FDA Warns Promoters of Herbal Addiction Treatments

By Pat Anson, Editor

The U.S. Food and Drug Administration is following through on its threat to crackdown on companies selling kratom and other herbal supplements as treatments for opioid addiction and withdrawal.

The FDA and the Federal Trade Commission (FTC) have sent joint warning letters to the distributors of 15 herbal supplements for illegally marketing unapproved products.

“The FDA is increasingly concerned with the proliferation of products claiming to treat or cure serious diseases like opioid addiction and withdrawal,” said FDA Commissioner Scott Gottlieb, MD. “People who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims.”

The companies used websites or social media to make claims about their products' ability to cure, treat or prevent opioid withdrawal and addiction.

TaperAid, for example, claims its “17 all-natural organic herbs” can relieve symptoms of withdrawal and even reduce tolerance to opioid painkillers.

“Use of TaperAid may increase sensitivity to opioids. You may need to lower your usual intake of opioids to account for reduced tolerance,” the company claimed. “People using short acting opioids (which includes many pain management medications and heroin) will notice a significant lowering of tolerance to their opiate of choice.”

TaperAid’s website and Facebook account have been taken down, although a TaperAid review can still be found on YouTube.

“Opioid addiction is a serious health epidemic that affects millions of Americans,” said acting FTC Chairman Maureen Ohlhausen. “Individuals and their loved ones who struggle with this disease need real help, not unproven treatments.”

In addition to the warning letters, the FTC released a “fact sheet” warning consumers about companies that promise miracle cures or fast results.

“Dietary supplements – such as herbal blends, vitamins, and minerals – have not been scientifically proven to ease withdrawal or to treat opioid dependence,” the FTC warned. “Products like Kratom, which some claim can help, are actually not proven treatments, and can be addictive and dangerous to your health.”

The FDA issued a public health advisory about kratom last November, saying there was “no reliable evidence to support the use of kratom as a treatment for opioid use disorder.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties.  Millions of Americans have discovered kratom in recent years, and use it to treat addiction, chronic pain, anxiety and depression. The herb is not approved by the FDA for any medical condition. 

In 2016, the Drug Enforcement Administration attempted to list kratom’s two active ingredients as Schedule I controlled substances, which would have made it a felony to possess or sell kratom. The DEA suspended its plan after a public outcry, saying it would wait for a scheduling recommendation and medical evaluation of kratom from the FDA. Over a year later, that report has still not been released.

New Hope for Hard-to-Treat Migraine Patients

Amgen and Novartis have announced promising results from a Phase III clinical trial of an injectable new migraine drug called Aimovig (erenumab).

In a study of 246 patients with episodic migraine, significantly more patients injected with Aimovig had at least a 50 percent reduction in the number of monthly migraine days compared to a placebo. The study was the first of its kind to include hard-to-treat patients who have tried and failed at least two other migraine medications due to lack of efficacy or intolerable side effects.

"We've purposely designed a clinical program for Aimovig that examined a broad spectrum of migraine patients, ranging from those who have never tried a preventive treatment to patients who have tried and failed such treatments," said Sean Harper, MD, executive vice president of Research and Development at Amgen.

"These data in patients with multiple treatment failures, who are not only considered difficult to treat but also have few options available, add to the consistent body of evidence for Aimovig.”

Aimovig belongs to a new class of medication – known as fully human monoclonal antibodies -- that target and block receptors in the brain where migraines are thought to originate. It is designed to be administered once a month with a self-injection device for migraine prevention.

"The results add to the consistent body of evidence for erenumab (Aimovig) across the full spectrum of migraine patients, from those trying preventive medication for the first time through to those who have failed multiple therapies and have been suffering for years,” said Danny Bar-Zohar, Global Head of Neuroscience Development for Novartis.

“We look forward to making erenumab, the first targeted preventive option specifically designed for migraine, available to patients as soon as possible."

Amgen and Novartis expect the Food and Drug Administration to make a decision on Aimovig in May. The two companies will share sales rights to Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize it in Europe and the rest of world.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

About half of people living with migraine are undiagnosed. Current medications to prevent migraines have been repurposed from other medical conditions, and are often associated with poor results.

4 O’s That Can Help Relieve Chronic Pain

By Barby Ingle, Columnist 

Each pain patient is different, even when we share the same disease or condition. How we treat, manage and find solutions for our chronic pain is also different, due to biological makeup and life experiences. A one-size-fits-all approach to treating pain is impractical and will not yield the best results. 

This month I continue my alphabet series on alternative pain therapies by looking at four O’s – oral orthotics, orthomolecular medicine, osteopathy and occupational therapy -- treatments that may help you or a loved one in chronic pain. 

Oral Orthotics

An oral orthotic (OO) device is a topic I have written about and made home videos of, as it is a treatment I personally have used since 2012. 

The OO is used to change the size, shape, and relationship of the bones in the face and jaw, to create a symmetry and balance that helps lower neuro-inflammation in your spine and brain. Many people with chronic pain don’t realize that their spinal nerves run right through the small space in their temporal mandibular joint (TMJ) before reaching the brain.

I underwent multiple tests before being fitted for my orthotics, including cat-scans, X-rays and other measurement tests. I also participated in an OO research study, which helped me learn how the device can work for chronic pain and other neuro-inflammatory diseases.

I didn’t fully understand in the beginning how creating the proper spacing and mechanics in my jaw could actually help the burning pain in my feet and legs. My orthotics have helped me reduce my pain levels and allowed me to stop taking daily pain medication. They work so well for me that I have even been able to cut back on my IV ketamine infusions. 

I have two orthotic devices, for use during the day and night. My day version snaps over my bottom teeth, and my night version has two parts for the top and bottom teeth. Each has different mechanics, which work to best fit my needs.

Every patient is different, and each device has to be measured and made specifically for you. For more information you can check out Dr. Gary Demerjian’s site: TMJ Connection.  

