An Open Letter to the CDC Center for Injury Prevention

By Richard “Red” Lawhern, Guest Columnist

Dear Dr. Robert Redfield and Dr. Debra Houry,

By its passive refusal to conduct a thorough review of the impact and outcomes of its 2016 opioid prescribing guideline, the CDC’s National Center for Injury Prevention and Control is actively causing harm to hundreds of thousands of pain patients.   

Deserted by their doctors in a hostile regulatory environment, many are going into the streets seeking pain relief.  Possibly hundreds may already be dead of illegal fentanyl poisoning or suicide.  Military veterans, in particular, face draconian restrictions on the availability of safe and effective opioid medication therapy.   

And all for no good reason!

I suggest with every intention of professional and personal courtesy, that government organizations can no longer stand aside from this centrally important issue.  Such a stance will make you and other federal agencies accessories to state-sanctioned torture and negligent homicide.  That is unacceptable.   

As a former military officer, I respect a well-tried motto that I urge each of our regulators to take on as their own:   

      Lead, follow, or get out of the way! 

It has become clear that the CDC guideline must be immediately withdrawn for a major rewrite.  In its present form, the guideline is unjustifiably biased against opioid pain relievers, factually incomplete, in error on basic science, and founded on untested assumptions that do not hold up under any degree of careful scrutiny.   

The guideline is directly responsible for a vast regulatory over-reach by DEA and state authorities that is driving doctors out of pain management and denying safe and effective pain treatment for hundreds of thousands of patients.  

The CDC guideline has been publicly repudiated by no less an authority than the American Medical Association. Over 300 medical professionals have called for a rewrite of the guideline from the ground up. And a recent draft report by a federal task force calls for a reorientation of the guideline towards individualized patient-centered care, not the one-size-fits-all approach of the CDC. 

Multiple published papers have conclusively invalidated the guideline’s contention that there is a maximum dose threshold of risk for opioid addiction and overdose.   

Likewise, contrary to assertions in the guideline, there are presently no validated long-term studies to support the use of non-opioid analgesics and NSAIDs, or the off-label prescribing of anti-seizure and anti-depressant drugs to treat pain. No Phase II or Phase III trials have been published on "alternative" techniques such as acupuncture, massage or meditation.  And there are no trials which directly compare these techniques to opioid therapy under documented protocols.  Alternative treatments can at best be regarded as adjuncts to be added to analgesic or anti-inflammatory treatment.  

Published papers also demonstrate that criteria used by CDC and other federal agencies to identify risk of opioid abuse or overdose have very limited predictive accuracy. These faulty criteria are now being used by Prescription Drug Monitoring Programs (PDMP’s) to "flag" patients presumed to be at risk, who are in fact not at risk but are being denied pain treatment due to false alarms.  

Opioids, Overdoses and Demographics 

We can now take this narrative a step further.  I have compiled overdose data directly from the CDC Wonder database and from the Agency for Healthcare Research and Quality Data. This data focuses specifically on deaths directly attributable to opioid-related overdoses or suicide. The chart below shows rates of mortality by age group from 1999 to 2017.

GRAPHICS BY RED LAWHERN

Note that the highest rates of opioid-related mortality are among youth and young adults, while the lowest rates are among people over age 55.  Moreover, mortality in youth has skyrocketed by 1,800% over 17 years, while remaining relatively stable in people 55 and older.

The chart below documents the contrast in opioid prescribing by age group in 2016.  Unsurprisingly, older adults and seniors are much more likely to experience chronic pain and are prescribed opioids at a rate nearly double that of young adults. These two demographic trends contradict the idea that opioid overdoses are linked to prescribing.  They’re not and the evidence proves it. 

An updated analysis report further summarizes major themes we found in the overdose data.  The report reveals that “over-prescribing” of medical opioids was never a significant driver in opioid overdoses. There is no cause-and-effect relationship between rates of opioid prescribing versus rates of opioid overdose. In fact, it can be argued that in states where prescribing rates are highest, the trend may be in the opposite direction. 

The downward sloping red line in the chart below is called a "regression" line.  This is the trend line for the overdose and prescribing data from all 50 states in 2016. If there were a connection between high rates of opioid prescribing and overdoses, we’d expect the regression line to be pointing upward, not downward.

Overdose mortality rates are actually lower in high-prescribing states! 

One plausible explanation for the downward sloping line is that in states where prescribing has been more suppressed, patients are being driven into unsafe street markets or are committing suicide when overwhelmed by pain.   

These findings have previously been published in the blog of Dr. Lynn Webster, former President of the American Academy of Pain Medicine and author of "The Painful Truth." 

The implications of this analysis are glaring: the National Center for Injury Prevention and Control has created a fatally flawed guideline which actively increases injury rather than reducing it.   

