Will CDC Start Listening to Chronic Pain Patients?

By Pat Anson, Editor

Friday’s announcement by the Centers for Disease Control and Prevention (CDC) that it will reconsider and delay implementing its controversial draft guidelines for opioid prescribing throws open a process that’s been largely concealed from the public.

But will it lead to changes in the guidelines themselves? And will the agency start listening to pain patients who fear losing access to opioid pain medication?

There are many different opinions from experts and activists who’ve been closely following the debate.

“A delay will not stop the inevitable, nor will a few months serve as a cooling blanket for the medical professionals and patients that are outraged by the approach CDC has taken on these guidelines.  CDC’s behavior was so outlandish that is caused an avalanche of pushback,” said Jeffrey Fudin, a pharmacist and founder of Professionals for Rational Opioid Monitoring & Pharmacotherapy (PROMPT).

“It is heartening to see that CDC has decided to do now what it really should have done in the beginning, and I hope the result is a set of recommendations that everyone can support,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

“Some have said that this delay is a victory for ‘the opioid lobby,’ but I think it’s not really a victory for anyone; 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 process that CDC used in developing the guidelines was unusually secretive and one-sided for a public agency. As Pain News Network has reported, the CDC handpicked outside advisers dominated by special interest groups and addiction treatment specialists, most of whom were determined to rein in opioid prescribing. The CDC’s panel of experts and stakeholders included five board members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. Few patient advocates and pain physicians were included in the process.

Not surprisingly, the resulting draft guidelines discourage primary care physicians from prescribing opioids for chronic pain. “Non-pharmacological therapy” such as exercise and cognitive behavioral therapy were recommended instead, along with non-opioid drugs such as over-the-counter pain relievers.

The guidelines were unveiled to a select online audience in September and only a brief 48-hour window was allowed for public comment. That sparked an outcry from the pain community. In a survey of over 2,000 pain patients by Pain News Network and the Power of Pain Foundation, large majorities complained that non-opioid treatments didn’t work for them or were not covered by insurance. Others predicted the guidelines would cause even more addiction and overdoses, not less.

The CDC largely ignored the complaints and said it would continue with plans to implement the guidelines in January, as planned.

Only in recent weeks, when the CDC started getting “feedback” from others did the agency reconsider. It was threatened with a lawsuit by the pro-business Washington Legal Foundation and officials from other federal agencies mocked the guidelines as “ridiculous” and “an embarrassment to the government.”

“CDC appreciates the feedback we have received to date, which has informed and strengthened the document thus far, and we look forward to receiving further input to improve the way opioids are prescribed,” said Debra Houry, MD,  the CDC official in charge of developing the guidelines, in an email Friday to stakeholders.

The agency now says it will reopen the public comment period for 30 days, starting on Monday, December 14th. The draft guidelines will also be reviewed by a scientific advisory panel, which will appoint a new work group to consider changes, a process that could take several months or more.

“I think it's a good idea to get broader input. Some have been critical of CDC, but the criticism has swirled primarily around the process itself, particularly the need for more input. More input can't hurt. It's my sense that the draft guidelines themselves have generally been well-received,” said David Juurlink, MD, a PROP board member who served on one of the CDC’s advisory committees. 

“Regarding the Washington Legal Foundation, I note that they've lobbied previously on behalf of Exxon Mobil, Philip Morris and Purdue Pharma. People can infer from this what they will.”

Jeff Fudin thinks the review process is yet a smokescreen.

“It seems to me that CDC is forming more committees and more layers to shield liability and hide behind their transgressions.  Rather than do this, I’d like to see a committee formed to examine how CDC’s actions around the guidelines happened in the first place, including but not limited to the choice of committee members and all potential conflicts and alliances among participants. Only after we understand how the CDC went awry can a fair scientific board be put in place to avoid a snowball of transgressions,” Fudin said in an email to Pain News Network. 

“The CDC realizes that they created a fire storm with their politically driven guidelines,” said Lynn Webster, MD, past president of American Academy of Pain Medicine. “It is good that they have heard the crescendoing opposition to what they have done.  We will have to see if it is just a maneuver to appease the concerns or if they are truly interested in working to be more inclusive and scientific in developing the guidelines.

“There are two fundamental concerns with the proposed guidelines.  The first is the secretive process and inclusion of advisers who are biased and prejudicial against opioids.  The other major concern is that the recommendations do not match the level of evidence.  This is what is most bizarre from the CDC, since the CDC is supposed to be a scientific body which uses best evidence in proposing health recommendations for the country. They failed to follow this principle in this case.”

Another bizarre part of the process is that – outside of September’s webinar -- the CDC has never made the guidelines available on its website, in a news release, or in any public forum. That will finally change on Monday when the draft guidelines are published in the federal register.

CDC Delays Opioid Prescribing Guidelines

By Pat Anson, Editor

Faced with the threat of lawsuits and growing ridicule from patients, physicians and other federal agencies, the Centers for Disease Control and Prevention (CDC) has apparently decided to delay for several months plans to implement its controversial opioid prescribing guidelines for chronic pain.

Today the agency filed a formal notice in the federal register that it was opening a 30-day public comment period on the guidelines, which had been scheduled for adoption in January. The guidelines would discourage primary care physicians from prescribing opioid pain medication in an effort to end what has been called an “epidemic” of addiction and overdoses.

“In response to feedback, CDC is posting its draft opioid prescribing guideline for chronic pain in the Federal Register for 30 days of public comment. In addition, in early 2016 the CDC National Center for Injury Prevention and Control’s Board of Scientific Counselors (BSC), a federal advisory committee, will review the draft guideline. CDC will ask the BSC to form a workgroup to review the guideline and public comments and present recommendations to the BSC,” the CDC said in a statement to Pain News Network.   

The public comment period will run from December 14th  until January 13, 2016.

The CDC unveiled the guidelines in September to a select online audience and then only allowed a 48-hour public comment period. The agency was roundly criticized for its secrecy during the drafting of the guidelines and for consulting with special interest groups, but few pain patients or pain physicians. The agency never made the guidelines available on its website or in any public form outside of the webinar.

A spokesperson told PNN the guidelines will finally become available for public scrutiny on Monday when they are published in the federal register.

A list of the dozen draft guidelines that were released in September can be found here. They recommend “non-pharmacological therapy” as the “preferred” treatment for non-cancer pain, and state that limited quantities and doses of opioids should be prescribed for both acute and chronic pain. The CDC later said the draft guidelines were being revised, but didn't release the changes.

Last week, a key government panel that oversees pain research indicated it would file a formal objection to the guidelines. Politico reported that the National Institute of Health’s Interagency Pain Research Coordinating Committee believes there is little or no evidence to support many of the prescribing guidelines. Some committee members reportedly called the agency’s recommendations “ridiculous” and “an embarrassment to the government” during a meeting.

Sharon Hertz, a top FDA official, was quoted as saying the evidence used to support the guidelines "is low to very low and that's a problem."

Another top official in the Department of Health and Human Services told the research committee the CDC’s guidelines were “shortsighted” and there was a rush to judgement.

"You know, damn the torpedoes. Full speed ahead," said Wanda Jones, principal deputy assistant secretary for health at HHS.