This type of treatment isn't cheap. It costs from $2,500 to $5,000 to start, and a few hundred dollars a year to maintain. But It helps me avoid paying for many other expensive therapies and medications. It is well worth the price and effort, when done by a competent neuro-dentist who understands chronic pain and the TMJ connection. 

Orthomolecular Medicine

Orthomolecular medicine is based on maintaining human health through nutritional supplements. Supporters of this treatment believe that vitamins, minerals, amino acids and other natural substances can be used to correct imbalances and deficiencies in the body that lead to illness.

Orthomolecular providers may also incorporate dietary restrictions and mega doses of vitamins and pharmacological medications.

Large doses of any substance can cause problems. For example, too much vitamin B12 can cause hypersensitivity and neuropathy pain. Some vitamins in large doses can also increase the risk of cardiovascular disease and cancer.

I personally have not tried this method myself, as all of my blood testing shows that my vitamin levels are fine and my providers recommend against it. I do know a few patients, including my mom, who have tried it.

My mom had complications from high doses of Vitamins B6 and B12. She experienced nerve damage and “pins and needles” pain in her hands from B6; while B12 caused side effects such as headaches, dizziness, diarrhea, indigestion, nausea, back pain, swelling, anxiety and lack of coordination. 

Most of the other patients I know who tried this method did it with high doses of Vitamin C pills or infusions. They believe it helped prevent their disease from spreading or getting worse. 

Osteopathy

Osteopathy is a type of alternative medicine that emphasizes manual readjustments, myofascial release and physical manipulation of muscle tissues and bones.

I have had myofascial release and other physical manipulation treatments for my muscle and bone pain. They were helpful in lowering my pain levels, but the benefits were not significant or long-lasting.

Osteopathy medicine is recognized internationally in the treatment of many pain diseases involving muscle and bone. However, the profession has branched into two directions: non-physician manual medicine osteopaths and medical osteopathic physicians. They practice distinctly different techniques and function as two separate professions.  

Doctors of Osteopathic Medicine (DO) are fully licensed physicians who practice in all areas of medicine. They emphasize a whole-person approach to treatment and care, and are trained to listen and partner with their patients to help them get healthy and stay well.

My general practitioner is a DO and many of the best practitioners I know are as well. I do see a difference in their approaches to care, how I am listened to, and in the treatments they offer.

Although many countries consider there is good evidence behind manual manipulation, they differ on the parts of the body where it is most helpful. Most believe that it is best for low back pain. There is limited evidence for other issues like neck, shoulder or lower limb pain, and in recovery after hip or knee operations.

I personally used the myofascial release after a knee surgery in 2001, as well as similar treatments after an auto accident in 2002. For me, they didn’t help with my headaches, migraines, digestive issues or nerve pain.

Occupational Therapy

Occupational therapy (OT) is often confused with occupational medicine, which deals with the maintenance of health in the workplace. Occupational therapy, on the other hand, is used to help a patient recover or maintain meaningful daily activities.

After a hospitalization with internal bleeding, an OT therapist would come to my home to help me learn and regain abilities to do daily activities around the house. When the therapist first arrived, I was a bit confused myself. I thought she was there to teach me new skills so I could find a job or go back to work. Instead she worked with me to make my daily life better.

She made suggestions like moving utensils to a place in the kitchen where there would not require reaching, and switching to paper plates and plastic cups so that when I dropped them it didn’t hurt me further. She taught me how to find ways around the challenges of my disabilities and impairments, and when to ask for help when needed. I was surprised when said she couldn’t help me with anything else on my body but upper extremity movement. My insurance covered the care and I didn’t have any out of pocket charges.

Other OT modalities include helping children with disabilities participate in school and social settings, injury rehabilitation, and helping older adults with Alzheimer's and other physical and cognitive changes.

Remaining open minded about alternative therapies and talking about them with your care team is very important. Don’t do any treatments you are not comfortable with for pain management, whether they are traditional or alternative therapies.

I wish you all knowledge, research and the best chance at positive outcomes possible for your daily pain care. I encourage you to find your own solutions and to keep working toward lower pain levels that can be managed through the right care.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International 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.

Opioid Commission Member Calls Panel a ‘Charade’

By Pat Anson, Editor

The Trump Administration and Congress have so neglected the country’s opioid crisis that they have turned the work of the president's opioid commission into a "charade" and a "sham," according to one panel member.

In a wide ranging interview with CNN, former Democratic Rep. Patrick Kennedy lamented a lack of focus and funding the opioid crisis has received since President Trump declared the overdose and addiction epidemic a national public health emergency last October.

"This and the administration's other efforts to address the epidemic are tantamount to reshuffling chairs on the Titanic," said Kennedy.

"The emergency declaration has accomplished little because there's no funding behind it. You can't expect to stem the tide of a public health crisis that is claiming over 64,000 lives per year without putting your money where your mouth is."

PATRICK KENNEDY

Without funding and resources, Kennedy said he believes the opioid commission's work had become a charade.

"I do. I honestly do. It means nothing if it has no funding to push it forward.... this thing's a charade,”” he told CNN. "I have to be true to the way I feel. This is essentially a sham."

President Trump appointed the bipartisan panel in March to give him a list of recommendations to combat drug addiction and the overdose crisis. 

COMMISSION on combating drug abuse and the opioid crisis

After a series of public hearings, the commission released its final report in November, an ambitious list of over four dozen recommendations aimed at treating addiction, preventing overdoses, and further restrictions on opioid prescribing.

But since the report’s release, little money has been set aside by Congress or the administration to implement the panel’s recommendations, except to increase border security and detect illegal drugs.

Last week President Trump proposed cutting the budget of the White House Office of National Drug Control Policy – which oversaw the opioid commission’s work -- by 95 percent.  After a year in office, the president has yet to appoint a permanent director for the office, which currently has a 24-year old deputy chief of staff fresh out of college with no prior experience in management or drug control policy.

