High Use of Opioids by Older Adults with COPD

By Pat Anson, Editor

Canadian researchers have found significantly high rates of opioid use among older adults with chronic obstructive pulmonary disease (COPD), according to a large study published in the British Journal of Clinical Pharmacology. Over half of the patients received a new opioid prescription after their COPD diagnosis.

"The new use of opioids was remarkably high among adults with COPD living in the community," said Nicholas Vozoris, MD, a respirologist at St. Michael's Hospital in Toronto. "The amount of opioid use is concerning given this is an older population, and older adults are more sensitive to narcotic side effects."

The study is based on records for more than 120,000 adults in Ontario age 66 and older with COPD, a progressive lung disease that makes it harder to breathe. COPD causes coughing, wheezing, shortness of breath, chest tightness and other symptoms. Most people who have COPD smoke or used to smoke, according to the National Institutes of Health.

Between 2003 and 2012, 70 per cent of the COPD patients who lived in their own home were given a new opioid prescription, while about 55% of those living in long-term care facilities received a new opioid prescription. Many were given multiple opioid prescriptions, early refills, and prescriptions that lasted more than 30 days.

Opioids might be prescribed more frequently among older adults with COPD to treat chronic muscle pain, breathlessness and insomnia.

"Sometimes patients are looking for what they think are quick fixes to chronic pain and chronic breathing problems," said Vozoris. "And physicians sometimes believe that narcotics may be a quick fix to COPD symptoms."

Common side effects of opioids in older adults include falls and fractures, confusion, memory impairment, fatigue, constipation, nausea, vomiting and abdominal pain. Vozoris says opioids may also negatively affect lung health by reducing breathing rates and volume, which can result in decreased blood oxygen levels and higher carbon dioxide levels.

"This is a population that has chronic lung disease, and this drug class may also adversely affect breathing and lung health in people who already have chronically compromised lungs," he said.

Most of the opioid prescriptions were written by family physicians, usually for pain medications that combine an opioid with acetaminophen.

"Patients and prescribers should reflect on the way narcotics are being used in this older and respiratory-vulnerable population," said Dr. Vozoris. "They should be more careful about when narcotics are used and how they're being used."

A study published in Clinical Interventions in Aging warned about the risk of “polypharmacy” in older adults, who often take multiple medications written by different providers.

“The elderly population is especially challenging when one has to consider all of the pharmacodynamic changes that occur with normal aging. The side effect profile of opiates is similar for all age groups; however the elderly population is at a greater risk for these side effects given their comorbidities and high incidence of polypharmacy. Using opiates appropriately and at the most efficacious dosage for the severity and type of pain becomes crucial in the elderly,” the study said.

Drug Shows Promise for Treating Psoriatic Arthritis

By Pat Anson, Editor

An injectable drug used to treat plaque psoriasis may also be effective in treating psoriatic arthritis, according to new research published in the New England Journal of Medicine.

Secukinumab – which is sold by Novartis under the brand name Cosentyx – helped reduce swollen joints in a double-blind Phase III study involving over 600 patients with psoriatic arthritis. Treatment with Cosentyx resulted in rapid and significant improvements in about half of the patients compared to a placebo.

The study was neither large enough or long enough to evaluate side effects associated with long-term use of Cosentyx.

Psoriatic arthritis is a form of arthritis that affects about a third of people who have psoriasis — a condition that features red skin lesions. Joint pain, stiffness and swelling are the main symptoms of psoriatic arthritis, which can affect any part of the body, including the fingertips and spine.  

No cure for psoriatic arthritis exists, so the focus is on controlling symptoms and preventing further damage to joints.

Cosentyx was approved in Europe early this year as a first-line treatment for moderate-to-severe plaque psoriasis. The drug is also approved in the U.S. as a treatment for plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).

Novartis has applied for Cosentyx to be used as a treatment for psoriatic arthritis and ankylosing spondylitis.

Psoriatic arthritis can develop at any time, but it most commonly appears between the ages of 30 and 50, according to the National Psoriasis Foundation. Genes, the immune system and environmental factors all appear to play a role in the onset of the disease. About 10 percent of people inherit one or more of the genes that could eventually lead to psoriasis, but only 2 to 3 percent actually develop the disease.

The Link Between Empathy and Pain

Pat Anson, Editor

The Merriam-Webster dictionary defines the word empathy as “understanding, being aware of, being sensitive to, and vicariously experiencing the feelings, thoughts, and experience of another.”

Or as former President Bill Clinton famously said, “I feel your pain.”

But new research suggests empathy may be a lot more complicated than we think – at least when it comes to feeling the pain of others.

A team of European researchers has found evidence that empathy may be strongly influenced by neurotransmitters in the brain -- and is not just a form of emotional or social bonding.

Their findings suggest that empathy is dependent – not on feeling the pain of others --- but on experiencing pain yourself.

“Empathy is of major importance for everyday social interaction. Recent neuroscientific models suggest that pain empathy relies on the activation of brain areas that are also engaged during the first-hand experience of pain,” wrote psychologist Clauss Lamm of the University of Vienna, lead author of a study published in Proceedings of the National Academy of Sciences.

Lamm and his colleagues recruited 100 participants for an experimental trick with a placebo. They divided the volunteers into two groups and gave one group a pill they thought was a painkiller but was actually a placebo. The second group received no pill at all.

Both groups were given a small electric shock and asked to rate the degree of pain they felt -- and the degree of pain they saw in others who were also shocked.

The group that received the placebo not only reported less pain than the control group, but they also felt there was less pain experienced by others. That placebo-empathy effect was confirmed by MRI’s – which found there was less activity in brain areas of the placebo group that felt less pain and empathy for others.

Researchers tested the placebo-empathy effect in a second study in which they used the drug naltrexone to block opioid receptors in some of the volunteers. Those given naltrexone reported feeling more pain when shocked and felt that others felt more pain as well.

"This result strongly suggests an involvement of the opioid system in placebo-empathy, which is an important step to a more mechanistic understanding of empathy,” said Lamm.

"The present results show that empathy is strongly and directly grounded in our own experiences – even in their bodily and neural underpinnings. This might be one reason why feelings of others can affect us so immediately – as we literally feel these feelings as if we were to experience them ourselves, at least partially. On the other hand, these findings also explain why empathy can go wrong – as we judge the feelings of others based on our own perspective,” explains Lamm.

Lamm and his colleagues are now working on a follow-up study in which they are investigating the effects of opioids on empathy.

The Risks of Non-Opioid Pain Medications

By Emily Ullrich, Columnist

As a chronic pain patient for some years now, I have realized the necessity of self-advocacy and have made it a point to become extremely well-educated in regard to patient choices in pain treatment. I also pay very close attention to the constant barrage of anti-opioid propaganda that consumers are exposed to -- an agenda being pushed by the DEA, CDC, and powerful special interest groups.

As a patient advocate and delegate to the Power of Pain Foundation, I am also more aware of the increasing limitations and access to opioid pain treatment that patients are being subjected to. As pain patients, we must be aware of our options, and demand explanations from the medical community and government as to the real reasons why we are being denied or severely limited access to opioids.

The scariest part of this situation is that non-opioid pain medications are now being thrust upon us as one of the “preferred” treatments for chronic pain in the CDC’s draft guidelines for opioid prescribers.

First, it is important to consider the following facts:

Unless a doctor is board certified in pain treatment, he or she receives little to no education in pain management under the current standard medical curriculum. Yet pain is the number one reason people go to a doctor or hospital.

This contradiction causes an enormous gap in knowledge and understanding when it comes to pain, and leads to a tremendous level of under-treated or untreated pain. Many well-intentioned, but uninformed doctors are intimidated by the prevailing climate of opioid hysteria and feel pressured to treat their patients' pain with newer, non-opioid therapies. Many of these medications are being prescribed to patients in an “off-label” fashion.

Two of the most commonly prescribed non-opioid “pain medications” are Lyrica (pregabalin) and Neurontin (gabapentin), both of which were initially approved by the FDA as anti-seizure drugs. The dangers of these medications are too often minimized by doctors, government agencies, and the media -- and to some degree remain unknown (particularly in the long-term).

One thing that has recently been unearthed is that these medicines prevent the formation of new brain synapses. This is not a minor side effect. It can lead to short and long-term memory loss, as well as Alzheimer's disease, among other things.

