Fed Report Blames DEA for Painkiller Shortages

By Pat Anson, Editor

Poor oversight by the U.S. Drug Enforcement Agency has led to a sharp increase in shortages of some prescription drugs – including many opioid painkillers – according to a new government study that calls the shortages “a risk to public health.”

The lengthy report by U.S. Government Accountability Office (GAO) faults the DEA for “weak internal controls” and poor management of the quota system under which controlled substances are produced and distributed.

Between 2001 and 2013, the GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers. There were also shortages of anti-anxiety medications, sedatives, and stimulants. All of the drugs belong to a class of medications that affect the central nervous system and are used to treat seizures, manage anxiety, and relieve pain.

The vast majority of drug shortages lasted over a month and some dragged on for years. An oral solution of oxycodone was in short supply over the course of four different shortages, with a combined duration of over eight and a half years.

“While we cannot establish a causal relationship between shortages of drugs containing controlled substances and DEA’s management of the quota setting process, the shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the report states.

The shortages have only grown worse in recent years, according to many pain patients, physicians and pharmacists, who say controlled substances such as hydrocodone are increasingly difficult to obtain in some parts of the country.

The DEA has blamed major pharmacy chains such as CVS and Walgreens for some of the shortages, claiming the companies made a “business decision” not to fill as many prescriptions for opioids, after they were fined tens of millions of dollars for violating rules for dispensing controlled substances.

But even small, independent pharmacies have complained that controlled substances are harder to obtain. In a 2013 survey of over 1,000 pharmacists, the National Community Pharmacists Association (NCPA) found that most had experienced delays of at least one week in obtaining shipments of painkillers and other controlled substances.

“Community pharmacists repeatedly cited having their supplies or shipments of controlled substances abruptly shut off by their wholesalers, which may have done so due to perceived pressure, intimidation or a lack of clear guidance from law enforcement officials, such as the Drug Enforcement Administration,” said B. Douglas Hoey, CEO of NCPA, which represents over 23,000 independent pharmacies.

Under federal rules, the manufacture and distribution of controlled substances is regulated by the DEA under a quota system to discourage diversion, while the Food and Drug Administration regulates what conditions the medications can be taken for. Drug manufacturers are required every year to apply to the DEA for quotas to make their drugs, but according to the GAO the DEA rarely responds in timely manner.

“Manufacturers who reported quota-related shortages cited late quota decisions as causing or exacerbating shortages of their drugs,” the GAO said.

The DEA and FDA are supposed to work together when shortages of controlled substances develop, but according to the GAO they do not have a “sufficiently collaborative relationship” and even “disagree about what constitutes a shortage.”

The inter-agency rivalry has at times led to finger pointing.

“DEA officials also said that they do not believe FDA appropriately validates or investigates the shortage information it posts on its website and that posting this information encourages manufacturers to falsely report shortages to obtain additional quota. However, FDA reports that it takes steps to investigate and confirm the shortages on its website,” the GAO report states.

The GAO recommended the DEA perform periodic data checks to better manage the quota process, improve the processing of quota applications, and do a better job coordinating with the FDA on how to handle drug shortages when they develop.

Surveys Find Most Americans Not Worried About Painkiller Risks

By Pat Anson, Editor

Health officials, regulators and politicians have been warning for years about the so-called epidemic of prescription drug abuse in the U.S. But two new surveys show that most Americans are not as concerned about the abuse of pain medications and don’t want the government to restrict access to them.

A survey of over 1,000 Americans by the National Safety Council found that only 1 in 5 (19%) consider prescription pain medication a serious safety threat. Two-thirds of those taking opioids are not worried about side effects and only 12% are concerned about addiction.

The survey found broad support for opioids among those who take the medications.

• 78% believe opioids are the fastest way to treat pain.
• 71% believe opioids are the “best overall solution” for pain.
• 69% believe opioids are the “most appropriate solution” for pain.
• 52% believe opioids are safer than other pain medications.
• 42% wrongly believe it is legal to share opioids with family and friends.

"Forty-five people die every day from overdosing on prescription painkillers," said Deborah A.P. Hersman, president and CEO of the National Safety Council. "These medications are federally controlled substances and gateway drugs to heroin. Sharing drugs is never worth the risk, especially when non-addictive, over-the-counter pain relievers are often better options."

A second survey of 1,600 Americans, conducted by the non-profit Alliance for Aging Research, found an overwhelming majority opposes the government restricting access to medication that contains acetaminophen -- the world’s most widely used over-the-counter (OTC) pain reliever.

Over 50 million people in the U.S. use acetaminophen each week for pain and fever – many not knowing the medication has long been associated with liver injury and allergic reactions such as skin rash. Over 50,000 emergency room visits each year in the U.S. are blamed on acetaminophen overdoses, including 25,000 hospitalizations and 450 deaths.

The Food and Drug Administration has considered requiring a doctor’s prescription for acetaminophen products such as extra-strength Tylenol.  But the vast majority of survey participants disagree with the concept of restrictions.

• 75% of those under age 60, and 70% of respondents over age 60, believe the FDA should not require a doctor's prescription to buy extra-strength Tylenol or an equivalent store brand.
• 52% of those under age 60, and 45% over age 60, believe that requiring a prescription will make it more difficult to obtain safe pain medications.
• Only 11% of those under age 60, and 19% over age 60, would go to a doctor for a prescription for acetaminophen.
• 77% of those under age 60 and 68% of those over 60 prefer consumer education to government restriction as a way to protect people from acetaminophen overdose.

"The aging of our population means that more Americans will be faced with persistent pain," says Cynthia Bens, Vice President of Public Policy for the Alliance for Aging Research. "Potential barriers to OTC medication access may have unintended health consequences for seniors who rely on OTC pain relievers that contain acetaminophen to reduce their pain and maintain their quality of life."