"Everyone is willing to tolerate the intolerable -- and not do anything about it," said Kennedy, who is recovering from alcohol and opioid addiction, and is a prominent mental health advocate.

“I'm as cynical as I've ever been about this stuff,” he said. “We've got a human addiction tsunami, and we need all hands on deck."

Bertha Madras, another member of the opioid commission, told CNN the panel has never received any direct feedback from Trump about its work. But she praised the selection of presidential advisor Kellyanne Conway as the key point person for the administration in dealing with the opioid crisis.

"That is really a very significant issue, bringing the implementation directly into the White House, as opposed to having intra-agency meetings," said Madras, a professor of psychobiology at Harvard Medical School. "Having been in government 10 years ago or so, I know how difficult it is to be able to generate change without having executive leadership behind you."

When asked by CNN about Kennedy's critique, she praised him for the "passion and depth he brings to the problem," but said it was premature for her to comment until she sees how much money is eventually allocated for the opioid crisis.

Senator’s Letter Ignores Constituent’s Chronic Pain

By Pat Anson, Editor

Pain News Network received hundreds of comments and emails from readers responding to the open letter we published from Charles Malinowski, a 59-year old California man who suffers from Reflex Sympathetic Dystrophy (RSD) and other chronic pain conditions.

Malinowski is no longer able to obtain opioid medication and blames the CDC opioid guidelines for his “unspeakable and crippling pain.”

CHARLES MALINOWSKI

“Within 60 days I expect that the CDC will have effectively killed me. I honestly don't see myself being able to tolerate the pain any longer than that,” Malinowski wrote in his letter. “Congress, in going along with this blindly, will be explicitly complicit in this negligent homicide - or homicide by depraved indifference, take your pick.”

Malinowski’s letter to Senator Kamala Harris (D-CA) hit home with many readers, who say they’ve been abandoned by doctors who are fearful of prescribing opioid medication.  

“You are correct in saying the CDC is in effect murdering us. I too suffer from chronic pain and am unable to obtain pain meds from a doctor due to CDC guidelines,” wrote one reader.

“I just read your letter and cried all the way through it. My son in law will turn 50 this month and has been living with RSD for over 8 years. His story is a carbon copy of yours. Since the change in his meds about a month ago, (he) is now showing signs of heart trouble,” wrote Jo Ellen.

“Charles you are not alone and this attack on pain patients is affecting every pain patient nationwide,” wrote Pam. “This is terrorism at its finest folks. How many more pain patients will die due to a fictitious opioid epidemic?”

“I’m stuck in bed suffering inhuman pain 24-7 days a week. I’m lucky I have sanity now to write this. For 17 years I was under the watchful eye of a very educated doctor. Now abandoned by all in the medical field,” wrote Christine.

“This exact thing happened to my husband. He unfortunately passed away from a heart attack 6 months later,” wrote Sharon. “I pray your letter falls into the correct place to save your life and many others that are now in the same situation.”

And what about Sen. Harris, who Malinowski wrote his letter to?

She sent him a form letter that completely ignored his severe pain and life-threatening situation. It focused instead on combating opioid abuse and treating addiction.

“Thank you for reaching out to me to express your concern about the opioid crisis,” Sen. Harris wrote. “This administration and Congress must treat opioid abuse as a public health crisis. We need more funding to combat the opioid epidemic that is threatening millions.”

Malinowski replied to Sen. Harris with a second letter.

“I was very disappointed to discover that your response to me was an apparent boilerplate letter about continuing the already out-of-control hysteria over the so-called opioid epidemic,” Malinowski wrote. “My letter had nothing to do with controlling the illicit dispersal of opioids.

SEN. KAMALA HARRIS (D-CA)

"My letter was about the new CDC opioids guidelines being a literal death sentence for people like me. This is a literal death sentence because medication we depend upon is being withheld from us in a grossly and medically irresponsible manner. How you could have completely missed the blatantly obvious topic of my letter and responded so completely off-topic is simply beyond me. I think your response was shamefully ignorant and completely irresponsible.”

Unfortunately, this is not the first time we’ve heard from patients who wrote to their senator or congressman about the poor state of their pain care and gotten a form letter in response about the “opioid epidemic.” Which is no reason to stop trying or holding politicians accountable.  

“I want to hear from you. Contact me,” Sen. Harris says on her homepage. 

PNN tried to contact you, Sen. Harris. We emailed, called and left messages at your offices in Washington and Los Angeles several times in the last two weeks. Not only were we unable to speak to anyone on your staff, we couldn't even get someone to answer your phone. And we have yet to get a reply.

Neither has Charles Malinowski.  

(Update: On January 26, I finally received a reply from Sen. Harris.  But her emailed letter was yet another misdirected form letter. It thanked me for reaching out "to share your views opposing abortion."   

Losing Weight Helps Lower Pain Levels

By Pat Anson, Editor

Those of us who made a New Year’s resolution to lose weight have a little more incentive to keep our pledge – thanks to new research showing that even a small weight loss reduces overall body pain, as well as fatigue and depression.

The University of Michigan study, published in The Journal of Pain, involved 123 obese participants who were put on a low-calorie liquid diet for 12 weeks and asked to gradually increase their physical activity. The goal was to lose at least 10 percent of their body weight.

“It’s been known for some time that people who are obese tend to have higher levels of pain, generally speaking,” says Andrew Schrepf, PhD, a research investigator at Michigan Medicine’s Chronic Pain and Fatigue Research Center. “But the assumption has always been the pain is going to be in the knees, hips and lower back — parts of the body that are weight-bearing.”

Schrepf and his colleagues found that losing weight not only lowered pain levels in the knees and hips, but in unexpected areas such as the abdomen, arm, chest and jaw. Study participants who could reach the goal of losing 10% of their weight also reported better mental health, improved cognition and more energy. Men in particular showed improvements in their energy levels.

The results are significant because previous research hasn’t shown how weight loss affects widespread pain throughout the body.

