PROP and the ‘Opioid Lobby’

By Pat Anson, Editor

With its signature accomplishment under fire from pain patients, health professionals and even some congressmen, Physicians for Responsible Opioid Prescribing (PROP) is now engaged in a public campaign to discredit critics by labeling them as pawns of the “opioid lobby.”

PROP, an advocacy group funded by the addiction treatment chain Phoenix House, played a key role in drafting the controversial opioid prescribing guidelines developed by the Centers for Disease Control and Prevention (CDC). Five PROP board members serve on CDC panels that helped develop the guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.

As many as 11 million Americans use opioids for long-term, chronic pain and many fear losing access to opioids if the guidelines are adopted.

The CDC planned to finalize the guidelines next month, but a wave of criticism that the guidelines are too restrictive, along with allegations that the agency violated federal law while secretly drafting them, forced the agency to reconsider.

“CDC’s plan was effectively blocked by intense pressure from the opioid lobby, which sees more cautious opioid use as a financial threat,” wrote PROP founder and Executive Director Andrew Kolodny, MD, in newsletter emailed Wednesday to PROP supporters. Kolodny is chief medical officer for Phoenix House.

“CDC was pressured into opening a federal docket on its draft guideline. This will tack months onto the process – it is also highly unusual – federal dockets are typically opened for public comment on proposed regulations – not for medical guidance issued by CDC,” Kolodny wrote.

In his “urgent request” to supporters, Kolodny asks them to visit this federal website and post comments in favor of the guidelines. He even offers several suggestions on what to write.

Over 600 comments have been received since the comment period opened on December 14 and many of the recent ones apparently are from PROP supporters. They often parrot instructions made by Kolodny in his newsletter.

“The medical community is urgently in need of guidance from CDC because aggressive opioid prescribing is harming pain patients and fueling an epidemic of addiction and overdose deaths,” wrote Janis McGrory, in a word-for-word rendition straight from Kolodny’s newsletter.

"I am in full support of the CDC guideline calling for more cautious opioid prescribing. My son died at the age of 26. He was a heroin user that started from prescribed opioids for a back injury," wrote Veronica Deborde. "I am sure if the opioid lobbyist lost a child to opioid use they wouldn't even consider blocking the CDC."

"The havoc that drug addiction can reap, not only on individuals but their entire family, is beyond devastating. Please don't let big pharma and financial implications weigh in on the issue of public safety," wrote pharmacist Sarah Randolph.

"Opioid Lobby" Funding

It’s not unusual for advocacy groups to urge their supporters to take action or to instruct them on what to do. Several groups opposed to the guidelines have been doing the exact same thing. But Kolodny takes it a step further, by challenging the integrity of non-profits, medical societies and others who oppose the guidelines.

“This is a big win for the opioid lobby,” Koldony said last week in a widely reported Associated Press story about the CDC’s decision to delay implementing the guidelines.

“The story here is how the opioid lobby is using the Cancer Action Network to discredit a public health effort to limit opioid prescribing,” Kolodny told The Hill.

“Here’s background on shady organization now attacking CDC’s draft opioid guideline,” Kolodny wrote in a Tweet.

As far back as September, Kolodny apparently knew the guidelines would generate controversy. That’s when he told the Milwaukee-Wisconsin Journal Sentinel that the U.S. Senate Finance Committee should release details of a 2012 investigation of opioid manufacturers’ ties to medical groups.

Why dig up a 3-year old investigation? Kolodny told the Journal Sentinel his goal was to discredit pain organizations who might oppose the guidelines.

"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," he said.

Kolodny has found many other eager listeners in the news media, who have adopted his views about opioids, the addiction and overdoses they can cause, and the alleged influence of the so-called opioid lobby.

For example, in a story this week headlined, “Makers of OxyContin Bankroll Efforts to Undermine Prescription Painkiller Reform,” The Intercept reported that opioid manufacturers “are funding nonprofit groups fighting furiously against efforts to reform how these drugs are prescribed.”

Among the groups singled out in The Intercept’s “investigation” was the Power of Pain Foundation, which has accepted funds from Purdue Pharma, the manufacturer of OxyContin.

Power of Pain President Barby Ingle, who is also a PNN columnist, is furious her non-profit was dragged into the controversy over a relatively small amount of money.

“Yes, to date (over the past 9 years) Purdue has given $15,000 total, all unrestricted grants to our foundation. A bulk of it is being used to produce our Music Moves Awareness project which will feature the stories of 20 pain patients with different pain diseases, all doing different pain treatments, representing youth, young adult, adult, and elderly patients,” said Ingle, a pain sufferer who happens to be allergic to OxyContin.

“None of our 10 voting board members takes opioid medications for any chronic illness. I also personally serve on the 2015 Purdue Pharma Patient Board of Advisory which paid me $100 for my personal opinions on the pain community and access to care issues.”

Another group often singled out as being part of the “opioid lobby” is the American Academy of Pain Management, which reportedly gets 10% of its revenue (about $300,000) from opioid manufacturers.

“Some have said that this delay (in the CDC guidelines) is a victory for ‘the opioid lobby,’ but I think it’s not really a victory for anyone,” said Bob Twillman, Executive Director of the American Academy of Pain Management. “It might be a victory for tried-and-true methods of developing practice guidelines, and a victory for transparency, but a delay in producing reasonable, workable guidelines actually does everyone a disservice. That could have been prevented, had CDC used a proper process from the beginning.”

The CDC’s public comment period on the guidelines continues until January 13th. You can make a comment by clicking here. 

The proposed prescribing guidelines and the reasoning behind them can be found in a 56-page report you can see by clicking here.

(For the record, Andrew Kolodny and I had a somewhat cordial and professional relationship until a few months ago, when he became unhappy with Pain News Network coverage of opioid issues and stopped communicating with me. PROP President Jane Ballantyne also has not responded to repeated requests for comment on various articles we’ve written about her.

PROP has a standing invitation from PNN for an op/ed column about its views on opioids and/or the CDC guidelines, which we would be happy to publish. The same offer is extended to other groups with similar views.)

Power of Pain: Making a Hospital Stay Easier

By Barby Ingle, Columnist 

Just as you should take a personal medical history to your doctor visits, being prepared for emergency room visits and hospital stays is also a good idea. A safe, smooth visit is exactly what you need when you are a chronic pain patient who is trying to heal or fight an illness.

I have unfortunately been to the hospital too many times now over the past 18 years. In the beginning, I did not go prepared. Nevertheless, through multiple visits, I have found a few things that allow me to get better treatment from the staff. 

For a better hospital stay, I now ask for a room in a quiet part of the hospital, as sharp and sudden noises exacerbate my pain. Most hospital rooms now have their own thermostat, so you can control your own temperature. If your room does not have its own, you can ask the nursing aide to assist with making you more comfortable, such as getting warm blankets.

When I am assigned a roommate, I ask for my bed to be farthest from the door so that their visitors don’t accidentally bump into me, and I can have less interruption with my resting. When possible, before their guests arrive, my husband or I inform them of my condition and how noise raises my pain levels. It is best to explain it to your roommate prior to his or her guest’s arrival so that he or she may explain it to them for better cooperation.

I have also learned to bring blankets and pillows from home. They are typically softer and my quilts are more comforting, both in warmth and as a reminder of home.

Most of the hospitals I have stayed in now offer an air mattress that can be used to adjust the bed to your preference. Comfort should be a big consideration so that you can heal faster.

It is almost unavoidable to not get poked with a needle as a patient in the hospital. They typically check blood at least once a day and use IV fluids to keep you hydrated. Medications are also administered with needles or through your IV. When they are drawing blood or putting in IV needles, ask for pediatric needles because any new trauma can cause RSD to spread to a new site.

If a person takes my blood and I find them to be supportive and cooperative, I have asked that they be the one to check my blood every time during that visit. I even had a nurse who agreed to come in to take my blood, even though she was off duty for one of the days I was in the hospital. I now have a “portacath” – a small catheter connected to a vein. I ask them to take blood draws from it for less needle poking.

