A Pained Life: It Never Hurts to Ask

By Carol Levy, Columnist

Recently a documentary was released on Netflix about Lady Gaga.  A part of her story is that she has fibromyalgia. 

I have not seen the film, but understand she devotes a little time to detailing and showing how she deals with chronic pain, both physicially and emotionally. Articles and posts abound in chronic pain social media about the film and Lady Gaga's pain.

The odd thing is many of the writers start by complaining that people don’t understand their pain, why they have to take drugs, and why they can't do many things that seem so easy to everyone else. 

Then, strangely, they do exactly what they complain happens to them.  They express doubts about Lady Gaga’s diagnosis, wonder if she is malingering, and say she can't really have fibro because her level of suffering and disability is not the same as theirs.

It seems we in the chronic pain community want to have our cake and eat it, too.  We want to have the discussion about chronic pain made public. We want awareness. But the awareness has to be exactly the way we want it or we don't want it at all

SCENE FROM "GAGA: FIVE FOOT TWO"

Many in the pain community express feelings that anything in the public eye that even hints of chronic pain should be about the person's struggles and life interruptions caused by pain.  Lady Gaga is a case in point. 

“She didn’t talk enough about fibro,” writes one person, others echoing the sentiment. “I thought from all the hype I heard it was going to be about that.” 

It would have been terrific if Lady Gaga had devoted more time to her disease and its effects on her life, but then that really was not the point of the documentary.

“Some of the film may actually be hurtful to some of us, as it shows her being able to do very physical things that are often beyond many of us as we struggle with the pain. If you have watched her perform she is not a sedentary singer,” wrote one poster on social media.  

Maybe it is worth asking her. Could you do something more, maybe another film or even just a commercial, that would bring needed attention to chronic pain and its effects on our lives?  

Last month was Pain Awareness Month, and it went by with almost no awareness or notice at all.  Lady Gaga might be the awareness hook that we need.

But we need to stop lamenting, hoping and complaining that no one is doing enough.  It is past time to take the bull by the horns.  We have to do it ourselves.  As they say, if not now, when? If not us, who?

And who knows? If someone or a bunch of someones ask Lady Gaga or another celebrity to be our voice, they might actually respond. If we don't ask, we’ll never know if they want to help the pain community.

The worst they can say is no.  And maybe, just maybe, we can get a “Yes.”

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.

9 Holistic Approaches to Relieve Joint Pain

By Nicole Noel, Guest Columnist

Whatever your ailment may be, holistic medicine has an answer.

A therapeutic method that dates back to early civilizations, holistic medicine takes into account the mind, body, emotions and spirit -- with the aim of helping patients achieve or restore proper balance in life and prevent or heal a range of conditions, including musculoskeletal pain. Holistic treatments offer a ray of hope for many patients suffering from arthritis, osteoporosis, fibromyalgia and other conditions that cause joint pain.

Not all alternative medicine is created equal, and some natural healing methods will produce better and quicker results. If you want to treat arthritis and other joint aches with holistic treatments, here are a few natural pain relievers you can try.

1. Tai Chi

A low-impact activity that can increase range of motion and strengthen joints and surrounding muscle tissue, tai chi is an ancient physical and spiritual practice that can help arthritis patients soldier through their pain.

According to a 2013 study, tai chi can relieve pain, stiffness, and other side-effects of osteoarthritis. In addition to pain relief, tai chi can help improve range of motion and alleviate joint pain for people living with fibromyalgia and rheumatoid arthritis.

2. Yoga

Another ancient technique which promotes natural healing, yoga is perfect for individuals suffering from lower back and joint pain. Gentle stretches and poses opening the joints can help prevent and alleviate chronic soreness in the shoulders, hips, and knees.

A form of yoga called mudras utilizes a series of hand gestures to increase energy, and improve mood and concentration.

3. Massage

An invigorating massage with warm essential oil can help many conditions, and joint pain is one of them.

By enhancing blood flow, relaxing the muscle tissue and soothing inflammation, a well-timed massage can ease joint stiffness and increase range of motion in individuals suffering from arthritis, fibromyalgia, and osteoporosis.

4. Acupuncture

A 2013 review of medical studies has shown that acupuncture can help relieve musculoskeletal pain caused by fibromyalgia. By activating the body’s natural pain relief system and stimulating the nerves, muscles and connective tissue, acupuncture can relieve joint aches for people who are resistant to other holistic pain relief techniques.

A 2010 study found that acupuncture can also be a beneficial for peripheral joint osteoarthritis.

5. Diet Changes

An apple a day may or may not keep the doctor away, but a custom-tailored diet can help you with joint pain. Nutritional tweaks can begin with increased intake of chondroitin sulfate, glucosamine, and Omega 3 fatty acids, which can reduce joint pain in arthritis and osteoporosis patients.

To ease joint problems, your pantry should be stocked with foods that promote healing and reduce inflammation, such as onions, carrots, and flaxseed. Herbs and spices such as turmeric (curcumin) and cayenne pepper can also help with pain relief.

6. Aromatherapy

If you think pain relief can’t smell good, you’re mistaken. Studies have shown that peppermint and eucalyptus oil can reduce swelling, pain and discomfort in patients with inflamed joints. For joint soreness and stiffness caused by arthritis, aromatherapy experts recommend regular application of myrrh, turmeric, orange, or frankincense oil to ease inflammation and pain, and to increase range of motion.

You can also combine aromatherapy with heat and cold treatments.  Be sure to keep the tender joints elevated during treatment to reduce swelling.

7. Spa Treatments

Few things can beat the appeal of a full-scale spa experience. If you’re suffering from knee, hip, shoulder or elbow pain and other holistic methods haven’t helped, try balneotherapy, which combines aqua massage with deep soaks in heated mineral water and medicinal mud baths.

One study found that balneotherapy significantly reduced knee and back pain in older adults.

8. Aquatic Sports

If you don’t want to immerse yourself in mud, you can supplement your holistic pain therapy with water aerobics, swimming, aqua jogging or aqua spinning. According to a 2014 study, water exercises can ease pain and improve joint function for osteoarthritis patients.

Additionally, a 2015 study found that aquatic circuit training can help relieve knee pain in cases of progressed osteoarthritis.

9. Capsaicin cream

Another natural treatment for joint pain and stiffness is homemade capsaicin cream, which can help reduce swelling and increase range of motion. To stay on the safe side, you should be careful when handling hot peppers when preparing the cream, and avoid using it on sensitive and damaged skin.

As our bodies age, joint pain can become a chronic. If you don’t want to take your chances with conventional pharmaceuticals, you can always turn to holistic medicine for answers and help. When musculoskeletal pain hits home, one or more of these holistic treatments can help.

Nicole Noel is a lifestyle blogger who is passionate about yoga and healthy living. She enjoys sharing her experiences and ideas on how to lead a happy and healthy life. If you want to read more from Nicole, you can find her on Twitter and Facebook.

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.

Unlikely Partners in Pain App Study

By Pat Anson, Editor

Purdue Pharma and a Pennsylvania-based healthcare provider have announced the enrollment of their first patient in a joint study of wearable health technology. As many as 240 people will eventually be enrolled in the two-year study, which is designed to see if “wearables” can help manage chronic pain.

It’s an unlikely partnership between Purdue Pharma, which faces multiple lawsuits over its promotion of the painkiller OxyContin, and the Geisinger Health System, which is actively trying to discourage the use of opioid pain medication. Geisinger provides healthcare to over 3 million people in Pennsylvania and New Jersey.