The Washington Legal Foundation (WLF) also signaled it was prepared to file a lawsuit to stop the guidelines from being implemented, accusing the CDC of “blatant violations” of federal law for not holding public hearings and refusing to publicly identify members of its advisory committees.

“The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers,” wrote WLF chief counsel Richard Samp to CDC director Tom Frieden.

In a survey of over 2,000 patients by Pain News Network and the Power of Pain Foundation, over 90% said the guidelines were discriminatory and would be more harmful than helpful to pain patients. Most said they had already tried non-opioid treatments, such as massage, acupuncture and cognitive behavioral therapy, and found that they didn’t work or were not covered by insurance. Many predicted the guidelines would lead to more suicides in the pain community, and cause more addiction and overdoses, not less.

Naltrexone ‘Changed Life’ of Fibromyalgia Patient

By Donna Gregory Burch

The pain in Janice Hollander’s legs was so excruciating that she wanted to cut them off. Diagnosed with fibromyalgia in 2013, she’d progressed through the normal litany of prescription drugs doled out by physicians – Lyrica, Cymbalta, gabapentin, muscle relaxers and narcotics – all without finding relief.

Then she happened to catch an episode of the Dr. Oz Show where a guest discussed using low-dose naltrexone (LDN) as a treatment for chronic pain. A few days later, she convinced her doctor to write a prescription and took her first dose of LDN.

“After about seven days, my pain lessened,” said Hollander of Michigan. “It lessened by 10 or 20 percent. That was huge! Even just that little bit of lessening was huge.”

After four weeks, the depression that had been stymying her for years lifted. At six weeks, she saw a noticeable increase in her energy levels. Her brain fog improved, and her memory returned.

Hollander has been taking LDN for about year now, and she’s probably one of its biggest fans within the fibromyalgia community. She regularly shares her success story in online support groups.

Hollander still has fibromyalgia symptoms, but they are more manageable thanks to LDN.

“I would say my leg pain is pretty much gone,” she said. “[LDN] has completely changed my life. I don’t know that I would be here today if it wasn’t for it. I don’t think I could go for another year in the misery I was in.” 

A growing number of fibromyalgia sufferers like Hollander are finding relief using LDN. It’s an unusual discovery since LDN is best known in the addiction treatment community. The U.S. Food and Drug Administration approved LDN to treat addiction to certain opiate drugs in 1984.

janice hollander

Dr. Jarred Younger, who conducted two LDN/fibromyalgia studies at Stanford University, believes LDN has an anti-inflammatory effect on the brain.

“This is one of the few drugs that can do that in the brain because it crosses the blood-brain barrier,” Younger said.

In simple terms, the brain contains microglial cells that look for problems within the central nervous system. When they discover an abnormality, these cells release chemicals into the body that cause fatigue, pain, cognitive disturbances and other symptoms common among fibromyalgia patients. In a healthy person, these chemicals are intended to slow down the body, to force it to rest, so that it can heal from whatever has caused the abnormality. In fibromyalgia, some researchers hypothesize this normal central nervous system response gets activated and doesn’t shut off.

“It’s like the central nervous system thinks you have an infection when you don’t,” Younger explained.

Fibromyalgia sufferers often speculate about what caused their condition, and researchers have debated various triggers for years. Viruses (herpes, Epstein Barr, etc.), chronic stress, genetics, obesity, aging and pollution are suspects, but according to Younger, it could be all of these.

He believes LDN works because it calms the microglial cells and reduces brain inflammation.

Penn State University researcher Ian Zagon posits a different mechanism behind LDN. Zagon’s opioid blockade hypothesis surmises that LDN blocks the brain’s opioid receptors, essentially tricking the body into increasing production of natural pain-suppressing chemicals.

Theoretically, both hypotheses could be correct.

Younger’s two Stanford University studies showed LDN outperformed Lyrica, Cymbalta and Savella, the three drugs currently approved to treat fibromyalgia in the U.S., and it did so with minimal side effects. The most common side effects are headache, insomnia, vivid dreams and nausea – all of which usually disappear over time.

“Probably 65 percent of people get an appreciable decrease of symptoms,” Younger said.

But more research is needed to confirm these early findings.

Next year, Younger will conduct at least two LDN/fibromyalgia studies at his new facility, the Neuroinflammation, Pain and Fatigue Lab at the University of Alabama at Birmingham.

One study will try to parse out the most effective dose of LDN for fibromyalgia. Most LDN users are prescribed the drug off-label, between 1.5mg and 4.5mg daily. But some rheumatologists have shared anecdotal accounts that certain patients respond better to higher doses, ranging up to 9mg.

A second trial will pair LDN with dextromethorphan, a common cough suppressant that’s believed to work similarly to LDN.

But many fibromyalgia sufferers aren’t waiting for the research. They’ve found ways to secure a prescription and try LDN for themselves.

Linda Elsegood, founder of the U.K.-based LDN Research Trust, has helped thousands of people gain access to LDN. She credits LDN with stabilizing her multiple sclerosis. At her worst, Elsegood was wheelchair bound, had no control of her bowels or bladder and had lost much of her sight and hearing. After 18 months on LDN, she was able to walk again on her own and had a reversal of most of her symptoms.

After her remarkable recovery, she wanted to educate others on the benefits of LDN.

“I wanted people to know that there is a choice, if you’ve been told, like me, that there’s nothing else that can be done for you,” she said. “Look into LDN. Do your research. … It is amazing the number of people who’ve found LDN works for them for so many different conditions.”

In addition to fibromyalgia, early research has found LDN to be useful in reducing the symptoms of certain autoimmune and central nervous system conditions, including multiple sclerosis, Crohn’s disease, rheumatoid arthritis and others.

But few doctors know about LDN as an emerging treatment, so it can be difficult to get a prescription.

“Some doctors are too busy to read the information,” Elsegood explained. “Some will not think outside of the box. It’s not what they learned in medical school, so they’re not prepared to consider something that is alternative. Other doctors won’t prescribe it because there aren’t enough trials.”

Unfortunately, it’s unlikely that any of the major drug companies will ever study LDN because it’s an older, generic drug and little profit can be made from it. So it falls to innovative researchers, like Younger, who secure donations and grants to fund trials.

Patients often encounter doctors who refuse to prescribe LDN even though it has a proven safety record and a low risk of side effects. The LDN Research Trust includes a list of LDN-friendly doctors and pharmacies on its website. For those who can’t find an LDN-friendly doctor locally, there are physicians who offer phone and online LDN consults.

“My advice is to always research it yourself, and then address it with your doctor,” Hollander said. “And if your doctor won’t agree to letting you try it, then find a doctor who will.

“I would drive to Florida to get it if I had to. It makes that big of a difference. I just wish more doctors would prescribe it, and more people would find help with it.”

For a list of helpful LDN resources, visit www.fedupwithfatigue.com/low-dose-naltrexone.

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained symptoms. Donna is the founder of Fed Up with Fatigue, a blog devoted to helping those with fibromyalgia and ME/CFS live better with these conditions.

Donna is an award-winning journalist whose work has appeared online and in local newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

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.