The survey also offered insights into the amount of pain people experience:

• More than 18% of respondents age 60 and over have bad or severe pain, while 37% have daily pain.
• 70% of those aged 60 and over use OTC pain medication.
• For those under age 60, bad or severe pain is experienced by 15%, while 25% experience daily pain.
• 81% of those under age 60 use an OTC pain medication.

The FDA recommends taking no more than 4,000 mg of acetaminophen in a 24-hour period. In 2011 the agency asked drug makers to limit acetaminophen to 325 mg per tablet or capsule. The FDA also required a “Boxed Warning” label – the agency’s strongest warning – which is used to call attention to serious risks.

Lyrica Fails in Study of Juveniles with Fibromyalgia

By Pat Anson, Editor

Lyrica, a blockbuster drug widely prescribed to treat chronic pain in adults, works no better than a placebo in treating juveniles with fibromyalgia, according to the results of a new study released by Pfizer (PFE). Lyrica is Pfizer’s top selling drug with annual worldwide sales of over $5 billion.

The double-blind Phase IV trial was conducted to fulfill a post-marketing study required by the Food and Drug Administration after Lyrica was approved for the management of fibromyalgia in adults in 2007. The generic name of Lyrica is pregabalin, which was originally developed as an anti-epileptic drug.

“The primary endpoint of the study was not achieved as there was not a statistically significant difference between pregabalin and placebo in mean pain score,” Pfizer said in a statement.

A total of 107 adolescents (ages 12-17 years) were enrolled in the 15-week study at multiple centers across the U.S., Europe and Asia. It was the first large study on the efficacy and safety of Lyrica in juveniles with fibromyalgia.

The National Institutes of Health estimates that about 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, mood swings and insomnia.

In the study, Lyrica was administered twice daily, starting at 75 mg/day and then increasing to up to 450 mg/day, depending on the tolerability and response of the patient. The most common side effects in the study were dizziness, nausea, headache, increased weight and fatigue. Many other patients who take Lyrica complain of similar symptoms.

"Pfizer is committed to better understanding the full clinical profile of our approved medicines in pediatric and adolescent patients. This study advances the understanding of this patient population," said Steve Romano, MD, senior vice president of Global Medicines Development for Pfizer. "These results do not change the established benefit of Lyrica for its approved indications, including fibromyalgia in adults."

In addition to fibromyalgia, Lyrica is approved by the FDA to treat chronic pain associated with epilepsy, shingles, diabetic peripheral neuropathy, and spinal cord injury. The drug is also prescribed “off label” to treat lumbar spinal stenosis, the most common type of lower back pain in older adults.

Researchers Say Brain Processes Pain Emotionally

By Pat Anson, Editor

Many chronic pain sufferers resent being told their pain is “all in your head” or that they’re being too emotional about their pain.

But tests conducted by German researchers suggest that the human brain begins to shift from sensory to emotional processing of pain after just a few minutes of painful stimuli.

Scientists at Technische Universität München (TUM) in Munich enrolled 41 people in a study to measure brain activity as they were exposed to painful heat stimulation of a hand. Participants wore a cap with 64 electrodes that measured nerve cell activity in the brain throughout the experiment. The electroencephalograms (EEGs) made it possible to pinpoint which nerve cells respond to pain.

Participants were then given painful heat stimuli to the hand for ten minutes, with the intensity of the heat varying throughout the experiment. The test subjects were asked to continuously assess the level of their pain on a scale of one to a hundred with the other hand using a slider.

"We were absolutely amazed by the results. After just a few minutes, the subjective perception of pain changed. For example, the subjects felt changes in pain when the objective stimulus remained unchanged. The sensation of pain became detached from the objective stimulus after just a few minutes," said Markus Ploner, MD, a professor for human pain research at the TUM School of Medicine.

Previous studies have shown that brief pain stimulation is predominantly processed by sensory areas of the brain that process signals from nerves in the skin. However, in the heat experiment with longer-lasting pain, the EEGs showed that emotional areas of the brain became active.

"If pain persists over a prolonged period of time, the associated brain activity shows that it changes from a pure perception process to a more emotional process. This realization is extremely interesting for the diagnosis and treatment of chronic pain where pain persists for months and years," explained Ploner.

A second experiment showed that it is not just the duration, but also the anticipation of pain that affects perception. Twenty test subjects were given different intensities of painful laser pulses on two areas of the back of the hand. The participants then verbally rated how strong they perceived the pain to be.

In a second round of testing, the subjects were again given the same stimuli, but this time with two creams applied to both hand areas. Although neither cream contained an analgesic, the subjects were told that one of the creams had a pain-relieving effect.

Researchers found the cream had a placebo effect.

"The subjects assessed the pain on the skin area with the allegedly pain-relieving cream as significantly lower than on the other area of skin," said Ploner.

In addition to feeling less pain, the EEGs showed that nerve cells triggered a different pattern of brain activity.

"Our results show how differently our brain processes the same pain stimuli. Systematically mapping and better understanding this complex neurological phenomenon of 'pain' in the brain is a big challenge, but is absolutely essential for improving therapeutic options for pain patients," added Ploner.

OxyContin Still Being Abused by Addicts

By Pat Anson, Editor

Drug addicts are still finding ways to snort and inject OxyContin, five years after the painkiller was reintroduced in an abuse deterrent formula.

Researchers at Washington University School of Medicine in St. Louis surveyed almost 11,000 opioid abusers at 150 drug-treatment facilities and found that over a quarter of them still abused the painkiller, even though the new formulation of OxyContin is harder to crush or liquefy. Their study is being published in JAMA Psychiatry.

The abuse-deterrent formulation of OxyContin was introduced by Purdue Pharma in 2010, at a time when the painkiller was widely being abused. Nearly half of patients entering drug treatment facilities that year for opioid abuse said they had used OxyContin to get high at least once in the previous 30 days.