“We know when people lose a lot of weight they tend to feel better,” Schrepf says. “But astonishingly, no one ever looked at where in the body the pain gets better.”

Researchers surveyed participants about their pain and other symptoms before and after the 12 week diet, using fibromyalgia assessment criteria to make their determinations. Participants were also evaluated and counseled by physicians and dietitians who specialize in endocrinology and obesity medicine.

Of the 123 participants, 99 were able to lose 10 percent or more of their body weight.

“The focus in the program is on calorie restriction and long-term weight loss, although all patients are encouraged to get more physically active for the other health benefits that exercise provides,” says Amy Rothberg, MD, an associate professor of endocrinology nutritional sciences at U-M. “The truth is people are, paradoxically, far more energetic on a low-energy diet and find after they begin losing weight that they can do more and are more physically active.”

Participants who met the weight loss goal reported widespread improvement in pain compared to those who did not. Their blood samples also showed a spike in anti-inflammatory molecules — a key weapon in fighting many types of pain. Researchers say the widespread improvement in body pain suggests that joints aren’t the only conduit of chronic pain.

“What we think that means is this process of losing weight may be affecting the central mechanisms of pain control related to the brain and spinal cord,” said Schrepf.

In future research, the team hopes to better understand why losing 10% of body weight was the dividing line for reduced pain.

“Some of your earliest weight loss isn’t all fat; it could be water,” Schrepf says. “Somewhere around 10 percent we’re reaching some kind of critical mass, but it’s hard to know exactly what that means.”

How Stem Cells Can Reverse Opioid Tolerance

By A. Rahman Ford, Columnist

On January 10, Pennsylvania Governor Tom Wolf declared a disaster emergency to fight the scourge of heroin and opioid abuse in his state, which has one of the highest overdose rates in the country.

“Pennsylvania’s opioid crisis impacts all areas of the state – including urban, suburban and rural communities and all ages including both young people and older Pennsylvanians – and is unprejudiced in its reach and devastation,” the declaration says. Virginia and other states have issued similar declarations.

Gov. Wolf’s effort comes months after President Trump declared the opioid crisis a national public health emergency and the president’s opioid commission released its final report, recommending more federal funding for addiction treatment, further restrictions on opioid prescribing, and the development of new non-opioid painkillers.

However, the commission’s report spent little time discussing an issue that is key to confronting the problems of opioid addiction and overdose – opioid tolerance.  “Tolerance” is defined as a decrease in effect following repeated or prolonged use of a drug, which can result in the need for higher and higher doses to achieve the same result.  For patients suffering from acute or chronic pain, this means that they need more pills to alleviate their pain. 

Tolerance can lead to a dangerous cascade of consequences. According to researchers at the National Institutes of Health, “the repeated administration of any opioid  almost inevitably results in the development of tolerance and physical dependence.” 

Although not all who become opioid tolerant become addicted, the World Health Organization asserts that people dependent on opioids are the group most likely to suffer an overdose. Given the seriousness of the problem, researchers have been looking for a way to prevent opioid tolerance and keep opioid users in a state of analgesia.  In that quest, some have found an answer in stem cells. 

In a recent study, Dr. Jianguo Cheng and scientists at the Cleveland Clinic and the Affiliated Hospital of Qingdao University in China hypothesized that mesenchymal stem cells (MSCs) could prevent or reverse opioid tolerance and opioid-induced hyperalgesia because of their profound anti-inflammatory properties. 

To prove their hypothesis, they induced opioid tolerance in laboratory mice and rats by injecting them with morphine for four weeks.  Astoundingly, after administering MSC therapy to the opioid-tolerant rodents, tolerance was reversed within as little as 2 days. The injections appeared to be completely safe.  All of the rodents showed normal movement, food and fluid intake, and body weight gain.  Their livers, kidneys and other major organs continued to function normally.

The authors concluded that MSCs have “enormous potential to profoundly impact clinical practice and improve opioid efficacy and safety.”  Their study builds on previous research that found MSC therapy “does not produce unwanted side effects and is well tolerated and safe.”  Rejection of the stem cells was not an issue because MSCs are immune-privileged.

America’s opioid problem is as destructive as ever.  If the states and the president’s commission truly seek novel, innovative and readily-implementable solutions to the opioid crisis, tolerance is a critical target and stem cell therapy may be a viable solution.  Patients in pain need solutions now.

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.

Tom Petty Overdosed on Opioids and Anxiety Medication

By Pat Anson, Editor

Tom Petty died from an accidental overdose caused by a potent cocktail of opioid painkillers, anti-anxiety medication and an anti-depressant that the singer was taking for chronic pain and other illnesses, according to autopsy findings and family members. Two of the drugs detected were illegal fentanyl analogues.

The 66-year old rock legend died last October after suffering cardiac arrest and collapsing at his home in Malibu. He had just completed a grueling tour to mark the 40th anniversary of his band, Tom Petty and the Heartbreakers.

In autopsy results released Friday, the Los Angeles County Coroner listed Petty’s cause of death as  "multisystem organ failure due to resuscitated cardiopulmonary arrest due to mixed drug toxicity."

Toxicology tests showed the presence of two prescription opioids (oxycodone and fentanyl), as well as two benzodiazepines (temazepam and alprazolam) for anxiety and the anti-depressant citalopram. Doctors have long warned that such a combination of prescription drugs can be deadly, leading to respiratory depression and overdose.

In addition, the coroner also listed two chemical cousins of fentanyl: acetyl fentanyl and despropionyl fentanyl. They are not prescription drugs, but are illegal synthetic opioids increasingly appearing on the black market in counterfeit medication.  The brief statement by the coroner did not point this out, nor did it list the blood levels at which any of the drugs were detected.

TOM PETTY

Petty’s wife Dana and daughter Adria released a statement saying the singer was prescribed "various pain medications for a multitude of issues including fentanyl patches," and that he suffered from emphysema, knee problems and a fractured hip.

