Is Vitamin D Making Me Feel Better?

By Crystal Lindell, Columnist

This is the story of how I have turned into the crazy lady constantly telling everyone I meet to get their vitamin D level tested.

The thing about the vitamin D is that it could either be the cure I’ve been searching for, or have absolutely nothing to do with why I’ve been feeling better since about July. Either way though, I am feeling better these days.

Back in May, I went to visit a local weight loss clinic to try and lose some of the 60 lbs. I’ve gained since getting sick. While I was there they ran some routine blood work. And it turns out my vitamin D was low. Not like, “Oh, it’s just a little low, you should probably take a supplement” low.

My level was 6 ng/ml. It was literally the lowest the doctor at the weight loss clinic had ever seen.

To put it in perspective, the Vitamin D Council says it’s best to be between 40-80 ng/ml, while the University of Wisconsin recommends being between 30-80 ng/ml.

I had tested low before, like 19 ng/ml, but it was years before I suddenly woke up feeling like someone was stabbing me in the ribs. And I honestly don’t remember the doctor at the time impressing on me that it was any sort of an issue. I just figured it was like needing an oil change every 3,000 miles. Sure that’s the ideal, but your car isn’t going to just shut off if you wait until 5,000 miles.

So I told my primary care doctor about the results, and he and the weight loss doctor decided to put me on prescription-strength 50,000 IU vitamin D for three months, followed by a daily dose of 4,000 IU after that.

When I got home from my appointment, I looked through all my medical records — from Loyola University, the Mayo Clinic and the University of Wisconsin-Madison — and realized that not once had anyone thought to test my vitamin D.

I have literally had more than 35 blood tests, a handful of urine tests, and a more imaging than is probably healthy, but none of them were for vitamin D!

It turns out vitamin D is pretty important though, and has been shown to have direct links to chronic pain. It’s also not actually a vitamin, so much as a hormone. There’s all sorts of research on how low vitamin D can cause chronic pain, even specifically rib pain, which is what I have.

A recent study in The Pain Physician journal shows that, "Vitamin D, a hormone precursor essential for maintaining homeostasis of the musculoskeletal system, has long been proposed as an associated factor in CWP (chronic widespread pain). The most severe type of hypovitaminosis D, osteomalacia, features generalized body pain, especially in the shoulder, rib cage, and lumbar and pelvic regions."

And another study from the American Academy of of Pain Medicine showed that, “The prevalence and clinical correlates identified in this pilot study provide the basis for the assertion that vitamin D inadequacy may represent an under-recognized source of nociception and impaired neuromuscular functioning among patients with chronic pain.”

In other words, if low levels aren’t the cause, not having enough vitamin D can make chronic pain more severe. And, low Vitamin D can also make pain medications less effective.

According to an article on the Mayo Clinic website, “patients who required narcotic pain medication, and who also had inadequate levels of vitamin D, were taking much higher doses of pain medication — nearly twice as much — as those who had adequate levels.”

So I was cautiously optimistic that getting my vitamin D levels back up could at the very least make my pain medications more effective.

But for the first few months, I didn’t really feel much different. I only told a few people about the vitamin D because constantly talking about possible cures is exhausting — everyone wants it to work so much, and then when it doesn’t you feel like you have personally failed at something.

So I only told my mom, my boyfriend at the time, and my best friend. My then-boyfriend was hoping for a miracle by day two. But alas, nothing. My best friend was hoping for a miracle by month two. But alas, nothing. And my mom, who I live with, wasn’t really putting her hope in it all. She had seen too many things not work.

But then, in July, I started noticing things. Like little things. Like I could go for a walk and not die afterward. And then, in August, I cleaned the freaking bathroom! Seriously, I did the floors, washed the mirrors and scrubbed the tub, all without ending up in the hospital!! And by September, I was even able to make the four-hour round trip trek to work without having to spend the entire next day recovering.

Slowly, but surely, I have started feeling better. I mean, I’m not cured. And I’m not holding my breath that I ever will be. I’m also completely aware of the fact that I could backslide at any moment.

And, I still take morphine on a daily basis, for now anyway. But I have literally gone off almost all my other meds, including the sleeping pill amitriptyline and the nerve pain medication Cymbalta. As for the hydrocodone, I’m down to like one or two pills a week at the most. And sometimes, I can go the whole week without taking any at all — which is pretty much a miracle of God if there ever was one.

There’s also been some weight loss. I honestly never went back to the weight loss clinic because they wanted to put me on a weight loss drug, and over the last couple years I’ve come to a place where I just don’t want to be on any drugs unless I have to.

Even so though, feeling better has meant that I’ve been able to walk three to five miles about six days a week all summer, and I’m excited to report that since May I’ve lost 30 pounds! WHAT?

I had a visit with my amazing doctor last week, and we talked about whether or not the vitamin D deserved any credit for my newfound ability to shower almost every single day.

When I showed him that I had a whole bottle of hydrocodone left over — I honestly used to run out of the drug a week early each month — he literally said, “Congratulations!”

He tested my vitamin D, and I’m happy to report that I’m now at 35 ng/mL — a much healthier level than six. As my doctor remarked on the top of the lab results, “Your vitamin D level looks good. You can safely keep taking your current dose of vitamin D supplements.”

When we talked about it during the appointment, he told me that the vitamin D could be part of why I’m feeling better, or it could be that the nerve that they think was causing the pain had shifted somehow. Or it could be something else all together. Maybe it’s the placebo effect, or maybe it’s all those Taco Bell Cheesy Gordita Crunches I eat every other day that have something magical in them.

So yeah, I don’t know if the vitamin D is the reason I’m feeling better or how long-term this could be, but honestly, I don’t care. I’m just happy that I can clean the bathroom again.

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.

Millennium Wins FDA Contract Despite Fraud Charges

By Pat Anson, Editor

Just days after agreeing to pay $256 million to the federal government to settle fraud and kickback charges, Millennium Health has been selected to provide urine drug tests to the Food and Drug Administration for a clinical trial.

The trial will assess the development of opioid tolerance in patients taking pain medication with an abuse deterrent formula. Millennium could potentially make $1.6 million under the FDA contract.

"Long term opioid treatment can produce positive outcomes when prescribed and used appropriately, but they also carry risks that must be managed. UDT (urine drug testing) plays a critical role in aiding the clinician in evaluating patient safety. Millennium's selection as a service partner in this important initiative reflects our advanced technical and analytic capabilities and commitment to excellence," said Millennium CEO Brock Hardaway.

Millennium -- the nation’s largest drug testing company -- won the contract soon after it agreed to settle fraud charges under the Federal False Claims Act. Millennium was accused of bilking Medicare, Medicaid and other federal health care programs for a large number of medically unnecessary urine drug and genetic tests. The San Diego based firm was also accused of violating federal kickback laws by providing physicians with free urine “point of care” (POC) test cups if they referred more expensive laboratory testing to Millennium.  