Taken in sum, the evidence reveals that key assumptions on which the CDC guideline is based are simply and conclusively wrong.  Continued refusal to reevaluate the guideline is morally, ethically, medically and legally wrong. The 2016 CDC guideline on opioids must be retracted.  NOW! 

(Editor’s note: Dr. Redfield is CDC Director and Dr. Houry is Director of the CDC National Center for Injury Prevention and Control. A longer version of this open letter has been sent by email to other federal agencies and officials.)

Richard “Red” Lawhern, PhD, has for over 20 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  Red is co-founder and Director of Research for The Alliance for the Treatment of Intractable Pain.

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

1 in 5 Multiple Sclerosis Patients Misdiagnosed

By Pat Anson, PNN Editor

Nearly one in five patients who are told they have multiple sclerosis are misdiagnosed with the autoimmune disease, according to a new study of patients referred to two MS treatment centers in Los Angeles. The patients spent an average of four years being treated for MS before receiving a correct diagnosis.

MS is a chronic disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision, and fatigue. The symptoms are similar to those of several other chronic conditions – including neuropathy, migraine and fibromyalgia – which often leads to a misdiagnosis.

Researchers at the Cedars-Sinai Multiple Sclerosis and Neuroimmunology Center analyzed the cases of 241 patients who had been diagnosed by other physicians and then referred to the Cedars-Sinai or UCLA MS clinics.

Their findings, published in the journal Multiple Sclerosis and Related Disorders, indicate that 43 of the 241 patients (18%) with a previous diagnosis of MS did not meet the criteria for the disease.

"The diagnosis of MS is tricky. Both the symptoms and MRI testing results can look like other conditions, such as stroke, migraines and vitamin B12 deficiency," said lead author Marwa Kaisey, MD. "You have to rule out any other diagnoses, and it's not a perfect science."

The most common correct diagnoses was migraine (16%), radiologically isolated syndrome (RIS) (9%), spondylopathy (7%), and neuropathy (7%). RIS is a condition in which patients do not experience symptoms of MS even though their imaging tests look similar to those of MS patients.

The misdiagnosed patients received approximately 110 patient-years of unnecessary MS disease modifying drugs. Nearly half received medications that carry a known risk of developing progressive multifocal leukoencephalopathy, a potentially fatal brain infection.

"I've seen patients suffering side effects from the medication they were taking for a disease they didn't have," Kaisey said. "Meanwhile, they weren't getting treatment for what they did have. The cost to the patient is huge — medically, psychologically, financially."

The cost of disease modifying medications for an MS patient in the U.S. exceeds $50,000 a year. Investigators estimated that the unnecessary treatments identified in this study alone cost almost $10 million. 

Researchers hope the results of the study will lead to new biomarkers and improved imaging techniques to help prevent future MS misdiagnoses.

A similar study in 2016 also found that MS patients were often misdiagnosed. One third of the patients were misdiagnosed for a decade or longer, most took unnecessary and potentially harmful medication to treat a disease they didn't have, and some even participated in clinical trials for experimental MS therapies. About a third suffered from morbid thoughts of death.

Can Pain Be Used to Treat Pain?

By Jeanne McArdle, Guest Columnist

“Can you cure pain with more pain?” was the provocative question posed last month by National Public Radio’s Invisibilia podcast, “The Fifth Vital Sign.”  

The show features the story of Devyn, a 16-year old former gymnast living with chronic pain. Devyn broke the end of her thighbone and required surgery, but the injury never fully healed and her pain was spreading. She was diagnosed with “amplified pain syndrome” and enrolled in a rehabilitation program for children at a Kansas City hospital that combines intense physical therapy with psychotherapy.

Put simply, Devyn was taught to ignore her pain by being exposed to more of it.

The resounding backlash from the chronic pain and illness community was swift and fierce, blowing up NPR’s social media feeds with charges of endorsing torture and demands to pull the episode. An apology for “triggering” pain patients from podcast hosts Hanna Rosen and Alix Spiegel served only to generate more ire.

NPR’s Public Editor, Elizabeth Jensen, stepped in on March 15, publishing an opinion piece that parsed individual points of contention while somehow missing the main one: Patients were outraged that NPR provided free publicity to treatment programs that put children in tremendous pain on purpose.   

The original pain rehabilitation program profiled in the Invisibilia podcast operates out of Children’s Hospital of Philadelphia. It is based on founder Dr. David Sherry’s belief that we do not accept pain as a natural part of life anymore. We focus too much attention on pain and try to eliminate it — often making it worse.  

