapentin in 2015, a 42% increase since 2011.

After steadily increasing for several years, the number of prescriptions for tramadol appears to have leveled off, according to IMS. Last year about 43 million prescriptions were written for tramadol, a weaker acting opioid also used to treat chronic pain.

Overall spending in prescription drugs reached $310 billion in 2015, according to IMS, a 8.5% increase largely fueled by expensive new brand name and specialty drugs.

Learning Mindfulness and a Positive Attitude

By Barby Ingle, Columnist

Mental health can be disrupted when living with chronic pain. Anxiety, depression, isolation, and feelings of hopelessness and helplessness can increase to dangerous levels. Life can become overwhelming -- particularly for people who have been suffering with chronic pain for a long period of time. The idea of living with this horrible disease with no cure is astounding.

When my chronic pain started doctors often told me, “Just do this and you will be okay.” I would build up my hopes and follow their directions. But when I did not get better, I came crashing down and so did life around me.

When I finally realized there was no cure for my chronic pain and that my future would include pain on a daily basis, I began to have dark thoughts. I went through a grieving process in the course of coming to grips with my new reality. It is hard for many pain sufferers to accept their changing life, and the loss of independence and function.

It is very important for you and your family to recognize the symptoms of diminished emotional well-being and take action or you may end up at risk of suicide. There are going to be good and bad days, and if this is a bad day for you, remember to focus on the good days, good feelings and positive past and future experiences.

It was when I began looking for solutions, and displayed a positive attitude, self-esteem and confidence, that I began to attract other people who wanted to help me accomplish my needs and goals. Be sure to surround yourself with a team that is on your side, or you will be in a fight in which you will have trouble winning.

Creating a positive attitude starts with being inspired. You can begin by finding new interests and hobbies you can enjoy. A few suggestions are joining a non-profit cause, solving puzzles, writing a journal, joining or starting a support group, or even starting a blog. Creating a purpose can assist with your self-esteem and confidence.

I have learned that every person has a value no matter how big or small they seem. Believing in yourself and in your abilities, choosing happiness and thinking creatively is good motivation when it comes to accomplishing your goals. Learn to expect success when you are going through your daily activities. It might take you longer or you may need to use more constructive thinking to achieve success, but it is possible. 

There are great benefits to having a positive attitude, especially when things are not going your way. Staying optimistic will give you more energy, happiness and lower your pain levels. Success is achieved faster and more easily through positive thinking, and it will inspire and motivate you and others. I have found that when I am letting the pain get the better of me, it comes across to others as disrespect and brings those around me down.

No matter the challenges of today, they will pass, and will not seem as bad as time moves on. Challenges often turn out to be a bump that looked like a mountain at the time. You can be mentally positive and happy even when there are large obstacles to overcome.

No person or thing can make you happy and positive. Choosing to be happy starts with mindfulness.  

You can learn about mindfulness and moving beyond psychological suffering in a free two-part webinar I’ll be hosting, featuring Dr. Melissa Geraghty on April 28 and Dr. Karen Cassiday on May 13.  You can register for the webinars and learn more about treatments for anxiety and depression by clicking here.

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation (iPain). 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.

PROP Leads New Effort to Silence Pain Patients

By Pat Anson, Editor

Physicians for Responsible Opioid Prescribing (PROP) has joined in the lobbying effort to stop asking hospital patients about the quality of their pain care.

In a petition to the Centers for Medicare and Medicaid Services (CMS), PROP founder and Executive Director Andrew Kolodny calls on the agency to stop requiring hospitals to survey patients about their pain care because it encourages “aggressive opioid use.” PROP is funded and operated by Phoenix House, which runs a chain of addiction treatment centers, and Kolodny is its chief medical officer.

“Medication is not the only way to manage pain and should not be over-emphasized. Setting unrealistic expectations for pain relief can lead to dissatisfaction with care even when best efforts have been made to resolve pain. Aggressive management of pain should not be equated with quality healthcare,” Kolodny wrote in the petition on PROP stationary, which is co-signed by dozens of addiction treatment specialists, healthcare officials, consumer advocates and PROP board members.

The same group signed a letter, also on PROP stationary, to The Joint Commission (TJC) that accredits hospitals and healthcare organizations, asking it to change its pain management standards.