“Millennium allegedly promoted indiscriminate and unnecessary testing that increased medical costs without serving patients’ real medical needs,” said U.S. Attorney Carmen M. Ortiz of the District of Massachusetts.  “A laboratory that promotes and knowingly conducts medically unnecessary drug testing operates unlawfully and squanders our precious federal health care resources.”

Under terms of its settlement with the Department of Justice (DOJ), Millennium will pay $237 million to settle claims for unnecessary urine and genetic tests. Millennium also entered into a corporate integrity agreement with the Department of Health and Human Services, and will pay $19.2 million to the Centers for Medicare and Medicaid Services to resolve issues over its billing practices. The government, in turn, will pay whistleblowers over $30 million for their help in building the case against Millennium.

“Millennium used a variety of schemes to cause physicians, including many of its biggest referrers, to routinely order excessive amounts of UDT (urine drug tests) for all patients (including Medicare and Medicaid patients) regardless of individual patient assessment or need. Millennium’s abusive practices included the use of physician standing order forms to encourage routine, excessive UDT, and the dissemination of false and misleading statements about drug abuse rates and the value of its testing,” the original government complaint said.

"While Millennium may debate some of the merits of the DOJ's allegations, we respect the government's role in health care oversight and enforcement,” said Millennium's Hardaway. “At the end of the day, it was time to bring closure to an investigation that began nearly four years ago. Millennium Health is currently a very different organization than we were in the past. We fully embrace our obligation to both commercial and publicly funded health plans to provide value to the health care system overall and ensure that doctors who order our testing solutions adequately demonstrate that those solutions are clinically necessary.”

After the settlement was reached, Moody's Investors Service downgraded Millennium's Health's corporate debt rating and said its rating outlook was negative.

"The downgrade reflects Moody's expectation that Millennium will complete a distressed debt exchange or file for Chapter 11 bankruptcy in the near term. Moody's is estimating that lenders will suffer material losses in the event of a default," Moody's said in a statement.

Millennium is not the first drug testing company to face fraud and kickback charges. Competitors Amertiox, Calloway Labs, Quest Diagnostics, and LabCorp have all faced similar charges and paid millions of dollars in fines.As a result of these cases, Medicare has proposed lowering its billing rates for diagnostic testing as early as 2016, moving to a flat-rate fee structure to prevent drug-testing companies from charging more by testing for more substances.

As Pain News Network has reported, urine drug testing grew into a lucrative $4 billion industry – what some call “liquid gold” – largely because so many doctors who treat addicts and chronic pain patients require them to submit to urine drug screens. In many cases, point-of-care tests are used, even though many experts consider them unreliable.

Power of Pain: Choosing to be Happy

By Barby Ingle, Columnist  

Mental health can be disrupted by chronic pain. Anxiety, depression, hopelessness, isolation and helplessness can increase to dangerous levels. Particularly for people who have been suffering with chronic pain for a long period of time, life can become overwhelming.

When I finally realized that chronic pain had no cure and that my future would include pain on a daily basis, I began to have dark thoughts. I did not want to end up at risk of suicide, so I started to build tools into my life for emotional comfort. 

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, positive past, and future experiences. It is very important for you and your family to recognize the symptoms of diminished emotional well-being and take action.

Understand that these feelings and thoughts are common among people living with chronic pain. It is helpful to create an overall strategy to get through the rough times.  Chronic pain patients learn over time that they can better cope and adjust to both the physical and psychological consequences of their disorder with the help and support of spiritual guidance, family and therapists.

Creating an arsenal of tools, such as spirituality, physical modalities and meditation, are all ways to better your situation. Turning to God has especially helped me with anxiety, depression, and other psychological and physical challenges; and it offers a great way to cope with and put situations into proper perspective so we can learn to live with them.

Chronic pain is not understood very well, and there are physicians and psychiatrists who believe that it is all in our heads or that people just complain for the sake of getting worker’s compensation or some other benefit. If we are seen as malingering patients who just won’t go away, doctors who don’t understand chronic pain may find it difficult to look for any other diagnosis other than psychological. A lot of my stress could have been avoided if doctors had really listened to me from the start, instead of looking at my marriage troubles as an excuse to “be ill for attention.” 

There were stages to my grieving. First was hope. I hoped that there was some cure to make the pain go away. Second, wondering if the treatment I was receiving was appropriate, I got angry. Feeling resentment and depression when I realized that this is not temporary is sometimes overwhelming in itself.

When this happens, I try to rationalize and evaluate the changes in my life and how I live it. In doing this I come to an understanding and acceptance of what my place is with permanent pain.

Despite the difficulties we experience, it is important that patients with chronic pain and other chronic conditions maintain a healthy lifestyle, including getting enough sleep, exercising, and eating healthy foods.

There are long-term health consequences created by leading a more sedentary lifestyle due to our pain. Because we are less active, we are at greater risk for developing other medical problems. We need to watch out for cardiovascular disease, diabetes and osteoporosis, as the risk for these conditions is heightened by inactivity.

I myself have been dealing with poor posture and sudden weight gain and loss. I fall easily and have trouble gripping and holding onto things.  

No matter the challenges of today, they will pass, and in retrospect, they will not seem as bad as time moves on. The challenges may just turn out to be a bump that looked like a mountain at the time.

I have found that when I live life with a negative attitude I am saying that I do not respect myself and do not believe success is possible. Try working on displaying a positive attitude and the moods of others and the challenges of life will become easier to deal with.

Choosing to be happy starts with you. No person or thing can make you happy and positive. It is a skill you have to practice and develop when living with chronic pain. When you are able to live in a happy, positive and optimistic light, your life will become a life worth the ups and downs that come with it.

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the Power of Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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

Feds Unveil Opioid Mapping Tool

By Pat Anson, Editor

Big Brother is watching your doctor. And now you can watch too.

In a graphic display of just how closely the government is tracking the prescribing of opioid pain medication, the Centers for Medicare & Medicaid Services (CMS) has released an interactive online map that allows ordinary citizens to follow opioid prescribing trends across the United States.

The map not only permits users to see the number and percentage of opioid prescription claims for each state filed under Medicare Part D – but to drill down on the data to counties, ZIP codes and even prescribers. Over 31 million people are enrolled in Medicare Part D, which subsidizes the cost of prescription drugs for Medicare beneficiaries.

“The opioid epidemic impacts every state, county and municipality. To address this epidemic, while ensuring that individuals with pain receive effective treatment, we need accurate, timely information about where the problems are and to what extent they exist,” said CMS Acting Administrator Andy Slavitt. 

“This new mapping tool gives providers, local health officials, and others the data to become knowledgeable about their community’s Medicare opioid prescription rate.”

The data used in the mapping tool is from Medicare Part D prescription drug claims in 2013, when over 80 million claims for opioids were filed at a cost of $3.7 billion.