While you are asking for better ways to get through a blood draw, have a nurse place a sign above your bed designating your affected limb(s). I had a nurse at the last hospital who put a red bracelet on my unaffected limb and a red sticker on my chart. This served as a good reminder to the nurse and aides as they walked into the room. They see multiple patients on your floor, and as patients come and go often, you want to stay on top of your care. Be your own “chief of staff” and employ the same practices at the hospital that you do with your regular doctors.            

I also bring to the ER and hospital a list of medications. Sometimes I have had to have my own brought in. I think it is good to have my own supply there so I can control when I take them. Otherwise, have the nurse check with the hospital pharmacy to see if they carry all of your medications. Nurses can’t always be there at the appropriate time to administer medications or help with other needs due to an overload of patients. Therefore, if you have your meds available, you can stay on schedule.

I also have found that the hospital has charged me for taking my own medications, even when I brought them from home, although the cost will be less than having them providing you the medication. This can also save you from mix-ups in medications by their pharmacist. When you are on pain medication at the hospital, make sure to not wait until it is worn off before asking for more. Hospital employees often times are taught to order your medications 30 minutes after you ask for them, so it could be 45 minutes or more before they actually arrive to your room from the time you ask for them. Keeping pain low is easier then lowering pain after it has skyrocketed again.                       

Something I do at home is keep items on the bedside table for easy reach and use. In the hospital, I use my tray table to serve the same purpose.  I have it placed in a position so I do not bump into it when resting, but it is close enough to utilize it for my things.  Also, if a nurse moves it to assist me or take blood pressure, I am sure to ask her to move it back into position when she is finished.

Healthcare institutions that are accredited to assess and treat your pain have been mandated to treat pain as the fifth vital sign.  You have the right to be taken seriously, believed and demand pain control. If you feel that your needs are being overlooked or intentionally ignored, ask to speak with hospital administration as soon as possible. Remember to be calm when complaining or they may not take you seriously. 

It never hurts to ask for things that can make your stay more enjoyable and comfortable.

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.

Researchers Say Chronic Pain Rewires Brain

By Pat Anson, Editor

Researchers at Northwestern University say a brain region that controls whether we feel happy or sad is rewired by chronic pain.

Their research on laboratory rats, published in the journal Nature Neuroscience, may have also uncovered a new treatment strategy that restores the brain and dramatically lessens pain.

'It was surprising to us that chronic pain actually rewires the part of the brain controlling whether you feel happy or sad," said corresponding author D. James Surmeier, chair of physiology at Northwestern University Feinberg School of Medicine. "By understanding what was causing these changes, we were able to design a corrective therapy that worked remarkably well in the models. The question now is whether it will work in humans."

The new treatment combines a Parkinson's drug, L-dopa, and a non-steroidal anti-inflammatory drug (NSAID), both of which are FDA approved. The combined drugs target brain circuits in the nucleus accumbens and completely eliminated chronic pain behavior when administered to rodents. The key is administering the drugs together and soon after an injury.

The scientists hope to begin a clinical trial on humans to further test their theory.

"The study shows you can think of chronic pain as the brain getting addicted to pain," said A. Vania Apkarian, a professor of physiology at Feinberg. "The brain circuit that has to do with addiction has gotten involved in the pain process itself."

The researchers found that a group of neurons thought to be responsible for negative emotions became hyper-excitable within days after an injury that triggers chronic pain. This change was triggered by a drop in dopamine, a neurotransmitter.

"These results establish chronic pain cannot be viewed as a purely sensory phenomenon but instead is closely related to emotions," Apkarian said.

When scientists gave the rats the NSAID and L-dopa, which raises dopamine levels, the changes in the brain were reversed and the animals' chronic pain behavior stopped. That suggests supplementing anti-inflammatories with a medication that activates dopamine receptors or raises dopamine levels might be an effective way of treating chronic pain or preventing the transition from acute to chronic pain.

Scientists also treated the rats with another Parkinson's drug, pramipexole, which activates dopamine receptors and mimics dopamine's effect. That drug also decreased the animals' pain-like behavior.

"It is remarkable that by changing the activity of a single cell type in an emotional area of the brain, we can prevent the pain behavior," said Marco Martina, an associate professor of physiology at Feinberg.

In addition to Parkinson’s, L-Dopa is used to combat anxiety and depression, and to improve the ability to concentrate and focus. L-Dopa is sold under the brand names Levodopa, Sinemet, Madopar, Stalevo, and Prolopa.

A recent study by British researchers also found that brain chemistry is changed by chronic pain.

Researchers at the University of Manchester used PET scans to measure the spread of opioid receptors in the brains of 17 arthritis sufferers and nine healthy control subjects. The number of opioid receptors was highest in the arthritis sufferers, suggesting their brain chemistry had changed and made them more resilient to pain. That could explain why some people are better able to cope with pain than others.

The University of Manchester study is being published in Pain, the official journal of the International Association of the Study of Pain.

Congress Investigating CDC’s Opioid Guidelines

By Pat Anson, Editor

A congressional committee has launched an investigation into efforts by the Centers for Disease Control and Prevention (CDC) to develop new guidelines for the prescribing of opioid pain medication. The controversial draft guidelines discourage primary care physicians from prescribing opioids for chronic pain. As many as 11 million Americans take opioids daily for long term, chronic pain.

In a letter to CDC director Thomas Frieden, the chairman of the House Committee on Oversight and Government Reform questioned whether the agency broke federal law by appointing a biased advisory panel and refusing to disclose the identities of its members. Rep. Jason Chaffetz (R-Utah) asked Frieden to supply documents and information about the guidelines process “as soon as possible.”

At issue is the “Core Expert Group,” a panel composed of 17 members, most of them health researchers, state regulators and addiction treatment specialists. Although the CDC never publicly disclosed who was on the panel, their identities were leaked to Pain News Network and other websites. Critics charged that some members had conflicts of interests and strong biases against opioids. No patients or active pain management physicians are on the panel.

“Some groups have raised concern that the proposed guidelines may be insufficient to treat those suffering from chronic pain,” wrote Rep. Jason Chaffetz (R-Utah).  “We expect CDC’s guidelines drafting process to seek an appropriate balance between the risk of addiction and the need to address chronic pain. The CDC has utilized a ‘Core Expert Group’ in the drafting and development of opioid prescribing guidelines, raising questions as to whether CDC is complying with FACA (Federal Advisory Committee Act).”

Chaffetz’s letter was co-signed by five other committee members; Rep. Elijah Cummings (D- Maryland), Rep. Jim Jordan (R-Ohio), Rep. Matt Cartwright (D-Pennsylvania), Rep. Mark Meadows (R-North Carolina), and Rep. Gerald Connolly (D-Virginia).

Two members of the Core Expert Group are Jane Ballantyne, MD, and Gary Franklin, MD, who are the President and Vice-President, respectively, of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which runs a chain of addiction treatment centers.

Ballantyne and Franklin, who have been vocal critics of opioid prescribing, played key roles in the development of opioid regulations in Washington State, which has some of the toughest prescribing laws in the nation.

Ballantyne has served as a paid consultant to a law firm that is suing pharmaceutical companies over their opioid marketing practices. She also recently came under fire for co-authoring an article in the New England Journal of Medicine that said reducing pain intensity should not be the goal of doctors that treat chronic pain.

In all, five PROP board members are advising the CDC in different capacities, including its founder, Andrew Kolodny, MD, who has called opioid pain relievers “heroin pills.”   

Another member of the Core Expert Group is Lewis Nelson, MD, an emergency physician and toxicologist at New York University Langone Medical Center. Nelson has also compared prescription opioids to heroin and said the risks of taking them outweigh the benefits.

"As a civilization we somehow managed to survive for 50,000 years without OxyContin and I think we will continue to survive," Nelson recently told the Associated Press.

In his letter to Frieden, Chaffetz asked the CDC to provide all documents related to the selection of the Core Expert Group, as well as any documentation related to their meetings or advice they gave to the agency. They asked Frieden to provide the information by January 8th.

"CDC has received the letter and is complying with the request," a spokesperson for the agency told PNN.