It can also mean that the brain becomes incapable of neuroplacticity. According to the Huntington Outreach Project at Stanford University, our brains rely on neuroplasticity to “compensate for injury and adjust their activity in response to new situations or changes in their environment.” In lay terms, these drugs cause brain damage.

In addition to the under-reported peril involved in the use of these drugs (and many others that are being used in place of opioids), they also have long and worrisome side effects. The potential side effects of both Lyrica and Neurontin are far too many to list, but include vomiting of blood, pancreatitis, hearing loss, non-Hodgkin's lymphoma, “oncologic” (cancerous) potential, heart disease, heart attack, acute kidney failure, and “life-threatening angioedema with respiratory compromise.”

Compare these potential side effects to those of opioids. When used appropriately, the major side effects of opioid pain medication are constipation and dependence -- both of which also happen to be listed as side effects of Lyrica and Neurontin.

When one sees that the most frequently prescribed non-opioid “pain medications” can cause cancer, heart attack, kidney failure, etc., we must question the motives behind this movement to eliminate or greatly reduce the use of opioids. When used properly, opioids have a proven track record of pain relief. So, why are we being told they are so dangerous?

One loathes the idea that a doctor might have ulterior motives when prescribing or that the FDA, DEA, and CDC may have less than ethical intentions. However, it seems necessary to consider the possibility that drug companies may further sicken patients with their “treatments” to ensure lifetime consumers who are forced to buy additional medications to treat the conditions caused by their very own products.

You can easily look up the financial contributions made by “Big Pharma” to your doctors, politicians, special interest groups, and other influential voices in the medical community by visiting ProPublica’s “Dollars for Docs,” Medicare’s Open Payments Database, and OpenSecrets.org.

Pfizer for example – the maker of Lyrica and Neurontin – was the top contributor in the health care industry to candidates and political parties during the 2014 election cycle – donating over $1,534,000 to both Democrats and Republicans alike. The top two recipients were Sen. Cory Booker (D-NJ) and Senate majority leader Mitch McConell (R-KY).

We must ask these difficult questions and have these taboo conversations for our own good. It is unfortunate that our society has come to this, but if we continue not to question, we will continue to be marginalized. Pain patients suffer enough. We need solutions, not restrictions.

I, for one, will continue to use alternative therapies and choose responsible opioid therapy over newer and more dangerous medications, as long as the law allows. I will continue to push for answers and I hope readers will be incentivized to join me.

Emily Ullrich suffers from Complex Regional Pain Syndrome (CRPS/RSD), Sphincter of Oddi Dysfunction, Carpal Tunnel Syndrome, Endometriosis, chronic gastritis, Interstitial Cystitis, Migraines, Fibromyalgia, Osteoarthritis, Periodic Limb Movement Disorder, Restless Leg Syndrome, Myoclonic episodes, generalized anxiety disorder, insomnia, bursitis, depression, multiple chemical sensitivity, and Irritable Bowel Syndrome.

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

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

Take Our Survey About the CDC Opioid Guidelines

(Editor's Note: This survey is now closed. To see our stories about the survey results, click here and here. For a complete look at all of the survey result, visit the "CDC Survey Results" tab at the top of this page or click here.)

By Pat Anson, Editor

As we’ve been reporting over the last several days, chronic pain patients had little role or voice in the development of opioid prescribing guidelines recently announced by the Centers for Disease Control and Prevention (CDC).

The guidelines for primary care physicians are aimed at reducing rates of addiction and overdose, but they are likely to lead to further restrictions on the prescribing of opioid pain medication for both acute and chronic pain.

The CDC recommends “non-pharmacological therapy” and other types of pain relievers as preferred treatments for chronic non-cancer pain. Smaller doses and quantities of opioids are recommended for patients who continue using the drugs.  A complete list of the guidelines can be found here.

While the CDC is no longer accepting public comment on the guidelines, your opinion matters to us and it’s not too late to let your feelings be known.

Pain News Network and the Power of Pain Foundation are joining forces to conduct a survey of pain patients to see what they think of the CDC’s guidelines.

To take our quick survey, click here.

“As pain patients, we already have major roadblocks in our health care system to get access to proper and timely treatment. I predict these new CDC guidelines will have a devastating impact on our pain care,” says Barby Ingle, founder and president of the Power of Pain Foundation. “Many more people will suffer from arbitrary guidelines set by a panel of people who are not in the everyday trenches with pain patients. These guidelines force the same care for all. We are not all the same.

“Taking our survey about the CDC's opioid prescribing guidelines gives patients a voice in this process. Raise your voice and be heard, something that was not done when the guidelines were drafted. Share your story, share your experiences and share what it’s like to live in the pain community as the expert of your pain.”

Some of the questions we’re asking include whether you think opioids are overprescribed;  what effect the guidelines will have on rates of addiction and overdoses;  whether pain patients should be required to take urine drug tests; and if the guidelines discriminate against pain sufferers.

In addition to taking the survey, Ingle says it’s time for pain sufferers to step up and be better advocates for themselves.

“We must participate in studies and surveys on this topic, and write letters to those trying to dictate our lives and what appropriate care should be,” she says. “The only way to ensure access to proper and timely care is to keep the relationship between the patient and their providers."

The CDC is planning to release the prescribing guidelines in January.  Although voluntary, some experts predict the guidelines could quickly be adopted by state health departments and licensing boards, making them “standards of practice” for physicians.

High Dose Patients Worried by CDC Opioid Guidelines

By Pat Anson, Editor

The draft guidelines for opioid prescribing released by the Centers for Disease Control and Prevention (CDC) this month have many chronic pain patients worried – especially those who are taking high doses of opioid pain medication.

The CDC guidelines state that physicians “should avoid” increasing opioid doses over a certain level -- 90 milligrams MEQ (morphine equivalent) a day. And if that dose isn’t high enough to relieve pain? Instead of increasing it, the CDC recommends that doctors “should consider working with patients to taper and discontinue opioids.”

“I am totally freaked out about this new limit,” says Gary Snook, a 62-year old Montana man who has Arachnoiditis, a chronic and painful inflammation of the spinal cord. “The new limit would leave me no option but suicide or becoming a felon.”

Snook needs high doses of opioids not only because of the damage done to his spine by a series of epidural injections for back pain – but because of a genetic condition that makes opioids less potent in his system. Snook takes extremely high daily doses of oxycodone – averaging the equivalent of 540 milligrams of morphine – or six times more than what the CDC recommends.

“I never feel high, still drive. The only side effect I notice from the meds is pain relief,” says Snook, who used to be on even higher doses.

He believes the CDC guidelines would amount to a death sentence for him.

gary snook

“I cannot sleep at night and my pain has been elevated from the stress of all this. I used to think doctors were limiting medication to force us into procedures which are not an option for me. Now I believe this is a well-planned extermination of a disadvantaged segment of society,” Snook says.

“The CDC draft and activity is disturbing.  Their guidelines are good, but their 90mg ceiling is a problem,” says Forest Tennant, MD, a pain management specialist who treats Snook. “The word ‘avoid’ in traditional pharmaceutical prescribing usually means don't exceed the dose unless absolutely necessary.  I would like to see the 90mg dosage be preceded or followed with the statement ‘whenever possible.’

"The major issue here is whether legacy patients -- those given high opioid dosages in the past when there were no alternatives -- can continue.  New patients seldom need to go over 90mg as we now have non-opioid neuro-inflammatory and neuro-hormonal therapies."

If the CDC guidelines are adopted, Tennant wonders if other doctors will continue to treat high dose patients like Snook.  Providers will still be able to prescribe high doses “off label” – but many physicians already feel pressured by insurers and the DEA to prescribe lower doses.

“I hear almost on a daily basis of patients being forced to reduce their opioid dose despite being stable and functional for years,” says Lynn Webster, MD, past president of the American Academy of Pain Medicine.

“The suggested limit on opioid dose is without evidence. There are millions of people who have been on much more than 90 mg MEQ for years if not decades who are functional because of their dose. This recommendation is going to cause enormous suffering.”

“One appalling aspect of CDC involvement is simply the fact that this is an agency that deals with communicable diseases -- not intractable pain,” said Tennant. “Gosh knows which ‘experts’ they consulted to arbitrarily pick 90mg.”

As Pain News Network has reported, Physicians for Responsible Opioid Prescribing (PROP) – an advocacy group that is trying to reduce the prescribing of opioids – apparently played a significant role behind the scenes in developing the CDC’s guidelines.