The names of Medicare patients are not included in the online map, but prescribers can be looked up by name.

“By openly sharing data in a secure, broad, and interactive way, CMS and the U.S. Department of Health and Human Services (HHS) believe that this level of transparency will inform community awareness among providers and local public health officials,” the CMS said in a statement.

That kind of easy access to prescribing data -- without any context -- is chilling to Mark Ibsen, a Montana doctor who stopped prescribing opioid pain medication to patients because he feared prosecution or losing his medical license.

"Let's keep threatening data bases on car dealers and the crashes that happen, or pharmacies and who dies from their meds, or oncologists and what they prescribe, or police officers and who they have shot, or people we have dated and where they live," Ibsen said in an email to Pain News Network.

"Whatever useless data we can, thinking because it may be useful, using it, regardless of ANY forethought about harm, unintended consequences, or impact on prescribers, patients, business or law enforcement. This has gotten so carried away. I'm done. Whatever evil idea is going on, whoever thought this up, needs to be reeled in."

A look at the national map shows that Alabama, Oklahoma and Nevada have the highest rates of opioid prescribing for Medicare Part D beneficiaries. Over 7 percent of the claims in those states were filed for opioid pain medication, compared to a national average of 5 percent.

Counties and ZIP Codes can have much higher rates, as the map below shows. ZIP code 89081 is north of Las Vegas, near Nellis Air Force Base. Over 34% of the Medicare claims filed by two prescribers in that ZIP code were for opioids.

“The opioid abuse and overdose epidemic continues to devastate American families,” said CDC Director Tom Frieden, MD. “This mapping tool will help doctors, nurses, and other health care providers assess opioid-prescribing habits while continuing to ensure patients have access to the most effective pain treatment. Informing prescribers can help reduce opioid use disorder among patients.”

The CDC is trying to rein in opioid prescribing by issuing guidelines for primary care physicians, who prescribe most of the nation’s opioids. Those guidelines, which are expected to be released in January, encourage doctors to prescribe non-opioid pain relievers and “non-pharmacological” treatments for chronic non-cancer pain.

A recent survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation found that 90 percent are worried they will lose access to opioid pain medication if the guidelines are adopted. Many also believe the guidelines will lead to more addiction and overdoses, not less.

Opioid Use Stabilized in U.S. Decade Ago

By Pat Anson, Editor

The use of prescription drugs has soared in the United States since the turn of the century, with nearly six out of ten adults taking a prescribed medication at least once in the last 30 days, according to a new survey.

But while the use of blood pressure medication, statins and anti-depressants rose sharply from 1999 to 2012 -- the use of opioid pain medication appears to have stabilized and gone into decline over a decade ago.

“Although increased use of narcotic analgesics may raise concern about their potential misuse or abuse, it should be noted that use stabilized after 2003-2004. This flattening trend may reflect increased awareness of prescription opioid drug misuse or abuse, although underreporting of these drugs may have increased with awareness regarding their potential for abuse,” wrote lead author Elizabeth Kantor, PhD, formerly of the Harvard T.H. Chan School of Public Health, who is now with the Memorial Sloan Kettering Cancer Center.

The study findings are published in JAMA, the official journal of the American Medical Association.

The use of opioids rose from 3.8% of adults in 1999 to 5.7% in 2004, according to the study. Since then they have begun to decline slightly. The use of non-opioid pain relievers also appears to have leveled off. 

The data for the survey was compiled differently than most other studies of prescription drugs, which rely on pharmacy databases and insurance claims, not on actual use of the drugs.

The survey involved nearly 38,000 adults across the U.S. and was collected during household interviews.  Participants were asked if they had taken a prescription drug during the last 30 days. If they responded “yes” they were asked to name the medication or to show the drug’s container.

Although other studies have indicated that opioid prescribing is in decline, the Centers for Disease Control and Prevention (CDC) claims there is an “urgent need for improved prescribing practices.” It plans to issue new prescribing guidelines for primary care physicians in January that would limit the quantities and doses of opioids for both acute and chronic pain.  A complete list of the guidelines can be found here.

The opioid hydrocodone was once the most widely prescribed medication in the U.S. But hydrocodone does not appear in the list of top ten drugs used by participants in the survey, nor does any other opioid. The most commonly used prescribed medication in 2011-2012 was simvastatin, followed by lisinopril, levothyroxine, metoprolol, metformin, hydrochlorothiazide, omeprazole, amlodipine, atorvastatin, and albuterol.

“Eight of the 10 most commonly used drugs in 2011-2012 are used to treat components of the cardiometabolic syndrome, including hypertension, diabetes, and dyslipidemia. Another is a proton-pump inhibitor used for gastroesophageal reflux, a condition more prevalent among individuals who are overweight or obese. Thus, the increase in use of some agents may reflect the growing need for treatment of complications associated with the increase in overweight and obesity,” said Kantor.

The researchers found that prescription drug use increased from 51% of adults in 1999-2000 to 59% in 2011-2012. The prevalence of polypharmacy (use of five or more prescription drugs) nearly doubled, from 8% to 15% of those surveyed.

What’s Killing Middle-Aged White Americans?

By Pat Anson, Editor

A quiet epidemic of chronic pain, suicide, alcohol abuse and drug overdoses has killed a “lost generation” of nearly half a million middle aged white Americans in the last 15 years, according to a startling new study by Princeton University researchers.

Using data culled from a variety of sources and reports, researchers found a disturbing increase in the death rate for whites aged 45 to 54. Between 1999 and 2013, the mortality rate for middle aged whites rose by 2% annually, a reversal from previous decades when their death rate declined by an average of 1.8% a year.

The spike in mortality is estimated to have led to the early deaths of 488,500 white Americans, a figure comparable to the number of deaths caused by the AIDS epidemic.

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

No other race or ethnic group saw such an increase in mortality. African-Americans, Hispanics and those aged 65 and older continued to see their mortality rates fall.

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

It also coincided with a sharp increase in the prescribing of opioid pain medication, and seems likely to fuel a chicken and egg debate over which came first.

“The epidemic of pain which the opioids were designed to treat is real enough, although the data here cannot establish whether the increase in opioid use or the increase in pain came first. Both increased rapidly after the mid-1990s. Pain prevalence might have been even higher without the drugs, although long-term opioid use may exacerbate pain for some, and consensus on the effectiveness and risks of long-term opioid use has been hampered by lack of research evidence,” wrote Case and Deaton.

“Pain is also a risk factor for suicide. Increased alcohol abuse and suicides are likely symptoms of the same underlying epidemic, and have increased alongside it, both temporally and spatially.”

“The findings are astonishing, and a testament to the enormous toll opioids are taking in the U.S.,” said David Juurlink, MD, who heads the Division of Clinical Pharmacology and Toxicology at the University of Toronto. “It is very difficult to argue against cause-and-effect here. In my view it is a damning indictment of the widespread use of opioids for chronic pain, and should cause prescribers and patients alike to reflect on the role of these drugs, which have essentially no evidence behind them.”