Controversy Grows over Journal Article on Pain Treatment

By Pat Anson, Editor

It’s not uncommon for colleagues in the medical profession to disagree. Egos and different medical backgrounds can sometimes lead to heated discussions about the best way to treat patients. But those arguments are usually kept private. 

That is why it is so unusual for a prominent pain physician to publicly call for another doctor to resign or be fired from her faculty position at a prestigious medical school.

“I believe she should resign her academic post,” says Forest Tennant, MD, referring to Jane Ballantyne, MD, a professor at the University of Washington School of Medicine, who recently co-authored a controversial article in the New England Journal of Medicine (NEJM) that said reducing pain intensity should not be the goal of doctors who treat chronic pain. The article also suggests that patients should learn to accept their pain and move on with their lives.

“For somebody in her position as a professor at a university to call for physicians to quit treating pain – or pain intensity – whether acute, chronic, whether rich, poor, disabled or what have you, is totally inappropriate. And it’s an insult to the physicians of the world and an insult to patients. And frankly, she should not be a professor.” Tennant told Pain News Network.

“To suggest that physicians should no longer treat pain intensity and let patients suffer goes beyond any sort of decency or concern for humanity.”

Tennant is a pain management specialist who has treated patients for over 40 years at his pain clinic in West Covina, California. He’s authored over 300 scientific articles and books, is editor emeritus of Practical Pain Management, and is highly regarded  in the pain community for accepting difficult, hard-to-treat patients that other doctors have given up on.

dr. forest tennant

Tennant was surprised the influential, peer-reviewed New England Journal of Medicine, which reaches over 600,000 people each week, even published the article.

“I know that they’re biased and they’ve got all their medical device people there and all their academia and all that, but I think they have a responsibility also. They are supposedly representing medicine,” says Tennant. “Why do I have a medical degree if I’m not supposed to treat pain intensity? Give me an answer to that. She didn’t have an alternative did she?”

dr. jane ballantyne

Exactly what Ballantyne and co-author Mark Sullivan, MD, meant to say is open to interpretation. Pain News Network has been unable to get comment from either about the controversy.

They began their article by saying “pain that can be relieved should be relieved,” but then veer off in another direction, stating that chronic pain should not be treated with opioid pain medication.

“Is a reduction in pain intensity the right goal for the treatment of chronic pain? We have watched as opioids have been used with increasing frequency and in escalating doses in an attempt to drive down pain scores — all the while increasing rates of toxic drug effects, exposing vulnerable populations to risk, and failing to relieve the burden of chronic pain,” they wrote, dismissing the pain intensity scales that are widely used by physicians to measure pain levels.

“We propose that pain intensity is not the best measure of the success of chronic-pain treatment. When pain is chronic, its intensity isn't a simple measure of something that can be easily fixed.”

Ballantyne and Sullivan offered no alternative “fixes” for pain treatment, other than patients learning to live with pain and sitting down for a chat with their doctors.

“Nothing is more revealing or therapeutic than a conversation between a patient and a clinician, which allows the patient to be heard and the clinician to appreciate the patient's experiences and offer empathy, encouragement, mentorship, and hope,” they wrote.

Angry Comments from Readers

The article infuriated both patients and physicians, including dozens who left angry comments on the NEJM website.

“Great job. I will be going into the coffin business thanks to these believers that people should suck it up. How NEJM even recognizes these people as doctors and not quacks is beyond me,” wrote Michael Shabi, who identified himself as a family practice physician.

“I take just enough narcotic pain meds to cut the edge off of my pain to be coherent enough to love my wife and respond to your constant misinformation. I have had 21 neurological surgeries and procedures and live in constant pain. So why in the heck do you people have such a problem in hearing us?” asked pain patient Kerry Smith.

“Only an idiot might conclude that one can dismiss the effects of living with a healthcare problem that reminds you of its presence with every move you make,” wrote Terri Lewis, PhD, a specialist in rehabilitation.

Both Ballantyne and Sullivan have lengthy careers in medicine and have been active in organizations that discourage the use of opioids. 

According to the University of Washington website, Ballantyne received her medical degree from the Royal Free Hospital School of Medicine in London and trained in anesthesiology at John Radcliffe Hospital in Oxford. She moved to Massachusetts General Hospital in Boston in 1990 and then to the University of Washington in 2011, as a Professor of Education and Research and as Director of the UW Pain Fellowship. 

Last year Ballantyne was named president of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. She also serves as an expert adviser to the Centers for Disease Control and Prevention (CDC) as it develops controversial new guidelines that discourage primary care physicians from prescribing opioids. Ballantyne is one of five PROP board members who are advising the CDC on the guidelines.

Sullivan is a Professor of Psychiatry and Behavioral Sciences -- also at the University of Washington School of Medicine -- and is executive director of Collaborative Opioid Prescribing Education (COPE), a program that educates healthcare providers about safe opioid prescribing practices. He is also a PROP board member.

Sullivan has authored several research articles on opioids, including a recent one warning about the co-prescribing of sedatives and opioids.

“He’s not as well known,” says Tennant. “He doesn’t carry the public influence that she does. She’s sitting on federal committees, advising CDC that pain patients should not be treated and the intensity scale should not be used. I cannot imagine anyone making that statement. I can’t imagine the New England Journal of Medicine publishing it. The atrocity here is just awful.

dr. mark sullivan

“Any semblance of decency left among physicians in PROP, if that’s what they believe, then I think the whole organization ought to close its doors. I didn’t know they were going to say we didn’t want pain treated at all. They said they wanted to use opioids responsibly. Well, that’s fair. But that’s not what she said.”

Tennant is urging the pain community to contact Paul Ramsey, the CEO of UW Medicine and Dean of the School of Medicine to ask that Ballantyne be fired. He’s gotten a few takers, including Becky Roberts, who suffers from arachnoiditis.

“I do not feel she should be teaching new medical students. Professor influence is big when you are a student. I am sure if any one of them read her article, most were probably shocked,” Roberts said in an email to Pain News Network.

“They did not get into medicine because they are uncaring. Compassion for other human beings is why they went to medical school. To help heal human beings is their goal. I really do think she needs to be removed from that position. How long has she been teaching this kind of logic?”

The UW School of Medicine has about 4,500 students enrolled in undergraduate, professional, and post-graduate programs. 

Power of Pain: How to Make Holidays Less Stressful

By Barby Ingle, Columnist                                               

Maintaining holiday traditions can be hectic and stressful -- even for healthy people. This should be an enjoyable time of year for everyone, but for people with chronic pain and physical limitations, they bring an extra element of challenges and stress. 

How do you cope with the holidays? Do you approach them in a hectic manner or do you break down the tasks into manageable ones? How do you get through the holiday season and enjoy it?

Here are a few tips I’ve learned about planning ahead, gift giving, and setting the expectation.

Start by prioritizing activities and only worry about things that are important to you and your family. Organize your schedule to include a time for each item to be completed by time frame and importance. Begin early with more complicated tasks and expect a “bad” day or two so they don’t cause stressful situations at the last minute.

It is important to avoid the last minute rush of gift buying and other holiday activities. Either cut out the nonessential steps, get help setting them up, or start early giving yourself plenty of time.