Is there scientific evidence to support the theory that paying too much attention to pain causes it to spread elsewhere in the body? I couldn’t find any. I believe Sherry’s idea is just woo and bunk. Widely accepted pain research shows that once nerves are sensitized it takes less and less stimuli to create more severe and widespread pain. It is important to break that cycle and to treat the pain, before moving forward with physical therapy and other treatments.

Sherry’s program takes the opposite approach. It rests on the unproven idea that flooding the patient with pain will reset her brain’s response to pain. Take away the patient’s pain meds, force her to engage in many hours of hard exercise each day, subject her to other painful stimuli, and her brain will no longer process pain as dangerous. It will become bored with pain.

Would you want someone with such an extreme view of pain to be in charge of your pain management program? Would you want him in charge of your child’s pain management program?

On March 20, the Society for Pediatric Pain Medicine weighed in with an open letter to Cara Tallo, Invisibilia’s Executive Producer:

“(We) are deeply concerned that your episode promotes the misconceptions around pediatric pain and undermines the diligent scientific discovery by scientists, doctors and clinicians over the past several decades.

Pain is NOT simply a matter of attention and psychological state of mind. It does not just respond to putting children in intense/more intense pain and teaching them to push through.

Instead, it requires a clear understanding of its complex nature and treating the physical, biological, and psychological issues carefully and simultaneously, in a delicate dance that sometimes may be harder in the beginning.”

The Invisibilia podcast followed Devyn as she participated in the pain program at Children’s Mercy Hospital in Kansas City, where the goal was “to put Devyn in as much pain as they possibly could.”

Devyn and other patients are told to jump in and out of a pool as fast as they can for five minutes straight. One of the girls struggles to swim and jump in and out because she’s lost the use of one side of her body. She is cut no slack.

During the podcast we hear Devyn’s trainer deny her asthma medication when she has trouble breathing. The trainer tells Devyn to stuff a tissue up her nose and continue to exercise even when she springs a nosebleed. We hear Devyn vomit from exertion. Apparently, exercising to the point of vomiting is common; there are barf bags set up around the gym. Devyn is told to “push through” no matter what. 

The girls who enter this rehabilitation program have, we’re told, completed extensive medical testing to rule out underlying medical problems. But people in the pain community know how often diagnoses are missed. It can take years to find a doctor who even knows what to look for. We know how much harm can be inflicted by inappropriate therapy. 

The program claims to have precautions in place so that patients with Ehlers-Danlos syndrome (EDS), a condition that causes fragile connective tissue and autonomic dysfunction, don’t injure themselves. Having EDS myself, I know that the essence of this program — pushing people through pain — is inappropriate for anyone with EDS.

I have personally met and have spoken online to other EDS patients who have been through Dr. Sherry’s program and emerged from it with more injuries and pain than they had when they began. There are even reports of people who have come out of his program with PTSD. It is easy to understand how that might happen. 

Even if these programs worked some of the time for some people, they are bound to harm others. Pain is complicated. We are only beginning to understand its mechanisms.

Attention is not a switch that can be turned on or off. Attention can take many forms. Attention can be nonjudgmental. It can be loving. It can be kind. It can be curious. It can be gentle. Choosing the proper form of attention to bring to your pain can be a tool for dealing effectively with it. Attention is not the blunt, malign force that the podcast describes.

We have lived through decades-long diagnostic delays while enduring brutal and futile treatments. We have been blamed for our symptoms only to discover they were beyond our control. We know how easy it is to harm, how difficult it is to heal, and how much the larger community wants simple solutions to our complex problems.

The backlash against NPR from the pain community was actually a plea to “First do no harm.” Programs that deny pain have permanently, irreparably harmed countless pain patients and chronically ill people. Don’t present them as solutions. We deserve better and children with widespread pain deserve better. 

Jeanne McArdle lives with Ehlers-Danlos syndrome. She administers a regional support group for people with EDS in Central NY and has served on the boards of several nonprofits. Jeanne is a former technical writer and earned an MPS in Communication from Cornell University.

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.

FDA Finds Unsafe Levels of Heavy Metals in Kratom

By Pat Anson, PNN Editor

The American Kratom Association’s new certified vendor program has gotten off to an inauspicious start. Kraken Kratom, the first vendor to qualify under the AKA’s Good Manufacturing Standards (GMP) program, has been flagged by the Food and Drug Administration for having dangerous levels of heavy metals in some of its products.

The FDA this week released the final test results on 30 kratom products found to contain levels of lead and nickel considered unsafe for daily human consumption. Five of the 30 samples that tested positive came from Kraken Kratom or one of its affiliated vendors.

“The analysis found significant levels of lead and nickel at concentrations that exceed safe exposure for oral daily drug intake,” the FDA said in a statement. “Based on these test results, the typical long-term kratom user could potentially develop heavy metal poisoning, which could include nervous system or kidney damage, anemia, high blood pressure, and/or increased risk of certain cancers.”