Two years later, after the abuse-deterrent formulation was introduced, the percentage of opioid abusers entering rehab who used OxyContin had fallen to 26 percent.

"We found that the abuse-deterrent formulation was useful as a first line of defense. OxyContin abuse in people seeking treatment declined, but that decline slowed after a while," said senior investigator Theodore J. Cicero, PhD, a professor of neuropharmacology in psychiatry.

"The newer formulations are less attractive to abusers, but the reality is -- and our data demonstrate this quite clearly -- it's naïve to think that by making an abuse-deterrent pill we can eliminate drug abuse. There are people who will continue to use, no matter what the drug makers do, and until we focus more on why people use these drugs, we won't be able to solve this problem."

The findings are not unexpected, according to a prominent pain physician.

“No one should expect that ADF's (abuse deterrent formulations) are not going to be abused.  They will.  Some ADF's will be more effective in deterring certain methods of abuse like injecting or snorting.  People who want to abuse can just take more orally or with enough effort can overcome the ADF technology,” said Lynn R. Webster, MD, a past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.

“As long as an opioid has rewarding properties a certain part of society will seek them out for abuse.  This is why we need to be realistic about what an ADF can accomplish.  We need to decrease the demand and eventually replace the type of opioids that produce liking with drugs that are not as rewarding but more effective.”   

Researchers say about a third of the addicts who still abused OxyContin had found a way to inhale or inject it. The rest took the painkiller orally. Even more worrisome, almost half of the drug abusers surveyed in 2014 reported they had used heroin in the 30 days before they entered treatment.

"Some people found ways to get around the abuse-deterrent formulation so that they could snort or inject it, and others simply swallowed the pills," Cicero explained. "But many people switched to heroin, and that's a major concern."

Cicero says 70% of the addicts who stopped using OxyContin and switched to other drugs were using heroin.

“Abuse-deterrent formulations can have the intended purpose of curtailing abuse, but the extent of their effectiveness has clear limits, resulting in a significant level of residual abuse. Consequently, although drug abuse policy should focus on limiting supplies of prescription analgesics for abuse, including ADF technology, efforts to reduce supply alone will not mitigate the opioid abuse problem in this country,” Cicero wrote in the study.

“We agree with Dr. Cicero that abuse-deterrent formulations are a valuable public health tool that must be part of any comprehensive approach to combatting prescription drug abuse. The report parallels other studies that show reformulated OxyContin is associated with a reduction in abuse,” said David Haddox, MD, V.P. of health policy at Purdue Pharma.  

“The product’s label states that OxyContin has physical and chemical properties expected to make abuse via injection difficult and to reduce abuse via snorting. The label also states that abuse of OxyContin by these routes, as well as the oral route, is still possible.”

Many pain patients with legitimate prescriptions for OxyContin say the abuse deterrent formulation is not as effective at providing pain relief as the old one. Others complain about side effects such as gastrointestinal problems.

Abuse deterrent technology is a key part of the Food and Drug Administration’s efforts at combatting the so-called epidemic of prescription drug abuse. Over 16,500 deaths in the U.S. were linked to opioids in 2010.

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

Counseling and Behavioral Therapy Help Vets in Chronic Pain

By Pat Anson, Editor

An innovative two-step program that combines analgesics with deep breathing, relaxation techniques and counseling significantly reduced pain levels in U.S. military veterans who suffer from chronic pain, according to a new study at a VA Medical Center.

Researchers at the Roudebush VA Medical Center in Indianapolis, the Regenstrief Institute and the Indiana University School of Medicine studied 241 veterans who returned from deployments in Iraq and Afghanistan. Findings from the ESCAPE trial -- short for Evaluation of Stepped Care for Chronic Pain – are being published in JAMA Internal Medicine.

It is a critical health issue among veterans, many of whom had multiple, often lengthy deployments. Many have significant long-term pain. We know that medications alone are only modestly successful in helping them; current pain treatments haven't made much of a dent,” said Matthew Blair, MD, the study’s lead investigator and an associate professor of medicine at Indiana University.

A recent study found that nearly half of the American soldiers deployed to Iraq and Afghanistan return home to the U.S. in chronic pain, and about one in seven were using opioid pain relievers. Although pain is a common condition, researchers say no intervention studies had been conducted on the best ways to treat chronic pain in these veterans.

“The absence of studies is concerning because chronic pain may prove even more disabling in veterans of recent conflicts than in veterans of previous eras owing to the high combat intensity,” said Bair, who served for eight years as a U.S. Army physician.

The veterans in the ESCAPE study suffered from moderate to severe chronic pain in the back, knee, neck or shoulder for at least three months. Veterans with substance or abuse problems were excluded from the study, as were those with suicidal thoughts, active psychosis or schizophrenia.

In the first phase of ESCAPE, patients were given 12 weeks of pain medication, ranging from acetaminophen to opioids. Because analgesics may not relieve pain sufficiently when used alone, the veterans were educated about self-management strategies such as goal setting, problem solving, deep breathing and relaxation techniques. Patients were also encouraged to minimize bed rest, return to normal activities, and perform stretching and strengthening exercises.

Step two involved 12 weeks of cognitive behavioral therapy that included psychological counseling for both pain and depression. Nurse care managers consulted with veterans over the telephone, helping them counter negative thoughts – such as helping them understand that while they may not be able to perform the same physical activities they enjoyed before deployment, a substitute activity like swimming might be achievable and decrease their pain.

Those who received the two-step ESCAPE program saw improvement in their function and a decrease in pain severity and pain interference -- how pain interferes with their mood, physical activity, work, relationships, sleep and enjoyment of life.

“The decrease in pain severity and 30 percent improvement in pain-related disability we achieved in the ESCAPE study are clinically significant, and we found that improvement lasted for at least nine months," said Blair.