At least five PROP board members, including President Jane Ballantyne, MD, Vice-President Gary Franklin, MD, and PROP founder Andrew Kolodny, MD, are on CDC panels that helped develop the guidelines. Kolodny is chief medical officer for Phoenix House, a non-profit that offers addiction treatment programs around the country.

The CDC’s “Core Expert Group” -- the panel that drafted the guidelines -- is dominated by researchers and government regulators who have little experience in treating pain patients.

“The last thing they want is for true experts to ever testify,” says Tennant.  

“The CDC has been manipulated by payers who want to reduce their costs of opioids and by individuals who just don't understand that there are people who find opioids lifesaving,” adds Webster.

Pain News Network has also reported that only two patient advocacy groups were among the 50 organizations invited to an online “webinar” -- the first and only time the CDC publicly disclosed its prescribing guidelines and sought public input. Other organizations that were invited were physicians’ groups, insurance companies, pharmacists and several non-profits focused on fighting addiction and drug abuse.

The CDC, which is no longer accepting public comment on the guidelines, plans to finalize them by January 2016 – leaving high dose patients like Gary Snook wondering about their futures.

“This is the smallest dose I have been on for a decade and it is a struggle. I have no side effects from these high doses and am always alert and coherent. I never share my medication as I would never make it until the end of the month,” he said. "I am suicidal on lower doses, but can have a life at these levels but have no hobbies and can't work although I would love too."

Tai Chi Relieves Chronic Pain of Arthritis

By Pat Anson, Editor

The ancient Chinese exercise Tai Chi improves pain and stiffness in older adults suffering from osteoarthritis, according to a study published in the British Journal of Sports Medicine. Researchers also found that Tai Chi improved the physical condition of older patients with breast cancer, heart failure and chronic obstructive pulmonary disease (COPD).

Tai Chi consists of slow, choreographed movements that aim to boost muscle power, balance, and posture. It also includes mindfulness, relaxation, and breath control.

In a meta-analysis (a study of studies), researchers looked at 34 studies involving nearly 1,600 participants to see how effective Tai Chi was in four chronic long term conditions that are common in older adults – cancer, heart failure, COPD and osteoarthritis.

Osteoarthritis is a progressive joint disorder which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

Participants ranged in age from their mid-50s to early 70s. On average, they took part in two to three Tai Chi sessions a week for 12 weeks, with most classes lasting an hour.

Researchers found that Tai Chi was associated with improvements in physical capacity and muscle strength in most or all four conditions, including a six minute walking test, bending and stretching at the knees, and the time it took to get from a sitting to a standing position.

Breathlessness was reduced in patients with COPD, and osteoarthritis patients showed improvement in the symptoms of pain and stiffness.

“The results demonstrated a favorable effect or tendency of Tai Chi to improve physical performance and showed that this type of exercise could be performed by individuals with different chronic conditions,” researchers said.

A previous study of Tai Chi have found that it significantly reduces pain in as little as 8 weeks in patients with fibromyalgia, as well as sustained benefits in sleep, fatigue, anxiety, physical function and overall well-being. That study is published online in Arthritis Research & Therapy.

Fibromyalgia is a complex disorder characterized by chronic pain, fatigue, difficulty sleeping and mood swings.

Special Interest Groups Behind CDC Opioid Guidelines

By Pat Anson, Editor

Dozens of organizations representing physicians, pharmacies, insurance companies and other special interest groups were invited to participate in an online “webinar” last week, when the Centers for Disease Control and Prevention (CDC) unveiled its controversial new guidelines for opioid prescribing.  But there were only two seats at the cyber table for groups representing pain patients – the people most affected by the proposed guidelines.

The CDC has provided a list to Pain News Network of over 50 organizations that were sent invitations to the webinar – the first and only time the CDC publicly disclosed its prescribing guidelines and sought public input. A full list of the invited groups will be listed at the end of this article.

Among the organizations that were invited were the pharmacy chain CVS Caremark and insurers Blue Cross Blue Shield, Humana, Cigna and Kaiser Permanente.

“It is unbelievable that the CDC would include payers in the development of treatment guidelines. Payers profit from depriving patients access to treatment,” said Lynn Webster, MD, past President of the American Academy of Pain Medicine. “I cannot express the magnitude of my level of disappointment in the CDC.”

If adopted, the CDC’s draft guidance for primary care physicians would lead to further restrictions on the prescribing of opioid pain medications for both acute and chronic pain. A full list of the guidelines can be found here.

The agency is promoting “non-pharmacological therapy” such as exercise and cognitive behavioral therapy as an alternative to opioids – treatments usually not covered by insurance. The goal is to reduce the so-called epidemic of overdoses and prescription drug abuse.

“Since opioid prescribing and overdoses have been steadily declining since 2010, the motivation for all the restrictive guidelines is, I believe, primarily profits and greed of the big players under Obamacare,” said Forest Tennant, MD, a prominent pain physician and researcher in West Covina, California. 

“Have you seen the unbelievable profits the insurance, hospital, pharmaceutical, and drug store chains are now making?  To keep up the gravy train, the big players have to continue to reduce patient benefits and physician payments. There is no question in my mind. Patients and their families and advocates have to speak loudly, firmly, and progressively going forward.”

Patients and their advocates have played only a minimal role in the development of the CDC guidelines. The only two patient advocacy groups invited to the webinar were the American Chronic Pain Association and the American Cancer Society.

One group that was well represented at the webinar were non-profits focused on fighting addiction and drug abuse, includingThe Partnership at Drugfree.org,  Safe States, Community Anti-Drug Coalitions of America, Harm Reduction Coalition, ShatterProof, and Physicians for Responsible Opioid Prescribing (PROP).

As Pain News Network has reported, PROP has played a significant role behind the scenes in the development of the CDC’s opioid prescribing guidelines. At least five PROP board members, including President Jane Ballantyne, MD, Vice-President Gary Franklin, MD, and PROP founder Andrew Kolodny, MD, are on CDC panels that developed the guidelines. Kolodny is chief medical officer for Phoenix House, a non-profit that operates a chain of addiction treatment clinics.

Was CDC "Hoodwinked" by Experts?

“I am surprised that the CDC would secretly align with PROP and others with conflicts, especially since many, if not most of their proposed guideline statements are not scientifically based,” said Jeffrey Fudin, PharmD, a pharmacist and founder of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT).

“CDC should be ashamed at their approach, as they were obviously hoodwinked by the presumed experts, most of whom have no formal training in pain management whatsoever.  I am surprised that participants were not required to disclose potential conflicts. It disgusts me that the very stakeholders that are paying for opioids are on a panel with an agenda to save money by denying opioid use.”

The CDC said it selected a “diverse” panel of experts for its various committees, including the "Core Expert Group" (CEG) that apparently played the largest role in developing the guidelines. A list of CEG members and peer reviewers will be listed at the end of this article.

"For a guideline to be credible, it is important to eliminate or effectively manage sources of bias. These sources of bias might include financial relationships with industry, intellectual preconceptions, and previously stated public positions. Prior to participation, CDC asked CEG members to reveal potential conflicts of interest. Members could not serve if they held conflicts that could be anticipated to have a direct and predictable effect on the recommendations," the agency said in internal documents obtained by Pain News Network.

According to those documents, CEG members Ballantyne and Franklin did not disclose they were PROP office holders or indicate they had a conflict of interest as members of PROP. 

Ballantyne did disclose that she served as a paid consultant to Cohen Milstein Sellers & Toll, a law firm that specializes in antitrust litigation, including lawsuits against pharmaceutical companies.  Ballanytne also disclosed that she serves on a special advisory committee reviewing opioid abuse deterrence for the Food and Drug Administration.

"There is strong evidence that increased prescribing for chronic pain has produced increases in dependence, overdose and death without improving pain relief, function or quality of life for many individuals with common chronic pain diagnoses," wrote Ballantyne in a recent letter on behalf of PROP to an official with the National Institutes of Health, which is developing the National Pain Strategy. 

Franklin did not disclose any conflicts, although he played a significant role in the development of opioid prescribing regulations in Washington state, which has some of the toughest prescribing laws in the nation. For that, Franklin was honored by the workers compensation industry for "his pioneering research and outspokenness on the overprescribing of opioid pain medications."