“The Pain Management Standards foster dangerous pain control practices, the endpoint of which is often the inappropriate provision of opioids with disastrous adverse consequences for individuals, families and communities. To help stem the opioid addiction epidemic, we request that TJC reexamine these Standards immediately,” the letter states.

Medicare has a funding formula that requires hospitals to prove they provide good care through a patient satisfaction survey known as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS).  The formula rewards hospitals that are rated highly by patients, while penalizing those that are not. 

The petition asks that these three questions be removed from the survey:

During this hospital stay, did you need medicine for pain?

During this hospital stay, how often was your pain well controlled?

During this hospital stay, how often did the hospital staff do everything they could to help you with your pain?

As Pain News Network has reported, 26 U.S. senators and the Americans College of Emergency Physicians have sent similar letters to Medicare asking that the pain questions by dropped from the survey. A recently introduced bill in the U.S. Senate called the PROP Act of 2016 would also amend the Social Security Act to remove "any assessments" of pain in hospitalized patients.

The PROP-led petition cites a 2013 study that found opioid pain medication was prescribed to over half of the non-surgical patients admitted to nearly 300 U.S. hospitals.

“Pain management is obviously an important part of patient care and we’ve always acknowledged that. But the problem here is that one should not have financial incentives and that’s essentially what happens through the CMS survey,” said Dr. Michael Carome of the consumer advocacy group Public Citizen, who co-signed the petition.

“The way the CMS survey and Joint Commission standards have driven the focus on pain has overemphasized its importance. We’re not saying don’t assess it at all, we’re saying the survey and standards have done more harm than good,” Carome told Pain News Network.

A top Medicare official recently wrote an article in JAMA defending the CMS survey.

"It has been alleged that, in pursuit of better patient responses and higher reimbursement, HCAHPS compels clinicians to prescribe prescription opioids. However, there is no empirical evidence that failing to prescribe opioids lowers a hospital’s HCAHPS scores," wrote Lemeneh Tefera, MD, Centers for Medicare & Medicaid Services. “Nothing in the survey suggests that opioids are a preferred way to control pain.”

Before joining Phoenix House in 2013, Kolodny was Chairman of Psychiatry at Maimonides Medical Center in New York City, a hospital that was given a one-star rating by patients in the CMS survey.   Only 61 percent of the patients said their pain was "always" well controlled at Maimonides and 11 percent said their pain was "sometimes" or "never" controlled. Only 59% of the patients said they would recommend Maimonides, compared to a national average for hospitals of 71 percent.

PROP has long been active in lobbying federal agencies to rein in the prescribing of opioids. It recently had some major successes in achieving its goals.

Five PROP board members helped draft the opioid prescribing guidelines released by the Centers for Disease Control and Prevention, which discourage primary care physicians from prescribing opioids for chronic pain. 

The Obama administration also recently asked Congress for over a billion dollars in additional funding to fight opioid abuse, with most of the money earmarked for addiction treatment programs such as those offered by Phoenix House, which operates a chain of addiction treatment clinics. A proposed rule would also double the number of patients that physicians can treat with buprenorphine, an addiction treatment drug. 

According to OpenSecrets, Phoenix House spent over a million dollars on lobbying from 2006-2012.  PROP calls itself “a program of the Phoenix House Foundation” on its website.     

PNN and the International Pain Foundation recently conducted a survey of over 1,250 pain patients and found that over half rated the quality of their pain treatment in hospitals as poor or very poor. Over 80 percent said hospital staffs are not adequately trained in pain management. Nine out of ten patients also said they should be asked about their pain care in hospital satisfaction surveys.

Canada: Abuse Deterrent Opioids Too Expensive

By Pat Anson, Editor

At a time when the U.S. Food and Drug Administration is actively promoting the development of more opioid pain medication with abuse deterrent formulas (ADFs), Canada is saying the drugs are too expensive and will have “little to no effect” in the fight against opioid abuse and addiction.

Health Canada last week rejected a proposed regulation that would require all medications containing the painkiller oxycodone to have tamper resistant properties.  ADFs generally make it harder for drug abusers to crush or liquefy opioids so they can be snorted or injected.

“(After) a review of the latest scientific evidence, the department has concluded that this specific regulatory approach, requiring tamper-resistance, would not have had the intended health and safety impact,” Health Canada said in a statement.

“Specifically, requiring tamper-resistant properties on all legitimate preparations of controlled-release oxycodone would have served to eliminate certain lower cost drugs from the market, increasing costs for patients and the health system, while having little to no effect in the fight against problematic opioid use.”