Geisinger patients enrolled in the study will get an Apple Watch and iPhone equipped with pain apps that will measure their physical activity, self-reported pain, disability, sleep quality, depression, medication use and heart rate.

Patients who report pain will be prompted to try non-pharmaceutical alternative therapies, such as stretching, mindfulness and thermotherapy.

“The goal of this technology is to improve patient function and quality of life while reducing the need for analgesic medications. It provides objective measures of numerous aspects of pain, function and treatment effectiveness so that information can be gathered for the patient and the healthcare provider in between visits,” said Dr. Tracy Mayne, who heads Medical Affairs Strategic Research at Purdue Pharma.

“We are pleased to partner with Geisinger on this important initiative and believe real-time data may have the potential to support an improved understanding of chronic pain patients’ experiences and needs.”

The study's primary goals are to assess whether the use of wearables can reduce pain, depression, medication use, and healthcare costs.

“We are incorporating advanced technology into the traditional healthcare setting to redirect and empower the patient to take more control of their own well-being. The proposed multi-level integrated platform will facilitate and accelerate the speed of communication between the patient and healthcare providers, thereby allowing quicker patient access to appropriate care,” said John Han, MD, director of Pain Medicine at Geisinger.

“Furthermore, it is hoped providing more education as well as alternative, non-opioid treatment options and coaching to promote a long-term sustainable healthy lifestyle will improve patient function and quality of life.”

Further details about the study can be found here.

The study comes as Purdue fights a seemingly endless series of court battles with state and local governments over its marketing of OxyContin over a decade ago. Critics contend the overprescribing and abuse of OxyContin helped launch the overdose crisis.

A recent study by Geisinger found that opioids are ineffective in treating chronic pain and increase the risk of overdose and death.

"Opioids are not the answer," said Mellar Davis, MD, a palliative care physician for Geisinger. "Chronic pain rehabilitation, exercise, cognitive behavioral therapies, acupuncture, yoga or tai chi are all better options than opioids."

Cigna Won’t Pay for OxyContin in 2018

By John Burke, Guest Columnist

A major health insurance company -- Cigna -- announced this week that they it is removing OxyContin from its list of approved medications and replacing it with another extended release oxycodone product.

“Our focus is on helping customers get the most value from their medications — this means obtaining effective pain relief while also guarding against opioid misuse," said Jon Maesner, Cigna's chief pharmacy officer.

OxyContin is the only opioid-based prescription painkiller that Cigna is removing in 2018 as "a preferred option" from its formulary, a list of medications that its health plans will pay for.

On the surface, this declaration might appear to be a great stride toward reducing prescription drug abuse. Cigna is replacing OxyContin with Collegium’s product, Xtampza ER, which is also an abuse deterrent extended release oxycodone product. 

My problem with this announcement is that OxyContin, along with the other abuse deterrent formulations (ADFs), have very little abuse issues. OxyContin certainly did up until its reformulation in August 2010, but that was over 7 years ago! Since then, there is much documentation from a variety of sources that show the diversion of OxyContin has fallen extensively.

Xtampa ER and the other abuse deterrent formulations also have little to no abuse issues since they have been on the market. 

If Cigna wants to change drugs, that’s likely a financial decision and one they should make, but please don’t tout your move as striking a blow for reducing drug diversion.

It will do nothing to reduce drug diversion, since the clear majority of diversion falls into the immediate release opioids, primarily oxycodone and hydrocodone. 

What is even more concerning to me is the vilifying of any drug that hundreds of thousands of legitimate pain patients take to live a semblance of a normal life, especially when that drug does not have a recent history of abuse and diversion. It also tends to make suspect any and all abuse deterrent products, which is deceptive at best. 

One thing the abuse deterrent formulations have done is to help narrow their focus to legitimate pain patients. Those seeking to get “high” moved to immediate release opioids or black market heroin/fentanyl combinations, not the ADF products. That’s why the FDA is now considering requiring companies that produce generic opioids to develop ADF properties for their drugs. 

No matter what Cigna declares, the bottom line is that ADF’s have been successful. They are not an end all to diversion and abuse, but they do help pain patients get easier access to pain medication. I am hoping that is everybody’s ultimate goal. 

John Burke recently retired after nearly 50 years in drug and law enforcement in southwestern Ohio.

John is a former president of the National Association of Drug Diversion Investigators and current president of the International Health Facility Diversion Association.

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.

Can Analgesic Creams Treat Chronic Pain?

By Pat Anson, Editor

An Irish opera singer who suffered from the same chronic pain condition as Lady Gaga claims she was “cured” of fibromyalgia by rubbing a topical cream on her body.

“I was amazed that within a few hours of putting the cream on my knees and my neck, the pain started to ease and the swelling abated slightly,” Liz Farrell told the Daily Mail. “By the end of the first week I was able to start reducing my daily intake of painkillers.”

Farrell was diagnosed six years ago with fibromyalgia – a condition that causes widespread body pain, fatigue and insomnia. The 40-year old singer tried a cocktail of drugs that included tramadol, Cymbalta, Lyrica and anti-inflammatory medications, but her pain only grew worse and she stopped performing.

Then Farrell started using Celafen, a drug-free topical cream that contains menthol, Vitamin E and a patented blend of fatty acids called Celadrin, which lubricates cell membranes and has anti-inflammatory properties.

“I felt completely normal again, like my old self. I was able to start driving again, which I’d not been able to do for two years,” said Farrell, who recently started performing again. “It has been like coming to the end of a prison sentence, to have that freedom back again.” 

"I can’t begin to imagine how Lady Gaga has been coping with her stage performances with this crippling condition; she must be a very brave lady.”

Lady Gaga’s battle with chronic pain has received a great deal of media coverage lately. She recently cancelled concert appearances in Brazil and Europe to focus on her health.

Would Celadrin help Lady Gaga? Would it help you? The reviews online are a bit mixed.

“Celadrin works very well for me. I've been dealing with a shoulder injury for about six months, and I have tried almost every pain control cream and gel on the market. This is one of the best I've found,” said one reviewer.

“I'm using it on a painful knee and surrounding muscles and ligaments,” another reviewer wrote. “I was really hoping this cream would provide relief. I need to take pain pills so I can walk so I'm not sure how much this cream really helps.”

“It is truly amazing how it takes away all my aches & pains. I suffer from disc issues - cervical to lumbar area. I get referred pain in my upper arms from my cervical disc issues. I rub this on and instantly I feel so much comfort,” a woman wrote.

“Expensive. Smelly and doesn't do a thing,” said another. 

Whether it works or not, it’s fairly cheap. Celafen cream is sold online in the U.K. for £9.95 – or $11.65. You can also buy Celadrin in various formulations on Amazon for about the same price.

Study Finds Analgesic Creams Effective

Topical analgesic creams are mostly used to treat acute pain in sore muscles and joints – not the intractable pain that comes from severe chronic illness. But a new study published in the Journal of Pain Research suggests that creams are effective and could be safer than opioids and other prescription drugs in managing chronic pain.

In the observational study of 631 patients with moderately severe chronic pain, Clarity Science researchers found significant decreases in pain in patients who used generic analgesic creams daily for 3 to 6 months. Most of the creams contained diclofenac, ketoprofen or flurbiprofen, non-steroidal anti-inflammatory drugs (NSAIDS) that were combined with other neuropathic agents.