Juurlink, who is a board member of Physicians for Responsible Opioid Prescribing (PROP), is advising the Centers Disease for Disease Control and Prevention (CDC) about its draft guidelines for the prescribing of opoids. He says it’s no coincidence that deaths in middle-aged whites rose just as opioid prescribing increased.

“It is an unarguable fact that opioids play a causal role in a good many of these deaths. People have drunk alcohol to excess for millenia, and have taken benzodiazepines needlessly for decades. And yet we see a striking surge in poisoning deaths coincident with surging opioid sales,” Juurlink wrote in an email to Pain News Network.

“As for suicide, you can put me on the record as speculating that opioids trigger suicide in some patients, and perhaps quite a high number. I raise this point because it's sometimes asserted that opioids can prevent suicide in patients with chronic pain. There is no evidence that this is true, but there are ample grounds to assert that they might in fact be a component cause.”

Another recent study published in JAMA found that drug overdose deaths associated with opioids nearly doubled in the last decade, rising from 4.5 deaths per 100,000 people in 2003 to 7.8 deaths per 100,000 in 2013.

But others says opioids are the not the cause of rising deaths, but more a symptom of a deeper problem.

“I can tell you absolutely that opioids do not lead this dysfunction.  Abuse, addiction, disability, and suicide are symptoms of a failing healthcare system,” says Terri Lewis, PhD, a rehabilitation specialist and patient advocate. “This population of white Americans has also been largely uninsured or underinsured.  They turn to self medication practices that involve alcohol because that is what is available.  Their acute care is often dependent on emergency room services where there is no continuity or recovery model in place.”

Deaths Hit Least Educated Hardest

The Princeton study found that death rates related to drugs, alcohol and suicides rose for middle-aged whites at all education levels, but the largest increases were seen among those with the least education. For those with a high school degree or less, deaths caused by drug and alcohol poisoning rose fourfold; suicides rose by 81 percent; and deaths caused by liver disease and cirrhosis rose by 50 percent.

“All cause” mortality rose by 22% for this least-educated group. Those with some college education saw little change in overall death rates, and those with a bachelor's degree or higher actually saw death rates decline.

The researchers speculated that financial stress may have played a role in the rising death rate. Median household incomes of whites began falling in the late 1990s, and wage stagnation hit especially hard those with a high school or less education.

“These were folks who were also disproportionately represented in the downturn of the economy and loss of jobs from rural communities,” says Lewis. “When the economy failed, their disability and reduced level of functioning did not allow them to migrate into other locations or jobs – their educational levels and physical limitations simply imposed too much of a barrier.  The loss of employment put many onto the disability roles.” 

The rise in mortality occurred in all regions of the U.S., although suicide rates were marginally higher in the South and West than in the Midwest and Northeast. In each region, death by way of accidental drug and alcohol poisoning rose at twice the rate of suicide.

In all age groups researchers said there were marked increases in deaths related to drug and alcohol poisoning, suicide and chronic liver disease and cirrhosis. The midlife group differed only in that the number of deaths was so large that it changed the direction of their overall mortality.

If that trend is not reversed, researchers warn, there will be an enormous cost to the healthcare system. 

“A serious concern is that those currently in midlife will age into Medicare in worse health than the currently elderly. This is not automatic; if the epidemic is brought under control, its survivors may have a healthy old age. However, addictions are hard to treat and pain is hard to control, so those currently in midlife may be a ‘lost generation’ whose future is less bright than those who preceded them,” they said.

Low Levels of Vitamin D Linked to Fibromyalgia

By Pat Anson, Editor

Some recent studies are highlighting the importance of the "sunshine vitamin" -- Vitamin D -- in maintaining overall health, as well as possible links to fibromyalgia, rheumatoid arthritis and other chronic conditions.

Low levels of serum vitamin D were found in over 1,800 fibromyalgia patients with chronic widespread pain, according to the results of a meta-analysis (a study of studies) published in the journal Pain Physician.

Researchers at National Taiwan University Hospital found a “positive crude association” between chronic widespread pain and hypovitaminosis D, which is caused by poor nutritional intake of Vitamin D, inadequate sunlight exposure or conditions that limit Vitamin D absorption.

The most severe type of hypovitaminosis D causes general body pain, especially in the shoulder, rib cage, lumbar and pelvic regions.

A number of previous studies have explored the association between hypovitaminosis D with widespread musculoskeletal pain, including fibromyalgia, but the results were inconclusive. Fibromyalgia is a poorly understood disorder that is characterized by deep tissue pain, fatigue, depression and insomnia.

According to the Vitamin D Council, low levels of Vitamin D could be the result of fibromyalgia, rather than the cause of the disease.

Vitamin D helps control levels of calcium and phosphate in the blood and is essential for the formation of strong bones and teeth. Vitamin D also modulates cell growth, improves neuromuscular and immune function, and reduces inflammation

Sources of Vitamin D include oily fish and eggs, but it can be difficult to get enough through diet alone. Ultraviolet rays in sunlight are a principal source of Vitamin D for most people.

Taking Vitamin D supplements can improve exercise performance and lower the risk of heart disease, according to the findings of a small study at Queen Margaret University in Scotland presented at the Society for Endocrinology annual conference in Edinburgh.

Researchers gave 13 healthy adults Vitamin D supplements or a placebo daily for a period of two weeks.

The adults supplemented with Vitamin D had lower blood pressure compared to those given a placebo, as well as lower levels of the stress hormone cortisol in their urine. Previous studies suggest that Vitamin D can block the action of an enzyme which is needed to make cortisol.

A fitness test found that the group taking vitamin D could cycle 6.5km (about 4 miles) in 20 minutes, compared to just 5km at the start of the experiment. Despite cycling 30% further, the Vitamin D group showed lower signs of physical exertion.

"Our pilot study suggests that taking vitamin D supplements can improve fitness levels and lower cardiovascular risk factors such as blood pressure", said Dr. Raquel Revuelta Iniesta, co-author of the study. "Our next step is to perform a larger clinical trial for a longer period of time in both healthy individuals and large groups of athletes such as cyclists or long-distance runners.”

Around 10 million people in England have low vitamin D levels. On average, one in ten adults has low levels of vitamin D in summer, compared to two in five in winter. Because people with darker skin are less efficient at using sunlight to make vitamin D, up to three out of four adults with dark skin are deficient in winter.

"Vitamin D deficiency is a silent syndrome linked to insulin resistance, diabetes, rheumatoid, and a higher risk for certain cancers,” said lead author Dr. Emad Al-Dujaili. "Our study adds to the body of evidence showing the importance of tackling this widespread problem.”

Danish researchers recently reported that exposure to sunlight may delay the onset of multiple sclerosis (MS). Patients who spent time in the sun every day during the summer as teenagers developed the disease later in life than those who spent their summers indoors.