Like the United States, Canada has a severe and growing drug problem. According to the World Health Organization, Canada consumes more opioid painkillers per capita than any other country.

But Health Canada recently told drug makers to conduct more research demonstrating that ADFs do not change the safety and effectiveness of drugs. Until those studies are completed, the agency said it would rely on programs educating patients and prescribers about the safe use of opioids.

Purdue Pharma Canada released a statement saying it was disappointed in Health Canada’s decision and asked Health Minister Jane Philpott to reconsider.

“We continue to believe products with features designed to deter misuse, abuse and diversion, can and do have a positive impact on public health, based on the abundance of published evidence,” Purdue said in a statement. The company also urged Canada to “align with the FDA” by moving to require ADFs “across the entire class of opioids.”

In 2010, Purdue's OxyContin became the first opioid to be reformulated to make it harder for addicts to crush or liquefy. Since then, four other ADF opioids have been approved by the FDA and drug makers have spent hundreds of millions of dollars developing new formulas to make opioids even harder to abuse. Last month the FDA issued draft guidance encouraging drug makers to develop generic versions of opioids with ADF.

A major issue that has slowed the use of opioids with ADF is their cost. According to the Healthcare Bluebook, a website that estimates the market price of medications, the fair price for a 60-day supply of OxyContin 20mg in southern California is $352. A 60-day generic version of oxycodone -- without abuse deterrence -- retails for as little as $138.

Many health insurers have been reluctant to pay the extra cost of ADF.  A recent study found that only a third of Medicare Part D plans cover OxyContin and in many cases prior authorization is needed. Oxycodone, however, is covered by all Medicare Part D plans and prior authorization is rarely required.

Another recent study found that over a quarter of patients admitted to drug treatment facilities in the U.S. were still abusing OxyContin, five years after it was reformulated.

Pain Companion: When Pain Hijacks Your Brain

By Sarah Anne Shockley, Columnist

I had a great inspiration for this article a couple of weeks ago and immediately forgot what it was. I exhausted myself, uselessly racking my brain for the idea I’d had. What was it I thought was so perfect to write for Pain News Network?

Several days went by with me trying to find the elusive idea. I couldn’t even figure out what it related to. It was as if it had completely left the universe and was utterly irretrievable. Gone without a trace.

Ever feel like that?

Studies have shown that chronic pain affects the brain, but most of us living with chronic pain don’t need researchers to tell us that. We live with brains that don’t seem to be firing on all cylinders every day. I don’t know if there is an official term for it, so I’m just calling it “Pain Brain.”

In this and my next column, I’ll discuss some of the ways in which Pain Brain affects our ability to cogitate -- and some practical ways I’ve found to live with it a little more gracefully and even to coax the brain back online.

Dealing with Blank Spaces        

Do you find yourself in the middle of a sentence and can’t remember what you were talking about? Sometimes can’t come up with the words for even the most common items like chair, book, pen? 

We worry that we might be getting Alzheimer’s and sometimes find ourselves very embarrassed when, in the midst of telling someone something important, our brains simply turn off.

We’re left with our mouths hanging open in mid-sentence, whatever we were just talking about an utter mystery to us. We draw a complete blank. Sometimes it’s just a word, but often it’s the whole concept. Just gone. This can be extremely disconcerting.                                    

I find, particularly when I’m tired, that I’m creating sentences with a whole lot of blank spaces in them. “Can you hand me the... the... the... the... you know, I mean, uh... the… the... the.....” You’ve probably done this too.            

Stop. Breathe. Relax. Laugh. Choose another word. Or just let it go and carry on without that word or even that idea. It’s not that your brain is dying, you’re in pain.            

I’ve found that it’s usually not all that helpful to exert a lot of energy to try and recapture the word I lost. I’ve found that my efforts usually don’t make a bit of difference. I can’t conjure up that exact word or thought no matter how hard I try - and I just wear myself out and get flustered.                   

Pushing your brain to get back into gear creates tension, and you don’t need any more of that. Trying to find the exact word leaves a longer silence in your conversation, and you get the deer-in-the-headlights look, and that’s when you begin to feel uncomfortable and embarrassed. You want to say, I’m not really stupid or senile or easily distracted, I used to be able to converse with the best of them!                   