Researchers say the ESCAPE program could be duplicated to treat chronic pain at other VA medical centers and other large health care systems outside the VA. However, implementing the program in smaller community settings or in private settings may be challenging.

"This is an important, methodologically rigorous study that underscores the value of psychobehavioral treatment in chronic pain,” said Beth Darnall, PhD, a pain psychologist and author of Less Pain, Fewer Pills. “Cognitive-behavioral therapy and the use of relaxation strategies work exceedingly well within the context of a comprehensive pain management program, and when the techniques are used regularly.”

Darnall recommends the same techniques used in the VA study in her own private practice.

“It’s important for people to know that the results from psychobehavioral skills build over time.  In other words, use them daily and your results will unfold and strengthen over the course of weeks and months,” she wrote in an email to Pain News Network.

Time for a More Rational Cannabis Policy

By Lynn R. Webster, MD, Guest Columnist

Individuals who suffer from severe chronic pain are caught in a double bind. Opioids contribute to the enormous societal harms of unintentional overdose, diversion and addiction, and data on their long-term effectiveness are conflicting and inadequate. But for patients who are helped by opioids, policies and regulations to address societal harms are, in some cases, impeding access to treatment, making it difficult even to find a knowledgeable physician. The need for safer and more effective analgesics has never been greater.

Answers do not lie in pitting one serious disease (i.e., chronic pain) against another (i.e., addiction) but in seeking scientific breakthroughs that lead to serious analgesic benefits without addictive properties or risk for respiratory depression. Rigorous research of cannabinoids has the potential to unlock a medicinal benefit on a societal scale. But committing to the necessary research requires rethinking how we classify cannabinoids as a controlled substance.

Inching Toward Safer Pain Treatments

Tetrahydrocannabinol (THC) produces the “high” effect associated with marijuana. On its own, cannabidiol (CBD) displays a plethora of actions including anticonvulsive, sedative, hypnotic, antipsychotic, anti-inflammatory and neuroprotective properties, and is believed to have fewer undesirable psychoactive effects than THC. Practically speaking, harnessing the potential medicinal benefits of marijuana without these unwanted effects would be a long-awaited breakthrough for science. Despite many strictures, scientists -- largely from other countries -- are inching closer to the finish line with products that could replace opioids in some instances.

On this point, we must speak cautiously and with a clear understanding: The current literature is weak at best. For example, Sativex, an oral spray composed of CBD and delta-9-THC currently on the market in Europe, Canada and Mexico, did not meet its primary end point of statistical difference from placebo for relief of cancer pain in an initial Phase III trial. Research in this area is in a nascent stage, and the ultimate conclusions are uncertain. But conclusive evidence requires rigorous study at a far faster pace and greater volume than is currently possible. Therein lies the problem.

Sadly, research is stymied due, in large part, to a federal and state regulatory structure that hamstrings researchers from gaining access to legal supplies of THC/CBD for scientific purposes. To study cannabis in the United States, scientists must comply with the Controlled Substances Act of 1970, which classifies cannabinoids as a Schedule I drug. Scheduling is controlled by the Drug Enforcement Administration (DEA), and Schedule I drugs are deemed to have no medicinal value and a high potential for abuse. 

Because of this, a researcher must pass through a gauntlet of onerous and time-intensive requirements to gain access to cannabinoids. The requirements to secure a license with the DEA, to register with the FDA, and to comply with a long checklist of rules from the National Institute on Drug Abuse to obtain research-grade cannabis all conspire to make the process protracted and costly.

Yet the patchwork of public policy on marijuana is anything but consistent: 23 states and the District of Columbia have now legalized marijuana use in some form. Furthermore, public opinion is evolving to erase some of the historical stigma surrounding marijuana use.

Marathon runners have recently been using marijuana-infused balms and edible marijuana to treat pain and swelling. In a climate where it is now possible to ask in the pages of “Men’s Fitness,” “Does pot make you a better athlete?” the current classification of marijuana under Schedule I doesn’t make sense. Why define a substance as having no medical value when the evidence and the laws of many states now say otherwise? Reclassifying cannabinoids to Schedule II could help expand research opportunities and determine appropriate indications.

More importantly, rescheduling cannabinoids will not necessarily open the floodgates to irresponsible use. The American Society of Addiction Medicine warns that marijuana is not benign but a psychoactive drug with risks for abuse and addiction and subject to a risk–benefit profile discussion with patients in clinical settings. Rightly, Schedule II drugs are recognized as having a high potential for abuse and dependence and are heavily regulated. Thus, rescheduling would still recognize risks associated with cannabinoids in recreational use, while accepting that the potential medicinal benefits could help people suffering from a variety of diseases, including chronic pain. Given that opioids have significant risks as a medical treatment, including life-threatening respiratory depression, and have fueled a nationwide prescription drug abuse crisis, research to explore new pathways to analgesia-like cannabis would point us in a new and, we hope, better direction.

We cannot afford to wait. With more than 100 million Americans suffering from chronic pain annually—affecting more people than diabetes, heart disease, stroke and cancer combined, according to the Institute of Medicine—public policymakers must recognize and reschedule this potentially therapeutic modality.

Lynn R. Webster, MD, is Past President of the American Academy of Pain Medicine, and vice president of scientific affairs at PRA Health Sciences. He is a Pain Medicine News editorial board member and author of a forthcoming book, “The Painful Truth.” His blog can be found at lynnwebstermd.com. He lives in Salt Lake City. Follow him on Twitter @LynnRWebsterMD, Facebook and LinkedIn.

This column is republished with permission of Pain Medicine News.

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.

How to be Healthy When You're Sick

By Crystal Lindell, Columnist

I’m trying to find ways to be healthy despite the fact that I constantly feel like I’m dying.