Therapy Helps Chronic Pain Sufferers Sleep

By Pat Anson, Editor

British researchers say cognitive behavioral therapy can effectively treat insomnia in chronic pain patients – reducing their pain, fatigue and depression. But the therapy works best when delivered in person.

Cognitive behavioral therapy (CBT) is a form of psychotherapy, in which a therapist works with a patient to reduce unhelpful thinking and behavior. Poor sleep habits and insomnia have long been known to aggravate chronic pain conditions.

Researchers at the University of Warwick analyzed 72 studies involving over 1,000 patients who suffered from insomnia and chronic pain, and found that CBT was “moderately or strongly effective” in treating insomnia. The study has been published in the journal Sleep.

"This study is particularly important because the use of drugs to treat insomnia is not recommended over a long period of time, therefore the condition needs to be addressed using a non-pharmacological treatment,” said lead researcher Dr. Nicole Tang of the University of Warwick’s Department of Psychology.

"Poor sleep is a potential cause of ill health and previous studies suggest it can lead to obesity, diabetes, stroke, coronary heart disease - even death. Insomnia can also increase the risk of depression, anxiety and substance misuse. It is also a major problem for those suffering pain that lasts longer than three to six months and that is why we looked at this group.”

The most popular CBT strategies included education about good sleeping habits, such as a regular sleeping patterns and avoiding stimulus before going to bed.

Researchers found there was a mild to moderate decrease in pain immediately after therapy, as well as a decrease in depression. But CBT was not as effective when delivered electronically - either over the phone or via the Internet.

"We found little evidence that using therapies delivered either by phone or computer benefitted insomniacs. The jury is still out on the effectiveness of using automated sleep treatments. We found that, at the moment at least, delivering therapies personally had the most positive effect on sleeplessness," said Tang.

Several previous studies have found that getting a good night’s sleep helps reduce sensitivity to pain.

Researchers in Norway measured pain sensitivity in more than 10,000 adults and found a strong link between pain and insomnia. Patients with severe insomnia and chronic pain were twice as likely to pull their hands out of cold water early – a standard test to measure pain – than people who had neither condition.

A small 2012 study at Wayne State University found that people who had 10 hours of sleep a night had less sensitivity to pain in a heat test.

Heroin: The Coming Tsunami

By Percy Menzies, Guest Columnist

The unintended consequences of legalization of marijuana in several states, coupled with the political unrest in the Afghanistan, Pakistan and Burma, are combining to create a heroin epidemic of a magnitude that has never before been seen in the United States.

Non-medical use of marijuana is legal in Colorado and Washington, and medical use of the drug is legal in 23 states. States are developing plans to grow marijuana in their respective counties to meet the expected demand for medicinal marijuana.

With the availability of legal marijuana growing nationwide, demand for Mexican marijuana is drying up. So, Mexican farmers are switching to opium, the easy-to-grow crop that is used to produce heroin.

More Mexican heroin is being smuggled every year into the United States, hidden in vehicles or carried across the border in backpacks. The number of heroin seizures along the southwest border has quadrupled since 2008, according to the Drug Enforcement Agency.

As the supply increases, heroin is becoming cheaper and more available than ever before.

Exacerbating the problem is that Afghanistan and Burma, which together produce 90 percent of the world's heroin supply, have borders that are insecure, making smuggling into Iran, India, China, Thailand, Pakistan, the former Soviet Republics and Russia relatively easy.

With the availability of legal marijuana growing nationwide, demand for Mexican marijuana is drying up. So, Mexican farmers are switching to opium, the easy-to-grow crop that is used to produce heroin.

More Mexican heroin is being smuggled every year into the United States, hidden in vehicles or carried across the border in backpacks. The number of heroin seizures along the southwest border has quadrupled since 2008, according to the Drug Enforcement Agency.

As the supply increases, heroin is becoming cheaper and more available than ever before.

Exacerbating the problem is that Afghanistan and Burma, which together produce 90 percent of the world's heroin supply, have borders that are insecure, making smuggling into Iran, India, China, Thailand, Pakistan, the former Soviet Republics and Russia relatively easy.

As a result, there are 1.6 million heroin addicts in Afghanistan, which translates to 5.3 percent of the population – one of the highest heroin addiction rates in the world. There are 1.8 million heroin addicts in Pakistan. Heroin is so ubiquitous in parts of Afghanistan and Pakistan that it is easier to find than life-saving medications.

Burma's Shan State is its main area for heroin production, and it is regaining its notoriety as part of the Golden Triangle. The heroin is smuggled from Burma primarily into three countries, China, India and Thailand.

Drug traffickers are becoming bolder, and rather than relying on land routes, they are increasingly shipping heroin through sea routes to lightly patrolled coasts in African, where it is then distributed to Europe, and eventually North America.

During the past 18 months, the Combined Maritime Forces, a partnership of 30 seafaring nations including the U.S., Canada and Saudi Arabia, has seized 4,200 kilograms of heroin traveling on that route, according to the Wall Street Journal.

It is simple economics: as supply goes up, price goes down. As price goes down, use goes up.

Heroin use in the United States has already reached a new high since people addicted to prescription opiates switch to heroin because it's so much cheaper. Street prices range from $5 to $10 for one button of heroin, good for one use, compared to $50 or more for one tablet of a prescription opiate.

Heroin addiction has been growing steadily in the United States for more than a decade, and overdose deaths more than doubled from 2010 to 2012, according to the Centers for Disease Control and Prevention report released in October.

The U.S. is unprepared for the coming tsunami. We were caught unprepared for the “man-made” addiction to prescription pain medications. Heroin quickly became the “generic” version for the prescription opioids and may well become the primary drug of choice.

The treatment of opioid addiction is further complicated by the fact that the two most widely used medications to treat opioid addiction, methadone and buprenorphine, are abusable and their use is restricted. The widespread use of buprenorphine has inadvertently contributed to increased addiction.

We have a lot of work to do, especially in the area of prevention and offering evidence-based treatment programs. It's not going to be enough to just expand needle exchange programs and distribute Narcan (naloxone) kits that can reverse opioid overdoses. Few patients, policymakers, medical and law enforcement professionals are aware of treatment options, especially the class of non-addicting medications like naltrexone (a drug closely related to naloxone) that protect patients from relapsing.

We need to aggressively combat this problem by educating people on the danger of heroin addiction and by offering viable treatments options for those addicted to heroin.

Percy Menzies is the president of the Assisted Recovery Centers of America, a treatment center based in St Louis, Missouri.

He can be reached at: percymenzies@arcamidwest.com

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.

Study Finds ‘Notable Downturn’ in Opioid Abuse

By Pat Anson, Editor

A “notable downturn” in the abuse of opioid pain medication in the United States is being overshadowed by a sharp rise in heroin use, according to a large new study outlined in a letter to the New England Journal of Medicine.