Ironically, last month Kraken Kraken became the first company to receive the AKA’s seal of approval as a certified GMP vendor. To qualify, participants must undergo a third-party audit and inspection of their manufacturing and packaging facilities.   

The company said in a statement posted online that it was never contacted by the FDA about the heavy metal findings or told to take its kratom products off the market.

“Kraken has no information regarding the samples the FDA used in their tests, including when or how the FDA acquired our products or when they tested the samples they obtained,” the statement said.

This isn’t the first time Kraken Kratom has come under FDA scrutiny. Its parent company, PDX Aromatics of Portland, Oregon, recalled thousands of kratom packages last year after samples tested positive for Salmonella bacteria. The company believes the samples that tested positive for heavy metals may have come from an FDA inspection in March, 2018.

“If these samples are from that investigation, their product lots were pulled from the market over 12 months ago as part of the extensive recall we did in cooperation with the FDA. Further, it would indicate that the FDA was rehashing old information, not in an attempt to protect the public, but as a way to target and further stigmatize kratom,” the company said.

In recent years, millions of Americans have discovered kratom, an herb grown and used in southeast Asia for centuries as a natural stimulant and pain reliever. Kratom is widely available online and in smoke shops, but the quality of what’s being sold and what country it came from are often unknown. Like other dietary supplements, kratom products are essentially unregulated and there are little or no quality controls.

That’s one of the reasons the AKA launched its GMP certification program. The organization said it wanted to protect kratom consumers from “unscrupulous vendors using sloppy manufacturing procedures” and those who adulterate kratom to boost its potency by adding substances like fentanyl or morphine.

But under the AKA’s certification program, no kratom products are actually tested for Salmonella bacteria, heavy metals, fentanyl or any other foreign substances.

“No, absolutely not. That is not our function,” AKA President Dave Herman told PNN. “The audit does not inspect the products. The audit inspects the procedures in place to manage the facility.”

Herman says third party auditors hired by the vendor and approved by the AKA only inspect manufacturing procedures — not the kratom itself. He declined to comment on the FDA’s discovery of heavy metals in Kraken Kratom products.

“I have no way of knowing when samples were taken or under what conditions they were taken,” he said. “Was it prior to an inspection? After an inspection? And without that knowledge I’m not sure I can say anything intelligent,” Herman said.

A handful of states have banned kratom and there is speculation the Drug Enforcement Administration will try again to schedule it as a controlled substance, something the agency backed away from in 2016 after a public outcry. FDA commissioner Scott Gottlieb, MD – who leaves office today -- has also mounted an extended public relations campaign against kratom.

"Over the last year, the FDA has issued numerous warnings about the serious risks associated with the use of kratom, including novel risks due to the variability in how kratom products are formulated, sold and used both recreationally and by those who are seeking to self-medicate for pain or to treat opioid withdrawal symptoms,” Gottlieb said in a statement.

“Data suggest that certain substances in kratom have opioid properties and that one or more have the potential for abuse. The findings of identifying heavy metals in kratom only strengthen our public health warnings around this substance and concern for the health and safety of Americans using it."

Canada Forms Chronic Pain Task Force

By Marvin Ross

Canadian chronic pain patients were given a glimmer of hope this week when federal health minister Ginette Petitpas Taylor announced the establishment of a national task force to examine how to prevent and manage chronic pain and remove barriers to pain treatment.

“This is the first step in addressing the issue of chronic pain in this country,” Ginette Petitpas Taylor said at the annual meeting of the Canadian Pain Society in Toronto. “We have to recognize that Canada’s a big country and we certainly know there’s inconsistent services in provinces and territories, so I have to really have a good understanding of what’s available and what’s happening out there.”

One in five Canadians lives with chronic pain and -- like their counterparts in the U.S. – many have been on the receiving end of the crackdown on opiates.

After the U.S. Centers for Disease Control and Prevention released its 2016 opioid guideline, Canada followed with its own very similar set of recommendations, which were developed by a panel at McMaster University chaired by lead investigator Dr. Jason Busse, a chiropractor.

Although the guidelines are voluntary, medical regulatory colleges across Canada have been pressuring their physician members to drastically reduce opioid prescribing and many doctors now fear for their licenses if they don’t comply.

Petitpas Taylor acknowledged that Canada’s response to the overdose crisis contributed to “stigmatizing attitudes and behaviours” about opioids and created barriers “that may prevent people with chronic pain from receiving the health services they need.”

She said the task force will consult with governments and advocacy groups, and provide an initial report to Health Canada in June, followed by two more in 2020 and 2021.