The CDC recently announced it would delay implementing the guidelines, reopen a public comment period, and have the guidelines reviewed by its scientific advisory committee. As Pain News Network has reported, the agency also said the Core Expert Group and other outside advisers are expected to continue advising the CDC. 

Fed Panel 'Appalled' by Guidelines

Some of the sharpest criticism of the CDC has come from officials in other federal agencies, such as the Food and Drug Administration, which normally plays a lead role in setting guidelines for prescription drugs.

“I think we need to recognize that CDC wants to substantially limit opioid prescribing. Period,” said Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products, at a recent meeting of a federal pain research panel.

Hertz said the evidence cited to support the guidelines was “low to very low and that's a problem." She also told the National Institute of Health’s Interagency Pain Research Coordinating Committee that the FDA “did have an opportunity to look at the product and comment,” but otherwise was not involved in its development.

Other panel members expressed alarm that, although “voluntary” and meant for primary care physicians, the guidelines could quickly become policy throughout the country.

“I see how our state health department looks at CDC. They really take direction from CDC.  CDC has a great name for good reason. They’ve done incredibly good work in many areas,” one panel member said. “And I have to say this has really diminished my respect for CDC. I have to say that this process was horrible. I’m appalled, appalled at the process CDC used to develop these in secrecy, not allowing input from the pain community and pain physicians.”

“I think we cannot for one minute be naïve enough to imagine that these will be seen as recommendations and that state medical societies, boards of healing arts, legislators, will not jump all over this,” said Myra Christopher, of the Center for Practical Bioethics.

"This is a ridiculous recommendation from my perspective. Very low quality of evidence, yet a strong recommendation. How do you possibly do that?” asked Richard Ricciardi, PhD, of the Agency for Healthcare Research and Quality.

“I would be remiss and I’m certain so would many of my government colleagues if I didn’t go back to my director and say there’s a report coming out of the CDC that has very low quality of evidence and there’s a strong recommendation. That’s an embarrassment to the government.”

The CDC’s own briefing papers make clear that the agency’s ultimate goal is for the guidelines to be widely adopted.

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings,” the agency says in documents obtained by Pain News Network.  “CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.”

Even though the guidelines may be several months away from being finalized, Congress last week passed and President Obama signed into law a federal spending bill that requires the Veterans Administration to adopt the CDC’s guidelines as official policy when VA doctors treat veterans suffering from chronic pain.

VA to Adopt CDC Opioid Guidelines

By Pat Anson, Editor

The massive $1.1 trillion spending bill passed by Congress and signed into law by President Obama last week contains an early Christmas present for the nation’s veterans.

Or it could be a lump of coal -- depending on your view about opioid pain medication.

Buried in the 2,009 page document is a provision requiring the Veteran’s Administration to implement a number of measures to stop the “overdose epidemic” among veterans, including adoption of the controversial opioid prescribing guidelines being developed by the Centers for Disease Control and Prevention (CDC).

Those guidelines, which discourage primary care physicians from prescribing opioids for chronic pain, have now become official government policy at a federal agency before they’re even finalized. 

“To address mounting concerns about prescription drug abuse and an overdose epidemic among veterans, the bill directs VA to adopt the opioid prescribing guidelines developed by the Centers of Disease Control; to develop IT systems to track and monitor opioid prescriptions; to ensure all VA medical facilities are equipped with opioid receptor antagonists to treat drug overdoses; and to provide additional training to medical personnel who prescribe controlled substances,” Sen. Barbara Mikulski (D-Maryland), Vice Chairwoman of the Senate Appropriations Committee, said in a summary of the omnibus bill sent to colleagues.

The VA was also instructed to report to Congress within 90 days on alternative treatments to opioids, as well as “how VA can better facilitate the use of safe and effective complementary and integrative health therapies for pain management.”  

The CDC, which recently delayed implementation of the opioid guidelines after widespread criticism from patients and advocacy groups, has repeatedly said the guidelines are “voluntary” and not intended for anyone other than primary care physicians.

But adoption of the guidelines by a federal agency that provides health care services to over 6 million patients is an early sign they will have a much broader impact, voluntary or not. Critics have warned that state regulators, licensing boards and professional medical societies could also adopt the CDC's guidelines, which would likely have a chilling effect on all doctors who prescribe opioids.

"This is disturbing. It doesn't help solve the opioid problem by codifying low evidence or no evidence recommendations," said Lynn Webster, MD, past president of the American Academy of Pain Medicine.

"The opioid crisis is serious, requiring thoughtful interventions that are evidence based.  There are many evidence based recommendations that could be promulgated but have been ignored.  I am very concerned that the soldiers who have sacrificed so much are not going to receive the treatment they deserve."

According to an Inspector General’s study, more than half of the veterans being treated at the VA experience chronic pain, as well as other conditions that contribute to it, such as post-traumatic stress disorder. Because veterans are at high risk of opioid abuse and overdose, the VA implemented the Opioid Safety Initiative in 2013 to discourage its doctors from prescribing the drugs. The number of veterans prescribed opioids fell by 110,000, but alarms were raised when some vets turned to street drugs or suicide to stop their pain.

"Veterans are now required to see a prescriber every 30 days, but at the El Paso VA, they are unable to get an appointment, so they go without, or they do something they shouldn't — they buy them on the street," Rep. Beto O'Rourke, (D-Texas), told Military Times. “At a minimum, these veterans are suffering and in some cases, I would connect that suffering to suicide."

Several veterans have written to Pain News Network recently about their difficulty obtaining opioids from the VA for their chronic pain.

“The VA will only prescribe 10 mg oxycodone 3 times a day. This gives me no relief at all and now I'm very worried about what may come next,” wrote an Army veteran with diabetic nerve pain who had a toe amputated. “When I asked to have this increased my VA PC (primary care) doc raised my gabapentin script and says if that doesn't work for my increased pain levels we may try Lyrica next . He ignores my statement that 15 mg of Oxy works in reducing my pain by 30%”

“After taking opiate pain meds for nearly 15 years, the VA has now decided to take them away. I had a decent life while on these, and now they have cut them in half, I am in constant pain. I wish some of these people that make these stupid decisions had to live like I do,” a Vietnam veteran who had a leg amputated above the knee wrote to PNN.

“The pain meds allowed me to have some semblance of a normal life. Now that is gone. I don't know what I am going to do. I can understand now why vets turn to alcohol and other street drugs, because you have to do something to take the edge off this constant pain. But do they care? Not one whit. They practically throw this stuff at you when I first started going, now it is up to me to figure out how I am going to make it without any of it.”

The federal spending bill provides $7.2 billion in funding for the CDC, which is $278 million more than last year.  That includes $70 million to support state efforts to address prescription opioid abuse – more than triple the amount included in last year’s bill. 

The bill also provides $3.8 billion to the Substance Abuse and Mental Health Services Administration (SAMHSA), which is $160 million more than last year.  Nearly $50 million is directed to address the “epidemic” of prescription drug and heroin overdose, $25 million is for addiction treatment in high-risk states, $12 million for naloxone distribution in 10 states; and $10 million for drug abuse prevention efforts in up to 20 states.

A Pained Life: Time for a New Direction

By Carol Levy, Columnist

I keep reading comments and articles from those who live with chronic pain, or care for a pain sufferer, decrying the lack of treatment for chronic pain, and what is going on in the academic and regulating communities regarding opioid prescriptions.

It seems to me there is a major component missing: the term “chronic pain,” even if it is a disease unto itself, is a disputed theory and possibly a term in search of a meaning.

I am not a doctor or medical person. I am merely someone who has lived for decades with chronic disabling pain.

Some surgery worked, but most did not. Medications, including opioids, worked somewhat, slightly, or not at all. One reaction to the drug that worked best, a precipitous rise in my white blood count, was so potentially harmful I was told never, ever to take it again. So where does that leave me?

Where does that leave any of us when all the various medications do not work or we are unable to take them?

More importantly, where does it leave the pharmaceutical industry, particularly in terms of research and development?

Why do we keep seeing newer forms of opioids at the same time they are being denounced as evil and the cause of the "painkiller epidemic"?

Why condemn opioids when it appears no other drugs, with different forms of action against pain, are being created or brought to market?