In the nationwide study of over 15,000 patients being treated for addiction, the number of addicts who abused opioids alone fell from 70% in 2010 to less than 50% in 2014.

At the same time, however, researchers at Washington University School of Medicine in St. Louis found that many addicts were using heroin and opioids concurrently. Forty-two percent said they had taken heroin and prescription opioids within a month of entering treatment, up from nearly 24 percent in 2008.

"We see very few people transition completely from prescription opioids to heroin; rather, they use both drugs," said lead author Theodore J. Cicero, PhD. "There's not a total transition to heroin, I think, because of concerns about becoming a stereotypical drug addict."

The use of heroin alone – although still relatively low -- more than doubled from 2008 to 2014, from 4.3% to 9% of the addicts under treatment.

Heroin has spread beyond inner cities into suburban and rural areas, according to Cicero. His research also found regional variations in the use of heroin and prescription opioids.

"On the East and West coasts, combined heroin and prescription drug use has surpassed the exclusive use of prescription opioids," Cicero said. “This trend is less apparent in the Midwest, and in the Deep South, (where) we saw a persistent use of prescription drugs -- but not much heroin.”

The study did not make clear how many of the addicts were legitimate pain patients who took opioids to relieve their pain or whether they were recreational users who started taking opioids to get high.

Cicero says a crackdown on "pill mills" and doctors overprescribing opioids has made it harder to get the drugs. For those who are addicted, heroin has become the new drug of choice.

"If users can't get a prescription drug, they might take whatever else is there, and if that's heroin, they use heroin," he said.

Heroin is more accessible and cheaper today, said Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis area.

“Political events triggered the present heroin problem. 90% of the world's heroin comes from just three countries - Afghanistan, Burma and Mexico. The Afghan and Burmese heroin was a perfect cash crop for insurgency groups and the heroin addiction spread rapidly in countries bordering Afghanistan and Burma. Mexico is a bigger problem for us because farmers in that country have switched to growing the poppy,” said Menzies in an email to Pain News Network.

Opioids aren’t the only “gateway” drug to heroin, according to Menzies. He believes the increasing use of buprenorphine (Suboxone) to treat addiction is fueling the heroin epidemic because addicts have found they can use the drug to ease systems of withdrawal.

“We are seeing more and more patients getting exposed to heroin and it is going to get worse. Sadly, the heroin addiction is being sustained by buprenorphine preparations,” Menzies said.

Menzies has more to say about buprenorphine, marijuana legalization, and "the coming tsunami" in heroin use in this guest column.

Study Finds Doctors Order Too Many Imaging Tests

By Pat Anson, Editor

Doctors are still ordering too many imaging tests for low back pain and headache, according to an early study of the effectiveness of the Choosing Wisely campaign, a national effort to reduce the number of unnecessary medical treatments and procedures.

In an analysis of seven clinical services with questionable benefit to patients, published in JAMA Internal Medicine, researchers found that the use of five procedures either increased or stayed the same; while there were only slight declines in the use of two others.

CT and MRI imaging tests for simple headache decreased from 14.9 percent to 13.4 percent, while cardiac imaging for patients with no history of heart problems dropped from 10.8 percent to 9.7 percent.

The prescribing of nonsteroidal anti-inflammatory drugs (NSAIDs) increased from 14.4% to 16.2% for hypertension, heart failure or chronic kidney disease. Testing for human papillomavirus (HPV) in young women also rose, from 4.8% to 6%.

Imaging tests for low back pain (53.7%), pre-operative chest x-rays (91.5%), and antibiotics for sinusitis (91.5%) remained stubbornly high.

The study was based on a database of insurance claims from 2013 for about 25 million members of Blue Cross and Blue Shield health plans.

“It remains an open question whether clinicians or consumers at large are aware of specific Choosing Wisely recommendations or have changed their attitude toward unnecessary tests and procedures,” wrote Ralph Gonzalez, MD, in a commentary published in JAMA Internal Medicine.

“In a fee-for services system, most delivery systems continue to get paid for tests and drugs. Payers are able to pass on these costs to employers and patients, creating a vicious cycle.”

The Choosing Wisely campaign was launched in 2012 by the ABIM Foundation (American Board of Internal Medicine) with the goal of reducing waste and unnecessary medical tests and treatments. It has grown to include a list of hundreds of frequently used procedures that have little value or may, in fact, be risky.

“Most people with lower-back pain feel better in about a month whether they get an imaging test or not. In fact, those tests can lead to additional procedures that complicate recovery,” Choosing Wisely states on its website.

“A study that looked at 1,800 people with back pain found that those who had imaging tests soon after reporting the problem fared no better and sometimes did worse than people who took simple steps like applying heat, staying active, and taking an OTC pain reliever. Another study found that back-pain sufferers who had an MRI in the first month were eight times more likely to have surgery, and had a five-fold increase in medical expenses.”

The Choosing Wisely campaign also discourages doctors from performing epidural steroid injections if a patient doesn’t show signs of improvement after one injection. A number of prominent pain doctors have told Pain News Network the shots are overused, with some patients getting dozens of injections.  

New Setback for Medical Marijuana Spray

By Pat Anson, Editor

A British drug maker has announced more disappointing results from clinical studies on the use of a medical marijuana spray to treat cancer pain.

GW Pharmaceuticals (NASDAQ: GWPH) said results from two new Phase III studies showed that its Sativex oral spray worked no better than a placebo in treating cancer pain. That was the same finding the company reported in January from an earlier study involving nearly 400 patients in the United States, Mexico and Europe.

However, patients in the U.S. did show “statistically significant improvement” in their pain levels when Sativex was taken along with an opioid pain medication. GW and its partner, Otuska Pharmaceutical, have requested a meeting with the U.S. Food and Drug Administration to explain that finding. Sativex is getting a “fast track” review from the agency as a treatment for cancer pain.

"In light of the missed primary endpoint in the first trial earlier this year, these additional results are not a surprise. Nevertheless, we are encouraged by data across the trials which consistently show positive outcomes for U.S. patients when analysed as a separate cohort," said Justin Gover, GW's Chief Executive Officer.

image courtesy of gw pharmaceuticals

"We believe that this finding may provide important guidance in determining the optimal target patient population for Sativex and look forward to a discussion with the FDA on a potential path forward."

Sativex is composed primarily of two cannabinoids, CBD and THC, which are administered in an oral spray. Sativex is already being sold in Europe, Canada and Mexico to treat muscle tightness and contractions caused by multiple sclerosis. Canada also allows Sativex to be used for the treatment of neuropathic pain and advanced cancer pain.

The spray is not currently approved for use in the U.S. for any condition. It is estimated that over 400,000 cancer patients in the U.S. suffer from pain that is not well controlled by opioid pain medications.