"The study is important in that existing topical analgesics that have lost big Pharma interest have been found not only to have a profound therapeutic effect, but also offer a safe and effective alternative to opioids," Dennis Harris, MD, Clarity's Chief Medical Officer said in a press release. “New and experimental drugs are not always the answer to current issues."

Researchers say 54% of treated patients in the 3-month group and 60% of treated patients in the 6-month group reduced their use of pain medications. Over half the patients who were not treated with analgesic creams increased their use of pain medication.

Treated patients also reported a preference for topical treatments and only a few had side effects.

"The results of this study show that topical analgesics were associated with reductions of up to 60% in the use of concurrent pain medications, including oral opioid analgesics,” said Jeffrey Gudin, MD, lead investigator of the study and the Director of Pain and Palliative Care at Englewood Hospital in New Jersey.

“Topical agents have the potential to provide analgesic effects without the risk of abuse, misuse, and addiction or systemic adverse events (AEs) associated with oral analgesics. Also, they lower the risk of systemic AEs and drug-drug interactions, have limited systemic absorption, offer simple-dose determination, provide direct access to the target site, and are easy for patients to apply."

For the record, Dr. Gudin was paid to participate in the Clarity Science study. Gudin is a popular speaker at pain management conferences and last year received nearly $280,000 in speaking and consulting fees from opioid manufacturers and other drug makers. Clarity Science received funding for the study from several independent specialty pharmacies that sell analgesic creams.

Gabapentin Raises Risk of Opioid Overdose

By Pat Anson, Editor

Another study is raising questions about the safety of the anti-seizure drug gabapentin, especially when it’s taken with opioid pain medication.

According to research published online in PLOS Medicine, combining gabapentin with opioid painkillers is associated with a significantly higher risk of dying from an opioid overdose than opioid use alone.

"Clinicians should consider carefully whether to continue prescribing this combination of products, and when deemed necessary, should closely monitor their patients and adjust opioid dose accordingly," wrote lead author Tara Gomes, PhD, principal investigator for the Ontario Drug Policy Research Network and an assistant professor at the University of Toronto.

Gomes and her colleagues analyzed data from 1,256 people in Ontario, Canada who died from opioid-related causes, and compared them with a control group of 4,619 people who also used opioid medication, but did not die of an opioid-related cause.

Overall, 12.3% of the people who died and 6.8% in the control group were prescribed gabapentin in the prior 120 days. After adjusting for additional risk factors, the researchers estimated that the combination of gabapentin and opioids was associated with a 49% higher risk of dying from an opioid overdose.

Although gabapentin is an anticonvulsant originally developed as a treatment for epilepsy, it is now widely prescribed for neuropathy and other chronic pain conditions, sometimes in combination with opioids.

Until now, no previous study had examined the risks of using gabapentin and opioid medication simultaneously, even though both are known to cause respiratory depression that can lead to an overdose.

“Our study has important implications for public health, particularly given the high degree of co-prescription. Almost 10% of patients treated with an opioid in our study also used gabapentin, while nearly half of patients treated with gabapentin were co-prescribed opioids,” said Gomes.

“Gabapentin is frequently used as an adjunct to opioids for neuropathic pain syndromes, but physicians may not be aware of the potential for respiratory depression with this drug; thus, increased awareness among patients and clinicians about the potential for a life-threatening interaction between these drugs is essential.”

The researchers believe pregabalin, an anticonvulsant that acts similarly to gabapentin, may also raise the risk of overdose when taken with opioids. But they were unable to test their theory because of the limited use of pregabalin during the study period.

Both pregabalin and gabapentin are produced by Pfizer -- under the brand names Lyrica and Neurontin -- and are two of its top selling drugs. Pfizer did not respond to a request for comment on the Canadian study.

A previous study linked pregabalin and gabapentin to an uptick in opioid overdoses in England and Wales. Some addicts believe the drugs can boost the “high” they get from heroin and other illicit substances.

Gabapentin is approved by the FDA to treat epilepsy and neuropathic pain caused by shingles. It is also prescribed “off-label” for depression, migraine, fibromyalgia and bipolar disorder. About 64 million prescriptions were written for gabapentin in the U.S. in 2016, a 49% increase since 2011.

Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, epilepsy, post-herpetic neuralgia caused by shingles and spinal cord injury. It is also prescribed off label to treat a variety of other conditions.

The CDC’s opioid prescribing guidelines recommend both pregabalin and gabapentin as alternatives to opioids, without saying a word about their potential for abuse or side effects. Pfizer has signed agreements with local prosecutors in Chicago and Santa Clara County, California to support the CDC guidelines and withdraw funding from patient advocacy groups and non-profits that question their validity.   

A recent commentary in the The New England Journal of Medicine warned that gabapentinoids -- the class of medication that Neurontin and Lyrica belong to -- are being overprescribed.

"We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” wrote Christopher Goodman, MD, and Allan Brett, MD. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain."

How the FDA Can Help Solve the Overdose Crisis

By A. Rahman Ford, Columnist

As the U.S. Food and Drug Administration prepares to issue new guidelines on stem cell therapy, it must give due consideration to the ever-increasing number of Americans who suffer from intolerable chronic pain.

According to the National Institutes of Health, over 25 million American adults suffer from chronic pain and nearly 40 million have severe levels of pain.  To alleviate that pain, many turn to addictive opioid medications, sometimes with deadly consequences. 

Under former FDA Commissioner Robert Califf, the agency took several steps to reduce opioid addiction, including improved warning labels, enhanced education for prescribers, and the development of abuse-deterrent drug formulations. 

Unfortunately, those initiatives have had negligible success in stemming the tide of opioid overdose, perhaps because, as Califf himself put it, “financial incentives in the (pharmaceutical) industry can lead to a focus on short-term profits instead of patient well-being.”

Indeed, although opioid addiction has seeped into the public consciousness and ascended to the top of many politicians’ agendas, the attention has been largely rhetorical -- practical, immediate-term solutions to the overdose crisis remain few and far between.  Clearly, new approaches are needed. 

Stem cell therapy can be a meaningful intervention in the effort to eradicate chronic pain and end opioid deaths.  The fact is that many physicians are already using stem cells to treat chronic pain safely and effectively, and have been doing so for years. 

Stem cell therapy can be a meaningful intervention in the effort to eradicate chronic pain and end opioid deaths.  The fact is that many physicians are already using stem cells to treat chronic pain safely and effectively, and have been doing so for years.  But with the issuance of new guidelines, which are expected this fall, the FDA could very well limit access to stem cell therapy, even to stem cells that come from our own bodies. 

Current FDA Commissioner Scott Gottlieb recently said stem cells hold “significant promise for transformative and potentially curative treatments,” but some unscrupulous stem cell clinics were preying on sick people desperate to find cures. While cracking down on these bad actors, Gottlieb must not lose sight of the fact that stem cell therapy is a potential solution to everyday Americans’ chronic pain.

Science Supports Stem Cells for Pain

Let’s take a brief look at some of the recent scientific literature about stem cell therapy, and how it can attenuate or even eliminate the chronic pain that results from a myriad of medical conditions. 

A 2014 study in the Journal of Pain Research made the case for the use of adult stem cells to treat neuropathic pain.  Due to the "scarce response to the conventional analgesic therapy,” the authors said it was “mandatory to identify and propose novel approaches" to neuropathic pain. They noted the “fast onset and long-lasting effect on pain relief that one injection (of stem cells) could provide,” an outcome far superior to drugs which require chronic administration, have side effects, and require periodic dose increases.