Having chronic pain is like waking up every single day feeling like you’ve just been mugged, then hit by a semi-truck, and simultaneously come into contact with the plague.

And when it first hits you, you’re like, “I can’t be expected to function under these conditions. Nobody could function under these conditions. I must call in sick to life.”

But after a month of laying on the couch watching every episode of Burn Notice three times, you suddenly realize you’re probably not going to be getting better any time soon, so maybe you should try to, you know, shower or something.

That’s where the drugs come in. And suddenly, you wake up one day and you’re literally taking six different medications before you even get out of bed in the morning. But hey! At least you’re getting out of bed.

And over the next few months or years or whatever it takes for you, you just sort of live in this drugged-up state of barely existing. It’s how I would imagine high school pot heads hope their life turns out, except without all the stupid stabbing pain in my ribs (or wherever yours may be). 

Aside from being high daily, you find all the shortcuts you can. For me, I ended up working from home. I moved in with my mom because doing my own laundry and washing my own dishes is literally too difficult. I shower once a week to save my energy. I shop online. And I never, ever, ever wear high heels. Ever!

On one level, I’m just happy that I’m no longer in so much pain that I literally hope I don’t wake up alive in the morning. But on another, I don’t really like what I see when I look down the long, dark road that’s probably going to be my life for, what? Another 50? Or even 60 years if I’m terribly unlucky?

Which brings me to the yoga. Yes, it’s true. I have started doing yoga. I’m hoping this is the next stage in the chronic pain life cycle, which will be followed quickly by, “Find a cure, and live happily ever after.”

While I’m here though, barely living, I figure I might as well get really good at downward dog. I started with a 30-minute PM yoga session for beginners on DVD. The hardest part is when I had to take two deep breaths in a plank pose. And, guess what? It didn’t suck.

I mean, I can admit when I’m wrong. And I was totally wrong about yoga. I really, really thought that bending my body in new, crazy ways would only make things worse. It’s just the human intuition in me, saying, “You’re in pain, stop doing stuff.” But, with chronic pain, you have to learn to override that voice.

And so, I’ve even done the 30-minute AM session, and I didn’t even die from that either. Plus, I also found another DVD by the same soothing instructor that’s 51-mintues long, and I did that one too, all without any trips to the hospital or anything! I’m pretty excited about the whole situation.

After each session I feel really relaxed, and it seems like I’m going through fewer pain pills when I do the yoga as opposed to when I don’t.

I’ve also started drinking tea. Back in the day, when my body didn’t hate me, I used to say things like, “Tea is literally just dirty water. Ick.”  But now, I’m sicker and wiser -- and I need to find ways to bring a sense of peace to my wounded body.

So, yeah, tea. It’s got to be better than Coke, right?

There’s a morning tea that seems to ward off the overwhelming feeling of being high that the meds give me. And then there’s a night tea that helps me poop — something I’ve really missed doing ever since my prescription pills took that seemingly natural bodily function away from me.

Truth be told, I am secretly hoping all these new changes will help me lose some of the 50 stupid pounds I’ve gained since getting sick. But if they even help me do more than shower or something, I’d be cool with that too.

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

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

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

Nerve Stimulation Effective in Treating Cluster Headache (VIDEO)

By Pat Anson, Editor

A neuromodulation device that stimulates a nerve in the neck substantially reduced the number and frequency of attacks in patients suffering from cluster headache, according to small study published in the journal Neurology. 

Image courtesy of electrocore

Seventy-nine percent of patients who completed the study (15 out of 19) reported an overall improvement in their condition after using gammaCore, a nerve stimulator that sends electrical signals along the vagus nerve, which runs through the neck to the brain. Eleven of the patients had chronic cluster headaches, and eight were classified as episodic.

“Cluster headache is a dreadful, extremely painful and disabling condition that can be very complex to manage. Given the unmet need for effective and safe treatments, we were excited to see the outcomes in these patients of an approach offering very considerable promise for future development.” said Peter Goadsby, PhD, who led the research at the Royal Free Hospital in London and the Beaumont Hospital in Dublin.

Cluster headache is a neurological disorder characterized by recurring, severe headaches on one side of the head, often around the eye. Attacks occur suddenly and can range from 15 minutes to three hours. Recommended treatments for cluster headaches include oxygen or triptan. 

Nearly half (47%) of the acute attacks treated with gammaCore ended in an average of 11 minutes.  Ten patients reduced their use of oxygen by 55% and nine patients reduced their triptan use by 48%. Preventative use of the gammaCore device resulted in a substantial reduction in the frequency of attacks, from 4.5 attacks every 24 hours to 2.6 after treatment. 

The treatment, which is self-administered by the patient for two minutes, involves placing the hand-held gammaCore device on the skin of the neck over the vagus nerve. In the study, patients administered two to three rounds of neurostimulation twice per day. Acute attacks were treated with up to six doses at the onset of the attack. Patients reported no serious side events.

GammaCore, which is manufactured by New Jersey based electroCore, is not currently approved by the Food and Drug Administration and is not available in the United States. 

The company is seeking FDA approval for gammaCore in the treatment and prevention of cluster headache. The device currently has regulatory approval for the acute and/or prophylactic treatment of cluster headache, migraine and medication overuse headache in the European Union, South Africa, India, New Zealand, Australia, Colombia, Brazil, Malaysia, and Canada. 

“It is not certain how vagus nerve stimulation treats and prevents migraines and cluster headaches, but data suggest that it may work by sending signals into the brain that reduce the amount of a substance, called glutamate, that has been associated with headache symptoms,” the company says in a statement on its website.

ElectroCore is developing Vagus Nerve Stimulation (nVNS) therapies for the treatment of multiple conditions in neurology, psychiatry, gastroenterology and respiratory fields. The company’s initial focus is on the treatment of primary headaches (migraine and cluster headache), and the associated chronic co-morbidities of gastric motility, psychiatric, sleep, and pain disorders.