"While the results overall have been disappointing, and not necessarily wholly consistent with clinical experience, nonetheless they suggest that Sativex may have a useful role in the treatment of certain subgroups of patients with advanced cancer pain who have exhausted opioid treatments," stated Dr. Marie Fallon, Professor of Palliative Care, University of Edinburgh and a principal investigator in the Phase III program.

"In particular, the U.S. patients enrolled in this program showed a useful therapeutic benefit whereas results in European patients were generally not favorable. These U.S. patients were less frail, hence the Sativex intervention was subjected to less ‘noise,’ providing clearer results and valuable guidance in determining the optimal target patient population for Sativex. This is a patient population with a significant unmet need and I believe that this important observation for Sativex warrants further investigation."

Cancer patients in all three studies were given Sativex or a placebo spray 3-to-10 times a day over a 5-week period. Patients remained on opioid therapy during the studies. Sativex was well tolerated, with the only side effects in some patients being dizziness and somnolence.

GW is developing other cannabis-based medicines to treat epilepsy, glioma, ulcerative colitis, type-2 diabetes, and schizophrenia.

Wear, Tear & Care: Emotional Insight App

By J.W. Kain, Columnist

Biofeedback is probably the closest thing to having actual superpowers. To quote the Mayo Clinic, it’s “a technique you can use to learn to control your body’s functions, such as your heart rate” by using electrical sensors to "receive information (feedback) about your body (bio).”

In theory, this can help you learn to control things like muscle relaxation, which often helps to lessen pain.

What if you want to go deeper than that, though?

In my own experience as a chronic pain patient, I’ve come to realize that much of pain -- or rather, the compounding of pain -- is emotionally derived. It can be stress from work, an argument with a spouse, dreading a rent payment, or anything else that thrills against your nerves. How does one separate the emotional aspect of pain from the physical? How do you know when you’re being your own worst enemy?

You look inward.

Somehow my father stumbled across the Emotional Insight app and sent it my way. I was very curious, as it seemed comparable to biofeedback. But how did it work without wires and electrical sensors? The price tag surprised me -- $49.95 for the app -- and so I reached out to the makers of the program, Possibility Wave, to ask if I could take it for a test drive.

Soon enough I found myself Skypeing with the delightful Garnet Dupuis, one of the founders of Possibility Wave and the creator of the app. He hails from Canada but now lives in Thailand with his wife, and I could hear the sounds of the jungle when we spoke. Suffice it to say he is a cool guy.

When processing experiences, Mr. Dupuis said, “It’s helpful to say it to somebody. A person begins a process of self-reflection even just by talking into a mirror.”

When asked how this relates to the app, Dupuis told me that it does exactly what it says on the tin: It provides emotional insight. “Something about declaration” helps people come to terms with things, he says.

In other words, just talk it out.

Clients have reported as much progress and growth in two to three app sessions as they would achieve in one to two years of actual therapy. As Dupuis says, “these are like quick spiritual experiences.” He calls Emotional Insight a form of “neurofeedback,” which made more sense to me; when I played with the app, I found it had nothing to do with the body and everything to do with the mind. Even so, “it’s a little bit like exercise,” Dupuis said -- as in, the more you work at it, the more you can discover about yourself.

This app is all about sharing information. Technically speaking, improvements could be made; there is so much data that at times the app freezes, and talking out loud can be impractical. That is when I realized this app was not made to be used on a train while traveling somewhere or while standing in line at the bank. This is literally a pocket therapist, but the therapist is the user.

It surprised me constantly, like a shrewd psychic, but in reality I was only talking with myself. Not only does it make you type out a problem, but it makes you repeat it aloud. This irritated me until I realized that I was resisting saying it out loud, because somehow, saying it out loud is harder.

When you open the app, you have three choices in terms of sessions. I chose “Spontaneous Insight.” You are prompted to speak aloud and identify the issue you want to explore.

This is when it becomes stranger. The voice analysis program does not pick up words you say; rather, it picks up the tones in which they were said and matches it to certain emotional responses. So if I say, “I regret the loss of the person I used to be,” it brings back three “clues” regarding the emotions behind my speech: longing, gladness, uneasiness.

The app brought up the fact that I am a workaholic. Considering I have a full-time job and still do things on the side, I would say that’s accurate. It told me to compose an “I” sentence with one of those clues. Somehow I came up with: “I’m glad my pain is getting worse because I’m a workaholic.” What? I am in no way glad about having pain, but I also know that I will run and run and run like the Energizer Bunny until I die, because I refuse to let my pain dictate my life.

By insisting that I don’t need help and that I can function like other people, I am making myself worse. It will take an outside force to make me stop. I have to admit to myself that I am not like other people anymore. I can’t do everything that I used to do. I have to mourn that loss and begin again.

Then the app essentially asks: “What are you going to do about it?”

I was squirming now, uncomfortable with what I was saying. “I need to stop working so hard in order to deal with my pain.”

The app then plays Sonic Signatures and the Crystalline Strategy, which I honestly do not understand. They are coded sound signatures that represent certain remedies, and you are supposed to listen to them a few times each day in order to reinforce what you have learned. It sounds like a whole store full of wind chimes and the signals of a lost radio station. There is a YouTube video that explains these “sound drops” (like herbal tinctures for your ears, if you will).

“The app never tells you what to do,” Mr. Dupuis said to me in our Skype chat. “It guides you, but you have to declare it to yourself.” That being said, the app is as enlightening an experience as you make it. For me, it brought up several things I have been avoiding; it was a strange experience, because I like to think that I face my problems directly. However, I learned that this is very far from the truth. 

Mr. Dupuis was intrigued that I am a columnist for a pain-related publication and that I wanted to use the app in this way. “Everybody hurts in one way or another,” he said.

Pain can compound for a variety of reasons. This app is a way for people to face what is haunting them, whatever that ghost might be.

J. W. Kain is an attorney in the Greater Boston area who also works as a writer and editor in her spare time.  She has chronic back and neck pain after two car accidents.

You can read more about J.W. on her blog, Wear, Tear, & Care.  

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

FDA Approves New Opioid Film Patch

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new delivery system for the treatment of chronic pain – the first of its kind to use an oral film patch containing buprenorphine.

The film patch – which will be sold under the brand name Belbuca -- was jointly developed by Endo International (NASDAQ: ENDP) and BioDelivery Sciences (NASDAQ: BDSI). It’s expected to become available early next year.

image courtesy biodelivery sciences

Belbuca is designed to dissolve in the mouth, delivering buprenorphine through the inside lining of the cheek and into the bloodstream faster than conventional pills or skin patches. Buprenorphine is a weaker acting opioid that has long been used to treat both addiction and chronic pain.

“Belbuca provides a unique approach for chronic pain management, combining the proven efficacy and established safety of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility," said Richard Rauck, MD, Director of Carolinas Pain Institute in Winston Salem, NC.

"For both opioid-naïve and opioid-experienced patients who require around-the-clock treatment and for whom alternative treatment options are inadequate, Belbuca offers appropriate, consistent pain relief and a low incidence of typical opioid-like side effects.”