That same year, an editorial in the British Journal of Medical Practitioners entitled “Stem Cell Therapy: The Future of Pain Medicine” claimed that “recent advancements for SCT (stem cell therapy) for pain due to degenerative diseases in the spine and joints are promising and indicative that SCT will undoubtedly play a major role in the future.” 

A 2015 review in the World Journal of Stem Cells examined the plausibility of using stem cells to treat acute, chronic and neuropathic musculoskeletal pain, concluding that stem cells “show promise for several chronic non-life-threatening yet disabling conditions.”

Just this year, in a review published in Frontiers in Immunology, researchers said stem cells derived from a patient’s bone marrow “may provide efficient, long-term, and safe therapy for patients with painful diseases” such as osteoarthritis, degenerative disc injuries, inflammatory bowel disease, neuropathic pain, and pain associated with cancer and radiotherapy.

Stem cells can alleviate pain in a myriad of ways.  A recent study published in Military Medicine found that a low-dose stem cell injection significantly attenuated neuropathic pain in injured rats, regardless of whether the cells were derived from bone marrow or adipose (fatty) tissue.  The authors concluded that the therapy “has great potential to emerge as an innovative, safe, efficacious, and cost-effective therapy for the treatment [of] neuropathic pain or other chronic pain conditions.”

A 2016 study published in International Orthopaedics followed 26 patients who suffered from chronic discogenic lower back pain who were injected with their own bone marrow concentrate.  All 26 patients had a significant decline in their pain and disability scores, and were able to avoid surgery. 

Stem Cells Can be a Remarkable Solution

As the above sampling of literature suggests, stem cells can treat chronic pain caused by several illnesses.  It is important to note that no subjects in any of the referenced studies experienced significant adverse effects.  Safety was simply not an issue.  The results regarding the use of autologous stem cells – a patient’s own stem cells -- are especially noteworthy because, so long as the cells are “minimally manipulated,” under current FDA regulations approval is not required.

If this were to change due or be restricted under new FDA guidelines, many patients would be left with no viable pain treatment options.  Let us not forget that former Texas governor and current Secretary of Energy Rick Perry once suffered from chronic back pain, and found no answer in surgery or pills.  Perry found relief in his own stem cells.  All of us deserve that chance.

On June 13 of this year, Commissioner Gottlieb made it clear that “everyone at the FDA is committed to focusing on all aspects of the [opioid] epidemic” and promised to seek input from the public “to share additional steps and information that the FDA should consider in addressing these challenges.” 

Commissioner Gottlieb, a growing number of Americans like Secretary Perry are already using stem cells to solve problems that current treatment modalities have failed to cure.  They're traveling to clinics at home and abroad because their pain is disabling and insufferable. 

Commissioner Gottlieb, by adopting a forward-thinking policy on stem cell therapy – specifically autologous stem cell therapy – you can fulfill your promise to the American people.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

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.

Patient Advocates Call on Brandeis to Fire Kolodny

By Pat Anson, Editor

A coalition of physicians, patient advocates and pain sufferers has written an open letter to Brandeis University asking for the dismissal of Andrew Kolodny, MD, a longtime critic of opioid prescribing who is co-director of opioid policy research at the university’s Heller School for Social Policy and Management.

Kolodny is the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that has lobbied politicians and regulators for years to enact stronger measures to limit prescribing of opioid pain medication.

“Dr. Kolodny has been prominent in a national campaign to deny chronic pain patients even minimal management of their pain.  His actions are directed toward forcing draconian restrictions or outright withdrawal of this class of medications from medical practice,” reads the letter to Brandeis President Ronald Liebowitz and other top administrators at the university.

“He calls for forced tapering of patients formerly prescribed opioids. Policy positions for which he advocates are leading to the deaths of hundreds of chronic pain patients by suicide or pain-related heart failure and medical collapse.”

The letter was drafted by Richard Lawhern, PhD, and signed by over 60 healthcare professionals and patient advocates, including pain management specialists Forest Tennant, MD, and Aimee Chagnon, MD. Lawhern is the corresponding secretary of the “Opioid Policy Correspondents List,” an ad hoc volunteer group that advocates for better pain care. The group receives no funding from outside sources.

To read the letter in its entirety, click here.

Kolodny is a controversial figure in the pain community and is often quoted in the news media as an expert on issues involving pain management, even though his professional background is in psychiatry and addiction treatment.  He often refers to opioid medication as “heroin pills” and has suggested that patients shouldn’t trust doctors who prescribe opioids.

“I wish I could tell you that you should trust your doctor and talk to your doctor about this, but that may not be the case,” Kolodny said on C-SPAN in 2015. “We have doctors even prescribing to teenagers and parents not recognizing that the doctor has just essentially prescribed the teenager the equivalent of a heroin pill.”

“Although Dr. Kolodny has a work history in public health and addiction psychiatry, he is neither qualified nor Board Certified in pain management -- a closely related field that has been profoundly and negatively impacted by his assertions concerning public policy. From his published articles and interviews, it is clear to many readers that he knows or cares little about chronic pain patients and their treatment,” Lawhern’s letter states.

In a series of Tweets earlier this year, Kolodny said patients on “dangerously high doses” of opioids should be tapered to lower doses even if they refuse. He then asked for specific examples of doctors “forcing tapers in a risky fashion.”

Dozens of people responded with examples of patients becoming seriously ill or committing suicide after forced tapering, which Kolodny ignored.   

The letter to Brandeis calls Kolodny "one of the most polarizing and hated figures in medicine" among people in pain.

“In our view and those of many people whom he has harmed, Dr. Kolodny makes no positive contribution to the work or reputation of Brandeis or its research centers.  To the contrary, we believe it is ethically and morally imperative that he be dismissed immediately from the University, before his presence further damages both your reputation and your financial endowments,” the letter states.

The university did not respond to a request for comment on the letter. Neither did Kolodny.

Brandeis is a well-regarded liberal arts and private research university located near Boston. The Heller School for Social Policy and Management is often ranked as one of the top ten schools in social policy.  Kolodny joined Heller last year as a senior scientist after resigning as chief medical officer at Phoenix House, which runs a chain of addiction treatment centers.

Kolodny and PROP played central roles in developing the 2016 CDC opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. Although voluntary and only intended for primary care doctors, the guidelines have been widely adopted as mandatory by insurers, federal agencies and throughout the U.S. healthcare system.

In an online survey of over 3,100 pain patients and healthcare providers on the first anniversary of the guidelines’ release, most said the guidelines were harmful to patients, had not improved the quality of pain care, and failed to reduce opioid abuse and overdoses. Critics also cite anecdotal evidence that the guidelines have contributed to an increase in patient suicides.

Heroin Overdoses in ER's Surpass Rx Opioid Overdoses

By Pat Anson, Editor

The number of patients admitted and discharged from U.S. hospitals for abuse of opioid pain medication has declined significantly this decade, while the abuse of heroin and illicit fentanyl has surged, according to a new study that documents the shifting nature of the nation’s overdose crisis.

Researchers at Stanford University analyzed national trends in hospital inpatient and emergency department (ED) discharges for opioid abuse, dependence and poisoning from 1997 to 2014, the last year data was available.

They found that hospital admissions for overdoses from pain medication started falling in 2010, the same year that opioid prescriptions began declining.

At the same time, hospital discharge rates for heroin poisoning increased at an annual rate of over 31 percent. By 2014, heroin overdoses exceeded those from prescription opioids in emergency rooms by almost a 2 to 1 margin.