There are drugs for the various miseries that cause pain, such as multiple sclerosis, lupus, trigeminal neuralgia, rheumatoid arthritis and so on. The one commonality is they all cause chronic pain, but the pain is not a common ancestor, if you will, that links them altogether.

So why should all of us benefit from one specific drug?

Is there ongoing research to try and isolate a pathway, a chemical release, or a biological, neurological, and anatomical mechanism that may be specific to all the disorders that cause chronic pain? I don't know. I do know that if there was, I’ve never heard about it.

Craziness is defined as doing the same thing over and over again and expecting a different result.

We keep banging our heads against a wall, crying out: stop regulating, stop calling us addicts, stop saying that opioids are crutches and of no real help.

I think it would help our cause much more if we did not focus on opioids or the problems we have getting prescriptions written and filled.

Instead, I think we need to redirect our energies and demand that research be devoted to finding non-narcotic pain relievers that have the same level of benefit that many opioids offer in reducing the pain.

Opioids cannot be the only answer.

Our voices are ignored when many of us say we hate the feeling of being narcotized. We need and want drug options that do not leave us feeling cloudy, cotton mouthed, and detached.

Only the pharmaceutical industry can change this. I believe that is where we need to direct our energies.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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.

Illegal Fentanyl Major Cause of Rising Overdose Deaths

By Pat Anson, Editor

Drug overdose deaths in the United States rose by 6.5% last year, in large part fueled by the increasing use of illicit fentanyl in many parts of the country. Over 47,000 poisoning deaths were reported in 2014, according to a new report from the Centers for Disease Control and Prevention (CDC).

After declining in the two year previous years, the CDC said there was a 9% increase in the number of deaths involving opioids. In 2014, opioids were "involved" in 28,647 deaths, or nearly two-thirds of all overdoses.

The agency admits, however, that some deaths may have been misclassified and some of the data is suspect. For example, if a doctor or medical examiner reports that an opioid was found in someone’s system after they die, the agency considers the death “opioid related” whether the drug was used medically or non-medically. Overdose deaths from specific drugs identified on death certificates also vary widely from state to state, an indication some of the data may not be reliable.

The statistics are further muddied by the fact that legal and some illegal opioids are lumped together in the same category.

“Historically, CDC has programmatically characterized all opioid pain reliever deaths (natural and semi-synthetic opioids, methadone, and other synthetic opioids) as 'prescription' opioid overdoses,” the agency acknowledged in its report.

The largest increase in the rate of drug overdose deaths involved synthetic opioids, primarily fentanyl and tramadol, which nearly doubled from 1.0 deaths per 100,000 to 1.8 per 100,000.

Tramadol is a weaker acting opioid that many doctors began prescribing for pain after hydrocodone was reclassified as a Schedule II medication in 2014, making it harder for many patients to obtain hydrocodone. The number of tramadol prescriptions dispensed in the U.S. has nearly doubled since 2010, coinciding with a decline in hydrocodone prescriptions.

Fentanyl, which is also classified as a Schedule II controlled substance, is a powerful painkiller that is increasingly being abused by addicts. Drug dealers are lacing heroin with fentanyl to make it more potent, while others are cutting up fentanyl patches so they can smoked or ingested.  Earlier this year, the Drug Enforcement Administration issued a nationwide alert about the abuse, diversion and illegal manufacture of fentanyl.

Thousands of people have died from fentanyl overdoses in the U.S. and Canada, but because of the nature of the drug it’s impossible to tell whether it was prescribed legally and used for medical reasons or manufactured illegally and used recreationally.  

“Toxicology tests used by coroners and medical examiners are unable to distinguish between prescription and illicit fentanyl,” the CDC report said. “Based on reports from states and drug seizure data, however, a substantial portion of the increase in synthetic opioid deaths appears to be related to increased availability of illicit fentanyl, although this cannot be confirmed with mortality data. For example, five jurisdictions (Florida, Maryland, Maine, Ohio, and Philadelphia, Pennsylvania) that reported sharp increases in illicit fentanyl seizures, and screened persons who died from a suspected drug overdose for fentanyl, detected similarly sharp increases in fentanyl-related deaths.”

The agency also admits that some heroin deaths might be misclassified as morphine, a prescription drug, because morphine and heroin are metabolized similarly. That might contribute to an underreporting of heroin overdose deaths.

"The increasing number of deaths from opioid overdose is alarming," said CDC Director Tom Frieden, MD. "The opioid epidemic is devastating American families and communities. To curb these trends and save lives, we must help prevent addiction and provide support and treatment to those who suffer from opioid use disorders. This report also shows how important it is that law enforcement intensify efforts to reduce the availability of heroin, illegal fentanyl, and other illegal opioids."

Frieden also used the overdose study to lobby for his agency’s much criticized effort to enact new guidelines for opioid prescribing. Frieden told the Associated Press that Americans were “primed” for heroin use because of their exposure to opioid pain medications.

"We want to make sure we don't go so fast that there are questions about our process, but we certainly don't want to see any further delay," Frieden said, explaining a recent decision to delay implementing the guidelines and seek more public input.

"But there is no way we can wait for better evidence while so many people are dying," he said.

How to Survive the Holidays Without Burning Out

By Elizabeth Katherine, Guest Columnist

My husband and I are very social and we love just about any reason to get the people we love together in a room, and the holiday season is great for that. But it can also be really hectic.

The thing I hear more than anything else this time of year is “I have so much to do.” As a chronic pain sufferer, I know daily life can be overwhelming, and when you throw in all the extras of the holiday season it can get real sticky real quick.

As a mom of three kids and an exceptionally busy husband, I often take on the household responsibilities as well as the additional tasks of holiday prep.

When my pain got to be an all-day everyday thing, I was heartbroken at the thought that these kinds of events wouldn’t be able to happen anymore, or that I wouldn’t be able to produce the kind of holiday that my kids were used to and I was used to.

Pelvic Congestion Syndrome causes me to have constant pain in my pelvis as well as my low back that gets worse the longer I am upright. As I have gotten to know my body and my limitations, I have been able to tailor the way I navigate the holiday season without burning myself out too much. I’d like to share some of my ideas with you all.  

The biggest piece of advice I can give you is to start with lists. Lists are the best thing that ever happened to those of us with brain fog and fatigue. Make a list of all the things you’d like to have done in order to prepare for the holidays. Create gift lists that layout who you’re buying for, and what’d you like to get them.

You can also avoid having to run out for that extra carton of eggs by making a list of the things you’d like to make for holiday meals and the ingredients you will need to make them.

Once you’ve laid out the what, it’s time to plan out the when. This is huge for us Spoonies because we have limited resources when it comes to getting things done. Sit down with your calendar and look at when you have free time. Schedule time to do your baking, household decorating, any parties you’d like to attend, and of course, time for gifts.

Make sure to schedule your rest time too. If you schedule in a 1-2 hour shopping trip, be sure that you also schedule yourself for some time on the couch or a movie afterwards.

Gifts are one of the biggest time sucks this time of year for anyone, but for those of us in the pain community it’s even worse because it involves so much shopping. If you haven’t yet, become familiar with online shopping, consider a membership to websites that offer discounts and free shipping such as Amazon Prime or Overstock.com. Utilizing this will cut down on the amount of time you need to spend out, plus, it’s a nice way to feel productive when you’re stuck on the couch.

If you enjoy the activity of shopping like I do, make sure you schedule a few different trips for that as well. Instead of running from one store to the next, map your plan out ahead of time. Make a list of the things you know you can get at each store you want to go to so you don’t waste your energy bouncing all around for one or two items. Consider pre-shopping online to see what colors and sizes the stores you are going to have in stock so you’re not disappointed when you get there.

Once you’ve got your gifts, you can use some of your resting time to wrap them. If you need help with this project, make it a social activity and invite a friend over to help with tape or scissors. This is also a good way to get any holiday crafting or homemade gifts done. Just don’t invite the person you’re making the gifts for!

Another way to get your to-do list done for the holidays is to delegate like a champ. Ask your spouse to move the decorations out from storage, and put the kids to work decorating the tree. You can curl up on your couch and watch it all while sipping hot cocoa and still feel involved. Or, if you prefer to do it all yourself, break it up into small bursts so that you don’t get too drained doing it all in one sitting.