“Despite this painful injury he insisted on keeping his commitment to his fans and he toured for 53 dates with a fractured hip and, as he did, it worsened to a more serious injury. On the day he died he was informed his hip had graduated to a full on break and it is our feeling that the pain was simply unbearable and was the cause for his over use of medication," the statement said.

“On a positive note we now know for certain he went painlessly and beautifully exhausted after doing what he loved the most, for one last time, performing live with his unmatchable rock band for his loyal fans on the biggest tour of his 40 plus year career. He was extremely proud of that achievement in the days before he passed.”

The family said it recognized Petty’s overdose may “spark a further discussion on the opioid crisis” and perhaps save some lives. “Many people who overdose begin with a legitimate injury or simply do not understand the potency and deadly nature of these medications,” they said.

Fentanyl and benzodiazepines were also linked to the deaths of the pop star Prince and the rapper Lil Peep.

In 2016, the Food and Drug Administration expanded the warning labels on all opioids and benzodiazepines because of the risk they pose when used together.

"It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together," said then FDA Commissioner Robert Califf, MD. "We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS (central nervous system) depressants more generally – together outweigh these serious risks."

5 DIY Tips to Reduce Lower Back Pain

By Mark El-Hayek, Guest Columnist

Lower back pain is the world's leading cause of disability. Almost all of us will at some point in our lives have to deal with it.

Lower back pain is any form of pain or discomfort in the lower part of the spine, which is known as the lumbar spine. It can be brought about by things like muscle tension, stress, improper diet, lack of exercise, poor posture, excess body weight and pregnancy.

We put together five simple do-it-yourself tips to help reduce lower back pain.

1) Correct Posture

Poor posture is one of the leading causes of lower back pain. Good posture involves sitting, walking, standing and sleeping in ways that do not weaken or over activate your supporting muscles. There are several things you can do to improve posture.

When sitting, avoid sitting on the edge of a chair as this puts a lot of strain on your back. Sit with your back straight and shoulders back.

The same is true for walking. Avoid bending or slouching over while walking. This strains your back and causes lower back pain.

When lying down, get into a position that is comfortable and one that does not compromise the curve in your back.

2) Ice and Heat

For many people, putting ice or something cold on an injured area provides relief from pain. Heat also works well in reducing lower back pain, but the two techniques work very differently.

When you put something cold on your lower back, the cold makes the blood vessels constrict, which reduces the pain caused by inflammation. Heat, on the other hand, relaxes blood vessels and increases blood flow, which helps heal the affected area.

It is advisable that when using ice and heat together, you start by doing the cold compress first and then the hot compress. You can use ice packs or frozen peas for the cold compress. For the hot compress, you can use a hot water bottle or a towel soaked in warm water.

Alternate between the cold and hot compresses for a few minutes and you will notice that your lower back pain has reduced.

3) Exercise

Regular exercise is a good way to prevent lower back pain. Make a point of exercising as often as you can. If you have a job that has you sitting for long hours, integrate exercises and movement into your everyday routine.

Walk to the bathroom or the water cooler a couple of times a day to keep your joints moving and lower back pain at bay. Take the stairs instead of the elevator or escalator to help stay fit.

4) Rest

Lower back pain is often caused by stress. The moment you start feeling back pain, take a couple of hours off to rest. You can start by taking a hot shower to help you relax. The shower will help your blood vessels relax and make oxygen flow freely to your lower back. After the hot shower, rest for a couple of hours and you will probably feel better.

5) Do not stay in bed too long

While resting is important, make sure you do not stay in bed too long. Lying down for an extended period of time, especially when your posture is poor or you do not have a good mattress, could increase your lower back pain. Instead of lying down, go for a slow walk to allow your joints and muscles to move and reduce inflammation.

Mark El-Hayek graduated from Macquarie University in Sydney, Australia with a Masters of Chiropractic and a Bachelor of Medical Science.  He is the head chiropractor and owner of Spine and Posture Care in Sydney.

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.

GOP Report Blames Medicaid for Opioid Crisis

By Pat Anson, Editor

A new congressional report claims there is “overwhelming evidence” that Medicaid has  contributed to the nation’s opioid crisis by making it easy for beneficiaries to obtain and abuse opioid prescriptions.

The lengthy report, called “Drugs for Dollars: How Medicaid Helps Fuel the Opioid Epidemic,” was prepared by the Republican controlled Senate Homeland Security and Governmental Affairs Committee. Democrats on the committee complained the report was concocted to discredit and demonize Medicaid expansion under the Affordable Care Act, also known as Obamacare.

The report cites 1,072 people since 2010 that have been convicted or accused of using Medicaid to improperly obtain prescription opioids.  That is only a tiny fraction of the nearly 70 million people enrolled in Medicaid, but the report nevertheless draws some sweeping conclusions.

“Overwhelming evidence shows that Medicaid has inadvertently contributed to the national tragedy that is the opioid epidemic, and has taken a toll that is playing out in courtrooms across the nation,” the committee staff reported.

“Other well-intended government programs, such as Medicare, may provide similar incentives for rational actors to engage in bad behavior with highly addictive opioids. These issues hold major ramifications for public policy, along with the nation’s health. They deserve serious consideration and a sober national debate, one we hope this staff report will help to initiate. The victims of this terrible epidemic deserve no less.”

The report cites dozens of examples of doctors and beneficiaries abusing the system, such as a $1 billion scheme to defraud Medicaid and Medicare that involved numerous health care providers.

Committee staff also claimed that drug overdose deaths were rising nearly twice as fast in Medicaid expansion states as in non-expansion states. About 12 million more Americans receive Medicaid coverage under Obamacare.

“While there is clearly no single cause to the epidemic, evidence has emerged that Medicaid is playing a perverse and unintended role in helping to fuel and fund the opioid epidemic,” Sen. Ron Johnson (R-WI) wrote in a letter to Eric Hargan, the Acting Secretary of the Department of Health and Human Services.