Instead, just move on with the conversation. Usually, sooner or later, the words you need pop back in. Sometimes much later. Sometimes in the middle of the night. But that’s okay. If we can just be easy with it, it’s not that big of a deal. It’s usually more disconcerting for us than the person we’re talking with.

Dealing with Brain Freeze

There are times, however, when it’s more than a particular word that’s missing. For me, it’s often a total brain freeze. Everything comes to a screeching halt, usually in mid-sentence. I have no idea what I was just saying, what the topic of the conversation was, or what direction I was headed in.                  

It’s pretty strange, because you don’t lose the power of speech, you just have no idea what you’re talking about anymore. It’s like the part of your brain dealing with that specific subject goes on a coffee break in the middle of a sentence, leaving you kind of stunned by its complete lack of presence.

For friends and family members, you can make up a code word or phrase for when you’re feeling disconnected from your own brain. I often just say, Sorry, my brain just stopped. It’s short and to the point, and they’ve learned what it means. They either remind me of what we were talking about, or we move onto something else.                   

For other people who don’t know your situation, and if you find yourself embarrassed by your own stupefaction, you might try just changing the topic. It’s really strange, but the brain seems to be able to go somewhere else and work relatively well, just not where you wanted it to go at the moment.

You can also distract other people’s attention from your sudden silence by asking them a direct question such as, What were you saying a moment ago? Or simply, What do you think? If they have something they have to respond to, it usually diverts their attention from your blank stare.

If you refer to what they were saying indirectly, without having to remember exactly what it was they actually said, they will often fill in the blanks for you and help you back on track -- without you having to explain that your brain just stopped.

Living with Pain Brain can be challenging, but in my experience, those of us who struggle with it notice the blank spaces and lost words much more than anyone we’re conversing with.    

In my next column, we’ll talk about memory loss and lowered capacity to cogitate. I’ll have some suggestions for working with them as well.                                

Sarah Anne Shockley suffers from Thoracic Outlet Syndrome, a painful condition that affects the nerves and arteries in the upper chest. Sarah is the author of The Pain Companion: Everyday Wisdom for Living With and Moving Beyond Chronic Pain.

 Sarah also writes for her blog, The Pain Companion.

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.

Neuropathy More Damaging Than Previously Thought

By Pat Anson, Editor

A tingling, sometimes painful sensation in the hands and feet – the early stages of small fiber neuropathy -- may be more damaging to the peripheral nervous system than previously thought, according to new research published in JAMA Neurology.

A 3-year study by Johns Hopkins neurologists found that patients with small fiber neuropathy showed unexpected deterioration over the entire length of sensory nerve fibers, not just nerve fibers at the surface of the skin.

“I liken small fiber neuropathy to the canary in the coal mine,” says senior author Michael Polydefkis, MD, professor of neurology at the Johns Hopkins University School of Medicine and director of the Cutaneous Nerve Lab. “It signals the beginning of nerve deterioration that with time involves other types of nerve fibers and becomes more apparent and dramatically affects people’s quality of life. The results of this new study add urgency to the need for more screening of those with the condition and faster intervention.”

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Small fiber neuropathy can also be caused by lupus, HIV, Lyme disease, celiac disease or alcoholism.

Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients feel pain or loss of feeling in their toes, feet, legs, hands and arms. It may also include a persistent burning, tingling or prickling sensation. The condition can eventually lead to injuries, chronic foot ulcers and even amputations.

Polydefkis and his colleagues found that small fiber nerve damage occurs even in patients with prediabetes, and the early symptoms of burning pain may be less benign than most clinicians think. Routine nerve tests, like nerve conduction, often fail to identify nerve damage because they mostly assess injury to large diameter nerve fibers.

In an effort to measure nerve damage more accurately, Johns Hopkins researchers took small samples of skin — the size of a large freckle — from 52 patients diagnosed with small fiber neuropathy and from 10 healthy controls. Skin samples were taken from the ankle, the lower thigh near the knee and the upper thigh. Three years later, samples from the same area in the same patients were taken for comparison.

Microscopic analysis of the skin samples showed that patients with small fiber neuropathy initially had fewer nerve fibers on the ankle compared to the upper thigh, demonstrating the most nerve damage was further down the leg. But after three years, researchers found that longer nerve fibers were also lost from the lower and upper thighs, something that was not expected.