My last piece of advice is to remember the reason for the season. It’s easy to get caught up in the craziness of it all, and even more so to look at all the things you can no longer do and feel frustrated.

At the core of it all, the holidays are about spending time with loved ones, and the intentions behind your choices are what matter the most. The people who love you aren’t going to care if you didn’t bring fruit cake to the party, even though it was your turn. The people you spend your time with during the holidays are the people who love you, chronic illness and all.

Elizabeth Katherine lives in Minnesota with her family. She writes about Pelvic Pain Syndrome and other topics on her blog, These Next 6 Months.

Elizabeth also enjoys the Facebook support group Spoonies for Life.

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.

Decline in Teen Opioid Abuse Continues

By Pat Anson, Editor

An annual survey that tracks teenage drug abuse continues to show a decline in the misuse of prescription opioid pain relievers, as well as heroin, alcohol, cigarettes, amphetamines and other substances.

The University of Michigan's Monitoring the Future Study (MTF) has tracked drug abuse among 8th, 10th, and 12th graders since 1975. This year’s survey included nearly 45,000 students at 382 public and private schools in the United States.

The MTF survey tracked the steady rise in teenage abuse of prescription opioids in the 1990's, before the trend reversed itself in the last decade. For the fifth year in a row, the survey found there was a significant decline in the misuse of opioids by teens (reported in the survey as “Narcotics Other Than Heroin”).

About 5% of 12th graders reported using an opioid pain medication in the last year, including 4.4% who used Vicodin and 3.7% who used OxyContin.

The number of teens reporting that prescription opioids were “fairly easy” or “very easy” to get also continues to drop.

Most teens abusing prescription opioids reported getting them from friends or family members. About one-third reported getting them from their own prescriptions.

"The recent declines in the abuse of prescription pain medicines among teens are encouraging. The Partnership has been working for quite some time through both our Above the Influence program and the Medicine Abuse Project to help educate teens, parents and communities about the risks of medicine abuse and we are glad to see continued progress," said Marcia Lee Taylor, President and CEO of the Partnership for Drug-Free Kids.

“While today's news about substance use among teens is mostly positive, we cannot let that take our focus off of the prescription drug and heroin crisis among other age groups.”

Despite widespread media reports about the so-called heroin “epidemic” in adults – heroin use among teens is at its lowest level since the MTF survey began. Past year use of heroin fell to 0.5% of 12th graders, an all-time low.

Use of several other illicit drugs – including MDMA (known as Ecstasy or Molly), amphetamines and synthetic marijuana – also showed a noted decline in this year's data. Use of alcohol and cigarettes reached their lowest points since the study began.

Marijuana, the most widely used illicit drug, did not show any significant change. After rising for several years, teenage marijuana use has leveled out since 2010, but still remains stubbornly high. In 2015, 12% of 8th ­graders, 25% of 10th­ graders and 35% of 12th­ graders reported using marijuana at least once in the past year. For the first time ever, daily marijuana use exceeds daily tobacco use among 12th graders.

"We are heartened to see that most illicit drug use is not increasing, non-medical use of prescription opioids is decreasing, and there is improvement in alcohol and cigarette use rates," said Nora D. Volkow, M.D., director of the National Institute of Drug Abuse, which funded the MTF survey.

"However, continued areas of concern are the high rate of daily marijuana smoking seen among high school students, because of marijuana’s potential deleterious effects on the developing brains of teenagers, and the high rates of overall tobacco products and nicotine containing e-cigarettes usage."

One growing area of concern is the abuse of Adderall and other prescription amphetamines, which are typically used to treat Attention Deficit Disorder (ADHD) but are widely perceived as a study aid.  About 7.5% of 12th graders used those drugs in the past year.

Wear, Tear & Care: The ActiPatch

By Jennifer Kain Kilgore, Columnist

Loyal readers, I have returned.

It’s been a tumultuous month of bad days and flares, so while I was absent from my writing duties, I was trying out a hodgepodge of products designed to offer pain relief.

Naturally, none of them worked. Let’s discuss.

A while ago it was suggested that I try the ActiPatch. I was originally introduced to this new form of pain product by Lil’ Bub, the celebrity cat.

I should probably explain that.

Lil’ Bub, full name Lillian Bubbles, is a perma-kitten, meaning that she will retain her kitten-like characteristics for her entire lifespan.

She also has an extreme case of dwarfism and a rare bone condition called osteopetrosis (the only cat in recorded history to have it), which causes her bones to become incredibly dense as she grows older. This causes pain and difficulty when she tries to go from Point A to Point B.

Her person, called the Dude (like Jeff Bridges in “The Big Lebowski”), discovered the Assisi Loop, which is designed to treat pain and inflammation in pets. The device uses targeted PEMF technology (or pulsed electromagnetic fields) to induce healing within the area of the plastic “loop.”

IMAGE COURTESY LILBUB.COM

Before starting her treatment, Lil’ Bub was becoming stiffer and less mobile.  But two years of therapy later, she's running, jumping, and acting like any other cat.

Fast forward to the present day and the explanation as to why I am talking about a cat. ActiPatch is the version of this for humans. I received a letter and package from the president of BioElectronics that contained a thick wad of research and loops for my back, knees, and muscles/joints. I tossed the ones aimed for knees to my husband and kept the rest for myself. Because I’m selfish.

The ActiPatch loops manipulate the body by means of electrical signals, much like TENS devices. The field created within the loop “induces an electrical field in the target tissue,” as  Andrew Whelan stated in his letter to me. These fields affect nerve fibers and cellular function by increasing blood flow and decreasing inflammation, thereby reducing pain.

Additionally, as Mr. Whelan said, the field is “periodically amplified by the background energy within the target tissue, a process called stochastic resonance.” This is when unpredictable fluctuations, or “random energy,” cause an increase in the signal transmission.

During their “Try and Tell” rollout campaign in the U.K. and Ireland, more than 5,000 responded to a survey of trial devices that were sent to interested individuals for only the cost of postage. The company claims there was a “consistent response” of 52 percent reporting sustained pain relief.

Back in my world, I encountered a few problems when trying out the ActiPatch. My pain, as I have mentioned before, is both widespread and diffuse. There are specific areas of genesis, but the pain is by no means contained to just my spine. I have injuries to my cervical, thoracic, and lumbar spine, but the sections with the “loudest” pain tend to be my shoulders, the sides of my neck, my ribs, and my low back. These loops, which are only about the size of a small plate, could not possibly reach all these spots. I’d look like a rubber band ball.

During my trial run, I decided to place the loops both in the “genesis areas” (IE, over my spine directly) and on my shoulder blades. Getting the loop to fit over the curve of my trapezius muscles was difficult. The loops came with a box of Band-Aid-like stickers to hold the loops in place, and I made quite the mess attaching all of them to my skin. Once the loops are placed, however, you simply press a button on the little magnet, a green light comes on, and off you go.

I pulled my shirt on over everything and encountered another issue: the green lights of the loop batteries showed through my shirt, as did the loops themselves. I looked like an undercover informant with poorly-hidden wires. The mafia would surely figure me for a rat. The solution: many layers!

The day I chose for my test run was a normal weekend day. I hadn’t planned anything strenuous and no activities were going to be out of the ordinary. I didn’t wear my Quell, and I also left off the roll-on Stopain that I usually slather on every day. I wanted a day where I could control the variables in order to test the efficacy of the device. My husband and I ran our weekend errands and then decided to take a short walk out in nature. 

My first observation: I did not feel anything from the devices themselves. Others who have used the ActiPatch have told me they felt the sensation of heat within the area of the loops. I didn’t feel anything. I have decreased sensitivity in many areas of my body anyway, so that was not surprising. Additionally, the ActiPatch website states that there will be no sensations.

My second observation: The areas outside of the loops hurt more than normal. I don’t know how good the devices are at affecting areas other than what is in the confine of the loop. The space within those circles felt like a black hole, which is better than pain. While something was definitely going on in the loops -- when I took them off at the end of the day, those areas were red, appearing almost sunburned -- I don’t feel like it helped my widespread pain to any significant degree.