“After 2008, ED discharge rates for heroin poisoning increased more sharply than the rates for any opioid poisoning -- signaling that the scope of heroin harm is worse than previously suggested -- while discharges for prescription opioid poisoning recently began to decline in both the ED and inpatient settings,” researchers reported in the journal Health Affairs.

“While these changes could be the result of national and local policies aimed at reducing the prescribing of opioids, the expanded availability of heroin and new lethal illicit drugs, such as nonpharmaceutical fentanyl, could mean that they are being used instead of prescription opioids.”

The findings add evidence to recent public health concerns that people misusing or addicted to prescription opioids are switching to heroin and synthetic opioids such as fentanyl because they are cheaper and easier to get.

"This suggests that the expanded availability of lethal illicit drugs are being used to replace prescription opioids in some cases," said Tina Hernandez-Boussard, PhD, associate professor of medicine, of biomedical data sciences and of surgery at Stanford University School of Medicine.

source: health affairs

The Centers for Disease Control and Prevention has been reluctant to admit that efforts to reduce opioid prescribing could be backfiring, although their own statistics indicate otherwise.  Deaths involving heroin and synthetic opioids overtook overdoses linked to prescription opioids in 2016, the same year the CDC released its opioid prescribing guidelines.

As PNN has reported,  the CDC last week launched a public awareness campaign to combat the abuse of prescription opioids, a marketing effort driven by surveys and focus groups that completely ignores the scourge of heroin and illicit fentanyl.

“The campaign does not include messages about heroin. Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging. Heroin is a related topic that also needs formative research and message testing,” the CDC explained.

The Stanford study found that discharge rates for prescription opioid poisonings declined annually by about 5 percent from 2010 to 2014, while discharge rates for heroin poisoning increased at an annual rate of 31.4 percent from 2008 to 2014. The trend has likely worsened since 2014, as heroin and illicit fentanyl are even more widely available on the black market.

"I'm cautiously optimistic that prescribing clinicians are positively reacting to the opioid crisis and therefore prescription opioids are contributing less to the overall drug epidemic," Hernandez-Boussard said. "That's the good news. The bad news is that although prescription opioid use decreased, heroin and methadone greatly increased.”

Anna Lembke, MD, an associate professor of psychiatry at Stanford and a board member of Physicians for Responsible Opioid Prescribing (PROP), says she has no doubt many people addicted to prescription opioids have switched to using heroin or illicit fentanyl.

"My patients have told me that's exactly what they did," said Lembke. "Heroin was cheaper and easier to get."

Getting off Painkillers With Lidocaine Infusions

By Crystal Lindell, Columnist

I keep telling myself I’ll write about my weekly lidocaine infusions when I finally have everything figured out. 

I just need to figure out how to pay the $80-a-week co-pay, figure out who can drive me two hours each way to the hospital, and figure out how to manage the extreme fatigue I endure for at least 24 hours after each infusion. And I need to figure out how I can possibly do this every single Friday for the rest of my life.  

And then, once I figure everything out, I can tell you guys how I solved all of it and you will think I’m awesome. 

But I can’t freaking figure anything out.

I started the infusions this summer at the suggestion of my pain management doctor. I did a trial run, which was completely insane, but actually worked to cure my chronic pain for six days. And then I decided to continue the treatments weekly, because that’s how long it lasts for me. 

The first infusion was intense. Symptoms included: randomly crying and laughing because I lost control of my emotions, my lips going numb, extreme fatigue, losing coordination in my legs, nausea, and not being able to make basic life choices afterward — to the extent that I couldn’t even pick out which rice I wanted at Qdoba.  

Thankfully, the symptoms seem to be less intense as you get more of the infusions. I’m still extremely tired after each one though, and unable to drive, and my heart always feels weak. Also, I still can never decide on which rice to get. But I don’t feel like I’ve lost my mind each time. 

Each one takes about two hours at the hospital from start to finish, but that also include a saline flush at the end. I also need a full 24 hours to recover from every single one. And it’s not like an “Oh, I’m so high and this is fun!” 24 hours. It’s more of a hangover/flu/fatigue 24 hours. 

Also, like I said above, I have an $80 co-pay every week that I cannot afford at all. But actually that’s a great deal because the total bill for each one is about $500. I’m blessed to work full-time from home and have great insurance that mostly covers it. As far as chronic pain patients go, I’m probably in the top 1 percent. But it’s still too much for me. 

Honestly though, the hardest part has been finding rides. It’s a two-hour drive each way I’m and way too out of it afterward to drive myself. I have not been able to find anyone locally who does the infusions because the treatment is relatively new for chronic pain. And my town is so rural that we don’t even have Uber. If I ever have to stop the infusions, it will probably be because of that.

At this point you might be asking, “Crystal, this sounds like A LOT! Why are you even doing this? Why not just stick with hydrocodone?”

Because it freaking works. Really freaking well. And I kind of hate that it works because it is a traumatic experience every time, and I literally lose a day of my life every week and have no money. 

But dang if I haven’t had the best summer of my (post-pain) life this year. I’ve lost 33 pounds. I’ve been walking about six miles a day, six days a week. And while I still have some flares, I have entire pain-free days with NO hydrocodone or any other types of pain meds. And that means I get to live my life AND have complete mental clarity. In short, my quality of life has improved dramatically. 

It’s been miraculous. And thus, I am highly motivated to continue this treatment. 

Since starting the infusions, I have discovered a few helpful things. For example, drinking a full-sugar Gatorade and eating a Snicker’s bar right before the infusion seems to help with the fatigue. And doing a longer saline flush also helps with the after-effects. 

Also, the less I do physically the day of the infusion, the easier it is for me to recover afterward. And it’s important to wear extremely comfortable clothes and a large sweater regardless of the weather because the medication messes with your body temperature. 

I have not figured out the transportation yet, obviously. I actually called my insurance company today to ask if they had any suggestions, and they literally said, “Have you tried Googling it?” 

Yes. I have tried Googling it. 

I also called the hospital and they told me the only transportation they do is with an ambulance. Cool. Thanks. 

I’ve called a million local pain doctors and infusion centers and had appointments with a handful of them trying to find a local provider. One pain doctor said he could do them for me once a month, but that’s not enough and I’d just end up going on and off hydrocodone all the time. 

Every time I talk to a new pain doctor I beg them to start or expand this treatment so that others with chronic pain can get the same relief I do. 

With all the anti-opioid hysteria you would think doctors would be begging patients to try treatments like this. But alas, they are still sticking to the classic list of things that don’t really work — mindfulness, Cymbalta, nerve blocks, epidurals, and my personal favorite: “You should be taking fewer meds but I have no alternatives to offer.”

In contrast, research is showing that lidocaine infusions can be very effective. In a study recently published in Pain Medicine, they were shown to provide long-lasting and adequate analgesia in 41 percent of patients with chronic pain, most of whom had neuropathic pain. 

I am holding out hope that treatments like this will become more common and less expensive. But there’s another part of me that does worry that pumping my body full of an intense drug every week could have long-term effects that haven’t been discovered yet. 

In the end of course, treatment decisions like this have to be made on an individual level. Only you and your doctor can decide if getting drugged every week is worth it for six pain-free days.

For me though, it definitely is. 

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.

Would You Support a Boycott of CVS?

By Pat Anson, Editor

One of the most talked about issues in the pain community over the last two weeks has been CVS Health’s announcement that its pharmacists would soon start restricting doses of opioid pain medication and limit the supply of opioids for acute pain to 7 days.