“We are all taught in medical school that the longest nerves degrade first, and we show that this isn’t always the case,” says lead author Mohammad Khoshnoodi, MD, assistant professor of neurology at Johns Hopkins,

Patients with prediabetes or diabetes had at least 50 percent fewer small nerve fibers in their ankles initially than those participants with an unknown cause for their small fiber neuropathy, indicating these patients started the study with more damage to their small nerve fibers.

The patients with prediabetes continued to have worsening damage to their small nerve fibers over the course of the study, losing about 10 percent of their nerve fiber density each year at all sites tested along the leg. Patients with diabetes also lost similar rates of nerve fibers along the three sites of the leg.

“I expected that people with diabetes would do worse, but I didn’t really expect people with prediabetes to experience a similar rate of degradation of their small nerve fibers,” says Polydefkis.

Researchers caution that their study was small, and that other factors such as high blood sugar, smoking, high blood pressure and high cholesterol, may also have contributed to the decline in nerve fibers.

Maddening Advice: When the Dots Don’t Connect

By Pat Akerberg, Columnist

If I didn’t have a neurological pain disorder that defies resolution, I would scream out loud in frustration.  But talking and screaming are huge pain triggers, so I avoid them. 

You might be thinking that I want to scream because of the hundreds of horrific electrical pain spikes I endure all over my skull every day.  But that’s not actually why -- uninvited and uninformed advice are what makes me want to scream!

Not a day goes by that I don’t read some comment, hear of some off-the-mark advice offered, or field some intrusive advice myself.  You know the kind. 

It’s advice that’s given as if it holds the illumination of the brightest sage on the planet; and ought to be surrounded by a glowing halo.  Forget that it doesn’t fit the whole picture – the complexity of my medical disorder, pain, history or my own experience.

Oftentimes the suggestions and advice come in the form of simplistic, sweeping generalizations, with a hint of judgment laced with a black and white attitude.  If it worked for my aunt, then it will work for you – an improbable dot.

Sometimes it even comes with a hurled platitude or two for extra measure.

My personal non-favorite is the one that implies that we’re not given more than we can handle. The implication being that we just handle it then. 

“Just” is another pesky diminishing, misguided dot.

What if the reality is that some days we can and others we can’t, hard as we try?  Sometimes the right action in response to Yoda’s, “there’s no try, only do” is to not do.  

And I marvel at the pull yourself up by your bootstraps, take charge, buck up, get happy, and do something to help yourself variety of advice. Chances are some version of that is usually offered by someone who either never has or only temporarily had to live with pain, and not of the disabling kind. It’s the kind of “tough love” pep talk more fitting for enablers to deliver to an addict. 

But we’re not addicts; nor are we malingerers. 

These one-way, one-size-fits-all approaches are not motivational, considerate, or even pertinent in most situations. 

Is it so hard to believe that there are various physical activities, like exercise, cardio, yoga, bike riding, etc.,  that are simply too demanding to bear for some people with debilitating illnesses?

Contrary to the no-pain, no-gain notion, sometimes those very activities actually thwart improvement. I can personally attest to experiencing those setbacks, causing me to regretfully cancel my Y-membership.

To some, that translates to I am not trying hard enough and don’t want wellness bad enough.  Or that I am weak, succumbing to defeat. I can’t imagine anyone thinking that a person would prefer to live an impaired life voluntarily.  If I could get back to work, I’d be out the door in a heartbeat.

What if instead I know my own body, limitations, and my history better than someone else does?  What if I’ve learned from a disastrous, damaging brain surgery how to pay keen attention to my gut instincts about potential harm?

A friend of mine calls that honing skill his “Spidey” sense.  The best part is that you don’t have to be a super hero to have it either.  I suspect a few of us have developed it the hard way.

Growth and development comes in many forms -- not always external in nature.  Though we may not be exercising or running; there’s plenty of internal growth going on in will, courage and fortitude.

It’s how we carry on. 

Then there are the obvious suggestions that test anemic up against the unrelenting pain wallops that resist much of what’s out there to abate them. 

It might surprise some advice givers to learn that serious chronic pain sufferers laugh silly at the notion that Tylenol, Advil, a good vitamin complex, bottled water (yes, I was offered that one), a certain diet, or doing _______(fill in the blank) will relieve our pain. 

You’ve probably heard others just as ill-fitting or absurd.  None of those dots that plop can stop the neuropathic pain strikes relayed through my faulty central nervous system.

Once I heard a man tell other pain sufferers that they could not have possibly tried all of the potential pain treatment options out there, that no one could in their lifetime. 