My third observation: I ended up crashing far earlier than normal. By early afternoon I was in my recliner and taking heavier medication.

My hypothesis: The ActiPatch device is probably great for somebody with an injury that is clearly restricted to a certain area. For instance, my husband hurt his knee while running. The loop would be able to focus on that since the pain does not radiate out all over the body.

For somebody like me (an anthropomorphic bruised banana), the loops are far too small. I would need a hula-hoop-sized device in order to make a dent in my daily pain.

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.

New Blood Test Predicts Early Rheumatoid Arthritis Risk

By Pat Anson, Editor

British researchers are developing a new blood test that could predict the likelihood of developing rheumatoid arthritis (RA) up to 16 years before the onset of symptoms. Such a test would substantially increase the early detection of RA and make treatment more effective.

Rheumatoid arthritis is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing pain, inflammation and bone erosion.

Researchers at the Kennedy Institute of Rheumatology at Oxford University developed a blood test that looks for antibodies in a protein called citrullinated tenascin-C (cTNC), which is often found in high levels in the joints of people with RA.  

In a study of over 2,000 patients, the blood test diagnosed RA in about 50% of cases. The test also had a very low rate of false positives.

"What is particularly exciting is that when we looked at samples taken from people before their arthritis began, we could see these antibodies to cTNC up to 16 years before the disease occurred – on average the antibodies could be found seven years before the disease appeared,” said Professor Kim Midwood of the Kennedy Institute.

"This discovery therefore gives us an additional test that can be used to increase the accuracy of the CCP assay and that can predict rheumatoid arthritis, enabling us to monitor people and spot the disease early. This early detection is key because early treatment is more effective."

Early RA treatment focuses on suppressing the immune system to reduce inflammation and slow progression of the disease.

"Early diagnosis is key, with research showing that there's often a narrow window of opportunity following the onset of symptoms for effective diagnosis and control of disease through treatment. Furthermore, current tests for rheumatoid arthritis are limited in their ability to diagnose disease in different patients,” said Stephen Simpson, director of research at Arthritis Research UK, which funded the study.

"This could have great potential to help patients with rheumatoid arthritis get the right treatment early to keep this painful and debilitating condition under control."

A similar diagnostic blood test for RA is already on the market in the United States, Canada, Europe, Japan and Australia. The JOINTstat test looks for another protein called 14-3-3η. A recent study of 149 RA patients in Japan found that serum 14-3-3η levels can predict disease severity and clinical outcomes. Drugs that reduce 14--3-3η levels can delay the onset and severity of RA, and increase the chances of remission.

About 1.5 million Americans and 1% of adults worldwide suffer from RA.

CDC Relying on Same Experts for Opioid Guidelines

By Pat Anson, Editor

The Centers for Disease Control and Prevention (CDC) will continue to rely on the same panel of experts to advise the agency about its opioid prescribing guidelines – even though some of the experts are allegedly biased and have conflicts of interest.

The CDC announced last week that it would review and delay implementing the controversial guidelines, after they drew widespread criticism from pain patients, advocacy groups, and medical societies. On Monday the agency also began accepting new public comments on the guidelines, which discourage primary care physicians from prescribing opioids for chronic pain.

The review of the guidelines will be conducted by the Board of Scientific Counselors (BSC) for the CDC’s National Center for Injury Prevention and Control. The CDC is developing the guidelines to combat what has been called an "epidemic" of prescription drug abuse, addiction and overdoses. As many as 11 million Americans use opioids for long-term chronic pain.

“We will be asking the BSC, the members of which represent expertise along the spectrum of injury and violence issue areas, to approve formation of a workgroup to review the draft guideline and comments received on the guideline, and present recommendations about the guideline to the BSC,” said Leslie Dorigo, a CDC spokesperson.

“Our intent is for the workgroup to be comprised of members of the original Core Expert Group, members of the BSC, and individuals who represent the perspectives of patients living with chronic pain and who have additional pain medicine expertise.”

The “Core Expert Group” has 17 members and is composed primarily of public health researchers and state regulators. At least two of its members have drawn the ire of critics who say they shouldn’t serve on the panel.

Jane Ballantyne, MD, and Gary Franklin, MD, are the President and Vice-President, respectively, of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which runs a chain of addiction treatment centers. Three other board members of PROP will also continue to advise the CDC in their roles as stakeholders and peer reviewers, according to Dorigo.

“For the life of me, I can’t understand why CDC insists on retaining such obvious bias on their panel, as it flies in the face of their scientific integrity,” said Jeffrey Fudin, a pharmacist and founder of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT).

“I find it hard to believe that CDC can’t find a single qualified physician to speak against opioids that is free from potential conflict.  With all that has been drudged up in the professional literature and lay press regarding potential or postulated physician conflicts, CDC’s behavior is nothing less than reverse discrimination.”

Ballantyne and Franklin, who have been vocal critics of opioid prescribing, played key roles in the development of opioid regulations in Washington State, which has some of the toughest prescribing laws in the nation.

dr. jane ballantyne

Ballantyne recently come under fire for co-authoring an article in the New England Journal of Medicine that said reducing pain intensity should not be the goal of doctors that treat chronic pain. That caused a prominent pain physician to call on Ballantyne to resign or be fired from her academic position at the University of Washington School of Medicine.

“To suggest that physicians should no longer treat pain intensity and let patients suffer goes beyond any sort of decency or concern for humanity,” said Forest Tennant, MD, who has treated pain patients for over 40 years.

Ballantyne’s ties to the pharmaceutical industry have also drawn attention. She has served as a paid consultant to Cohen Milstein Sellers & Toll, a law firm that specializes in antitrust litigation, including lawsuits against pharmaceutical companies over their marketing of opioids.

“I do have difficulty with someone like Ms. Ballantyne in particular because, quite apart from PROP, she appears to have a very strong conflict of interest and is on the payroll of plaintiff’s attorneys who have a lot of money to be made by suing manufacturers,” said Richard Samp, chief counsel for the pro-business Washington Legal Foundation, which has threatened to sue the CDC over its alleged violations of a federal open meetings law while drafting the guidelines.

“They have a strong interest in making sure that the CDC is critical of current prescribing practices, because that would strengthen their current lawsuits. For that reason, I can’t see how somebody who is on the payroll of plaintiff’s law firms is an appropriate person to be on the committee,” Samp told Pain News Network.  

Ballanytne could not be reached for comment.

“CDC takes conflict of interest seriously, and worked to eliminate or minimize sources of bias of the experts involved in the guideline development and peer review,” said the CDC’s Dorigo. “Our Core Expert Group was composed of a diverse group of subject matter experts—with substantial knowledge on several aspects of opioid prescribing. The group includes primary care professional society representatives, state agency representatives, an expert in guideline development methodology, and other subject experts.”

Dorigo said the CDC plans to add pain patients and pain management physicians to the new workgroup, but had not determined how many. The agency will hold a public conference call on January 7th to get input from the public on the composition of the panel. The workgroup will present its recommendations to the BSC in a public hearing at an undetermined date.

The Washington Legal Foundation’s chief counsel called that a “step in the right direction,” but emphasized that any deliberations of the workgroup need to be held publicly or it would be a violation of federal law. The Core Expert Group never met publicly.

“The problem was that this group met in secret and the materials submitted to that group were not made publicly available and the deliberations of that group and the materials they produced were never made public,” Samp said.

Fudin believes the CDC needs to start from scratch and appoint a completely new set of experts to advise it.

"In order to regain whatever shred of credibility CDC has left with pain clinicians, a new board should consist of all new members and include board certified pain clinicians that have active current practices with a focus on pain therapeutics in non-cancer pain.  In addition, it requires experts in public health, a psychiatrist, psychologist, and legal counsel with expertise in pain, plus matched expertise in addiction medicine,” Fudin said.

“We are happy to see that the CDC has asked its Board of Scientific Counselors to impanel a committee including additional members, which it should have done in the beginning,” said Bob Twillman, Executive Director of the American Academy of Pain Management.