It is also good to work on your preventative health: nutrition, posture, and positive mental attitude.

When it comes to attending parties, I would suggest you attend others instead of hosting them yourself. That way you can make an appearance and leave before all of your energy is spent. You can let the host know that you can only stay for a limited time due to other commitments, and if you decide to stay longer, all the better. Once you explain your limitations to the event host, you’ll find your stress level will be reduced. Setting the expectation early is very important in group settings.

When it comes to gift giving, my best tip is to buy gifts online -- no walking or waiting! The items will arrive at your house or theirs, and you’ll save your energy for other tasks. Take advantage of free shipping when possible and online coupon codes to save money.

When it comes to making your gifts presentable, use gift bags. They’re easier than traditional wrapping, and save time and energy. Although decorations are beautiful, downsizing can still be festive and keep everyone in the holiday mood.

Communication is key to a successful season. It helps to talk to guests or party hosts ahead of time and explain your limitations as a chronic pain patient. When you are hosting an event, delegate duties as much as possible. The same goes when it comes to decorating. It is okay to ask for help and accept your limitations without guilt or blame. It is not your fault that you live with chronic pain. Help others understand your limits by sharing with them ahead of time what they are and telling them what they can do to help make it easier for you and other guests.

For the guests that “will never understand,” realize that you are not there for them. You are there for yourself first and others at the holiday event who love and support you. You can have a great time no matter who else is there or if they understand your pain or not.

It doesn’t matter what anyone else thinks about your health and protecting your body and mind. It is okay to take care of yourself first, especially during the holidays.

Let go of the stress, guilt and excess. Trim down the excess and turn the hustle and bustle of the holidays into a fun enjoyable time to be thankful for, with great memories to hold onto for years to come.

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.

New Skin Patch Delivers Pain Relief with Ibuprofen

By Pat Anson, Editor

There are many different types of skin patches already on the market to treat pain --- containing everything from lidocaine to capsaicin to powerful opioids like fentanyl. Now British researchers say they’re a step closer to developing the first transdermal patch containing ibuprofen.

Researchers at the University of Warwick have formed a company called Medherent to produce and patent an adhesive patch that can deliver a high dose of ibuprofen through the skin for as long as 12 hours to treat conditions such as back pain, arthritis and neuralgia.

Their patch differs from others already on the market because the medication is embedded into the polymer matrix that sticks the patch to the patient’s skin. The embedding technology allows the patch to contain 5 to 10 times the amount of analgesic currently used in medical patches.

"Many commercial patches surprisingly don't contain any pain relief agents at all, they simply soothe the body by a warming effect,” says University of Warwick research chemist Professor David Haddleton.

image courtesy of medherent

“Our technology now means that we can for the first time produce patches that contain effective doses of active ingredients such as ibuprofen for which no patches currently exist. Also, we can improve the drug loading and stickiness of patches containing other active ingredients to improve patient comfort and outcome."

The researchers are now testing other analgesics to see if they too can be embedded into the polymers. So far they’ve had good results with methyl salicylate – a wintergreen-scented chemical used in some topical liniments and gels.

“We believe that many other over the counter and prescription drugs can exploit our technology and we are seeking opportunities to test a much wider range of drugs and treatments within our patch," says Haddleton.

In an email to Pain News Network, Medherent’s CEO said the technology is compatible with a wide range of drugs, including opioids. The company is currently seeking partners to help develop the patches.

"Our first products will be over-the-counter pain relief patches and through partnering we would expect to have the first of those products on the market in around 2 years,” said Nigel Davis. “In addition to our pain relief products, our technology also works with drugs in many other therapeutic areas. We can see considerable opportunities in working with pharmaceutical companies to develop innovative products using our next generation transdermal drug-delivery platform."

Adding opioids to the mix is tricky business, because some opioid patches already on the market are being abused. According to CBCNews, transdermal patches containing fentanyl are blamed for over 600 deaths in Canada. Addicts have learned they can cut up fentanyl patches to smoke or ingest them  

Asked if Medherent’s patch technology would prevent similar abuse, Davis said, “We hope so but need to do more work on that before we make claims of that sort. “

Decision on Opioid Implant Nears

Meanwhile, Titan Pharmaceuticals (NASDAQ: TTNP) has announced that the Food and Drug Administration has scheduled a meeting with the company next month to discuss its new drug application for Probuphine, an implant containing buprenorphine, a weak acting opioid used to treat addiction.

Ironically, some addicts have learned they can get high by abusing buprenorphine and it is prized as a street drug that can ease withdrawal pains from heroin. Buprenorphine, which is more widely known under the brand name Suboxone, is currently only available in pills and oral films.

The Probuphine implant would be difficult to abuse. About the size of a matchstick, it is designed to be inserted subcutaneously under the skin of the upper arm, where it can release steady doses of buprenorphine for as long as six months.

Titan and its partner, Braeburn Pharmaceuticals, believe the implant technology could someday be used to deliver other medications, including opioids for pain relief.

image courtesy of titan pharmaceuticals

Probuphine’s path to the marketplace hasn’t been a smooth one. Braeburn and Titan were stunned in 2013 when the FDA denied approval of the implant and asked for a new clinical study of Probuphine’s effectiveness. Since then, the companies have conducted a study showing that the implant was more effective than buprenorphine tablets in treating addiction. The companies are hoping for FDA approval in 2016.

The Importance of Treating Chronic Pain

By Emily Ulrich, Columnist

If you are a chronic pain sufferer, by now you may have read about the proposed opioid guidelines by the Centers for Disease Control and Prevention (CDC), and a recent article about opioids in the New England Journal of Medicine. In the latter, Jane Ballantyne, MD, and Mark Sullivan, MD, wrote that reducing pain intensity – pain relief – should not be the primary goal of doctors who treat pain patients. They suggest that patients should learn to accept their pain and move on with their lives.

This statement is nothing short of infuriating to me and I imagine to anyone who has to live with chronic pain. Many of us have already heard a doctor say, “I don't prescribe pain medicine. Pain won't kill you.”

There are so many things wrong with that ideology, and the “facts” that are being used to support it in the anti-opioid movement, that it's difficult to know where to begin. There are years of research that show that pain left untreated or under-treated does in fact kill. It may not happen right away, but it greatly affects our quality of life and kills us slowly in a variety of ways.

Most of us know that chronic pain causes depression, anxiety, and even suicidal thoughts. There is also a very long list of comorbidities that often come with chronic pain, including hormonal and metabolic imbalance, impaired immune function, skin rashes, ulcers, incontinence, high blood pressure, and much more -- all of which ultimately lead to a decline in quality of life and overall health.

Unrelieved pain can also permanently change the brain and nervous system, preventing the brain from fully resting and developing new cells to repair brain damage. Research shows that the brains of pain patients can deteriorate over the course of a year at a rate which would take a healthy person's brain one to two decades. Cerebral atrophy causes seizures and dementia, both of which can lead to death, and both of which are preventable in pain patients when given adequate pain care.

Staggeringly, none of this seems to have been taken into consideration by the CDC or the doctors who have written this recommended “treatment” approach. One is perplexed by the “sweep it under the rug” mentality of these doctors, and the many who will be influenced by the CDC and the anti-opioid suggestions published in the New England Journal of Medicine.