The policy only applies to customers enrolled in CVS Caremark’s pharmacy benefit management program, but it quickly triggered an online backlash from pain patients – including many who called for a boycott of CVS.

“I refuse to patronize companies that practice medicine without a license,” wrote Jeannette on PNN’s Facebook page.

“Don’t go there anymore. Hit them in their pocketbook,” wrote Lauren.

“I very rarely use a CVS and will never go there for prescriptions or anything else,” said Jackie.

“I left CVS years ago for Walgreens and I’m guessing many more will be doing so,” wrote Amanda.

"CVS has some nerve. The use of opioids, or any other drug, really, is up to the doctor and his or her patients, not a pharmacist. This is a terrible precedent, which will drive an even bigger wedge between physicians and patients,” cardiologist Arthur Kennish, MD, told the American Council on Science and Health.

The CVS boycott soon had its own hashtag on Twitter.

“Wrong way to handle, CVS! I will join the #BoycottCVS. You make it more difficult for the sick w/ no impact on the crisis,” Stephanie tweeted.

The online outrage even spilled over onto CVS’ Facebook page, where many negative posts were apparently deleted by the company.

“CVS Pharmacy, why did you take down all your Posts and comments regarding your big announcement over overriding doctor's orders and limiting patients' rights to their pain medication?” asked Lauri. “Where did they all go?”

People are so passionate about this issue that we started an online poll asking if they would support a boycott of CVS. Click here if you’d like to participate.

Would a Boycott Work?

But while there’s plenty of online enthusiasm for a boycott, it’s unlikely to be effective without the support of patient advocacy groups.  An informal survey of pain organizations by PNN found most were critical of CVS’ decision, but opposed to a boycott.

“I think boycotting CVS is not a good idea. I think a better idea is working with them for better care and finding the good in what they are doing and amplifying the bad.  They want better education, they want better disposal, and many other things we all fight for,” said Paul Gileno, President of the U.S. Pain Foundation.  “I don't think a boycott would work or be effective and can come across in a negative way. We need a loud conversation with CVS.”

“I don’t typically like boycotts” said Barby Ingle, President of the International Pain Foundation and a PNN columnist. “But if enough people have a bad experience or don’t like the CVS policies, they will see a drop in the market and will have to reevaluate what their policies will be.

“I wouldn’t call it a boycott, I would call it a shift in patients understanding that we have power and that we can choose to go to the healthcare places that fulfill our needs. Unless CVS changes their practices, I can see them continuing to lose business.”

Penney Cowan of the American Chronic Pain Association did not respond to a request for comment.

One patient advocate who gave full support for a boycott was Cynthia Toussaint, the founder of For Grace, a non-profit that supports women in pain.

“The lack of patient advocacy support for the boycott is totally surprising,” Toussaint wrote in an email. “We’ve all been beating the ‘don’t get between a doctor and a patient’ drum for years, and now that we can put our names behind that, we’re being sheepish.

“For Grace is ON BOARD with the boycott! This is chilling news for the pain world - and I hope our support helps many people. We understand CVS’s very real concern about the opioid crisis, but this new policy is too heavy handed and will greatly harm the chronic pain community!”

CVS is not the first pharmacy to restrict access to opioid medication. In 2013, Walgreens gave its pharmacists a “secret checklist” to help them screen patients with opioid prescriptions. Any red flags, such as a prescription written by a new doctor or a patient paying in cash, could result in a prescription not being filled. The policy was implemented after Walgreens was fined $80 million by the Drug Enforcement Agency for violating the rules for dispensing controlled substances.

CVS has also been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

A Florida pharmacist who was fired this year by Sam’s Club for not following the company's opioid policy says pharmacies are driven by profit, not patient care, and a boycott is unlikely to change their bottom line. 

“Patients won't need to boycott. CVS doesn't want the business anyway,” says Karl Deigert, who was fired after complaining that patient rights were being violated at Sam’s Club, which is owned by Walmart.  “Corporations are only acting in their own best interest and have no concern for the patient. Patients can save their breath and energy as any complaints filed will fall on deaf ears. 

“Overzealous corporate policy makers have no desire or interest to protect the patients' well-being. Their policy making is self-serving to protect their assets from DEA scrutiny and monetary penalties. The corporations and the majority of retail pharmacists simply do not care to help the chronic pain patient population.”

The new opioid policy at CVS doesn’t go into effect until February 1, 2018. But CVS Caremark is already tightening the rules for some opioid prescriptions. 

A Caremark client who has been getting fentanyl pain patches at CVS for years was recently notified by letter that new limits are being placed on the patches “to help ensure that your use of opioid medication for pain management is safe and appropriate.” 

But is it really about safe and appropriate use?

The letter goes on to say the patient will still be able to get the fentanyl patches, but without prior authorization they “will have to pay 100 percent of the cost.”

Painful Opioid Statistics

By Roger Chriss, Columnist

The opioid crisis continues to worsen, and media coverage continues to be overly simplistic.

Vox recently reported the U.S. “absolutely dwarfs” all other countries in opioid prescriptions, in a story headlined “America’s huge problem with opioid prescribing, in one quote.”

"Consider the amount of standard daily doses of opioids consumed in Japan. And then double it. And then double it again. And then double it again. And then double it again. And then double it a fifth time. That would make Japan No. 2 in the world, behind the United States," Stanford psychiatry professor Keith Humphreys told Vox.

Although Humphreys’ statement is accurate, it is a misleading oversimplification that omits important context, including the rising rate of heroin and fentanyl-related deaths, and the shifting landscape of opioid prescribing.

First, this statistic represents an average (or mean). It does not include the variance, a measure of how many people use what quantity of opioids. The average person in the U.S. does not use any opioids at all. But people suffering from opioid addiction may use a large quantity of opioids every single day of the year.

In statistical work, reporting an average without the variance is considered sloppy at best, misleading or manipulative at worst.

Humphreys’ statement also fails to distinguish between the legal and illegal use of “pharmaceutical opioids,” a convenient term to refer to legally manufactured opioids, regardless of whether they are used for valid medical purposes, or diverted, shared or sold.

In other words, the much higher number of pharmaceutical opioids in the U.S. compared to Japan reflects both medical use and misuse.  

Further, this statistic assumes that Japan’s level of pharmaceutical opioid consumption is somehow better. In fact, Japan has a well-documented history of undertreating pain because of fears about opioid addiction. Pain is so poorly treated in Japan, according to The New York Times, that the government launched a campaign in 2007 urging patients to request pain relief, with hospital posters urging patients to “Tell Us About Your Pain.”

Japan continues to struggle with high levels of chronic pain. A 2015 review found a “high prevalence and severity of chronic pain, associated factors, and significant impact on quality of life in the adult Japanese population."

The Vox article also fails to point out that opioid prescribing in the U.S. peaked in 2010 and has been declining ever since. Yet opioid addiction and overdose deaths have been steadily rising, fueled largely by illegal opioids such as heroin and illicit fentanyl.

Vox is not alone in oversimplifying a complex problem. CNBC, for example, reported last year that “80 percent of the global opioid supply is consumed in the United States.”

Many others have repeated that claim, including Missouri Sen. Claire McCaskill, who recently tweeted that, "We have 5% of world population. 80% of opioids."

PolitiFact ran a fact check on McCaskill’s numbers and found them “greatly exaggerated.”

“While the United States is clearly the largest consumer of opioids, it, at most, accounts for roughly 30 percent of global consumption. We rate McCaskill’s claim False," PolitiFact said.