The panel has two co-chairs. Dr. Fiona Campbell is a pediatric anesthesiologist and Associate Professor in the Department of Anaesthesia & Pain Medicine at the University of Toronto. The other co-chair is Maria Hudspith, who is the Executive Director of Pain BC, a non-profit charity working to improve the lives of people in pain.

Both co-chairs have been on the syndicated Roy Green Show discussing the increasing problems faced by pain patients. In 2017, Campbell told Green that patients who need opiates should not be marginalized and that opiates should be used when all other treatment modalities have failed. Hudspith was a guest on the Green show last year and is well aware that patients have been forcibly tapered or cut off from opioids and often have problems finding care.

That gives me some hope, as does the fact that the other six members of the task force are a combination of medical specialists and pain patients themselves. But not everyone is pleased with the appointments or that the panel’s work will take up to three years.

“Of course, we are happy they are actually acknowledging chronic pain is an issue. However, the time frame is wrong and a little bit too late. We are also quite disappointed in the individuals who have been chosen to lead this task force,” said Barry Ulmer of the Chronic Pain Association of Canada. “Although we were consulted to a degree, it seems our voices were not heard to any large extent.” 

"My colleagues and I provided a list of names of pain physicians who have decades worth of practical experience and have worked diligently to hone their knowledge and skills. We were extremely disappointed not to see a single name from this list appointed to the task force,” said Ann Marie Gaudon, a social worker, pain patient and PNN columnist. 

“Additionally, while we appreciate the Minister's efforts in setting up this task force, solutions must be found now or there will be more deaths and increasing needless suffering. These severely pained and severely stigmatized patients who have been forced off of necessary medications just do not have three years to wait for more information that we already have. There is an extreme urgency here that is not being addressed as such."

Chronic pain in Canada costs up to $60 billion per year in direct health care costs and lost productivity due to job loss and sick days. 

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

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.

‘Space Pants’ Help Patients Walk Again

By Steve Weakley

Specially designed “space pants” worn by astronauts to regulate their body temperature are helping patients with Peripheral Artery Disease (PAD) walk and exercise again with less pain.

More than eight million Americans suffer from PAD -- a narrowing of peripheral arteries in the legs that can cause severe pain and cramping after a short walk or even just climbing a flight of stairs.

“I have patients that have trouble going to their mailbox,” said Bruno Roseguini, PhD, an assistant professor in the Department of Health and Kinesiology at Purdue University. “These patients, in order to avoid that pain, become very inactive. So, this is a vicious cycle that leads to more impairment and more functional decline over time.”

PURDUE UNIVERSITY

To get PAD patients moving again, Roseguini and his research team turned to NASA and the elastic space pants worn by astronauts.  Woven into the pants is an elaborate tubing system that circulates warm water and helps keep the astronauts’ body temperatures normal in a weightless environment. 

Researchers modified the pants for a clinical study of PAD patients and found they were able to lower blood pressure and increase circulation in their legs. Patients who wore the pants for 90 minutes every day for eight weeks reported less pain and more mobility.

"It's like putting your legs in a hot tub without getting wet," says PAD patient Stephen Scott, who is now able to stand longer and walk longer distances. "It feels good."

“Based on our initial findings, it is conceivable that repeated exposures to heat therapy might enhance the ability of the arteries in the legs to vasodilate” Roseguini said. “What that means is there would be more blood flow and greater oxygen delivery to calf muscles during exercise, and we anticipate this will prolong the time they can walk before they feel pain.”

Roseguini explains how the pants work in the video below:

Roseguini calls physical exercise the “gold standard” for treating PAD, even if many patients choose other routes of relief.  Some have stents surgically inserted into their leg arteries, but they can narrow without exercise and may have to be replaced every few years. Medication and dietary changes can also help manage PAD, for which there is no cure.

“Exercise is painful for these patients and leg pain is one of the main reasons for why most of these patients do not adhere to structured exercise programs,” said Roseguini. “Heat therapy, on the other hand, is not painful. If anything, heat therapy might actually reduce leg pain, so the patients see that as a treatment they would potentially adhere to.”

Studies show heat therapy can also improve the health of blood vessels and help muscles recover after an injury.

“Heat therapy is a powerful tool for rehabilitation,” says Roseguini, who hopes to develop a portable battery-powered pump that PAD patients can wear without being tethered to an electric outlet. “I want the patients to be able to receive the therapy while walking and performing their daily living activities, such as going to the grocery store.”

Feds Warn CBD Marketers About False Medical Claims

By Pat Anson, PNN Editor.

The Food and Drug Administration and the Federal Trade Commission are tapping the brakes on the fast growing market for cannabidiol (CBD), warning companies not to make false claims that CBD products can be used to treat fibromyalgia, migraine, arthritis and other chronic illnesses.