“Whereas there is evidence for significant short-term pain relief, there is no substantial evidence for maintenance of pain relief or improved function over long periods of time without incurring serious risk of overdose, dependence, or addiction,” wrote Franklin in a position paper published last year in Neurology, the journal of the American Academy of Neurology.

The CDC said it carefully reviewed the financial relationships and "intellectual preconceptions" of CEG members --- and "determined the risk of these types of activities to be minimal."

A request for an interview with Debra Houry, Director of the CDC’s National Center for Injury Prevention and Control, which selected the panels, vetted the members, and oversaw development of the guidelines, was declined.

Guidelines "Bad News" for Pain Patients

Patient advocacy groups are only now waking up to the fact that they’ve had little role or voice in the CDC guidelines -- which are scheduled to be released in January. Only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.

"The CDC's draft guidelines regarding pain therapy are bad news for thousands of patients living with daily pain. They ignore the needs of patients and offer no real solutions to help physicians manage patients' pain. In addition, these guidelines were developed behind closed doors and have not been made publicly available. It is imperative that the CDC be transparent as they develop these guidelines," said Srinivas Nalamachu, MD, a member of the Alliance for Patient Access.

 In a letter sent to CDC Director Tom Frieden, a coalition of patient groups said they were “deeply concerned” that the prescribing guidelines are “inconsistent with established best practices” and show an “extreme imbalance” in the agency’s views about opioids.

They also complained about the webinar.

“The CDC slides presented on Wednesday were not transparent relative to process and failed to disclose the names, affiliations, and conflicts of interest of the individuals who participated in the construction of these guidelines. The presenters refused to provide any information other than to read exactly what was written on the slides even when asked directly by audience members to disclose the processes and people who had developed these prescribing guidelines,” the letter states.

It’s not the first time pain patients have been largely excluded from an issue that’s important to them, according to David Becker, a patient advocate and longtime critic of regulators and leaders in pain care.

“Until people in pain work together in common cause to have a real voice in pain care, then the designs of others in government and industry will continue to impose inhumane, degrading, and ineffective treatment on them - without their advice or consent,” Becker said.

Interestingly, the only media outlet invited to the CDC webinar was Consumer Reports, which last year did a cover story and special report on “The Dangers of Painkillers.”

Groups and organizations invited to the CDC webinar:

• American Academy of Family Physicians
• American Academy of General Physicians
• American Academy of Neurology
• American Academy of Pain Management
• American Academy of Pediatrics
• American Academy of Physical Medicine and Rehabilitation
• American Board of Internal Medicine
• American Cancer Society
• American Chronic Pain Association
• American College of Obstetrics and Gynecology
• American College of Occupational and Environmental Medicine
• American College of Physicians
• American College of Preventive Medicine
• American Geriatrics Society
• American Hospital Association
• American Insurance Association
• American Medical Association
• American Pain Society
• American Pharmacists Association
• American Physical Therapy Association
• American Public Health Association
• American Society of Addiction Medicine
• American Society of Anesthesiologists
• American Society of Clinical Oncology
• American Society of Health-System Pharmacists
• American Society of Hematology
• American Society of Interventional Pain Physicians
• Association of American Medical Colleges
• Blue Cross/Blue Shield(s)
• Brandeis PDMP Center of Excellence
• Cigna
• Clinton Global Initiative
• Colorado Department of Regulatory Agencies
• Community Anti-Drug Coalitions of America
• Consumer Reports
• CVS Caremark
• Federation of State Medical Boards
• Harm Reduction Coalition
• Kaiser Permanente Southern California
• MaineCare
• National Association of Boards of Pharmacy
• National Association of State Alcohol/Drug Abuse Directors
• National Association of State Medicaid Directors
• National Comprehensive Cancer Network
• National Conference of State Legislatures
• National Governors Association
• National Safety Council
• Pew Charitable Trusts
• Physicians for Responsible Opioid Prescribing
• Safe States
• ShatterProof
• Trust for America’s Health
• The Partnership at Drugfree.org
• American Association for the Treatment of Opioid Dependence
• Appalachian Regional Commission
• Association of State and Territorial Health Officials
• American College of Emergency Medicine
• National Association of County and City Health Officials
• Society of General Internal Medicine
• Core Core Violence & Injury Prevention Program (VIPP) grantees
• CDC Prevention for States grantees

Core Expert Group members:

• Pam Archer, MPH; Oklahoma State Department of Health
• Jane Ballantyne, MD; University of Washington/PROP President
• Amy Bohnert, MHS, PhD; University of Michigan
• Bonnie Burman, ScD; Ohio Department on Aging
• Roger Chou, MD; Oregon Health and Sciences University
• Phillip Coffin, MD, MIA; San Francisco Department of Public Health
• Gary Franklin, MD, MPH; University of Washington/PROP Vice-President
• Erin Krebs, MD, MPH; Minneapolis VA Health Care System/University of Minnesota
• Mitchel Mutter, MD; Tennessee Department of Health
• Lewis Nelson, MD, New York University School of Medicine
• Trupti Patel, MD; Arizona Department of Health Services
• Christina A. Porucznik, PhD, MSPH; University of Utah
• Robert Rich, MD, FAAFP; American Academy of Family Physicians
• Joanna Starrels, MD, MS; Albert Einstein College of Medicine of Yeshiva University
• Michael Steinman, MD; Society of General Internal Medicine
• Thomas Tape, MD; American College of Physicians
• Judith Turner, PhD; University of Washington

Peer Reviewers:

• Matthew Bair, MD, MS, Indiana University
• Jeanmarie Perrone, MD, University of Pennsylvania
• David Tauben, MD, University of Washington/PROP board member

Daily Marijuana Safe and Effective for Chronic Pain

By Pat Anson, Editor

Chronic pain patients who use medical marijuana daily for a year suffered no serious side effects and significantly improved their levels of pain, mood and quality of life, according to a new study in Canada.

The clinical study by researchers at McGill University in Montreal is one of the first to test the long term safety and efficacy of medical marijuana. It’s been published online in the Journal of Pain, the official journal of the American Pain Society.

“Quality-controlled herbal cannabis, when used by cannabis-experienced patients as part of a monitored treatment program over one year, appears to have a reasonable safety profile,” wrote lead author Mark Ware, an associate professor in Family Medicine and Anesthesia at McGill University and one of the world’s leading experts on medical marijuana.

Pain News Network had a lengthy interview with Ware about his research earlier this year.

In his most recent study, Ware and his colleagues assessed the long-term health of 216 medical marijuana users with chronic non-cancer pain who consumed a standardized dose (12.5% THC) of up to 5 grams of marijuana daily through inhaling or vaporization. They were compared to a control group of 215 chronic pain sufferers who did not use marijuana. Both groups were monitored over the course of the one year study.

Researchers said the cannabis users had no serious side effects compared to the control group, and had a significant improvement in their pain, anxiety, depression, anger and fatigue.

“We noted significant improvements in pain intensity and the physical dimension of quality of life over one year among the cannabis users compared to controls; there was also significant improvement among cannabis users in measures of the sensory component of pain, symptom distress, and total mood disturbance compared to controls. These findings, while not the primary outcomes of the study, are nevertheless important in considering the overall risk-benefit ratio of medical use of cannabis,” Ware wrote.

IMAGE COURTESY DRUG POLICY ALLIANCE

“The results suggest that cannabis at average doses of 2.5g/d in current cannabis users may be safe as part of carefully monitored pain management program when conventional treatments have been considered medically inappropriate or inadequate.”

The marijuana group did report more non-serious side effects, such as headache, nausea,  dizziness, and respiratory problems associated with smoking.

Chronic Pain Groups Blast CDC for Opioid Guidelines

By Pat Anson, Editor

A coalition of pain organizations and advocacy groups says newly drafted prescribing guidelines by the Centers for Disease Control and Prevention (CDC) would – if adopted -- result in the denial of opioid pain medication to patients with legitimate medical needs.

In a highly critical letter to CDC director Tom Frieden, the groups said they were “deeply concerned” that the prescribing guidelines are “inconsistent with established best practices” and show an “extreme imbalance” in the agency’s views about opioids.

The CDC’s draft guidance recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain. Smaller doses and quantities of opioids are also recommended for patients being treated for acute or chronic pain. A complete list of the guidelines can be found here.

“By addressing only how to limit or avoid opioids, the new guidelines will inevitably result in fewer prescriptions overall - including those needed by patients with legitimate medical needs,” the letter states.