Because the film delivers buprenorphine into the bloodstream faster than conventional methods, lower doses are needed to treat pain. Belbuca will be available in seven different dosage strengths, allowing for flexible dosing every 12 hours.

FDA approval of Belbuca was based on two Phase III studies involving over 1,500 patients with moderate to severe chronic low back pain. Patients who used Belbuca reported “statistically significant improvement” in pain relief over a 12-week period, compared to a placebo. The most common adverse reactions to Belbuca were nausea, constipation, headache, vomiting, fatigue, dizziness, somnolence, diarrhea, dry mouth, and upper respiratory tract infection.

Buprenorphine is a Schedule III controlled substance, which means it has a lower abuse potential than many other opioids. It may also be easier to get a prescription for than Schedule II drugs such as hydrocodone.

“If you’re going to use an opioid, I think based on its classification, Belbuca really does offer some significant benefits,” said Dr. Mark Sirgo, President and CEO of BioDeliversy Sciences.

“There are two areas this product will be used for. Those that are stepping up from a Motrin-like drug, a non-steroidal anti-inflammatory, that no longer controls their chronic pain. Those are good candidates for Belbuca. And in those that may already be on a Schedule II product such as Vicodon, one of the oxycodone products or morphine products, where a physician may feel more comfortable using a buprenorphine product than a Schedule II opioid."

Sirgo says Belbuca is also less likely to abused than a pill, because the film patches are difficult to grind or liquefy for snorting or injecting.

PROP Founder Calls Opioids ‘Heroin Pills’

By Pat Anson, Editor

The founder of an advocacy group that seeks to reduce the prescribing of opioid pain medication is calling the drugs “heroin pills” and says patients may not be able to trust doctors who prescribe them.

Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing, appeared on C-SPAN this weekend to speak about the Obama administration’s efforts to combat prescription drug abuse and the increasing use of heroin. He also answered calls from viewers, including one woman who recently started taking a pain medication for arthritis and was worried about becoming addicted.

“In general, if someone’s calling me and asking me about this medication, as a physician my inclination would be to tell you to listen to your doctor and to trust your doctor,” Kolodny told the woman.

“Unfortunately when it comes to opioids, we’re in a situation where many of the prescribers have very bad information about these drugs, they’re really underestimating how addictive and how risky they are and overestimating how helpful they can be.  So I wish I could tell you that you should trust your doctor and talk to your doctor about this, but that may not be the case. This is a really difficult situation. We have doctors even prescribing to teenagers and parents not recognizing that the doctor has just essentially prescribed the teenager the equivalent of a heroin pill.”

Kolodny also compared opioid pain medication to heroin during an addiction conference Friday at the University of Richmond.

“When we talk about opioid painkillers we are essentially talking about heroin pills,” Kolodny said, according to a story in the Richmond Times Dispatch.

He told the conference opioids were “very important medications” to ease suffering at the end of life or after major surgery, but were often not appropriate for chronic pain.

“The bulk of the U.S. opioid consumption is not for end-of-life care or acute pain. The bulk is for common chronic conditions where leading experts who study them say opioids are more likely to harm patients than help them.”

On C-SPAN, Kolodny said many patients taking opioids for chronic pain mistakenly believe the drugs are helping them, when “the vast majority of them are not doing well.”

“What may be happening for many of them is that the opioid is actually treating withdrawal pain. They may not really be getting pain relief when you’re on a consistent dose over a very long period of time,” Kolodny said.

Kolodny and Physicians for Responsible Opioid Prescribing (PROP) are drawing new attention because of a significant role the organization appears to be playing in the drafting of opioid prescribing guidelines by the Centers for Disease Control and Prevention (CDC). As Pain News Network has reported, at least five PROP board members, including Kolodny, are on CDC advisory panels that are developing the guidelines. A link to PROP literature recommending “cautious, evidence-based opioid prescribing” can also be found -- unedited -- on the CDC’s website.

PROP President Jane Ballantyne, MD, and Vice-President Gary Franklin, MD, are both members of the CDC’s Core Expert Group, and board member David Tauben, MD, is on the CDC’s peer review panel. All three were heavily involved in developing restrictive opioid prescribing guidelines in Washington state.

Kolodny and PROP board member David Juurlink, MD, are members of a “Stakeholder Review Group” that is also providing input on the CDC guidelines.

Those guidelines recommend that “non-pharmacological therapy” and non-opioid pain relievers be used to treat chronic pain. Lower doses and quantities of opioids are recommended for acute pain. A complete list of the guidelines can be found here.

The CDC is currently revising the guidelines to meet a January deadline, using "rapid reviews" of clinical evidence “to address an urgent public health need.” The agency blames opioid pain medication for the overdose deaths of over 16,000 Americans annually.

Many pain patients are worried they won’t be able to obtain opioids if the guidelines are adopted. In an online survey of over 2,000 patients by Pain News Network and the Power of Pain Foundation, 95 percent said the guidelines and other government regulations discriminate against them. Most patients also said non-opioid pain relievers didn’t work for them and that their insurance usually didn’t cover therapies like acupuncture, massage and chiropractic care.  

In a conference call last week with stakeholders, CDC officials said the guidelines are being modified to emphasize that they are mostly intended for new patients and that patients currently taking opioids will still have access to the drugs.

“We do need a better answer for these 10 to 12 million Americans who are already on opioids,” Kolodny said on C-SPAN. “We’ll need a compassionate way of helping that population. I think what might be a little easier to do is to prevent what I would call ‘new starts.’ We need to get the medical community to understand that for most patients with chronic pain, long term opioids may not be safe or effective. And let’s avoid getting patients stuck on these medications, medications that are highly addictive.”

Kolodny said existing patients should have easier access to addiction treatment.

“One of the most effective medications for opioid addiction is a drug called buprenorphine or Suboxone,” said Kolodny, who is chief medical officer for Phoenix House, a non-profit that operates addiction treatment clinics.

“Unfortunately there are federal limits on the number of patients a doctor can treat with this medicine. And what we’re seeing is in parts of the country, like West Virginia and Appalachia, and in communities that have been hit very hard, you have doctors who have maxed out on the number of patients they can treat, which is a maximum of one hundred. And there are patients on waiting lists for this medication who are actually dying of overdoses while waiting on this list to be able to get buprenorphine.”

Ironically, buprenorphine is an opioid that is used to treat both addiction and pain. Although praised by Kolodny and other addiction specialists as a tool to wean addicts off opioids, some are fearful the drug is overprescribed and misused. Many addicts have learned they can use buprenorphine to ease their withdrawal symptoms and some consider it more valuable than heroin as a street drug.

Over three million Americans with opioid addiction have been treated with buprenorphine.  According to one estimate, about half of the buprenorphine obtained through legitimate prescriptions is either being diverted or used illicitly.