The facts are this: Opioid misuse is not epidemic in the U.S. (opioid overdose is not even in the top 20 causes of death), but chronic pain is pandemic.

The overwhelming majority of pain patients who use opioids do not abuse or divert them. Yet the majority of patients are under-treated or even untreated for chronic pain. The roots of this mistreatment are myriad, and some are steeped in socio-economic factors such as gender, race, and disability. Minorities are more likely to have their pain minimized or ignored.

In addition, doctors have an exaggerated fear of addiction. Many fear repercussions from the DEA or their state medical board if they prescribe too many opioids, and there is a general lack of pain education on the part of many doctors.

Most of all, money is running the show. It seems that the American healthcare system sees us as useless members of society, who can either be eliminated or turned into eternal consumers. Treating us only with drugs that have dangerous side effects requires a whole new set of medications to treat the host of new ailments that their drugs have given us.

Another cog in the “Big Pharma” takeover of chronic pain (where we are offered treatments such as Lyrica, Neurontin, antidepressants, NSAIDs, biologics, etc., instead of inexpensive and proven opioid therapy) is that the CDC consulted with addiction treatment specialists, as well as insurance and drug company influenced “researchers” who have a conflict of interest.

Dr. Ballantyne, who is a member of the CDC's "Core Expert Group," reports receiving grants from Pfizer and being president of Physicians for Responsible Opioid Prescribing (PROP). She also served as a consultant to a law firm that litigates against opioid drug makers. Dr. Sullivan reports receiving grants from drug makers developing abuse deterrent products and personal fees from Janssen and Relievant.

We have to speak up. We have to educate ourselves and sometimes our doctors. Many of us don't realize (and some doctors don't want us to realize) that we have a basic human right to pain care. According to the Journal of American Society of Anesthesiology, “the unreasonable failure to treat pain is poor medicine, unethical practice, and is an abrogation of a fundamental human right.”

Doctors and patients must acknowledge that chronic pain is deadly. It can cause countless fatal conditions, not the least of which are heart attack, stroke and brain damage. And while opioids are not the only route to reduced pain, they are very important players in the path to pain relief. For most of us, opioids are part of a multi-modal treatment to lessen our pain, as well as a treatment of last resort.

The “alternative treatments” suggested by the CDC, Ballantyne and Sullivan include therapies most of us have either tried or had fail; or they are already part of our overall pain therapy.

In their article Ballantyne and Sullivan write, “Nothing is more revealing or therapeutic than a conversation between a patient and a clinician, which allows the patient to be heard and the clinician to appreciate the patient's experiences and offer empathy, encouragement, mentorship, and hope.”

I agree with them on this one point. However, they left out one essential element, the treatment plan that the patient and doctor come up with. For most of us, a main component of treatment is opioids.

Now is the time to speak up, before we have brain damage or die. Join me in creating a #PainedLivesMatter movement.

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.

My Life and the War on Pain Patients

By Suzanne Stewart, Guest Columnist

One of the arguments against gun control is that the "bad guys" will always have access and the “good guys” will die because their weapons are taken away.

That’s what’s happening now to chronic pain patients! We are fighting a war against being robbed of the very weapons we need to fight. I have complex regional pain syndrome (CRPS) and I’m fighting to live not "pain free," but with less pain and more living.

Those in positions to help, need to take the time to do so. All 50 states now have proclamations that explain the burning, fire-like pain of CRPS.  They discuss allodynia, or extreme sensitivity to touch, and the pain it brings.

But all of this means nothing if the government, FDA,CDC, physicians, and pharmacies take away the means of lessening our pain. We follow the rules, sign contracts with our pain doctors, and jump through hoops to get what we need to try and live some kind of life.  

On the other side of the spectrum are those who don't follow rules and who break laws. But they have a different disease called addiction and they ruin it for all of us. Only about 5% of opioid prescribed patients are addicted, yet they are making us all feel like criminals.

Would these same agencies and officials take anti-depressants away from the hopeless, or insulin from a diabetic?  

suzanne stewart

The CDC’s new opioid prescribing guidelines could make things a lot worse next year. Many physicians are already  refusing to give medicine for pain when it is truly needed. But those who who are true addicts always find a way to get what they need, while law abiding citizens, suffering daily, have no means other than self advocating. We need to rally and try to do something about this travesty.

Remember, we are not addicts! We are patients with chronic pain, who’s bodies are dependent on medications that help us live. Without proper pain control, there's nothing left.

It is despicable that some pain doctors are being forced to push invasive surgeries on more patients. Physicians who pledged to "do no harm" will do surgery,  instead of prescribing the medicine so desperately needed for the real chronic pain population.

There are new controversial prescribing guidelines coming and some already in effect. These are leading to more and more restrictions put upon our primary care physicians and even tying the hands of our pain management doctors. The CDC, FDA, and other groups think that they know more about pain and pain management, but when have they ever studied such things?

They are making a fake war on prescription drugs, when it’s really some kind of smokescreen for saving money!

I say pick on the real criminals, not the chronic pain sufferers. I went through an awful experience last year, when my doctor of 12 years unexpectedly left his practice under a cloud of suspicion. I never wanted to take any of these meds. I never smoked or drank!  I was just naive enough to think that I could finally trust someone in this life and then the rug was pulled out from under me.

I've read that they are taking most pain medications away from anyone with non-malignant pain. Who are these non-medical personnel, these agencies, to say that malignant cancer pain is worse than non-malignant pain? Unless they've experienced either, how would they know? CRPS is #43 on the McGill pain index, right next to childbirth or amputation of a finger.

These lay people and agencies are trying to tell us that  exercise and healthy eating habits, along with physical therapy and "behavioral therapy," are alternatives to pain medication. They say that the goal is to stop the overdoses and prescription drug abuse.

The “addiction specialists” scream "HYPERALGESIA" to everyone on opioids for any length of time. They say the pain meds stop working and that we all get addicted!  We are all individuals whose bodies may become physically dependent,  but that's very different from addiction. If it is working, then how can it be hyperalgesia?

In all honesty, if the doctor  is a good one, he or she will only prescribe the amount needed. Why take it away if the patient and doctor are doing everything right and when it gives some relief?  The innocents should not suffer for the crimes of a few.

Many patient advocacy groups have written to the CDC and the FDA and explained that they are not being transparent. They used biased teams to make up these new rules and guidelines. They didn't listen to the voices of the doctors and patients who live in the pain world. Many of the people who put these new rules together have a monetary gain.

One physician wrote in the Pain News Network that he has had patients on high doses of opioids for over 20 years and they have led quality lives. He also agrees that taking these meds from patients who've been on long term dosages is cruel and inhumane.

Sometimes people who want to change things to save a few dollars or get their products pushed, such as spinal cord stimulators and pain pumps, are not thinking of patients like me, who do not fit inside a nice neat box. My issues are different. I need these pain meds to survive.

So many lives have been lost because pain was not mangaged well! Chronic pain can kill you because it causes so many other issues and there’s a snowball effect when pain is not controlled.

Please use your voice and be heard. We need to form advocacy groups that will work together for the common good. Let’s stick together and not allow ourselves to be treated so inhumanely.