“Chronic pain advocacy organizations hear daily from increasing numbers of constituents who are not being able to access the opioid medications they’ve relied on to live with their chronic painful conditions. That is not an outcome that anyone involved in chronic pain and prescription opioid diversion and abuse wants but this guideline will produce.”

The letter, which was signed by the U.S. Pain Foundation, American Chronic Pain Association, American Academy of Pain Management and several other groups, was also addressed to Debra Houry, Director of the CDC’s National Center for Injury Prevention and Control, which oversaw the development of the guidelines.

The letter also takes the CDC to task for a lack of transparency in how the guidelines were developed and presented during an online “webinar.”

“The CDC slides presented on Wednesday were not transparent relative to process and failed to disclose the names, affiliations, and conflicts of interest of the individuals who participated in the construction of these guidelines. The presenters refused to provide any information other than to read exactly what was written on the slides even when asked directly by audience members to disclose the processes and people who had developed these prescribing guidelines,” the letter says.

As Pain News Network has reported, a lobbying organization that seeks to reduce the prescribing of opioids appears to have played a significant role in developing the guidelines. At least five board members of Physicians for Responsible Opioid Prescribing (PROP) are on CDC panels involved in developing the guidelines, including two board members who belong to a key committee that helped draft them.

The CDC has refused to make public a list of members on the “Core Expert Group” that drafted the guidelines, claiming their anonymity was important “to provide honest and independent comment and feedback.”

PROP President Jane Ballantyne, MD, and PROP Vice-President Gary Franklin, MD, are members of the Core Expert Group; and PROP board member David Tauben, MD, is on a peer review panel that will finalize the guidelines, according to internal agency documents obtained by Pain News Network.

In addition, PROP founder and Executive Director Andrew Kolodny, MD, and PROP board member, David Juurlink, MD, are part of a “Stakeholder Review Group” that are providing input on the guidelines.

The CDC and PROP appear to have a close working relationship -- a link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found -- unedited -- on the CDC’s website.

“CDC’s review panel members and experts represent diverse perspectives on this topic and were selected to minimize conflict of interest among members, enhance objective assessment of the evidence, and reduce scientific bias,” the agency said in a statement to Pain News Network. “Representation from advocacy organizations (e.g. pain management societies, societies focused on responsible opioid prescribing) and professional organizations (e.g. specialties by which opioids are commonly prescribed) were selected to ensure that patients and providers impacted by these recommendations would have a voice in the development process.”

Activists in the pain community were alarmed to learn about PROP's role.

“There are too many powerful lobbyists and competing interests at the federal level,” said Terri Anderson, a chronic pain sufferer and patient advocate.  “Organizations such as PROP, and many other professional medical societies, are exploiting the needs of both addicts and pain patients for their own financial gain.”

CDC's "Rapid Review" of Evidence

Secrecy continues to surround the prescribing guidelines, which are intended to help primary care providers that treat a majority of chronic pain patients. Even though the draft guidelines were released during last week’s webinar, only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.

There has also been little news coverage about the guidelines, in large part because the CDC never notified reporters or issued a news release about the webinar.

The CDC said it “streamlined” development of the guidelines so experts could conduct “rapid reviews” of clinical evidence to meet “an urgent public health need.” The agency plans to publish the final guidelines in January 2016 after they undergo peer review.

“Given uncertain benefits and substantial risks, experts agreed that opioids should not be considered first-line or routine therapy for chronic pain outside of end-of-life care,” the agency said in a review of evidence sent to stakeholders and peer reviewers.

“Non-pharmacologic therapy including exercise therapy and CBT (cognitive behavioral therapy) should be used to reduce pain and improve function in patients with chronic pain. If pharmacologic therapy is needed, non-pharmacologic therapy should be used in combination with non-opioid pharmacologic therapy to reduce pain and improve function.”

The pain organizations called that an “extreme” position in their letter to the CDC.

“It is CDC’s singular focus on prescription opioid diversion, abuse, addiction, and overdose over any improved understanding of chronic pain incidence, prevalence, trends, and optimal interventions that reveals within CDC an extreme imbalance in its own risk-benefit sensibilities when it comes to this class of medications,” the letter says. “FDA requires safety and efficacy trials that all approved opioid medications have met. Detailed prescribing instructions are developed based on proven studies. Yet the new guidelines ignore the FDA’s prescribing expertise, recommending different maximum daily doses that appear in no guidelines or package inserts.”

The FDA appears to have played little -- if any -- role in developing the guidelines with the CDC, even though both agencies are in the Department of Health and Human Services, under the leadership of Secretary Sylvia Burwell. An FDA spokesman would only say that the agency “did have an opportunity to comment on the current version” of the guidelines.

“I would ask you to consider what Secretary Burwell's role is in allowing such divisiveness between CDC and FDA. Shouldn't Burwell be trying to have the federal government have a united front on opioids?” asked David Becker, a social worker and patient advocate.

“It seems to me there is a lack of leadership from the Obama administration on opioids. In addition, they can’t seem to deal with the politics of pain care -- they are not bringing parties together to settle their differences. On the contrary they seem to encourage factionalism and convulsing society.  Individuals in pain are merely pawns in the chess game of pain -- with little power and say over their care.”

Bridging the Language Gap Between Doctor and Patient

By Pat Akerberg, Columnist

Like me, some of you may be hooked by a TV Series called Grey’s Anatomy.  The setting is a Seattle teaching hospital.  It’s a drama revolving around the surgical adventures and personal lives of a bright new surgical resident, Meredith Grey, her neurosurgeon husband, senior surgeons, and a group of Meredith’s fresh out of medical school counterparts.

The format begins with some type of traumatic emergency or compelling medical issue.  During rounds, residents are expected to provide a technically astute bedside rundown of a patient’s status right in front of them, their attending surgeon, and other residents to demonstrate their medical competence with confident dispatch. 

The patients are often fearful and overwhelmed as they glaze over in reaction to the stream of impersonal medical terminology washing over them like a tidal wave. 

Attuned to the shortfalls of foreign medical jargon, the attending surgeon typically intervenes.  Instead they slow down, address the patient by name, and compassionately translate the technical terms into everyday language. 

They bridge the gap by talking with the patient vs. at them. 

You can sense heightened tensions ease as patients respond positively to the difference in approach.  They begin to understand, enabling them to make more informed decisions. 

Using lay terms to describe and diagnose (a patient-centered approach) takes no more time or effort than using confusing text book terminology does (a disease centered approach). 

Having experienced the difference between the two approaches firsthand, I urge medical practitioners to adopt the patient-centered one and simply “tell it like it is”.

When I first heard my initial diagnosis of trigeminal neuralgia, it was so rare I had never heard of it.  When I asked my neurologist what it was and what caused it, his disease-centered explanation was to repeat the label and pass it off as just bad luck. 

Fast forward to an intimidating brain surgery -- “micro-vascular decompression” -- offered as a potential fix.  My neurosurgeon gave me a complex video to watch on-line.

When that surgery damaged my nerve leaving me in even worse pain, I was referred elsewhere to deal with the painful complication – “anesthesia dolorosa.”  What?

Marinating in medical terminology all along, the onus was on me to find a way to figure out what they were saying, what was happening to me. 

Through the internet, a patient-centered on-line support group, a compassionate and wise  neurologist/research scientist, and a few years later, I am better equipped now to translate my “bad luck.”

But it’s just not enough for our doctors to understand what’s going on with us.  We’ve been told by medical science for years that there’s a patient factor equally as important.  It’s called a “mind-body” connection, proven to enhance more favorable outcomes.

So why hijack such an influential connection that holds such positive potential by using hard to understand impersonal terms and technical jargon?

Here’s a sampling of some of the disease-based medical terms that doctors used standing between my pain and my understanding of it:  micro vascular decompression, iatrogenic, neuropathic pain syndrome, trigeminal deafferentation, anesthesia dolorosa, central nervous system sensitization, allodynia, hyperalgesia, dysthesias, intractable, refractory to treatment, paradoxical reaction, and progressive disorder, among others.

In patient-centered terms, here’s the translation that could have happened upfront to help me and save precious time and energy:

“I’m sorry that an unfortunate surgical complication occurred damaging your nerve.  The numbness and increased pain mean your nervous system is reactively firing constant pain signals now.”   