The agencies sent warning letters to three companies — Nutra Pure, PotNetwork Holdings, and Advanced Spine and Pain — for making false and unsubstantiated health claims about a variety of CBD oils, extracts and edibles.

The FDA and FTC sent the warning letters on March 28 and gave the companies 15 days to respond.

Nutra Pure’s website, according to regulators, claimed that “CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”

Claims were also made that CBD is “an effective and safe treatment alternative” for inflammatory conditions such as lupus, Celiac disease and rheumatoid arthritis.

Nutra Pure, which makes a line of hemp oil, has a small disclaimer on its website stating that “these products are not intended to diagnose, prevent, treat, or cure any disease.”

NUTRA PURE IMAGE

PotNetwork has a similar disclaimer on its website, where it sells everything from CBD infused gummy bears and energy drinks to moisturizers and pet care products. According to the FDA, the company falsely claimed that CBD “blocked the progression of arthritis” and “has also shown the ability to kill cancer cells directly.”  

In addition to marketing CBD products, Advanced Spine and Pain also offers stem cell therapy, steroid injections, trigger point injections and ketamine infusions at its “Relievus” clinics in New Jersey and Pennsylvania.

‘Open Questions’ About CBD Safety

The federal crackdown on CBD marketing comes at a time when CBD products are starting to appear in mainstream stores. CVS Pharmacy and Walgreens started selling cannabis-based lotions, tinctures, edibles and lozenges in stores last month. The CBD products are being sold over-the-counter and without a prescription.  

The FDA and FTC announced no actions against CVS, Walgreens or other retailers selling CBD products, but they sent a clear message that the marketing of CBD will be closely watched.

“We treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that’s marketed with a claim of therapeutic benefit to be approved by the FDA for its intended use before it may be introduced into interstate commerce,” FDA commissioner Scott Gottlieb, MD, said in a statement. “Additionally, it is unlawful to introduce food containing added CBD, or the psychoactive compound THC, into interstate commerce, or to market CBD or THC products as dietary supplements.”

The 2018 Farm Bill removed hemp – a less potent strain of marijuana – from the Controlled Substances Act. That made hemp products legal to sell, but left the FDA in charge of regulating dietary supplements containing CBD. The agency is still trying to figure out how to regulate a product for which there is growing consumer demand, but little scientific evidence to support its use.

“While the availability of CBD products in particular has increased dramatically in recent years, open questions remain regarding the safety considerations raised by their widespread use,” Gottlieb said. “There are also unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products, as well as questions regarding the intended functionality of CBD in such products.”

Gottlieb has announced plans to hold a public hearing on May 31 to review the safety and effectiveness of CBD products. The FDA is also forming an internal working group within the agency to explore what regulatory changes would be needed for CBD products to be marketed legally.  

Pets Help Take Our Minds Off Pain

By Pat Anson, PNN Editor

Pets make good companions, keep their owners physically active and help us enjoy life. But did you know that pets can also help take our minds off pain?

That’s one of the findings from a new National Poll on Healthy Aging conducted by AARP and the University of Michigan Institute for Healthcare Policy. Researchers surveyed over 2,000 American adults aged 50 to 80, who answered a wide range of questions online about the health benefits of pet ownership.

Companionship, social connection and physical activity were positive side effects of pet ownership for many poll respondents.

People said their pets helped them enjoy life (88%), make them feel loved (86%), help reduce stress (79%), keep them physically active (64%) and help them cope with physical and emotional symptoms (60%), including taking their mind off pain (34%).

For those who said their health was fair or poor, pet ownership offers the most benefits. More than 70 percent of those older adults said their pet helps them cope with physical or emotional symptoms, and nearly half (46%) said their pets help distract them from pain.

"Relationships with pets tend to be less complicated than those with humans, and pets are often a source of great enjoyment," says Mary Janevic, PhD, an assistant research scientist at the U-M School of Public Health. "They also provide older adults with a sense of being needed and loved."

More than half of those who owned pets said they did so specifically to have a companion and nearly two-thirds said having a pet helps connect them to other people.

"We have long known that pets are a common and naturally occurring source of support," says Cathleen Connell, PhD, a professor at the U-M School of Public Health. “Although the benefits of pets are significant, social connections and activities with friends and family are also key to quality of life across the lifespan. Helping older adults find low cost ways to support pet ownership while not sacrificing other important relationships and priorities is an investment in overall mental and physical health."

While pets come with benefits, they can also bring concerns. Nearly one in five older adults (18%) said having a pet puts a strain on their budget. Some owners even put their animals' needs ahead of their own health.

"For people living on a fixed income, expenses related to health care for pets, and especially pets that have chronic health issues, can be a struggle. Older adults can also develop health problems or disabilities that make pet care difficult," said Janevic.