Suzanne Stewart lives in Michigan. She suffers from CRPS and several other chronic pain conditions caused by a car accident.

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.

Fed Panel Opposes CDC Opioid Guidelines

By Pat Anson, Editor

A key government panel that oversees pain research will file a formal objection to proposed opioid prescribing guidelines being drafted by the Centers for Disease Control and Prevention (CDC). Those guidelines, which are set to be released next month, would discourage primary care physicians from prescribing opioid pain medications.

The National Institute of Health’s Interagency Pain Research Coordinating Committee believes there is little or no evidence to support many of the prescribing guidelines, according to Politico. Some committee members reportedly called the agency’s recommendations “ridiculous” and “an embarrassment to the government” during a meeting Thursday.

The pain research committee includes representatives from the Food and Drug Administration, Agency for Healthcare Research and Quality, Department of Veterans Affairs, Department of Defense, and the CDC itself.

Evidence cited to support the guidelines "is low to very low and that's a problem," said Sharon Hertz, the FDA's director of the Division of Anesthesia, Analgesia and Addiction Products.

The CDC unveiled the draft guidelines in September to a select online audience and then allowed only 48 hours for public comment. The guidelines, a list of which can be found here, recommend “non-pharmacological therapy” as the “preferred” treatment for non-cancer pain, and state that limited quantities and doses of opioids should be prescribed for both acute and chronic pain.  

Complaints immediately arose from physician organizations and patient advocacy groups that the guidelines were developed in secret, with too much input from special interest groups, addiction control specialists, and Physicians for Responsible Opioid Prescribing (PROP),  an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. Five PROP board members, including its President, Vice-President and founder, are on committees that helped the CDC draft the guidelines.

The CDC developed the guidelines to combat what is often called an epidemic of prescription drug abuse and overdoses, but the agency’s own documents acknowledge there is “low quality of evidence” or “very low quality” to support many of its recommendations. For example, one guideline would greatly expand access to addiction treatment drugs such as buprenorphine and encourages physicians to refer patients to addiction treatment programs. Although "strongly recommended" by the CDC, the quality of evidence for that guideline is considered low.

The agency also admitted it rushed through the process, apparently to meet a January deadline.

“CDC conducted ‘rapid reviews’ of the contextual evidence on alternative treatments, benefits and harms, values and preferences, and resource implications. Rapid reviews are used when there is a need to streamline the systematic review process to obtain evidence in a short time frame. Methods used to streamline the process include limiting searches by databases, years, and languages considered, and truncating quality assessment and data abstraction protocols. Given the public health urgency of developing opioid prescribing recommendations, a rapid review was required for the current guideline,” the agency said in briefing documents obtained by Pain News Network.

A top official in the Department of Health and Human Services told the NIH research committee the CDC’s guidelines were “shortsighted” and there was a rush to judgement.

"You know, damn the torpedoes. Full speed ahead," said Wanda Jones, principal deputy assistant secretary for health at HHS, according to Politico.

Pain patients agree the CDC guidelines are shortsighted and could have a disastrous impact on the pain community. In a survey of over 2,000 patients by Pain News Network and the Power of Pain Foundation, over 90% said the guidelines were discriminatory and would be more harmful than helpful to pain patients. Most said they had already tried non-opioid treatments, such as massage, acupuncture and cognitive behavioral therapy, and found that they didn’t work. Many predicted the guidelines would lead to more suicides in the pain community, and cause more addiction and overdoses, not less.

Last month the Washington Legal Foundation (WLF) accused the CDC of “blatant violations” of federal law for not holding public hearings and refusing to publicly identify members of its advisory committees.

“The overly secretive manner in which CDC has been developing the Guideline serves the interests of neither the healthcare community nor consumers,” wrote WLF chief counsel Richard Samp to CDC director Tom Frieden.

The WLF has a lengthy history of taking government agencies to court to overturn regulations and policies it considers unfriendly to business.

Additional reporting for this story can be found in DrugWonks.

Genetic Defect Holds Secret to Pain Free Life

By Pat Anson, Editor

An experimental study on genetically modified mice may have uncovered a way to make low doses of opioids more effective in treating chronic pain.

Researchers at University College London are studying “transgenic” mice that were modified to carry a genetic mutation from humans who are unable to feel pain. The humans have a defect in their nervous system that prevents them from sending pain signals through a sodium channel known as Nav1.7. People born without working Nav1.7 can still feel touch normally, but not pain.

The researchers found that that mice who lack Nav1.7 produce higher than normal levels of naturally-produced opioids. Transgenic mice have twice the levels of natural opioids as unmodified mice from the same litter.

To block the effects of the natural opioids, the researchers gave the mice naloxone, an opioid blocker used in addiction treatment, and found that they became able to feel pain.

They also gave naloxone to a 39-year-old woman with the same rare mutation and she felt pain for the first time in her life.

"Studying the mice showed us what was going on in the nervous system that led to painlessness and our findings were directly translatable to humans, as confirmed by the painless patient,” said senior author Professor John Wood, University College London.

"The secret ingredient turned out to be good old-fashioned opioid peptides, and we have now filed a patent for combining low dose opioids with Nav1.7 blockers. This should replicate the painlessness experienced by people with rare mutations, and we have already successfully tested this approach in unmodified mice."

Broad-spectrum sodium channel blockers are already used as local analgesics, but they are not suitable for long-term pain management because they cause complete numbness and can have serious side-effects over time.

Opioid painkillers such as morphine are effective at reducing pain, but long-term use can lead to dependence and tolerance. As the body becomes used to opioids, they become less effective and higher doses are needed. Side effects also become more severe.

"Used in combination with Nav1.7 blockers, the dose of opioid needed to prevent pain is very low," explains Wood. "People with non-functioning Nav1.7 produce low levels of opioids throughout their lives without developing tolerance or experiencing unpleasant side-effects. We hope to see our approach tested in human trials by 2017 and we can then start looking into drug combinations to help the millions of chronic pain patients around the world."

Wood’s study is being published in the journal Nature Communications. Wood has filed for an international patent on his discovery.

Cancer Painkiller Blamed for Hundreds of Deaths

By Pat Anson, Editor

An Arizona drug maker that developed a powerful painkiller for cancer patients falsified records so the drug would be prescribed to non-cancer pain patients, possibly resulting in hundreds of overdose deaths, according to a new report by the Southern Investigative Reporting Foundation.

Subsys has FDA approval for breakthrough cancer pain, but Insys Therapeutics allegedly misled insurers into paying for the drug and encouraged off-label prescribing for patients suffering from conditions such as joint pain and post-traumatic stress disorder.

Subsys is a fentanyl based spray-on painkiller, said to be 100 times stronger than morphine.

The new report, headlined “Murder Incorporated,”  adds to the growing body of evidence and critical media reports about the aggressive business tactics of Insys Therapeutics. Last month CNBC accused the company of “putting profits before patients as it makes millions off your pain.”