“Abnormal facial sensations will happen.  Simple things that normally don’t hurt will, like talking, a kiss, or breeze.  Things that normally hurt can hurt more.”  

“Science and medicine have not yet caught up with how to help with this difficult to treat condition.   However, research is ongoing for new medications and effective approaches. Other surgeries are not advisable.” 

“Neuropathic pain can slowly progress and create other issues.  I will do all I can to help you.”    

Understanding the story the terminology tells hasn’t yielded any answers or relief for me yet, but my reality is no longer lost in the obscurity of a medically precise barrage of unsettling terms.

An important step towards reaching acceptance is being able to name and claim our stories before we can hope to move them in any other direction.  I find that there is something empowering about unraveling my own story well enough to be able to name it and talk about my experience in my own terms.

It’s a way of taking our power back.  The unnecessary gap is pulled closer together.  The story doesn’t go away. It still stays with us, but differently.   

We become the authors.  Armed with greater understanding and hard-won wisdom, we can choose the words we use to connect with our doctors or others.  We can edit things in or out, and decide what, how, and with whom we’ll share.  

We can humanize what we’re experiencing so we’re back in the center where we belong -- no longer overshadowed by diagnostic, confusing, or impersonal terminology.

To really bridge the gap for a stronger mind-body connection, our physicians need to do more of the same in return.

Pat Akerberg suffers from trigeminal neuralgia, a rare facial pain disorder. Pat is a member of the TNA Facial Pain Association and serves as a moderator for their online support forum. She is also a supporter of the Trigeminal Neuralgia Research Foundation.

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

PROP Helped Draft CDC Opioid Guidelines

By Pat Anson, Editor

An advocacy group that seeks to reduce the prescribing of opioid pain medication appears to be playing a significant role in the drafting and development of opioid prescribing guidelines by the U.S. Centers for Disease Control and Prevention (CDC).

Those guidelines, which were released last week, have frightened and angered many patients in the pain community because they could further restrict access to opioids for the treatment of acute and chronic pain.

Pain News Network has learned that at least five board members of Physicians for Responsible Opioid Prescribing (PROP) are involved in developing the CDC guidelines, including two that belong to a key committee that helped draft them. The CDC has refused to make public a list of members on the “Core Expert Group” that drafted the guidelines, claiming their anonymity was important “to provide honest and independent comment and feedback.”

A PROP board member also sits on the CDC peer review panel that will finalize the guidelines, which are intended for primary care providers who treat the majority chronic pain patients.

PROP has been lobbying Congress and federal health officials for years to reduce opioid prescribing and has apparently found a sympathetic ear at the CDC.  

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.

In addition, PROP founder and Executive Director Andrew Kolodny, MD, and PROP board member, David Juurlink, MD, are part of a “Stakeholder Review Group” that will provide input on the CDC guidelines.

A complete list of PROP’s Board of Directors can be found here.

Ballantyne, Franklin and Tauben all have ties to the University of Washington; where Ballantyne is a professor of Anesthesiology and Pain Medicine at the UW School of Medicine, Franklin is a research professor at the UW School of Public Health, and Tauben is the Chief of Pain Medicine at the UW School of Medicine.  All three were involved in the development of opioid prescribing regulations in Washington state, which has some of the toughest prescribing laws in the nation.

“As a member of the Core Expert Group, I have been asked not to comment on the (CDC’s final) guideline until it is released,” said Ballantyne in an email to Pain News Network.

Ballantyne was hailed for her “wealth of experience on opioids” by Kolodny when she succeeded him as PROP’s President last year.

“I am delighted to be able to advance the mission of this important organization,” Ballantyne was quoted as saying in a news release. “Opioids are essential medications, especially when used to ease suffering at the end of life and when used short term for severe pain. Unfortunately, their widespread use for common, moderately painful conditions is harming many pain patients and fueling an addiction epidemic.”

Kolodny is chief medical officer for Phoenix House, a non-profit that operates a chain of addiction treatment clinics.

Juurlink is Canadian and a professor at the Sunnybrook Research Institute in Toronto. Juurlink also serves on the Medical Advisory Board of Advocates for the Reform of Prescription Opioids (ARPO), a non-profit based in Canada that seeks to “end the epidemic of death and addiction caused by prescription opioid drugs.” Kolodny also serves on ARPO’s Medical Advisory Board.

“I routinely see patients whose lives have been ruined by opioid painkillers — drugs like morphine, oxycodone and hydromorphone. Most of these patients started with back pain or arthritis; others were given a month’s worth of pills after surgery and simply continued taking them,” Juurlink recently wrote in an Op/Ed piece for the Toronto Star.

"Non-Pharmacological Therapy" for Chronic Pain

The CDC’s draft guidance on opioid prescribing recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain. Other guidelines recommend urine drug testing of all patients who are prescribed opioids, as well as smaller doses and quantities of opioids for patients being treated for acute or chronic pain. A complete list of the guidelines can be found here.

A veil of secrecy has surrounded the development of the CDC's guidelines. The agency refused to provide an advance copy of the guidelines before they were released during an online “webinar” and there was little public notice about the webinar itself. Only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on them.

News coverage about the proposed CDC guidelines has also been scant, in large part because the CDC never notified reporters or issued a news release about the webinar.

“Media were not directly included because this public engagement period is part of the guideline development process and was intended to invite feedback specifically from providers, patients, and clinical organizations that would be impacted by these recommendations,” a CDC spokeswoman said.

The CDC did notify health insurance providers, professional medical organizations, research entities and some patient advocacy groups about the webinar and gave them 48 hours to submit comments by email. During that period, the agency said 167 emails were received from interested parties.

The CDC has rushed to complete the guidelines over the last few months, using "rapid reviews" of clinical evidence on the effectiveness of opioids -- resulting in a limited search of medical databases by years, languages and quality assessment. According to internal agency documents obtained by Pain News Network, the CDC plans a "rapid publication of the guidelines to address an urgent public health need."

Still unclear is why the CDC is acting as the lead agency in developing guidelines for prescribers, a role traditionally reserved for the Food and Drug Administration. The FDA broke its silence about the CDC’s guidelines with its first public comment today, revealing little about its role – if any – in drafting them.

“The FDA did have an opportunity to comment on the current version of CDC’s Guideline for Prescribing Opioids for Chronic Pain. The guidance has not been finalized yet, so the FDA does not have comments to share at this time,” said Eric Pahon, an FDA spokesman, in an email to Pain News Network.

Prescribing Guidelines Called a 'Travesty'

“I am really concerned about the whole process.  First it appears that conflict of interest was not managed well.  I can't understand why payer representatives are part of any guideline where their vested interest is to limit access to treatments.  They obviously profit from limiting dosing,” said Lynn Webster, MD, past President of the American Academy of Pain Medicine. “The guidelines proposed by the CDC fail to address any of the root causes to either the addiction or pain epidemics in America.  This is a travesty.

“We need the CDC to recognize that addiction is a disease that needs access to care not available today.  We need to destigmatize the disease so people can get treatment without fearing prosecution and persecution. The CDC could lobby Congress to enact laws to increase access to treatment.  We need the CDC to recognize that pain is a disease as well and is associated with an alarming rate of suicides due to lack of effective therapies.  Making it harder for many patients to access opioids will increase the suicide rates among people with severe pain.”

Now that the draft guidelines have been released, they’ll be reviewed by the CDC’s Stakeholder Review Group that includes over a dozen professional organizations involved in the field of pain management.  Then they’ll be turned over to a three member peer review panel. The CDC hopes to finalize the guidelines for release in January.

PROP is already preparing for backlash from the pain community and some medical organizations when the final guidelines come out. PROP and other affiliated groups are lobbying the U.S. Senate Finance Committee to release details of its investigation into the financial ties that pharmaceutical companies had to certain doctors and non-profit pain organizations.

PROP’s goal, according to the Milwaukee-Wisconsin Journal Sentinel, is to silence critics before the CDC guidelines are released.

"By making the findings of the investigation public and exposing the financial relationships between pain organizations and opioid makers, it will be harder for them to claim that it is the interests of pain patients they are lobbying for," said PROP founder Andrew Kolodny.

The Senate Finance Committee began its investigation over three years ago, but has never released its findings. The investigation targeted Lynn Webster, along with other prominent pain physicians, and professional organizations such as the American Pain Society and the American Academy of Pain Medicine, both of which are part of the CDC’s Stakeholder Review Group.