“The data uncovered in this examination point to a larger systematic problem – because opioids are easily obtained and inexpensive through Medicaid, the structure of the program itself creates a series of incentives for beneficiaries to use opioids and sell them for potentially enormous profits.”

‘Total Hogwash’

The committee’s ranking Democrat, Sen. Claire McKaskill of Missouri, called the report misleading.

"This idea that Medicaid expansion is fueling the rise in opioid deaths is total hogwash," McCaskill said in a statement. "It is not supported by the facts. And I am concerned that this committee is using taxpayer dollars to push out this misinformation to advance a political agenda."

“Separate scientific studies conducted by other authors show that (the) opioid epidemic predates Medicaid expansion and that recent increases in overdoses stem from fentanyl and heroin, not prescriptions obtained through Medicaid.  Unlike the report released by the majority staff today, these studies were both scientific and comprehensive.”

The report’s conclusions were also questioned by a longtime critic of opioid prescribing.

“I believe the access to prescribers that Medicaid, Medicare and commercial insurance offers does increase the likelihood that someone might develop a disease often caused by prescriptions,” said Andrew Kolodny, MD, founder and Executive director of Physicians for Responsible Opioid Prescribing (PROP).

“But I do not believe that Medicaid should be singled out in this regard. Opioid overdoses have been increasing in people with all types of insurance and in people from all economic groups, from rich to poor.”

A report released this week by the Kaiser Family Foundation found that states with above average overdose death rates includes 18 states that expanded their Medicaid coverage and 8 states that did not.  Overall, Medicaid covers nearly 40% of the two million Americans estimated to have opioid addiction.

Opioid Medication Has Been a Godsend to Me

Susan Lay, Guest Columnist

I have been on pain medication for over 30 years, starting with Vicodin. My doctor at the time wasn't concerned about the hydrocodone in Vicodin as much as he was the amount of acetaminophen in it, as it could destroy my liver.

He sent me to an anesthesiologist, who has been my pain doctor for over 20 years. After all the nerve blocks, physical therapy, imagery, TENS unit, spinal cord stimulator, pain pump, etc., I was given Roxicodone. Afterwards, OxyContin was created and then time released OxyContin.

I couldn't tolerate them, so he gave me fentanyl patches (which were new on the market) with fentanyl lozenges for breakthrough pain. My insurance eventually denied the lozenges. The patches were wonderful because I had no feelings of being “high” like other drugs. They made it possible for me to continue working and have a life. I have used the patches since that first day and they've been a Godsend.

Subsys spray was prescribed for breakthrough pain about 6 years ago, but at $22,000 a month, my insurance only paid for a year.

I'm so fortunate to still have the same doctor, although he's getting older and will retire soon. My main issue has been with pharmacies. I live in a very rural area of California and about 2 years ago my regular pharmacy refused to fill any opioids due to DEA and other concerns. My doctor has continued to write scripts for me, but I found them extremely difficult to fill. All the pharmacies I tried, including Walmart, Rite Aid, Walgreens and Safeway, denied me. Some felt uneasy, would only fill a script for 2 months, or just plain would not fill them!

SUSAN LAY

I tried mail order prescriptions, but they eventually stopped. I tried a small pharmacy 2 hours away, but had to talk the pharmacist into it, after he requested 6 months of medical records and advised me they would only fill my prescriptions every 30 days, with no early refills for vacations.

All has been good this past year, although I don't know if my insurance will continue to cover my meds. I'm 70 and on Medicare Part D. I've never increased the amount of patches or strength I use. I have Dilaudid for breakthrough pain, which doesn't help much, but some. I do what many other pain patients do to get their medication: drive for hours to my doctor once a month, undergo drug tests, sign pain contracts, and use no alcohol. I must go to office if they call for a drug count.

I discovered withdrawal from the fentanyl patches isn't as horrible for me as it is for addicts who just want to get high. I've had to go without for 5-6 days a few times, when the pharmacy was closed or I couldn't get to the doctor. My doctor explained that those in real pain are wired differently and withdrawal is usually easier. He did give me a script for methadone if I'm ever in that position again.

I feel extremely lucky to have a doctor who actually cares enough to help his patients. His contract says if any patient must go off opioids (for missing an appointment, using alcohol or whatever) he will assist us through withdrawal so we don't suffer.

It's the insurance and pharmacies that are causing us so many problems. Does anyone in other states have these issues? Marijuana is legal in California and we're a progressive state, yet even in my small rural area we're having major issues. Several pharmacies have closed, due to scrutiny by the DEA and other government involvement. It's not worth it to be constantly going through records and double-checking the way they do things.

Insurers and pharmacists have more power than doctors. Even with an honest and necessary prescription, they continue to over-ride doctors’ decisions. Pharmacists refuse to fill for quantities doctors have written, even when insurance agrees with that quantity. When a doctor speaks to the pharmacist, it makes no difference. When did pharmacists become doctors? The same goes for insurance companies that now refuse to pay for prescriptions they've covered for years.

I just don't get it. I'll do anything I can to fight FOR chronic pain patients and AGAINST those who don't give a damn about us and think if you use opioids you're a drug addict!

Susan Lay is a retired nurse and day care operator. She lives with chronic shoulder and knee pain.

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 represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Surgery Patients Rarely Misuse Opioid Meds

By Pat Anson, Editor

A large new study published in the British Medical Journal is debunking some popular myths about the causes of opioid addiction.

One such myth is that many hospital patients abuse and become addicted to opioid pain medication while recovering from surgery.

But in a data analysis of over 568,000 patients who were prescribed opioids for post-surgical pain, researchers at Harvard Medical School identified only 5,906 patients (0.6%) who were later diagnosed with opioid dependence, abuse or a non-fatal overdose -- collectively known as opioid misuse.

Of those, only 1,857 patients (0.2%) showed signs of misuse in the first year after surgery – suggesting that the dependence or abuse that others later developed may have had little or nothing to do with the surgery itself.