Some sufferers have researched and lived with their chronic conditions for years, have seen dozens of specialists in multiple states, had multiple surgical procedures, and/or have taken an untold morass of medications – all factors the advice giver couldn’t have known or considered.

I do realize that sometimes people, even well intentioned, just don’t know what to say to someone who is suffering endlessly. 

But there’s actually no requirement that advice or suggestions be given, is there?  Support, the kind that connects, can be conveyed in so many practical, helpful ways based on the person’s actual needs.

Often self and other awareness can go a long way during difficult circumstances. I mean the pause of “until you’ve walked a mile in my shoes” kind of other awareness.  And the restraint of “err on the side of doing no harm” self awareness if you aren’t sure.   

People in pain are often misunderstood, maligned, barely listened to, or believed.  One of the greatest gifts someone can give to a chronic pain sufferer is their supportive presence.  A caring friend or family member simply willing to listen is balm for the spirit.

In the end, self care trumps unsolicited, disconnected advice.  Apparently today that involves tuning my Spidey advice radar up yet another notch.

Along with that comes the personal responsibility to do my best not to inflict the same unwanted practice on others.

Pat Akerberg lives in Florida. Pat is a member of the TNA Facial Pain Association and serves as a moderator for their online support forum. She is also a supporter of the Trigeminal Neuralgia Research Foundation.

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.

Fentanyl ‘Death Pills’ Spreading Coast-to-Coast

By Pat Anson, Editor

Law enforcement officials are warning that counterfeit pain and anxiety medications laced with illicit fentanyl have started appearing in Florida, where they are blamed for at least one overdose death.

The pills in Florida are disguised to look like oxycodone, Percocet or Xanax, but are actually made with fentanyl, a powerful and dangerous drug 50 times more potent than morphine. Similar counterfeit pills, made to look like Norco hydrocodone medication, are blamed for at least ten deaths and dozens of overdoses in the Sacramento, California area in recent weeks.

“I've had one of these so called super Norco’s,” said David, a 25-year old father of two, who started using street drugs for back pain.  “I only took a half just in case because of the news from the day and luckily I did. It was unlike any high I've had. It made me dizzy.  I couldn't see straight or sleep.”

As Pain News Network has reported, some of the victims in California are pain patients like David who sought opioid medication on the street because they can no longer get it prescribed legally.

"The people who have overdosed are not typically drug addicts," Olivia Kasirye of the Sacramento County health department told Agency France-Presse. “Many of the individuals said at one time or another they had a prescription and either they didn't get it refilled or the doctor said they didn't need it anymore."

Florida "Death Pills"

fake fentanyl pills disguised as norco

"It is here, it is deadly and it will continue to grow in our community,” said Danny Banks of the Florida Department of Law Enforcement in the Orlando Sentinel.

“If you are dependent upon or if you are experimenting with prescription painkillers, please make sure you are getting those painkillers from a licensed pharmacy. I cannot assure you right now, if you are buying prescription painkillers from either the black market or on the street, I cannot assure that they will not be laced with a deadly concoction that contains fentanyl. And it will kill you.”

In many cases, Banks said, neither buyers or sellers know the so-called “death pills” contain fentanyl.  He said fentanyl-laced pain pills have been seized in Osceola and Brevard counties, and have been linked to at least one fatality.

Florida’s Pinellas County Sheriff's Office has attributed nine recent fentanyl deaths to a batch of fake Xanax, an anxiety medication.

DEA Sees No Link to CDC Guidelines

In recent years, Illicit fentanyl has been blamed for thousands of overdose deaths. It is usually produced in China and then imported by Mexican drug cartels, which often mix fentanyl with heroin or cocaine before smuggling it into the U.S. The recent appearance of fentanyl in counterfeit pills is an ominous sign that drug dealers could now be targeting patients as customers, not just addicts.

But a DEA spokesman in Washington, DC disputes that notion.

“I don’t think you’re seeing that at all,” says the DEA’s Rusty Payne. “They’re going after anybody who will buy the product. By and large they are reaching hard-core addicts.”

Payne also sees no connection between the fake fentanyl pills and the recent adoption of the CDC’s opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. Many patients fear losing access to opioids because of the guidelines.