A spokesman for the Senate committee said it is “unable to release documents or findings until the conclusion of any investigation and the committee's issuance of an official report."

CDC Opioid Guidelines Could Lead to Malpractice

By Terri Lewis, PhD, Guest Columnist

The recent issuance of draft guidelines for opioid prescribing by the Centers for Disease Control and Prevention (CDC) posits some troubling guidelines for physicians – troubling because they prioritize the practice of prescribing over the treatment of patients. They infer that the use of opioids is tantamount to the onset of addiction and equate dosing levels with metrics unrelated to a patient resuming activities of daily living.

To ignore the individual patient’s needs in favor of applied population modeling for prescription overdose is tantamount to the institutionalization of malpractice and violates the very tenets of person-centered health care. 

Physicians are moving to an environment that will redefine and reclassify conditions associated with chronic pain based on a body systems approach.  In the arena of musculoskeletal systems alone, there are 99 classifications associated with pain levels that range from acute to chronic to intractable. All have the potential to require lifetime treatment at levels beyond those associated with acute pain. 

Medicating a person so that the impairment imposed by acute pain does not convert to chronic pain or disability is a very important concept in our health care decisions – both as providers and as consumers.  While long term opioid prescribing may have negative implications for some, this is largely a failure of models of care and not a failure of consumer utilization.  

A review of death and injury data maintained by the CDC indicates that prescription drug overdose is not even in the top 15 leading causes of death in the U.S. The number of overdoses that occur in the population annually should not be the primary filter through which we consider the needs of persons with chronic pain. 

The third largest measured harm to patients is associated with care by a physician or hospital – conditions over which patients have no control and which can result in lifetime injury. Wrong diagnosis, wrong prescribing, failure to rescue, hospital acquired infections, improper surgeries and other forms of malpractice all create conditions of significant injury that can lead to chronic pain.  Far more risk to the patient is associated with covering up harmful industry practices and the institutionalization of biases that opiod treatment causes addiction.  Correlation is not causation.

Before starting long term opioid therapy, providers should establish treatment goals with all patients, including realistic goals for aftercare, restoration of functional activities, and pain reduction.  No medication, including opioids, should be prescribed unless it is for conditions for which it was clinically trialed, or when there is clinically meaningful improvement in pain reduction and function that outweighs risks to patient safety.

Before starting any therapy, providers should discuss with patients risks, limitations, and realistic benefits of opioid therapy, as well as the patient’s and provider’s responsibilities for managing that therapy.  A careful history, an understanding of the context to which the patient will operate, the supportive resources available, and the daily demands upon their independence and functioning, are critical indicators for monitoring performance that have far more important meaning than dose limitations. 

The important question is not whether opioids are contraindicated by regulation, but whether opioids are likely to return the patient to a state of functional behavior or have a role in helping them maintain their independence and daily activities. 

When opioids are started, providers should prescribe the dose that is most likely to benefit the patient. For some, this will be a very low dose, but for others it may take more due to conditions associated with their personal genetic characteristics. Patients can build a tolerance to low dose medications when they are prescribed doses that do not alleviate pain.  Rather than being afraid to over-medicate, we should be just as concerned about the impact of under-medication in building tolerance.

The CDC’s recommendation that 3 days or less supply of prescribed opioids for non-traumatic acute pain may well fall short of individual needs.

Providers should evaluate patients frequently when starting long-term opioid, anti-epileptic, or anti-psychotic drugs alone or in combination.  Evaluation should include serum levels, behavioral observations, assessment of adaptive behavior and progress toward adaptive functioning. 

Patient contracts are ethically troublesome and tantamount to withholding medications based on characteristics or behaviors that may have nothing to do with patient outcomes. It is unethical to hold a person in chronic pain hostage to the withholding of effective treatment, and many believe this should not be the basis for informed consent conversations.  These conversations frequently occur within the first or second doctor visit, when little is understood about the patient, their condition, its causation, or direction for treatment. 

Another one of the CDC’s recommendations is for urine drug testing of patients on long term opioid therapy.  Urinalysis often falls far short as a metric for adherence and compliance with a prescribing routine. Differences in individual rates of metabolism may well cause providers to make errors of judgment when analyzing drug test results.  Many urine tests have significant rates of poor performance, physicians may not understand the potential for false positives and negatives, and some labs fail to employ procedures that are consistent. 

These tests also have the potential to add many hundreds of dollars to the patient’s bill, a cost for which they cannot be reimbursed on many insurance plans.  Failing a drug test may unnecessarily stigmatize the patient and impair the treating relationship. 

Risks and Benefits of Opioids

When the benefits might not outweigh harms of continued long term opioid therapy, providers should work with patients to periodically evaluate dosing, add other non-pharmacological therapy and, if possible, discontinue opioids when treatment so indicates. 

All patients are not equally vulnerable.  Before starting, and periodically during continuation of opioid therapy, providers should incorporate into the management plan strategies to mitigate risk, including patient and family education, gathering of information about the impact of the health condition on long term function and independence, interaction with other medications or foods, and rescue support if indicated.

Most providers are now required to review the patient’s history of controlled substance prescriptions by using prescription drug monitoring databases to determine whether the patient has access to excessive opioid dosages or dangerous combinations of medications. Used properly, this is an effective tool.  But it is important for providers to understand that this data itself has limitations and may be biased by the availability of medications, prescriber behavior practices, and pharmacy filling practices. 

Many a user has been accused of abuse for data that reflects limitations that have nothing to do with the patient.  Providers should be very careful about drawing conclusions and should balance this information with other indicators – patient reports, community supports, consumer functioning, and so forth.

It is important to understand that persons with chronic pain are, by their very nature, patients with complex care needs who have injuries to multiple body systems.  Chronic pain is a total body experience, no matter the origin of the injury or illness.  The person is not going to be “cured” and cure is not the treatment goal.  Returning the person to the best function possible is the goal, along with assuring them that you will be a partner in helping them achieve a quality of life through treatment they can depend on.

We have to change our thinking about approaches that require us to treat to the dose, and stop interpreting this issue of pain care within the acute care model. Those who would divert us from this goal are not leading the public conversation toward an effective national pain strategy.

Terri Lewis, PhD, is a specialist in Rehabilitation practice and teaches in the field of Allied Health.  She is the daughter and mother of persons who have lived with chronic pain.

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.

CDC Maintains Secrecy Over Opioid Guidelines

By Pat Anson, Editor

The Centers for Disease Control and Prevention (CDC) is refusing to disclose what outside advisors it consulted with during the drafting of its controversial opioid prescribing guidelines for physicians. The proposed guidelines, which were released this week, have angered many pain patients who think they could lead to sharp reductions in the prescribing of opioids for both acute and chronic pain.

“The anonymity of the reviewers engaged in this process is important during the ongoing development of these guidelines, as it allows reviewers to provide honest and independent comment and feedback,” said Courtney Lenard, a health communication specialist in the CDC’s National Center for Injury Prevention and Control. The panel of advisors is known within the CDC as the Core Expert Group.

“The Core Expert Group includes a limited number of CDC scientific staff, primary care professional society representatives, state agency representatives, experts in guideline development methodology, and other subject experts,” said Lenard.

Pain News Network has learned through a reliable source that about 15 people are in the Core Expert Group, only one of which is a physician with expertise in pain management.

The other members were “physicians and non-physicians, many of whom have been involved in efforts to rein in (opioid) prescribing.”

“Input from the pain management community in developing the guideline was, essentially, non-existent,” said the source, who identified Jane Ballantyne, MD, a professor of Anesthesiology and Pain Medicine at the University of Washington as the sole member with pain management expertise.

“As a member of the Core Expert Group, I have been asked not to comment on the (final) guideline until it is released,” said Ballantyne in an email to Pain News Network.

Ballantyne last year was named President of Physicians for Responsible Opioid Prescribing (PROP), a controversial organization that has lobbied Congress and criticized the Food and Drug Administration for not doing more to limit opioid prescribing.

The CDC and PROP appear to have a close working relationship -- a link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found -- unedited -- on the CDC’s website.

Asked if he was also a member of the CDC’s Core Expert Group that drafted the guidelines, PROP founder Andrew Kolodny said that he had no comment. Kolodny, who is chief medical officer for Phoenix House, which operates a chain of addiction treatment clinics, also said he would have no comment on the guidelines themselves.