But the remarkably low rate of opioid misuse by surgery patients was not the primary focus of the study. What researchers really wanted to know is whether the dose and duration of an opioid prescription influences future chances of abuse and addiction.

And here another myth was dispelled.

Researchers found that high doses of opioids after surgery appear to have little impact on misuse rates. Their findings show that how long a patient takes opioids is a more reliable predictor of misuse than how much medication they took. Dosage only emerged as a risk indicator for those who took opioids for extended periods.

"Our results indicate that each additional week of medication use, every refill is an important maker of risk for abuse or dependence," said study co-author Denis Agniel, a statistician at the RAND Corporation and a part-time lecturer in the Department of Biomedical Informatics at Harvard Medical School.

Researchers found that each additional week of opioid use increased the risk for dependence, abuse or overdose by 20 percent. And each refill boosted the risk by 44 percent.

But the risk of misuse still remains small. For those who had a single prescription with no refills – the vast majority of patients -- misuse occurred at a rate of only 145 cases per 100,000 patient years. The rate was still minuscule for those who refilled a prescription -- 293 cases per 100,000 patients years.

And for patients who took high doses for short periods -- two weeks or less -- the risk of misuse was no greater than those who took an average dose.

Agniel and his colleagues say their research indicates that opioids -- even at high doses -- can be safely prescribed to patients with post-surgical pain.

“These findings suggest a more nuanced understanding of the relationship between duration and dosage with a focus on early appropriate treatment of pain (including higher doses) for a limited time,” researchers concluded.

“Such findings suggest that optimal post-operative prescribing, which maximizes analgesia and minimizes the risk of misuse, may be achieved with moderate to high opioid dosages at shorter durations, a combination that merits further investigation in population-based and clinical studies.”

Anti-opioid activists and government regulators have long made sensational claims that even just a few painkillers can lead to addiction and death.

“The bottom line here is that prescription opiates are as addictive as heroin. They’re dangerous drugs,” former CDC Director Thomas Frieden told the Washington Post in 2016. “You take a few pills, you can be addicted for life. You take a few too many and you can die.”

The Harvard Medical School study was not the first to find that long term opioid use after surgery is rare. A 2016 Canadian study found that less than one percent of older adults were still taking opioid medication a year after major elective surgery.  

Many patients are dissatisfied with the quality of their pain care in hospitals. In a survey of over 1,200 patients by PNN and the International Pain Foundation, 60 percent said their pain was not adequately controlled in a hospital after surgery or treatment. And over half rated the quality of their hospital pain care as either poor or very poor.

Why I Am Closing My Pain Practice

(Editor’s note: Patient abandonment is a serious and growing problem in the pain community. Thousands of patients have been discharged by doctors who have grown fearful of treating chronic pain and losing their medical licenses for prescribing opioid medication. We were recently contacted by a nurse practitioner, who offered her perspective on this disturbing trend. The author asked to remain anonymous.)

I am a nurse practitioner who has been in the field of pain management for the past 4 years. Prior to that, I spent years as an intensive care unit nurse and in primary care as an advanced registered nurse practitioner (ARNP).

Working with chronic pain patients has been the highlight of my professional career. I absolutely love my job and about 99% of my patients. I have had two complaints about me made to the Washington State Department of Health, both of which accused me of prescribing too much opioid medication to my patients. Both complaints were investigated by the state and I was found to be practicing within the standards of care -- and essentially told to continue. Which I did.

Then the Seattle Pain Centers closed in 2016, leaving thousands of untreated pain patients in the Puget Sound area. I inherited some of their patients. I felt like I had been "vetted" by the state, and believed that if I continued to do everything according to the law, I would be safe from any legal action.

In my practice, we fight ALL THE TIME for our patients, against the state, insurance companies, pharmacies and even the patient's families sometimes (when they don't understand). I'm not afraid of a good fight, because I have seen patients’ lives turned around when they are finally given the correct amount of opioids. I believe in opioid therapy.

Of course, all the tools in the box should be used, and I refer routinely to physical therapy, interventional pain specialists, surgeons, acupuncturists, chiropractors and others, in addition to prescribing opioids for pain.

Now I find how naive I have been. I have been to national conferences to learn more about pain management, and have heard the top doctors and researchers talk. One of these giants, Dr. Forest Tennant, was recently raided by the DEA. With Jeff Sessions as Attorney General, there is apparently more money being allotted to these raids and more are promised in the future. I also went to a website called "Doctors of Courage" and learned more about the DEA.

My interpretation of the facts is that it doesn't matter if I practice legally anymore. The DEA will look at my prescribing patterns, and tell me that I MUST have known that the ONLY reason any patient would get that much medication is if they are selling it on the street. And therefore, I am a "drug trafficking organization.” The Justice Department takes over the case and the provider is prosecuted.

If convicted, which seems to be the case recently, the provider becomes a felon and serves a prison term. Medical license is lost, time is served and because it is a "drug crime," asset forfeiture law may be used to confiscate everything I own.

'My Fear Is Very Real'

I am married, with a daughter still at home. I cannot do this to my family. So I am joining the legions of others who are closing their pain practices. I have just begun to tell my patients, and have had many, many tears, thoughts of both suicide and homicide, and one very special patient who told me that she will no longer be able to keep her service dog because she will be unable to care for him.

This whole thing is making me literally sick to my stomach. I've cried a million tears for my patients already, and I'm just beginning. I will be carefully weaning them all down to 90 MED per day over the next 6 months, or arranging transfer of care to anywhere the patient would like. What a joke that is -- there is no one else prescribing effective doses of opioids for chronic pain patients. If I am to be thrown in prison, it should be for that -- not for keeping them on therapy that enriches their lives.

I keep asking my husband to tell me that I am overreacting, but as wonderful and encouraging as he has always been, he is scared too.