ElectroCore has raised more than $80 million from investors including Merck’s Global Healthcare Innovation fund.

Gene Therapy Lessens Pain of Diabetic Neuropathy (VIDEO)

By Pat Anson, Editor

An experimental gene therapy reduces pain and other symptoms by over 50 percent in patients with diabetic peripheral neuropathy, according to a new study at Northwestern University.

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Diabetic peripheral neuropathy (DPN) 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 lead to injuries, chronic foot ulcers and even amputations.

Keith Wenckowski, who has type-one diabetes, says it felt “like walking on glass” when he walked barefoot in sand.   

Wenckowski and 83 other participants in the Northwestern study received two low doses of a non-viral gene therapy called VM202. They went to a clinic twice in a two-week period for a series of injections into their calf muscles and lower legs. Some received injections of a saline placebo, others a low dose of the therapy and others a higher dose.

"Those who received the therapy reported more than a 50 percent reduction in their symptoms and virtually no side effects," said Dr. Jack Kessler, lead author of the study. "Not only did it improve their pain, it also improved their ability to perceive a very, very light touch."

After three months, patients in the low-dose group experienced a significant reduction in pain compared to the placebo group. The effect persisted at six and nine months in the low-dose group.

"I can now go to a beach and walk on the sand without feeling like I am walking on glass," says Wenckowski, more than a year after receiving the therapy. "I am hoping the effects I am feeling do not cease."

VM202 contains the human hepatocyte growth factor (HGF) gene. Growth factor is a naturally occurring protein in the body that acts on nerve cell to keep them alive, healthy and functioning. Future studies will investigate if the therapy can actually regenerate damaged nerves and reverse the neuropathy.

Patients with the most extreme form of the DPN feel intense pain with a slight graze or touch. The pain can interfere with daily activities, sleep, mood and can diminish quality of life. Many drugs used to treat DPN, such as Neurontin and Lyrica, either don’t work or have unpleasant side effects.

"We are hoping that the treatment will increase the local production of hepatocyte growth factor to help regenerate nerves and grow new blood vessels and therefore reduce the pain," said Senda Ajroud-Driss, MD, an attending physician at Northwestern Memorial Hospital and an author of the study.

"We found that the patients who received the low dose had a better reduction in pain than the people who received the high dose or the placebo. Side effects were limited to injection site reaction."

The results of this Phase II, double-blind, placebo-controlled study are being published in the journal Annals of Clinical and Translation Neurology.A future, much larger Phase III study will soon be underway.

"Right now there is no medication that can reverse neuropathy," Kessler said. "Our goal is to develop a treatment. If we can show with more patients that this is a very real phenomenon, then we can show we have not only improved the symptoms of the disease, namely the pain, but we have actually improved function."

New Drugs Show Promise in Treating Neuropathy

By Pat Anson, Editor

Drugs that selectively target the melatonin MT2 receptor in the brain could be used to develop a new class of pain medication to treat patients with neuropathy, according to an international team of scientists.

Neuropathic pain is characterized by tingling pain that develops as result of nerve damage caused by conditions such as shingles, diabetes, amputation, inflammation, and cancer. About 8% of adults worldwide suffer from neuropathy. Many drugs used to treat neuropathic pain, such as Neurontin and Lyrica, often don’t work or have unpleasant side effects.

"There are very limited treatments available for neuropathic pain, and a lot of patients use opioids," said Dr. Gabriella Gobbi, an associate professor in the Department of Psychiatry at McGill University in Montreal.  "In the long term, these (opioids) can lead to addiction and severe side effects, including dependence and tolerance, opioid-induced hyperalgesia , and risk of death. For these reasons, identifying novel analgesics is of keen interest in the medical field today."

Melatonin, a hormone present in mammals and some plants, acts on the brain by activating two receptors called "MT1" and "MT2" that are responsible for regulating sleep, depression and anxiety.  Melatonin is sold over-the-counter as a sleep aid and in the treatment of sleep disorders such as jet lag and insomnia. However, there have been few long-term clinical studies on the use of melatonin in humans.

In experiments on animals, Gobbi and her colleagues demonstrated that UCM924, a melatonin MT2 receptor drug, can relieve chronic pain. They also identified the drug's mechanism of action in the brain. UCM924 activates MT2 receptors in the periaqueductal grey area of the brain, switching off the neurons that trigger pain and switching on the ones that “turn off” pain.

Previous studies have shown that over-the-counter melatonin has very limited effect. Gobbi and her team demonstrated that this is because melatonin activates both the MT1 and MT2 receptors, which have conflicting and opposite effects.

In the course of their work to investigate the efficacy of MT2 receptor drugs, the researchers discovered that UCM924 also soothes neuropathic pain at lower doses. This suggests the drugs could offer relief both to people who suffer from pain during the day, using low doses, and from insomnia at night, using higher doses.

Over half of patients with neuropathy complain of significant sleep disturbance, and this new study unveils how the mechanisms of pain and sleep are closely related.

The research team is now looking for partners interested in pursuing clinical development and eventual commercialization of these novel drugs.

Scientists in Mexico and Italy also contributed to the study, which are reported in the journal PAIN.

Spider Venom Could Take the Sting Out of Chronic Pain

By Pat Anson, Editor

Black widow spiders are well known for their dangerous, painful and sometimes even lethal bites. The venom of a female black widow is 15 times as toxic as a rattlesnake’s.

But that venom also contains an ingredient that could be developed into a new class of potent painkilllers.

Researchers in Australia have identified seven compounds in the venom of spiders that block the body's ability to send signals to the brain through what is called the pain pathway – also known as Nav 1.7 channels.