This is a significant issue in the opioid crisis. While some journalists, politicians, and even physicians name villains, people suffering from opioid addiction continue to get substandard treatment. And people who benefit from opioid therapy are struggling more and more to find physicians willing to prescribe and pharmacies willing to fill opioid prescriptions so they can have a reasonable quality of life.

No one is suggesting that the U.S. needs more opioids, particularly in the acute care setting. Opioids should be prescribed with close monitoring by physicians with experience in pain management. The research literature and public health studies agree that over-prescribing occurred, especially in pill mills and dubious pain clinics. In addition, drug theft and diversion are huge problems.

So while a statistic that invokes multiple doublings for comparative purposes sounds impressive, its context is much more important. We need to focus on the crisis as it really is, without exaggeration, if we hope to have meaningful progress ending it.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

Fake Fentanyl Pills Found in 40 States

By Pat Anson, Editor

Counterfeit painkillers and fake medications made with illicit fentanyl have killed Americans in at least 16 states, according to a new report that found the highly dangerous pills have spread from coast to coast.

“We have documented the spread of counterfeit pills made with illegal fentanyl throughout 40 states. There is documentation that counterfeits made with fentanyl have killed Americans in at least 16 of those states. The other 24 states probably have deaths attributable to counterfeits made with fentanyl, but because of limited awareness of the problem, those deaths may not have been investigated for counterfeit drugs,” said the report by the Partnership for Safe Medicines (PSM) a coalition of pharmacy groups and other healthcare organizations.

The report is based on a review of court records, statements by law enforcement and public health agencies, and news reports.

Fentanyl is 50 to 100 times more potent than morphine. It is legally available in lozenges, patches and other medications to treat severe pain, but in recent years illicit fentanyl has become widely available on the black market, where it is often mixed with heroin or used in the production of counterfeit drugs.

Many addicts looking for a high or pain sufferers looking for relief have no idea what they’re buying. Experts say a single dose of fentanyl as small as two or three milligrams can be fatal.

“Up until now, it’s been difficult to grasp the scope and pervasiveness of the counterfeit drug problem,” said Dr. Marvin Shepherd, chairman of the PSM Board and former director of the Center for Pharmacoeconomic Studies at the University of Texas at Austin’s College of Pharmacy. “We’ve had a number of examples of counterfeit pill seizures and tragic fentanyl-related deaths, but this report paints a picture of a nation under siege from fake and lethal drugs coming across our borders.”

Massachusetts, Pennsylvania, New Jersey, Ohio and several states now report they have more people dying from overdoses of illicit fentanyl than from prescription opioids. 

Most of the illicit fentanyl is manufactured in China and smuggled into the U.S. by drug cartels. In August, the Mexican military found over 140 pounds of powdered fentanyl hidden inside a tractor trailer rig at a checkpoint near Yuma, Arizona. The shipment, which had an estimated street value of $1.2 billion, also included nearly 30,000 counterfeit tablets made with fentanyl.

The fake pills are often designed to look like oxycodone or the anti-anxiety drug Xanax, and are hard to distinguish from the real thing.

“They’re relatively cheap (to make) and the profit margin is phenomenal,” said Lisa McElhaney, President of the National Association of Drug Diversion Investigators, during a recent seminar for pain management providers. “You’re talking about such a miniscule amount (of fentanyl). But it has such a heavy potency and purity level that it is fatal.”

McElhaney said the black market in prescription drugs used to be dominated by legally-made medications that were stolen or diverted from medicine cabinets, pharmacies or drug manufacturers. She now believes most of the pills sold on the street are counterfeit.

counterfeit oxycodone pills

“I would say 99% of what we are seeing on the street, bought and sold, is product from China, India, Mexico, or from second or third-hand distributors. It is not pharmaceutical grade, FDA approved fentanyl,” she said.

While the DEA and other law enforcement agencies have been warning of the fentanyl problem for years, federal health officials have been slow to recognize or even address it – focusing instead on limiting the use of opioid pain medication.

For example, the Centers for Disease Control and Prevention recently launched a new marketing campaign, using videos, online advertising, billboards, newspapers and radio ads to raise awareness about the risks of prescription opioids. The campaign completely ignores the role of fentanyl and heroin in the overdose crisis, because the CDC didn't want to risk “diluting” its primary message.

“Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging,” the CDC explained.

Politicians are also focused on prescription opioids. Several states have adopted or are considering laws that limit opioid prescriptions for acute pain to only a few days’ supply – a move that President Trump’s opioid commission appears to be considering as a recommendation in its final report.

“This is a prevention measure… to limit the number of drugs that are out there for improper diversion and to make sure that we don’t inadvertently turn people into addicts by giving 30, 60, 90 pills the first time,” said commission chairman Gov. Chris Christie of New Jersey, whose state has adopted a five day limit on new opioid prescriptions.

This week the Pharmaceutical Research and Manufacturers of America -- an organization that represents virtually every major drug maker – told the commission that it would support a 7-day limit on opioid prescriptions for acute pain.  

CVS Defends Rx Opioid Policy

By Pat Anson, Editor

CVS Health has released new details about its plan to limit the dose of opioid pain medication and restrict new prescriptions for acute pain to a 7-day supply.

The new policy, which was announced last week, immediately sparked an online backlash from chronic pain patients, who fear they will no longer be able to refill their opioid prescriptions at CVS or will have to do it weekly.

“It's crazy what's going on. Every week going to doctors and pharmacists paying that extra money. This is a crime on the sick,” wrote Amy in a Facebook post.

“Even for new patients, this doesn't make sense,” wrote Jennifer in another online post. “After surgery some patients need these medications for longer than 7 days. Driving to the doctor to get a new script, then to the pharmacy to get more medication is not conducive to healing.”

“How can they single out medications and refuse when the doctor writes them for 30 days?” wrote Hazel. “Everyone should boycott them, not only for prescriptions but shopping there for anything. This is getting ridiculous!”

Asked to comment on these and other concerns, CVS Health emailed a statement to PNN answering a series of questions we had about its new opioid policy. We were not allowed to interview anyone at CVS directly.

The questions and answers below were edited for clarity:

PNN: Many of your customers with chronic pain believe they'll have to go to a CVS pharmacy four times a month to get their refills. Can you clarify that for them? 

CVS: The seven day quantity limit on opioid prescriptions, going into effect on February 1, 2018 for CVS Caremark's pharmacy benefit management (PBM) clients, applies only to prescriptions written for acute conditions, such as a minor surgery or dental procedure, that generally last only for a short duration. 

We recognize that there are patients with a legitimate need for pain medication, and our approach is carefully designed to ensure that those patients can access their medication in an appropriate manner.  We are dedicated to ensuring our retail and PBM approaches do not negatively affect patients who are in need of their chronic pain medication.   

PNN: What happens when a patient recovering from surgery needs opioid medication for more than 7 days? Do they go back to their doctor and get a new prescription?

CVS: Our program encourages safe and appropriate utilization of opioids by managing utilization in a manner consistent with the Guideline set forward by the CDC.  Our efforts to ensure safe and appropriate opioid use are designed to improve the quality of care and health outcomes for patients.  If a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: What about limiting opioid prescriptions to 90mg morphine equivalent (MME) doses? Some pain patients are prescribed more than that.

CVS:  The CDC recommends that clinicians prescribe the lowest effective opioid dose and use caution when prescribing opioids at any dosage.  Further, the Guideline indicates physicians should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day. 