Phoenix House was recently the subject of a highly critical report by Reuters, which claimed that in recent years the publicly funded institution “has consistently failed to provide the quality of care necessary to help addicts kick the habit.”

CDC Guidelines for Prescribing

Now that the draft guidelines have been released, the CDC plans to consult with a “Stakeholder Review Group” that includes over a dozen professional organizations involved in the field of pain management. Only two “stakeholders” – the American Chronic Pain Association and the American Cancer Society – represents pain patients.  A full list of the Stakeholder Review Group will be listed at the end of this article.

Secrecy has surrounded the development of the CDC's guidelines from their inception and continues today. The CDC refused to provide an advance copy of the guidelines before they were released Wednesday during an online “webinar.” Even after their release, only a summary of the guidelines is available on a CDC website and the agency is no longer accepting public comments on the guidelines after a 48-hour window of opportunity.

“Given the public health need to respond to the prescription overdose epidemic, it was critical to identify a public participation method and comment period that was rapid and efficient so that comments could be immediately provided to peer reviewers for their consideration,” explained the CDC’s Lenard in an email.

The first prescribing guideline recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain, and states that opioids should only be prescribed if the benefits of reducing pain outweigh the risk of addiction and overdose.

Other guidelines recommend urine drug testing of all patients who are prescribed opioids, both for illicit drugs and prescribed medications. Smaller doses and quantities of opioids are also recommended – including a “three or fewer days” supply of opioids for most types of acute pain. The guidelines also recommend that benzodiazepines not be prescribed concurrently with opioids. A complete list of the guidelines can be found here.

“We’re concerned about some of the provisions in here, and by the fact that such guidelines issued by CDC are often accepted, sometimes rather uncritically, by state health departments and licensing boards, and thus quickly become standards of practice,” said Bob Twillman, Executive Director of the American Academy of Pain Management, which is one of the stakeholder groups that will be consulted by the CDC.

“I was generally satisfied with the proposed guidelines,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids, who lost his teenage daughter to a single dose of OxyContin in 2006.

“My main concern at this stage is how the federal government will reconcile these guidelines with the FDA REMS guidelines for long-acting opioids, which were voluntary guidelines issued a few years ago by FDA and have not been effective at deterring the overprescribing,” Jackson told Pain News Network. “Hopefully the CDC's guidelines will supersede the wholly inadequate FDA guidelines.  I would also like to see the CDC implement a very intensive training program to support the implementation of their new guidelines."

Pain Patients Worried

Pain patients – including many who already find it difficult to get opioids for pain relief – are angered and worried by the CDC’s recommendations.

“This terrifies me. I take two Norco per day, it barely keeps my pain at tolerable levels so I can do fun things like shower and get out of bed. I already jump through hoops to get my prescriptions every month.” said Cynthia Mittel. “To arbitrarily take away my only chance to have a life halfway worth living is evil and very short-sighted! Government at its finest. Guess we'll all be getting our drugs off the street now!”

“This is such a slap in the face to the millions of pain sufferers in this country," wrote Sue B. "We are not addicted to opioids! We need them in order to live. Would you think of putting these strict guidelines on insulin? It is not our fault drug abusers use our meds, our lifelines, to sell and get high, yet we are constantly punished.”

“We are not treated properly now. We get drug tested and insulted now. I cannot believe this is even coming up after the last change in guidelines,” wrote Kryste Southwick.  “Why do junkies have more meaning than chronic pain patients? Why are you stripping us of what little lives we can have? Do your research people. If this happens there will be A LOT of suicidal blood on YOUR hands.”

“This is wrong of the CDC to try and force their guidelines in people who live with chronic pain. I am monitored by my rheumatologist for my pain medication. I do not abuse my medication nor am I addicted to them,” said Suzanne Stevenson. “These guidelines the CDC want to impose are wrong and unfair to so many people. What right does the CDC have in this matter? None!”

Many have wondered why the CDC is acting as the lead agency in creating the prescribing guidelines – a role traditionally played by the Food and Drug Administration. The FDA has yet to release a statement about the CDC guidelines or say what role – if any – it had in drafting them.

"CDC and FDA are federal partners and collaborate on many different issues and at many different levels, prescription drug overdose being one of them. FDA has been involved in the review process of the guidelines and we will continue to work with them on this prescription drug overdose epidemic," said the CDC's Lenard.

CDC officials have long been critical of opioid overprescribing and have repeatedly cited a study that claims over 16,000 Americans are killed annual by overdoses linked to pain medications.

"CDC’s top focus in developing these guidelines is improving patient safety and reducing the risk that any more patients will die from an overdose related to mixing medications, using alcohol while on treatment, or taking a dangerous dose of opioids," said Lenard.

"We want to provide tools that primary care physicians can use to help determine when and how to safely initiate, maintain, and discontinue use of opioid therapy for chronic pain outside the setting of end-of-life care.  We understand that pain is a complex problem and that some patients will require treatment with a pain specialist. These guidelines are not intended to guide that care. We want patients currently on opioid therapies to work with their doctors to stay safe while managing their pain."

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.

The CDC said it will now consult with the “stakeholders” group --and will then submit the guidelines to a peer review panel  -- before releasing a final version in January, 2016.

Members of the stakeholders group include the following: American Academy of Neurology; American Academy of Pain Management; American Academy of Pain Medicine; American Academy of Pediatrics; American Academy of Physical Medicine and Rehabilitation; American Cancer Society; American Chronic Pain Association; American College of Medical Toxicology; American College of Obstetrics and Gynecology; American Geriatrics Society; American Hospital Association; American Medical Association; American Pain Society; American Society of Addiction Medicine; American Society of Anesthesiologists; American Society of Hematology; American Society of Interventional Pain Physicians; and Physicians for Responsible Opioid Prescribing.

Power of Pain: 9 Tips for Cooking with Chronic Pain

By: Barby Ingle, Columnist

For those of us living with pain, we wish for a life worth living -- one that permits us to enjoy our family and friends.

Preparing and sharing a meal is something I enjoy doing, but pain can make even the simplest cooking tasks more difficult, especially those that affect our hands, fingers, wrists, elbows, and shoulders.

Here are nine tips I’ve learned to make cooking easier:

1. Use pots and pans with two handles

2. Buy a food processor, especially if you have difficulty with manual cooking tasks like chopping, cutting, and slicing.

• Choose a food processor that is manageable for you and your physical limitations
• Before you buy one, be sure you are able to change the blades easily and remove the plastic bowl and plastic lid from the processor
• Consider mini food processors for your needs

3.  Use specialty cooking tools such as "Rocker" knives.

• The two-handled design adds strength and control to cutting and chopping, while the rocker blade design has the motion built right in.

4.  Use a stool to sit on while you prepare and cook food.

• Cooking can be a long process, depending on how complicated the meal is you are preparing
• When counter work starts to increase your pain or when standing over the stove is wearing you out, be prepared to pull up a stool

5.  Crock pot meals

• Crock pots are helpful for people with pain to be able to cook nutritious meals, but in less time and more simply.

6.  Electric can opener to use on canned food or soups

• Soup is simple to prepare and nutritious
• Make sure you have canned soups available for when you are having bad pain days or the ingredients to make soup when you don’t feel up to cooking. Soup will warm you and soothe you.
• Use a ladle to pour soup into the bowl

7.  Double the size of your meals

• Create planned leftovers which you can freeze and have available for another day
• You will be glad you have nutritious meals in your freezer on days you don't feel well enough to cook

8.   Food Storage

•  Get food storage containers which are easy for you to open and easy for you to stack
•  Prepare and store foods which you commonly use and have them in ready-to-eat condition.

9.   Organize your kitchen

•  Get a stove with controls on the front rather than the back
•  Install cabinet handles which are easy to grasp
•  Install vertical dividers to store pans and trays so that they are not stacked
•  Raise the front bottom edge of the refrigerator so it closes automatically
•  Store frequently used items in cupboards between knee and shoulder height
•  Store kitchen items near the area they are used
•  Store spices in a drawer or on the counter rather than in a high cupboard

There are many choices and designs for cooking tools and kitchen aids that can make cooking easier, such as ergonomic, lightweight cooking tools, which have easy grips and non-slip handles.

Spatulas, spoons, ladles, whisks and other cooking tools which feel comfortable in your hand can greatly improve manual dexterity, reduce pain, and compensate for swollen and deformed joints.

What tips have you learned to make cooking easier?

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.