“We hope the new members will be representative of the pain community, including both clinicians and people with pain, and that their contributions to the committee process will be weighed equally with the opinions of the existing group. We’re a little concerned because all of this is taking place in yet another opaque process, but we have little choice but to trust the CDC to get it right this time.”

The CDC’s public comment period on the guidelines continues until January 13th. You can make a comment by clicking here. 

The proposed prescribing guidelines and the reasoning behind them can be found in a 56-page report you can see by clicking here.

5 Lessons About Finding a ‘New Normal’

By Pat Akerberg, Columnist

Once chronic pain and/or illness invade your life, any sense of normal that you once knew is shattered.

“Normal” implies that there’s some accepted standard or pattern that equals a widely adopted way of living or being.  It’s a consensus reality considered culturally acceptable or reliable.

Good health is one often taken-for-granted aspect of normal.  But what if your medical circumstances become anything but normal overnight? When that happened to me, I resembled a nomad who lost her way. I set out on a search for my next acceptable, reliable state.      

Feeling suddenly disenfranchised, without hope and alone, I longed for where I might fit again.  No wonder it was an appealing elixir to read books and articles that suggested a “new normal,” a reliable replacement for my previous one, could be found.   

How many of us have spent untold energy (that we pay for later) trying to find, construct, and mimic something resembling another version of normal when our lives fell apart?

It took me years, a lot of effort, and self doubt before I finally realized that the concept of “new normal” didn’t apply for me. 

After losing my health, a hazy cloud of guilt and embarrassment lingered over my perceived failure to meet others and my own expectations of normal. I was already questioning how a neurological disorder (trigeminal neuralgia) could run a swath of career and personal destruction through the middle of my life in record time.    

Family and friends kept slowly nudging me to get to a more predictable state.  Because I looked okay, they couldn’t appreciate my inability to keep plans on any given day.  Or understand why a multitude of doctor appointments, medications, or brain surgery didn’t make me “get better.”

Unless you live with a chronic illness or debilitating pain, it’s hard to fathom that they trump plans at will. 

Why couldn’t I find the place that the books/articles talked about?

Because pain has a life of its own that dictates yours despite your good intentions.

I finally let go of the unrealistic expectations swirling around me, realizing that constant change laughs in the face of pat answers that pose to corral it!

The kind of life altering changes that happened when I became medically compromised explain why chasing a “new normal” isn’t the journey its’ cracked up to be.

We know that change is a process that involves opportunity and stress (crisis) – even if the change involved is chosen, like changing jobs, buying a new house, changing a hairstyle, or dieting.  These kinds of changes are happening in your life and don’t really alter your life as a whole.  They are small, easy to digest changes.

Then there are the kinds of unfortunate changes that can happen to your life that carry more gravity.  They alter your life altogether.  Some can be temporary, like a divorce or job loss. Others, like losing a loved one, physical impairments, disabilities, or scary medical diagnoses that involve painful, progressive, or rare disorders transform your life overnight.

The very option of fitting into “normality” or consensus reality is taken away when those happen, despite our best efforts.  That’s a bell that rang true for me.

Sometimes ideas about finding a reliable substitute for normal can be motivational, if they’re realistic. But there are other times when expectations can set us out on a journey that disappoints if we’re not careful.  Elusive expectations can carry the potential to set you up for an emotional roller coaster ride.

Just because someone wrote about a concept doesn’t make it applicable or possible for all.  In some cases, expecting to find some steady state that’s reliable or trustworthy enough to call your “new normal” isn’t realistic.

If your condition is anything like mine, one that is progressive and creates other complications, continuous functional losses, or involves treatments that carry further risk, chasing some steady state becomes counterproductive.

What’s realistic instead is recognizing the state of constant change before you.  It’s an overwhelming kind of chaos. That means what’s predictable for me now is that my pain decides everything, not me.

I came to realize that the best way forward for me was to stop expecting myself to find and conform to the self help version of a “new normal” as the answer to feeling displaced. 

Here are five lessons I’ve learned about chasing normal and acceptance:

1)  When your circumstances are ever changing, your responses will too.  It’s all situational.

2)  Changes that happen to our lives present much tougher challenges, such as coming to grips with irreplaceable   losses. 

3)  Letting go of unrealistic expectations can be freeing when the circumstances impacting your health are constantly progressing or shifting.

4)  A "new normal" needs to to match the realities of living with chronic pain/illness.  Change is the constant, predictable steady state.

5) Chasing normal means going beyond the touted answers that we strive to pursue (equanimity, acceptance, letting go, etc.) and redefining them to fit our fluid situations. 

That’s a realistic journey that can deliver.

I know now that expecting my condition to fit into a predictable state won’t help me. Try as I might, chasing some concept of normal everyday while trying to fit in is truly out of my control, just like the weather.

Yet knowing that the weather always changes is something that can be counted on. And that’s a tried and true pattern that I can fit into.   That’s acceptance.

Pat Akerberg suffers from trigeminal neuralgia. 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.

CDC Made Few Changes in Opioid Guidelines

By Pat Anson, Editor

The Centers for Disease Control Prevention (CDC) has made few changes in its draft guidelines for opioid prescribing, three months after they were widely criticized by pain patients and healthcare providers.

The agency still maintains that “non-pharmacological therapy” and non-opioid pain relievers are the “preferred” treatments for chronic pain, while admitting there is little evidence to support many of its recommendations. The guidelines also fail to address other issues, such as the lack of insurance coverage for many of the treatments the CDC advocates.

The proposed guidelines for primary care physicians were publicly released for the first time today as the CDC opened a 30-day public comment period on them. You can make a comment by clicking here.

The dozen guidelines can be found in a 56-page report, along with the reasoning behind them. You can see the report by clicking here.

“This guideline provides recommendations that are based on the best available evidence that was interpreted and informed by expert opinion. The clinical scientific evidence informing the recommendations is low in quality,” the report states.

“To inform future guideline development, more research is necessary to fill in critical evidence gaps. The evidence reviews forming the basis of this guideline clearly illustrate that there is much yet to be learned about the effectiveness, safety, and economic efficiency of long-term opioid therapy.”

The CDC was roundly criticized for the way it prepared and handled the initial release of the guidelines in September to a select online audience.  The agency never made the guidelines available on its website or in any public form outside of the webinar, and only a 48-hour public comment period was allowed afterwards. The CDC also came under fire for secretly consulting with “experts” that included special interest groups and addiction treatment specialists, but few pain patients or pain physicians.

After getting feedback from critics, the CDC said it would make changes in its recommendations, but only a few changes can be found in the dozen guidelines released today:

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks to the patient.

2. Before starting opioid therapy for chronic pain, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should not initiate opioid therapy without consideration of how therapy will be discontinued if unsuccessful. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.  

3. Before starting and periodically during opioid therapy, providers should discuss with patients known risks and realistic benefits of opioid therapy and patient and provider responsibilities for managing therapy.

4. When starting opioid therapy for chronic pain, providers should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids.

5. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should generally avoid increasing dosage to ≥90 MME/ day

6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three or fewer days usually will be sufficient for most nontraumatic pain not related to major surgery.

7. Providers should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Providers should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, providers should work with patients to reduce opioid dosage and to discontinue opioids.

8. Before starting and periodically during continuation of opioid therapy, providers should evaluate risk factors for opioid-related harms. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, or higher opioid dosages (≥50 MME), are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving high opioid dosages or dangerous combinations that put him or her at high risk for overdose. Providers should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

10. When prescribing opioids for chronic pain, providers should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

11. Providers should avoid prescribing opioid pain medication for patients receiving benzodiazepines whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

Most of the dozen guidelines are strongly recommended by the CDC, even though the evidence used to support them was considered “limited” or there was “very limited confidence in the effect” of the recommendations.

Changes in Draft Guidelines

Some changes were made in guideline #5, which warns physicians to avoid giving patients high doses of opioids. The new guideline suggests that patients already taking high dosages “should be offered the opportunity to re-evaluate their continued use of opioids at high doses,” instead of having their medication abruptly changed to a lower dose.

However, no mention is made of a CYP450 genetic test, which can determine if a patient may need high doses of opioids.