“These CDC guidelines are brand spanking new. I think it’s hard to draw any sort of conclusions from that,” Payne told PNN. “I don’t think the Mexican cartels are paying one lick of attention to what the CDC guidelines are. What they see are thousands and thousands of addicts that they can push a product on, whether it be heroin or now fentanyl. And introducing it in pill form is just another way to make a lot of money."

In a survey of over 2,000 pain patients last fall by Pain News Network and the International Pain Foundation, 60 percent predicted patients would get opioids off the street or through other sources if the CDC guidelines were adopted. Another 70% said use of heroin and illegal drugs would increase.

According to a story in STAT, drug cartels are now shipping machinery into the U.S. that can manufacture pills, allowing dealers to mass produce fentanyl in pill form. In March, the DEA arrested four men in southern California who were operating four large presses to make counterfeit hydrocodone and Xanax pills.

Recently the Royal Canadian Mounted Police arrested 14 people in British Columbia, seizing firearms, diamonds, cash and about a thousand fentanyl pills.

CRPS Patients Needed for Clinical Study

By Pat Anson, Editor

About 80,000 Americans each year are diagnosed with Complex Regional Pain Syndrome (CRPS), a poorly understood condition caused by injury or trauma that leads to throbbing and burning pain that never goes away. It often takes years and multiple doctors before a patient is diagnosed with CRPS – and by then the pain has often migrated to other parts of the body and has become chronic.

That’s the dilemma now faced by Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical research company that hopes to win FDA approval for an experimental, non-opioid drug that would be the first medication of any kind approved for treating CRPS --- also known as Reflex Sympathetic Dystrophy (RSD).

Axsome is conducting a Phase 3 clinical study of the drug --- called AXS-02 --- in the United States, Canada, the United Kingdom and Australia.

The challenge? Although Axsome only needs about 190 patients for the CREATE-1 study, it’s having trouble finding enough eligible patients. They’re looking for patients who suffered their initial injury in the last year and who were diagnosed with CRPS in the last six months.

“We’re trying to find patients very early in the stages of CRPS,” says Randall Kaye, MD, chief medical officer of Axsome.  

It typically takes a year or more for a patient to get a CRSP diagnosis because its early symptoms are not all that different from acute pain caused by surgery, a broken bone or some other type of trauma. It takes an experienced doctor to recognize the early signs.

“These are patients who continue to have pain that just doesn’t quite follow the routine course. Even after about a week or two, something is different. The pain is too much or the quality of the pain is just different. They describe a burning sensation or there’s exquisite sensitivity to temperature,” says Kaye. “What happens to these patients is that they continue to see a variety of physicians before they’re given that label of CRPS.”

a CRPS PATIENT 6 MONTHS AFTER leg fracture

“I wish it was easy to diagnose Complex Regional Pain Syndrome,” says Barby Ingle, president of the International Pain Foundation (iPain), who was diagnosed with RSD/CRPS two years after a car accident that injured her shoulder. “I went from having RSD in my face and shoulder. It then spread to my right arm and hand, then my entire right side. By the time I was properly diagnosed I had full body including organ involvement.”

“I have personally spoken to thousands of patients who have been diagnosed with RSD/CRPS. Out of all of them, two were diagnosed within the first 3 months, most took over a year. For me, I saw 43 providers before receiving a proper diagnosis. Most pain providers were not educated and although providers are getting better education now, there are still major delays.”

Opioids and other pain medications only dull the pain of CRPS, but Axsome is hoping that AXS-02 can also treat the underlying condition that causes the disorder.

“I hope so,” says Kaye. “Instead of just relieving pain, we’re getting right at the underlying pathophysiology of the condition.”

AXS-02 is an oral formulation of zoledronic acid, an injectable bisphosphonate that inhibits the production of compounds that cause bone pain. Bisphosphonates have long been used to treat osteoporosis and Kaye believes they might also stop the progression of CRPS.

“It’s pretty straightforward. Patients take one tablet once a week for six weeks and they’re done,” Kaye told Pain News Network. “We don’t think there will be a reoccurrence based on the mechanism of action. But we want to be sure.”

Proving that AXS-02 can do more than just relieve symptoms of CRPS will take time. If it can find enough patients, Axsome hopes to finish the CREATE-1 study in mid-2017. Additional studies may then be needed. If the clinical results are positive, the Food and Drug Administration has granted “fast track” and “orphan drug” designation for AXS-02, which will speed up the application and approval process.

CRPS patients interested in applying for the CREATE-1 study should click here.