"A compound that blocks Nav 1.7 channels is of particular interest for us. Previous research shows indifference to pain among people who lack Nav 1.7 channels due to a naturally-occurring genetic mutation - so blocking these channels has the potential of turning off pain in people with normal pain pathways," said study leader Glenn King, PhD, of The University of Queensland's Institute for Molecular Bioscience.

King and his colleagues built a system that can rapidly analyze the protein molecules in spider venoms. They studied the venom of over 200 spider species and found that 40% of the venoms contained at least one compound that blocked human Nav 1.7 channels. Of the seven promising compounds identified so far, one is particularly potent and has a chemical structure that suggests it has a high level of chemical, thermal, and biological stability, which would be essential for administering in a new medicine.

"Untapping this natural source of new medicines brings a distinct hope of accelerating the development of a new class of painkillers that can help people who suffer from chronic pain that cannot be treated with current treatment options," said researcher Julie Kaae Klint, PhD.

Researchers have only scratched the surface. There are over 45,000 species of spiders, many of which kill their prey with venoms that contain hundreds - or even thousands - of protein molecules that block nerve activity.

"A conservative estimate indicates that there are nine million spider-venom peptides, and only 0.01% of this vast pharmacological landscape has been explored so far," says Klint.

The study is published in the British Journal of Pharmacology.

Researchers are also studying the potential of venom in cone snails for its potential for blocking pain signals in humans. German scientists at the Pharmaceutical Institute of the University of Bonn say one advantage of the peptides found in snail venom is that they decompose quickly and are unlikely to cause dependency.

A pharmaceutical drug derived from cone snail neurotoxins has already been developed and marketed under the brand name Prialt. The drug is injected in spinal cord fluid to treat severe pain caused by failed back surgery, injury, AIDS, and cancer.

New Opioid ‘Film’ Nears FDA Approval

By Pat Anson, Editor

The Food and Drug Administration has accepted a new drug application (NDA) for a new opioid film patch that could give chronic pain patients an alternative to hydrocodone and other painkillers that have become harder to get prescriptions for.

Image courtesy of biodelivery sciences

The buprenorphine film – to be sold under the brand name Belbuca -- was developed by Endo International (NASDAQ: ENDP) and BioDelivery Sciences (NASDAQ: BDSI) for the management of chronic pain requiring daily, long-term opioid treatment. The companies are hoping for final FDA approval by October, 2015.

Buprenorphine is an opioid that has long been used as an addiction treatment drug sold under the brand name Suboxone, but it can also be used to treat chronic pain.

"NDA acceptance represents an important step forward in our commitment to bringing to patients new therapeutic options for the treatment of chronic pain. We believe that Belbuca is a significant advancement in pain care, and an important extension to Endo's portfolio of products," said Rajiv De Silva, President and CEO of Endo.

Buprenorphine is a Schedule III controlled substance, meaning that it has been designated as having lower abuse potential than Schedule II drugs, a category which includes hydrocodone and most opioid painkillers. Many pain patients are having difficulty getting prescriptions for hydrocodone and other Schedule II drugs filled.

"The FDA's acceptance of our Belbuca NDA is a significant milestone for BDSI and in our partnership with Endo," said Dr. Mark Sirgo, President and CEO of BDSI. "We believe that Belbuca can offer those suffering with chronic pain with a novel treatment approach.”

Belbuca contains one-tenth to one-twentieth the amount of buprenorphine as Suboxone and other products that are used to treat opioid addiction.  Although the dose of buprenorphine is smaller, Sirgo says Belbuca film is effective in treating pain because the drug is absorbed through the inside lining of the cheek and enters the blood stream faster. In a Phase III study, he said the film was effective in treating patients who were taking a “hefty dose” of opioids equivalent to 160 mgs of morphine a day.

Belbuca is also less likely to be abused, according to Sirgo, because the patches are difficult to grind or liquefy for snorting or injecting.

Buprenorphine is already used to treat pain in transdermal skin patches made by Purdue Pharma under the brand name Butrans.

Finding Meaning in Chronic Illness

By Jennifer Martin, Columnist

I have never known life without chronic illness and pain.  I was diagnosed with juvenile rheumatoid arthritis (JRA) when I was 18 months old, so the life of a healthy person is foreign to me.  I don’t remember much about my early childhood with JRA other than daily medications, physical therapy and endless doctor’s appointments. 

When I was 6, my arthritis went into remission.  I took full advantage of that and began taking gymnastics, played street hockey with the neighborhood kids, and later joined the swim team.  Life was good. 

jennifer martin

Then one cold, rainy day before swim practice, I noticed that my knee was aching.  I shrugged it off and went to practice.  Later that night, the pain had increased and my knee was swollen.  I just knew my arthritis was back.  I was 15 years old at the time. 

A visit to the rheumatologist confirmed my fear.  Just like that I was back on multiple medications, forced to give up gymnastics and swimming, and was living again with daily pain. 

I was trying to find a balance between normal teenage life and dealing with chronic pain that none of my friends or family could relate to.  None of my friends had to give up activities they loved.  None of my friends had to have their knee drained when medication wasn’t keeping the swelling down.  None of my friends had to deal with taking pills for breakfast, lunch and dinner. 

So why did I have to do all these things? 

I remember one day when I was a senior in high school, I was in so much pain that I just sat home on the couch in tears all day instead of going to school.  It wasn’t too long after that that I had my first knee surgery due to my arthritis.

Fast forward several years to one day when I was 25 years old.  It is a day I will never forget.  I was at my mom’s house when I began feeling a little bloated.  I used the bathroom and when I looked down I saw bright red blood in the toilet.  My heart began pounding, my breath quickened and my hands began to shake. 

“What the heck is going on with me?” I remember thinking.  I took a few moments to calm myself down and then I convinced myself it must be nothing.  I went back downstairs and joined in the conversation without telling my family what happened. 