"More activity, through dog walking or other aspects of pet care, is almost always a good thing for older adults. But the risk of falls is real for many, and six percent of those in our poll said they had fallen or injured themselves due to a pet," said poll director Preeti Malani, MD. “At the same time, given the importance of pets to many people, the loss of a pet can deal a very real psychological blow that providers, family and friends should be attuned to."

More than half of older adults (55%) reported having a pet. Among pet owners, the majority (68%) had dogs, 48% had cats, and 16% had a small pet such as a bird, fish, or hamster.

Over half of pet owners (53%) reported that their pets sleep in their bed. Dog lovers are often told that’s a bad idea, but a recent study found an "overwhelmingly positive" response from owners who say they slept better with their dogs.

39 Attorneys General Practicing Medicine Without a License

By Pat Anson, PNN Editor

Over 5,000 healthcare providers, patients, caretakers and advocacy organizations have left comments in the Federal Register on a draft report by a federal advisory panel known as the Pain Management Best Practices Inter-Agency Task Force. The comment period ended April 1.

Most of the comments – which you can see by clicking here – are supportive of the report, which recommends that pain management be balanced, multimodal and focused on individualized patient care. Opioid pain medication should be prescribed cautiously, if prescribed at all, according to the task force.

Those may sound like reasonable and prudent goals, but one aspect of the draft report has stirred controversy and it’s a familiar one: the CDC’s 2016 opioid prescribing guideline.

While commending its “useful general guidance,” the report found that that guideline has had many unintended consequences, including forced opioid tapering, patient abandonment and suicide. The task force said the guideline was never meant to be mandatory or to be used as a model by states, insurers and pharmacies, and better evidence was needed to support its recommendations.

The task force stopped short of recommending a wholesale revision of the guideline, but suggested a “more even-handed approach” to pain care was needed.  

“In essence, clinicians should be able to use their clinical judgement to determine opioid duration for their patients,” the report concludes.

Those were fighting words to some anti-opioid crusaders and politicians who consider the CDC guideline a cornerstone of the government’s war on drugs.

“As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment that causes nearly 50,000 deaths annually,” warns a letter signed by 39 state and territory attorney generals.  “It is incomprehensible that officials would consider moving away from key components of the CDC Guideline.”

‘They Have Overreached’

The AG’s letter shows a fundamental and perhaps willful ignorance of what the guideline is – a voluntary set of recommendations intended only for primary care physicians. The letter also demonstrates how politicians have grown accustomed to inserting themselves into pain management decisions normally left between patients and their doctors. In essence, the AG’s are saying that doctors should not be allowed to use their own clinical judgement and should rely instead on treatment guidelines.  

“The Draft Report proposes to rely solely on the judgment of providers regarding the dose and duration of opioid treatment. With annual overdose deaths in the tens of thousands, evidence-based recommendations, such as documentation and consultation, are necessary,” the AG letter states. “Similarly, the Draft Report states that duration of opioid treatment for acute pain, including trauma and surgery, is best determined by providers without the need for guidelines to inform appropriate decision-making.”

Critics say the AG’s are essentially practicing medicine without a license.

“The foxes watching the hen house want more hens to watch, more justification for their existence,” says Mark Ibsen, MD, a Montana doctor all too familiar with government intrusion into pain care. Ibsen’s medical license was suspended in 2016 over allegations that he overprescribed opioids, a decision later reversed by a judge.

“They have overreached. I hope someone else notices, and takes law enforcement out of the practice of medicine, where they’ve been screwing up medical care since 1914. Abolish the DEA. Let law enforcement catch criminals, not make them up out of thin air,” Ibsen said.

This isn’t the first time the National Association of Attorneys General has tried to meddle in pain care. In 2017, the organization sent a letter to health insurers asking them to take steps to reduce the prescribing of opioid medication.

“Reducing the frequency with which opioids are prescribed will not leave patients without effective pain management options.”

— National Assn. of Attorneys General

“Reducing the frequency with which opioids are prescribed will not leave patients without effective pain management options,” the 2017 letter states. “When patients seek treatment for any of the myriad conditions that cause chronic pain, doctors should be encouraged to explore and prescribe effective non-opioid alternatives, ranging from non-opioid medications (such as NSAIDs) to physical therapy, acupuncture, massage, and chiropractic care.”

In their latest letter, it’s no longer a matter of “should.” The AG’s say doctors “must be encouraged” to reduce opioid prescriptions and to recognize that opioids have “well established risks.”  

“The Draft Report should be revised to clearly state that there is no completely safe opioid dose, and that higher doses are particularly – and predictably – risky,” the AG’s wrote.