We are aligning our standard utilization to these limits for all patients who are not in active cancer treatment, palliative care, or hospice care.  However, if a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: You say you are following the CDC guideline, but the guideline is voluntary and only intended for primary care physicians treating chronic pain. You are making them mandatory for all doctors and all patients for all types of pain.

CVS: Given the toll opioid misuse has taken on our country, we believe it is appropriate to align our utilization management of opioids for our members with the Guideline set by the CDC.  Our efforts to ensure safe and appropriate opioid use are designed to improve the quality of care and health outcomes for patients.  Notably, if a prescriber feels patient care should exceed these limits, the prescriber can request an exception. 

PNN: Many patients complain that there's already a tendency by some pharmacists to refuse to fill opioid prescriptions to avoid hassles, extra work, etc. and to send them away without their medication. How will CVS make sure its pharmacists abide by your rules and not invent new ones?

CVS: Our opioid utilization management program will be consistently executed as a coverage determination across all pharmacies in our PBM retail network.  Pharmacists at CVS Pharmacy, or any of the other retail pharmacies in our network, will not be making independent medical judgments about the appropriateness of opioid prescribing or the length of such prescribing. Additionally, the program we have recently announced does not impact prescriptions filled for CVS Pharmacy retail customers who are not covered by the CVS Caremark PBM.   

Our pharmacists are committed to providing the highest level of care for their patients.  At our retail pharmacies, we are also strengthening counseling for patients filling an opioid prescription with a robust safe opioid use education program highlighting opioid safety and the dangers of addiction. 

'Cookie Cutter' Approach to Pain Care

CVS is not the first pharmacy to adopt rules that limit the dispensing of opioids, but it is the first major chain to set a 7-day limit on prescriptions for acute pain. Given recent trends, it is probably not the last.

Several states have already adopted laws that limit opioids to a few days' supply for acute pain. And yesterday a major pharmaceutical organization announced its support for a 7-day limit on new opioid prescriptions.  

Critics say this “cookie cutter” approach to pain care ignores the fact that when acute pain is poorly treated or untreated, it can turn into chronic pain in a matter of months or even weeks.

And chronic pain can worsen or cause other life-threatening health problems, including high blood pressure, stroke, heart attack, depression and suicide ideation.

Each patient is also different. A large new study published this week in JAMA Surgery looked at the different lengths of time patients needed opioid medication while recovering from 8 common surgical procedures.

While a 7-day supply of opioids was adequate for most patients recovering from an appendectomy, hysterectomy, hernia repair and other common surgeries, an analysis of over 215,000 surgery patients found that about 20 percent of them needed at least one refill of their prescription. Orthopedic and neurological procedures were the most likely to require a refill, and Medicare patients were the most likely group to need opioids for more than 7 days after a surgery.

“Although 7-day limits on initial opioid pain medication prescriptions are likely adequate in many settings, and indeed also sufficient for many common general surgery and gynecologic procedures, in the postoperative setting, particularly after many orthopedic and neurosurgical procedures, a 7-day limit may be inappropriately restrictive," wrote lead author Louis Nguyen, MD, of Brigham and Women’s Hospital, Harvard Medical School.

But not everyone finds fault in the cookie cutter approach. In an editorial also published in JAMA Surgery, a leading surgeon wrote that “any effort” to reduce the frequency of opioid prescriptions was a good thing.

“Unfortunately, we have reached a point that 100% elimination of pain has become not only the goal but the expectation. If a surgeon allows a patient to expect a pain-free recovery, he or she will see refill requests increase,” wrote Selwyn Rogers, MD, chief of surgery at the University of Chicago Medicine Trauma Center.

“Alternatives to narcotics should be recommended and incorporated as the foundation of pain management. It does not take much time to explain the use of acetaminophen and ibuprofen and then follow up with a stronger option if the pain is not adequately relieved. It is also useful to prepare the patient to expect some discomfort, realize that complete relief of all pain is impossible, and that the cost of trying is not worth it.”

Chronic Pain in the Workplace

By Lana Barhum, Columnist

Unless you have lived with chronic pain, you cannot begin to fathom the physical and psychological torture many people in pain go through.  Chronic pain is an issue so often ignored in the workplace.

About a year ago, I wrote an article about “presenteeism,” which basically is the act of attending work while you are sick.  But presenteeism isn’t just showing up for work when you have a cold or the sniffles, it is showing up to work every day despite pain, fatigue and other symptoms that come with chronic pain and illness.

Presenteeism was recently researched by the Global Corporate Challenge (GCC), which found that while employees with chronic health conditions took an average of just four sick days a year, they confessed to being unproductive at work an average of 57.5 days a year.

The GCC report estimated that the cost of presenteeism was 10 times higher than absenteeism. Absent workers cost employers in the United States, United Kingdom and Australia about $150 billion a year, but those who came to work and were not fully productive cost them $1,500 billion.

The study’s authors noted the importance of companies to improve productivity by putting their focus on reducing presenteeism.

I am not sure employers know or even care how many of their people are dealing with chronic pain challenges.  And if they do, what expectations do they have of these employees? Do they even understand the difficulties of being productive when you are physically hurting?

Chronic Pain and Lost Productivity

According to another report from the Institute of Medicine Committee on Advancing Pain Research, Care and Education, chronic pain is costing the U.S. economy between $560 to $635 billion annually in healthcare costs and lost productivity. While many employees who live with pain continue to work, they struggle to be productive. 

One possible solution – opioid pain medication – is no longer easily accessible, even for pain patients who don’t misuse prescription drugs and who want to have normal, productive lives.

Research has shown that about two million Americans misuse opioids, and a good chunk of them wind up in emergency rooms. But that statistic ignores the millions of people that need pain medications and don’t abuse them.

Too many prescribing guidelines -- and fear of DEA oversight -- keep our doctors from writing prescriptions for pain medication, even for medicines that are relatively safe and have low risk of addiction.  Guidelines and insurance reimbursement policies have basically taken discretion away from responsible doctors in managing patient pain care.

Some chronic pain sufferers won’t even ask their doctors about pain medication because of the stigma attached to opioid misuse and abuse. Up until recently, I was one of them. I wouldn’t ask my doctor for medication to manage my pain because of that very stigma.  But my pain levels got so bad I had no other choice.  And my doctor, like so many others, was wary of writing a prescription and didn’t give in until I was practically begging. She explained she trusted my judgment, but was limited in her options due to government guidelines.

Working with Pain

The biggest concern I have on an almost a daily basis is how long I will be able to continue working. Will my boss get tired of the mistakes I make on the days I am hurting and my focus is off due to pain and lack of sleep? While my employers know I live with pain from rheumatoid arthritis and fibromyalgia, they really don’t care – most likely because my disability is invisible, but also because it isn’t their problem – it is mine.  

I am not sure most employers or coworkers understand the overwhelming and difficult responsibility of holding down a full-time job when you live with chronic pain.  Even if your employer provides accommodations – like workspace adjustments and options to work from home on occasion – the basic requirements of the job can still be great when you are hurting.

In an ideal world, employers would offer options for pain management on the job -- in the form of wellness programs and workplace accommodations – so we could work at full capacity.  Employees who feel supported will seek out all available help, feel better, and function better on the job. 

But most employers have yet to recognize the crucial role they play in helping to manage the pain epidemic in this country.  They see chronic pain as a personal problem, rather than a business dilemma.   Until that changes, we are on our own to suffer in silence and figure out how to work better, despite the pain that we endure. 

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother who lives with rheumatoid arthritis and fibromyalgia. Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit 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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.