Several days later however, my symptoms had worsened and there was still blood in the toilet.  I knew I had no choice but to tell my family.  That began months of doctor’s appointments and tests that no human should have to be subjected to.  When I was finally diagnosed with ulcerative colitis, I was relieved to have a name for what was going on and at the same time frustrated that this meant another chronic diagnosis, more medication and more uncertainty.

The next two years were a roller coaster.  I had flares, felt horrible, and then went into remission. 

February 2009 began the biggest challenge of my life.  It was six months after I got married.  I began having a flare and quickly knew that this flare was different than any I had experienced before.  The pain was more intense, the medications weren’t working, and I was quickly losing weight from my already thin 108 pound frame.  By April, I was admitted to the hospital 30 pounds lighter and experiencing constant, excruciating pain so intense that I literally could not stand up straight. 

Every time I was forced by my family to eat and any time I used the bathroom it felt like a thousand knifes slicing through my intestines.  I remember many nights in the bathroom covering my mouth to suppress screams because I didn’t want to worry my husband. 

The day after my hospital admission, I had a colonoscopy.  While coming out of anesthesia I heard my gastroenterologist say to one of her colleagues, “This is the worst case of ulcerative colitis I have ever seen.”

The next day, I was transferred to UC Irvine Medical Center where I was to have three surgeries.  Surgery one consisted of removing my colon and constructing an ileostomy.  Surgery two involved constructing an internal j-pouch which essentially acts as a pseudo colon.  Surgery three involved removing my ileostomy and connecting my j-pouch.  After my third surgery I experienced complications, due to the amount of weight I had lost and scar tissue which required further hospitalization.

While my third surgery was supposed to be my last, that was not the case.  Since then I have had three more surgeries due to my j-pouch twisting.  The last surgery was as recent as 11 months ago.  I’m hoping that was my last.

In the midst of all this craziness I managed to complete my doctoral degree in psychology and I now specialize in counseling individuals with chronic pain and chronic illness.  It has become my passion. 

Because of my own experiences, I understand the emotional issues that arise from living with chronic pain and chronic illness.  I understand the depression, the anxiety, and the feeling of being so sick and in so much pain that maybe it would be easier to end it. 

But I also understand how important it is to work through those feelings, to find meaning in your situation, and to find a way to live life despite your diagnosis.  That is what I try to instill in my patients.

I have also beaten the odds and had a son.  I was told that due to my surgeries I would only have a 20% chance of conceiving on my own.  I look at my son every day and know that he is my miracle.  I hope and pray that he will never know the pain of chronic illness and chronic pain, but if he does, I will be there for him and I will understand.

Jennifer Martin, PsyD, is a licensed psychologist in Newport Beach, California. In her blog “Your Color Looks Good” Jennifer writes about the psychological aspects of dealing with chronic pain and illness. 

Jennifer is a professional member of the Crohn’s and Colitis Foundation of America and has a Facebook page dedicated to providing support and information to people with Crohn’s, Colitis and Digestive Diseases.

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.

Mornings Worst for Lower Back Pain

By Pat Anson, Editor

People who suffer from lower back pain are significantly more likely to feel their first aches and pains after waking up in the morning, according to researchers in Australia.

Their study, which was published in the journal Arthritis Care & Research, found a variety of physical and psychosocial triggers that increase the risk of low back pain. People engaged in manual tasks involving awkward positions are eight times more likely to suffer from back pain, while people who are distracted or fatigued during activities were about four times more likely.

"Understanding which risk factors contribute to back pain and controlling exposure to these risks is an important first step in prevention," explains Manuela Ferreira, PhD, an associate professor at Sydney Medical School at The University of Sydney in New South Wales, Australia. "Our study is the first to examine brief exposure to a range of modifiable triggers for an acute episode of low back pain."

Researchers recruited nearly 1,000 participants from 300 primary care clinics in Sydney, Australia, who had acute low back pain. They were asked to self-report on a dozen physical or psychosocial factors in the 96 hours prior to the onset of their back pain.

The risk of a new episode of low back pain varied significantly depending on a range of triggers. Moderate to vigorous physical activity nearly tripled the risk of low back pain, while being distracted during an activity made participants 25 times more likely to have back pain.

Researchers recruited nearly 1,000 participants from 300 primary care clinics in Sydney, Australia, who had acute low back pain. They were asked to self-report on a dozen physical or psychosocial factors in the 96 hours prior to the onset of their back pain.

The risk of a new episode of low back pain varied significantly depending on a range of triggers. Moderate to vigorous physical activity nearly tripled the risk of low back pain, while being distracted during an activity made participants 25 times more likely to have back pain.

One finding not reported previously was that back pain risk was highest between 7:00 a.m. and noon. Ferreira believes that may be because people are not fully alert and discs in the spine may be more susceptible to damage in the morning.

One surprise finding is that growing older appears to moderate the risk of back pain caused by lifting heavy loads. The risk was 13.6 times higher for people at age 20. At age 40 it was 6.0 and at 60 years of age the risk was only 2.7 times higher.

Alcohol and sex appeared to have no association lower back pain.

"Understanding which modifiable risk factors lead to low back pain is an important step toward controlling a condition that affects so many worldwide," said Ferreira. "Our findings enhance knowledge of low back pain triggers and will assist the development of new prevention programs that can reduce suffering from this potentially disabling condition."

Lower back pain is the leading cause of disability worldwide, with nearly 10% of the world's population experiencing back pain at some point in their lives. Low back pain has a greater impact on global health than malaria, diabetes, or lung cancer; yet little progress has been made to identify effective prevention strategies.

Lower back pain is not usually linked to a serious disease. It can be triggered by everyday activities, including bad posture, bending awkwardly, lifting incorrectly or standing for long periods of time.