"I've been investigating drug cases for about 15 years now, and the conduct that we saw in this case was among the most unconscionable that I've seen," Oregon Assistant Attorney General told CNBC. "There was harm done to patients on a level I'm not used to seeing."

image courtesy of insys therapeutics

Insys is under federal and state investigations in Oregon, California, Massachusetts, Connecticut, Arizona and Illinois. The company has settled a class action lawsuit in Oregon for $1.1 million and another in Arizona for $6.1 million.

The Southern Investigative Reporting Foundation has spent the past year investigating Insys and its business practices. It reported the company set up a special unit to help patients get prior authorization for Subsys prescriptions, often by falsely claiming they were medically urgent cancer diagnoses.

“Our findings suggest that the federal prosecutors are on to something. The prior authorization unit was set up to assist patients with complex insurance paperwork. Its value proposition was simplicity itself: the patient signs a few forms and Insys handles the messy paperwork. Patients would get the medicine, prescribers wouldn't have to scramble for a replacement and Insys would book thousands of dollars in revenue per prescription,” the report says.

Since Subsys was introduced in 2012, the FDAs Adverse Events Reporting System lists 203 deaths where Subsys was listed as the probable cause for triggering an adverse reaction. The pace of Subsys-related deaths is accelerating, with 52 deaths in the second quarter of this year alone.

“Depending on the dosage, one package of 30 Subsys sprays can cost between $900 and $3,000. Insys generates almost all of its revenue from Subsys. Last month the company reported over $91 million in revenue during the third quarter, beating estimates.

CEO Mike Babich resigned the day before earnings were released, saying he wanted to spend more time with his family.

“Insys is committed to developing products for the supportive care of patients through the use of its drug delivery technologies.  Insys takes patient safety very seriously and is committed to working with the health care community,” the company said in a statement. “Based on its interactions with patients and prescribers, Insys believes that the success of Subsys is directly attributable to the clinical benefits of its product.”

Can Marijuana Help Treat Heroin Addicts?

By Pat Anson, Editor

There’s a new twist to the rising use of heroin in the United States – and what can be done to help addicts in recovery.

A recent study by researchers at Columbia University found that medical marijuana improves the treatment outcome of heroin addicts. Patients who were given dronabinol -- a prescription drug that contains THC, the active ingredient in marijuana -- had lower withdrawal symptoms compared than those given a placebo. In addition, patients who smoked marijuana regularly during the outpatient phase of treatment had fewer sleeping problems, less anxiety and were more likely to finish treatment.

"One of the interesting study findings was the observed beneficial effect of marijuana smoking on treatment retention," the researchers concluded.

"Participants who smoked marijuana had less difficulty with sleep and anxiety and were more likely to remain in treatment as compared to those who were not using marijuana, regardless of whether they were taking dronabinol or placebo."

The Columbia study appears in the journal Drug and Alcohol Dependence.

According to High Times, several other studies have reached similar conclusions. Studies at the New York Psychiatric Institute found that opiate addicts who consumed marijuana intermittently were less likely to start using opioids again, compared to those who never used marijuana or used it habitually.

Earlier this year, researchers at the RAND Corporation and the University of California, Irvine reported similar results in a study for the National Bureau of Economic Research – going so far as to suggest that marijuana is a good substitute for opioid pain medication.

“Many medical marijuana patients report using marijuana to alleviate chronic pain from musculoskeletal problems and other sources. If marijuana is used as a substitute for powerful and addictive pain relievers in medical marijuana states, a potential overlooked positive impact of medical marijuana laws may be a reduction in harms associated with opioid pain relievers,” they wrote. “We find that states permitting medical marijuana dispensaries experience a relative decrease in both opioid addictions and opioid overdose deaths compared to states that do not.”

And what happens in states where regulations make it harder to obtain prescription opioid medication?

There were unintended consequences in Washington, one of the first states in the country to impose strict new guidelines on opioid prescribing. From 2008 to 2014, the number of deaths from prescription opioids in Washington fell from 512 to 319. But over the same period, the number of heroin deaths almost doubled, to nearly 300.

But the surge in heroin use wasn’t confined to Washington. According to the National Survey on Drug Use and Health, the number of heroin users nationwide rose from 161,000 in 2007 to 289,000 in 2013, an increase of nearly 80%. During the same period, the U.S. Centers for Disease Control and Prevention (CDC) reported the number of poisoning deaths involving heroin rose from 3,041 to 8,257, an increase of 172%.

“There is no robust evidence that recently enacted policies regarding prescription opioids are responsible for large-scale shifts to heroin,” the CDC’s Courtney Lenard recently told Alcoholism & Drug Abuse Weekly. Only about 1 in 25 people who use prescription opioids recreationally start using heroin within five years, she said.

Tommie Copper Tarnished By Fed Charges

By Pat Anson, Editor

Some of the shine has come off athletic apparel company Tommie Copper, Inc.

The company has agreed to pay $1.35 million to settle federal charges that it deceptively advertised its copper-infused compression clothing would relieve pain and inflammation caused by arthritis, fibromyalgia and other chronic diseases.

Tommie Copper’s settlement with the Federal Trade Commission also requires the company and founder Thomas Kallish to have “competent and reliable” scientific evidence before making any future claims about pain relief, disease treatment, or the health benefits of their products.

Tommie Cooper advertised its copper-infused garments in infomercials, brochures, social media, and print media such as Arthritis Today magazine. The ads claimed the clothing alleviated pain caused by multiple sclerosis, arthritis, and fibromyalgia; and could provide pain relief comparable to or better than drugs or surgery.

Some of the infomercials feature talk show host Montel Williams, who suffers from multiple sclerosis, declaring, “Tommie Copper truly is pain relief without a pill.”

 “It’s tempting to believe that wearing certain clothing will eliminate severe pain, but Tommie Copper didn’t have science to back its claims,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “If you see an ad for a product that promises to replace the need for drugs or surgery, talk to a healthcare professional before you spend your money.”

The company’s website now only claims its products “can be worn all day to provide relief from everyday aches and pains.” The clothing, including sleeves, braces, shirts and socks, range in price from $29.95 to $69.50.

The proposed federal court order imposes an $86.8 million judgment against Tommie Copper, which will be suspended upon payment of $1.35 million by the company within seven days . The company neither admitted or denied any of the allegations in the settlement.

The so-called “healing power” and pain relieving power of copper can be traced back thousands of years. But a 2013 study by British researchers found that copper does nothing to alleviate the pain, swelling, or disease progression of rheumatoid arthritis. The study, published in PLOS ONE, found that copper bracelets worn by 70 patients provide no more meaningful therapeutic effect than a placebo.

Pot for Pain Approved in Minnesota

By Pat Anson, Editor

After months of debate, Minnesota’s health commissioner has decided to include chronic pain in the list of conditions that allow residents to legally use medical marijuana. They just have to wait another nine months before they can buy it.

Commissioner Ed Ehlinger said it was “the right and compassionate choice” to allow pain patients into the program.  Only nine health conditions currently qualify for marijuana prescriptions in Minnesota – and chronic, intractable pain won’t be added until August 1, 2016. Health care providers can start certifying intractable pain patients on July 1 of next year.

Ehlinger, who is a physician, said “the existing tools are not working well” to manage pain, according to the Minneapolis Star Tribune.