Please tell all patients that what may have started merely as a provider being paranoid about his or her license has recently morphed into something truly dangerous for us. I will be absolutely no good to anyone, once locked up. If I can stay clear of the DEA's witch hunt, perhaps I can remain a voice of advocacy for pain patients. God help us all.

Please don't use my name if you post this. I can tell you, my fear is VERY real, and I don't want to call any attention to my practice right now. Thank you for understanding.

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 represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

The Difference Between Intractable and Chronic Pain

By Forest Tennant, MD, DrPH

The current attempts by a number of parties to castigate and humiliate pain patients and their medical practitioners is not just pathetic and mostly false, it is dangerous to the fate and life of many intractable pain (IP) patients.  If it wasn’t so serious, some of the claims, biases and beliefs would make good comedy.

First and foremost there has been no discussion about the difference between intractable pain and chronic pain.  There really is no bigger issue. 

The proper identification and treatment of the IP patient is not only essential for the health and well-being of the IP patient, it is a major key to the prevention of overdoses and diversion of abusable drugs.  IP patients must have special care and monitoring.  

The basic definition of IP is a “moderate to severe, constant pain that has no known cure and requires daily medical treatment.” 

Chronic pain, on the other hand is a “mild to moderate, intermittent, recurring pain that does not require daily medical treatment.” While there are millions of persons with chronic pain, only about 10% are intractable.

The cause of “intractability” is two-fold:

1. The initial injury or disease which initiated IP was severe enough to cause a pathologic transformation of the microglial cells in the spinal cord and/or brain. It is this transformation that produces neuroinflammation and the constancy of the pain. This process is known as “centralization” or “central sensitivity.”

2. To have enough injury to cause “centralization” one must have a most serious disease or condition of which the most common are: adhesive arachnoiditis, traumatic brain injury, reflex sympathetic dystrophy, post-viral encephalopathy, or a genetic disease such as Ehlers-Danlos Syndrome, porphyria, or sickle cell disease.

Medical practitioners must have minimally-restricted prescribing authority and autonomy to adequately treat IP.  For example, the proper treatment of IP not only requires analgesics, opioids and non-opioid, but specific anti-inflammatory, hormonal, and corticosteroid agents that will cross the blood brain barrier and control inflamed and pathologic microglial cells.  Treatment of IP has to be individually tailored and may require non-standard, off-label, or an unusual treatment regimen.  

Make no mistake about it.  The new treatment approach to IP is quite effective in reducing pain, controlling neuroinflammation, and allowing patients to biologically function well enough to have a good quality of life.  Also be advised that the new IP approach is not just reducing pain but treating the underlying cause of pain.  Consequently, a lot of expensive procedures, therapies, and opioids are no longer needed. 

As long as I am practicing I will continue to push forward this new approach.

Dr. Tennant specializes in the research and treatment of intractable pain at the Veract Intractable Pain Clinic in West Covina, California, which remains in operation after recently being raided by DEA agents. Many of Dr. Tennant's patients travel from out-of-state because they are unable to find effective treatment elsewhere.

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.

Medical Cannabis Laws Cause Confusion for Travelers

By Roger Chriss, Columnist

Health problems do not care about maps. But the patchwork of medical marijuana laws in different states does make a map handy for anyone who travels and uses cannabis for a medical condition.

The recent decision by Attorney General Jeff Sessions to resume enforcing federal marijuana law further muddies this already complicated landscape. Even if medical cannabis remains insulated from prosecution by the Rohrabacher-Blumenauer Amendment, there is one important issue for people with chronic pain and related disorders that remains unaddressed.

What happens when someone who is using medical cannabis lawfully for an approved use in their own state has to travel to another state for diagnosis or treatment?

The rarer a medical condition is, the more likely local healthcare providers will prove inadequate and travel will be necessary. A wide range of disorders, including inborn errors of metabolism like porphyria, muscle diseases like nemaline myopathy, and hereditary neuropathies like Charcot-Marie-Tooth disease, require visits to specialists for evaluation and diagnosis. These specialists are often not nearby, making travel an essential step in medical care.

But state rulings on the approved uses for medical cannabis vary significantly and are changing rapidly.

In Colorado, for example, a person simply has to have “severe pain” to be considered for medical cannabis. By contrast, Connecticut and Illinois maintain extensive and detailed lists of dozens of qualifying medical conditions, from rheumatoid arthritis to Hepatitis C to Tourette syndrome.

Oregon compromises by giving examples of what it calls “debilitating medical conditions” and allows for specific symptoms such as cachexia and severe pain.

Moreover, states like Minnesota, Pennsylvania and Washington define intractable pain as pain unrelieved by standard medical treatments or medications. But they do not agree on what constitutes standard care, with Pennsylvania including “opiate therapy” while Minnesota does not.

Thus, a person could be in full compliance with his or her own state’s laws and regulations, but be unable to qualify for medical cannabis in another state. This would impact out-of-state travel for medical care.

In general, traveling with medical cannabis is very challenging. State governments can only pass laws within their borders. This means that air travel is effectively out of the question, because federal law says that it is illegal to carry marijuana in airline baggage or transport it across state lines.

Obtaining medical cannabis outside of one’s home state is similarly problematic. Some states accept out-of-state medical cannabis cards, but the number remains small and acceptance is at the discretion of the dispensary owner. Each such state has its own rules about medical cannabis possession as well, and these rules change frequently.

All of this creates a difficult landscape for people trying to navigate the U.S. healthcare system outside their home state. As state laws now stand, people with chronic pain disorders could end up breaking both federal and state law while seeking medically recommended cannabis products.

Further, a person who is on a stable regimen of medical cannabis in one state may not be able to visit or relocate to another state without losing that regimen. This may impact education and professional opportunities in a way presumably not intended by state laws.

Medical science and clinical practice should not change with state boundaries. State laws and accepted indications for medical cannabis need to be revised in order to create an environment that benefits people in need and does not inadvertently create legal conflicts or pitfalls. At present, there is simply too much room for error and harm.

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.