“The CYP450 omission is disturbing since 20 percent of the population has some defect. How can you have a prescribing policy without CYP450 testing?” asked Gary Snook, a Montana man who needs extremely high doses of opioids to relieve pain from adhesive arachnoiditis. “It makes me wonder, are these doctors really qualified to put forth this draft that will have such an impact on so many that live in severe 24/7 pain? I think not!”

One significant change, in guideline #10, acknowledges that the results of urine drug tests are often wrong or misinterpreted. It recommends drug testing before opioid therapy begins and then annually, but random drug testing is discouraged. The guideline also recommends that providers not test for substances such as marijuana, which may not affect the efficacy of pain management.  

If there are “unexpected results” from a urine drug test, the guideline says patients should not be terminated from a doctor’s practice, but should be counseled or offered treatment for substance abuse.

Pain Patients Urged to Comment

“I feel it's critical that members of the pain community, or people whose loved ones suffer from chronic pain, to take this rare second chance to refer to each of the guidelines and make their feelings known,” said Kim Miller, a pain patient and advocate..

“I feel it's important to keep your feelings out of comments to official government entities. Professionals are more receptive to calm remarks.  There's no need to be inflammatory; other agencies, law firms, and numerous medical providers have already expressed their disappointment and disapproval of the previous draft guidelines.  At this point, sticking to the facts is all that's necessary.”

The CDC is emphasizing the revised guidelines are voluntary and “intended to improve communication” between doctors and their patients.

Debra Houry, MD, the CDC official who oversaw development of the guidelines, even put out a Tweet, saying, “Patients & providers should decide together how to best treat long-term chronic pain.”

But critics say the guidelines, when adopted, could quickly become a standard of practice for state medical boards and professional healthcare societies, giving physicians little choice but to comply with them.

“These ‘guidelines’ are not looked at merely as suggestions,” Miller said. “When the CDC suggests there's no need for concern, after all these are only guidelines, it couldn't be further from the truth.  The pain community must be sure to give these guidelines very serious consideration, your medical providers will be.”

After the public comment period ends, the CDC says the guidelines will be reviewed by a scientific advisory group, which will then appoint another working group to refine the guidelines further.  The agency has not released a timetable or said if outside consultants who helped draft the initial guidelines will still be part of the process.

The CDC was criticized for consulting with five board members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which runs a chain of addiction treatment centers. Critics say PROP has a conflict of interest when it advocates that pain patients be given greater access to addiction treatment.

My Life with Fibromyalgia: An Open Letter to CDC

(Editor’s Note: The Centers for Disease Control and Prevention today reopened for public comment its proposed guidelines for opioid prescribing. Comments, which will accepted until January 13, 2016,  can be made by clicking here.)

By Emma Christensen, Guest Columnist

The over-regulation of opioid medications is so very wrong for pain patients. To withdraw their access to opioid medications is reckless and punitive.

Having lived with fibromyalgia for over 15 years, searching for credible medical help and treatment has been one of the most trying experiences of my life.

One physician I sought help from was so at a loss for treating the pain I was experiencing that he put me on heavy doses of morphine. When I learned more about the medication he put me on, I began to question if I truly needed that much in order to live. 

When another physician told me I was very young to be on that high of a dosage, I searched and found literature that supported using a low dosage of morphine to take the edge off of the pain. This method of pain reduction was done in order to allow patients to function using additional alternative solutions such as Tai Chi exercise, foam rolling and trigger point therapy to help reduce significant amounts of their pain. Eventually, I tried these methods and was able to step down to the lowest dose (15mg) that is available for doctors to prescribe.

emma christensen

This low dosage worked well. I felt like I was improving and having the first bits of success in pain reduction that did not require a pill or large amounts medication.  It was just enough to take the edge off the pain. This allowed me to begin to move, exercise, and use other alternative methods of pain relief.  However, it was not possible to do this without the opioid cutting into that first layer of pain. 

I describe pain as an onion -- I had just begun to peel it.  I could not do this without relying upon the small amounts of morphine I was prescribed.

I hate the fact that I have to take this medication. I hate the fact that there is not a better solution. However, all things considered, would you rather pay for a person to be on disability and all that goes with that? Or would you rather have them remain functional and working at a job supporting themselves? I chose to be functional and working, thereby keeping my self-respect and dignity.

The day someone wants to walk a day in my shoes with this painful condition, is the day that they can tell me how my doctor and I can treat my condition.  The pain is unbearable, horrific, and relentless. If I stop any of the methods I use to fight it, it can revert to the levels it was at before I began fighting it; as if I had never done anything to fight it at all.

The low dose morphine has helped me stay functional and keep my job all these years. It takes the edge off of the horrific pain that comes with having fibromyalgia. If anything, I have been more responsible than you have, as the “monitors of society” that wish to deprive me of the one thing that allows me to remain functional.

For years, I have taken only a 15 mg dose and not more, as was originally prescribed. I am prescribed two pills a day for 30 days. I have the extra burden of having to pick up the prescription in person and to sign for it, for each refill. For me, this means I must take time off from work to get the script (if my doctor’s office is not open on Saturday morning). This is another burden.  How much more difficult do you want to make my life?  Why can’t a quarterly prescription be available for someone like me who has a history of appropriate medication usage?

I am frightened to go without the medication because my pain is real. It hurts, fibromyalgia hurts, and it brings me to tears. Just moving my arms and legs is excruciating due to the myofascial knots and inflamed fascia that I endure with this condition.

If you want to question my need for this medication, go nose to nose with me and tell me why. Tell me what other solution you suggest that is just as good and will do what I need it to do, so I can work and keep my job. I have been out there trying every solution I can find for the last 15 years.

If you think you can solve the pain, solve it! Let me or any other person who lives with chronic pain be the judge of your solution, not you. It is very obvious to those of us living in chronic pain that the CDC’s opioid guidelines are being made by people who do not experience chronic pain themselves!

If I had a choice, I would not use this medication. I would not take morphine if I did not need it. I am against using illegal drugs.  In my lifetime, I have worked in two police departments, was married to a cop, and my father-in-law was a chief of police. Additionally, I hold a Master’s degree in Public Administration. I know full well what the abuse of drugs does to families and society.

However, that doesn’t give you the right to tell me and my doctors how to treat my condition.

Blanket mandates of restriction, without credible analysis of the situation, is not a substantial enough reason to deny a class of people who are suffering and in pain their medication.  Proposed regulations should not only solve an administrative problem; but, enhance the medical profession and the support the pain patient simultaneously. Any proposals that do not measure up to this standard are beneath consideration for good practices and reasonable implementation by professional public administrators. 

Like any other crime, incidences of abuse and misuse must be regulated and substantiated in a court of law following the principles of due process. To do otherwise is punitive and unjust towards people who are innocent of such allegations.

There is another reason I felt inspired to write this open letter to the CDC.  It is my education that requires me to respond. If I do not respond and say something now while I have a chance, I could be responsible for my own loss if they take away my medication. 

We all have to stand firm to let the CDC administrators know that they cannot make decisions in a vacuum.  If we allow them to get away with this, then we are less of a democracy and more dictatorship run by administrators who do not know the negative effect that they are having on our society.  My degree is all about building a "good society." Arbitrary rules against pain patients are not the solution to this problem.  You cannot solve a law enforcement issue by doing the minimum of public administration.

If you want to help chronic pain patients, such as myself, put your energies into finding a cure for the pain patients that require these medications to cope with their daily lives; remove the barriers to treatment. You can have my medical case files; my treatments are an open book, as far as I am concerned. I have never misused my medications and do not ever plan to. Please stop persecuting those of us who are ill and find a better way to spend your time.  I am one voice, but I speak for many people who are in pain.

This open letter to the CDC is intended to invite, stimulate and encourage further discussion and commentary on this most important issue of pain management and law enforcement of illegal drugs.

Emma Christensen lives in Illinois. She was diagnosed with fibromyalgia in 2000 after a whiplash injury from a vehicle accident. Emma is currently working to be certified as a fibromyalgia health coach and hopes to help others navigate their way through treatments in order to feel and be better.  She has a Facebook support group called Fibromyalgia Solutions.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org.

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