“There are strong and conflicting opinions ... in both the professional community and in the general population. However, as a physician who is concerned about the treatment each individual patient receives and as the Minnesota Health Commissioner who is concerned about the overall health of everyone in this state, I believe that adding intractable pain to the list of qualifying conditions for our medical cannabis program is the correct decision,” said Ehlinger

Last month a state advisory panel recommended against the inclusion of chronic pain in Minnesota’s marijuana program, saying cannabis was not a “magic bullet” and there wasn’t enough evidence to support its use for pain.

“Panel members expressed concern that patients eligible to use medical cannabis for pain have expectations that it would provide total relief and that such a perception may leave patients to abandon other proven pain-management methods, such as physical therapy,” the recommendation said.

“Panel members cited the recent opioid crisis, where good medications were demonized because prescribers used it to treat pain without knowing its proper uses. Even after studying the information available on medical cannabis, panel members said providers do not feel prepared to certify patients for its use.”

Over a dozen public hearings on the issue were held across the state, and the vast majority of speakers favored including intractable pain in the list of health conditions marijuana can be used for.

Intractable pain is defined as “a pain state in which the cause of the pain cannot be removed or otherwise treated with the consent of the patient and which, in the generally accepted course of medical practice, no relief or cure of the cause of the pain is possible, or none has been found after reasonable efforts.”

The nine conditions that currently qualify for medical marijuana in Minnesota are cancer, glaucoma, HIV/AIDS, Tourette Syndrome, Amyotrophic Lateral Sclerosis (ALS), seizures, severe muscle spasms, Crohn’s Disease and terminal illness. In addition to strict limits on conditions it can be prescribed for, medical marijuana is not available in leaf form and cannot legally be smoked in Minnesota.  It is only legal in a pill, vapor or liquid form.

The limits are so restrictive, less than 800 patients have enrolled in the program so far. Enrollment is expected to increase dramatically once chronic pain is included.

"Congratulations to the State  of Minnesota for now becoming a true state of compassion," said Ellen Lenox Smith, a medical marijuana advocate and a columnist for Pain News Network.  "I do hope that in the near future, they will also consider to adjust their stand on cannabis being sold only in pill or liquid form — nothing smoke-able.  For those of us in Rhode Island, we can choose to vaporize, use topicals, smoke if that is your only way to make it work for you, along with tinctures, drinks and edibles. We all have to find the right way to make this medicine work for our conditions, so may they realize their limitations are very controlling and holding back pain relief for many."

Minnesota is one of 23 states and the District of Columbia where medical marijuana is legal.

Going Off Morphine is Hell

By Crystal Lindell, Columnist

This past weekend, as I tried to get off morphine once and for all, one thought kept going through my mind — if the devil is any good at his job, hell will just be eternal opioid withdrawal.

It’s like, have you ever had the flu, and also food poisoning, and also been hit by a train, and also had the fight or flight anxiety that comes from being chased by a bear for a week straight — all the same time? Well it’s worse than that.

It’s effing hell.

And it’s all made even worse by the fact that I had the cure the whole time. Every single minute that went by, I knew that I all had to do to make it all go away was pop one of those little blue pills in my purse.

I made it to the 72 hour mark last night at midnight. That’s 72 hours without morphine or a hydrocodone. I haven’t gone a full 72 hours without an opioid in almost two and a half years.

I spent all of November tapering down my dose. Going so effing slow. Like three pills, then two pills, then three pills, then two pills. Then after a week, I’d do one pill then two pills, then one pill.

I was down to one pill every other day, of the lowest dose, and I knew the next step was going through withdrawal. I thought maybe it wouldn’t be that bad since I had been going so slowly with the tapering. I was wrong.

Honestly, the first 24 hours weren’t so bad. My body was just chilling, expecting another dose in a day or so. But then, at midnight, exactly 24 hours in, the involuntary leg movements started. I was lying in bed, in the middle of the night, and my right leg would just move. Also, my anxiety started skyrocketing so high you’d have thought I was in a war zone.

By the morning, about 31 hours in, the muscle aches had set in, and everything I had ever eaten over the last two years had started to come out. Diarrhea doesn’t sound like the worst thing in the world, until you literally spend so much time on the toilet that your legs go numb. And then when you do get up, you are so dehydrated that you can’t even walk without holding on to the wall.

There’s other stuff too, the kind of stuff that maybe sounds minor until it happens to you. Like, my nose was randomly running, and I was sneezing like there was a secret cat hidden in the bathtub. And I could not sleep. At all. And if somehow I did get a couple minutes of shut eye, I would wake up drenched in sweat. Also, everything made cry. Seeing the sun? Tears. Facebook posts about makeup? I’d start weeping. Basically the fact that I was alive was enough of a reason.

Again, all these things don’t sound so horrible, but when they are all happening at once, it is literally hell on earth. 

I spent most of the 72 hours watching Breaking Bad — which is either the worst show to watch during withdrawal because it’s all about drugs, or the best because it’s all about the horrible things drugs lead to.

I also spent most of the 72 hours trying to process how I got to this point. Morphine has been so good to me over the last two years. And I stand by the fact that it literally saved my life. If it wasn’t for the pain relief I got from the drug, I don’t know if I would have been able to endure. And I am thankful to morphine for that.

But I wouldn’t wish the morphine withdrawal on Hitler.

And I thought about everyone who has ever had to endure this for whatever reason. And my heart filled with compassion and love for them. Some people like to say that drug addicts are just weak, or lack self-control. Those people are a**holes.

I also thought a lot about how much I wanted to just pop a morphine and make everything better. I thought about it so hard. Vividly picturing the little blue pill in my head and fantasizing about how good it would feel to take just one.

And I thought about how going through withdrawal was a good thing because I wouldn’t even be going off morphine if I wasn’t feeling better. (See Crystal's last column: "Is Vitamin D Making Me Feel Better?")

I felt like this was a final step. A last stand by my pain to suck me in. I had to get off this drug to move on with my life. But it was so incredibly hard.

And I kept thinking about how, I am a good person. I am a strong person. I should be able to get through this. Why am I struggling so much?

My best friend was extremely supportive during the whole thing, constantly checking on me, praying for me, and sending me encouragement. And at one point she sent me a text that said, “I think the last two years were the toughest times of each of our lives (in different ways). Glad I get to see you on the other end.”

The other end. Wow. I honestly never thought I would ever get to see the other end. For a long time, I didn’t even think there was an “other end” to get to.

The idea that I could get to this proverbial “other end” though, it was enough to keep me going.

Honestly, I still feel like I was jumped, and then tossed in front of a train. But I’m doing a lot better than I was doing on day two. From what I can tell, the withdrawal symptoms can last anywhere from a week to months, but it’s those first 72 hours that are the most horrible. And I have made it through those.

I also discovered that there’s a cocktail of over-the-counter drugs that help. Specifically, I have been popping handfuls of Advil, Imodium and Benadryl.

I saw my brother this morning. And as I walked toward him, I felt like I was just regaining my footing after being in a plane crash. Still shaken up, disoriented and feeling like hell, I said, “Well, I’m finally feeling a little better. I made it to 72 hours.”

“Great. Now you have to make it a week,” he said.

Crap, I thought. He’s right.

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

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

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