But most opioid medications are not particularly risky, as PNN reported in a recent study of over half a million Medicare patients who were prescribed the drugs. Over 90 percent had a negligible risk of an overdose. Even among “high risk” patients on high opioid doses, the risk of an overdose is less than two percent.

‘Too Much Money On the Line’

Critics also point out the AG’s have a political and financial interest in demonizing opioid medication. Most have signed on as plaintiffs in over 1,600 class action lawsuits filed by states, cities and counties seeking billions of dollars in damages from opioid manufacturers and distributors. Oklahoma Attorney General Mike Hunter – one of the AG’s who signed the letter criticizing the task force report --  recently reached an out-of-court settlement with Purdue Pharma for $270 million.  

“There is just too much potential money on the line. This is not an argument about truth, or evidence, or anything except money," says Andrea Anderson, Executive Director of the Alliance for the Treatment of Intractable Pain (ATIP).  

“Since the Purdue/Oklahoma settlement of $270 million, all the AG’s of every state involved in this opioid litigation will focus solely on their potential financial gains until they get their piece of settlement pie. This will come at the cost of needed revisions to the flawed CDC Guidelines and a return to clinical common sense. People can remember these AG’s when they vote.” 

According to OpenSecrets.org, the law firm of Simmons Hanly Conroy donated over $1 million to congressional candidates during the 2018 election cycle. Simmons Hanly Conroy represents dozens of states and local governments that are suing drug makers over their marketing of opioids, and would pocket one-third of the proceeds from any settlements, according to reports.

A recent PNN survey found the CDC guideline was having a harmful effect on both patients and healthcare providers. Over 85 percent of patients say the guideline has made their pain and quality of life worse. Nearly half have considered suicide. Over two-thirds of practitioners are worried about being sanctioned or prosecuted for prescribing opioids. Rather than risk going to prison, many have stopped treating pain, closed their practice or retired.  

Finding Validation at the Migraine Symposium

By Mia Maysack, PNN Columnist

It was an honor to attend the annual Migraine Symposium and Awards Dinner held by the Association of Migraine Disorders (AMD) this past weekend at Brown University in Providence, Rhode Island.  

At the symposium there were more than 25 experts covering topics from breakthroughs in migraine research, emerging technology, holistic treatments, medicinal cannabis and one of the most painful conditions known to mankind: cluster headaches.        

As someone who lives with multiple brain diseases and disabling chronic intractable pain, sharing space with migraine community members and healthcare professionals that sincerely care made the occasion extraordinarily meaningful to me.

I was introduced to many exceptional human beings, each of whom I could easily write a column about, but for now I'd like to shine the spotlight on the President of AMD, Dr. Frederick Godley.  Not only is he an extraordinarily intelligent and kind soul, his positive attitude illuminated the entire room

#ShadesforMigraine

Let me share one of the very first moments of validation I'd ever experienced as a person living with migraine and cluster headaches caused by post-bacterial meningitis. Having inquired with many healthcare professionals as to whether or not I am living with a traumatic brain injury (and been disregarded by each and every one), my eyes fill up with tears while rejoicing when I write that although I am not a patient of Dr. Godley or being treated by him, he acknowledged that possibility.  

At the end of the day, it doesn't do those of us coping with severe ailments much good to fixate on any specific diagnosis. What's most important is we find a way to manage whatever hand we are dealt. But the validation helps. There have been moments when I've begun to question my own sanity. There's no possible way my head could be hurting *this* bad or for *this* long. Most others are in persistent disbelief as well, even though I crack jokes that if I were to ever wake up pain free, then I must be dead!

I am grateful that I am not and tremendously excited about the future possibilities in migraine treatment. Considering that for about 30 years one of our only options was a small class of medications, now is the best time to get involved in the migraine community because we're moving forward with such momentum. There have been funds granted for much needed further research.

PTSD and Psychedelics

Some other thoughts about the symposium:

The very significant validation that post-traumatic stress disorder (PTSD) is a common underlying element of pain or even a potential cause of it. Think about it. If your own body feels as though it is fighting and turning against you on a daily basis, how are we to live without stress or experience any sense of security? 

It's not as common as it should be to go into a doctor's office and be addressed as an entire person. In my experience it has been: “Let's do what we can to mask the symptoms and settle on normalizing what’s left.” That is not treatment. Unacceptable.

The same small class of medications that are one of the only options for people living with ongoing head pain have a similar chemical makeup to Psilocybin, a psychedelic compound found in mushrooms. Psilocybin and LSD are beginning to have more credibility as potential options in treating Trigeminal Autonomic Cephalalgia (TAC) or cluster headaches. There's hope they could be helpful in treating other conditions as well, despite the fact they've got an overall reputation as being hazardous drugs. 

Ever come across a rule that just seems absolutely ridiculous? That's kind of how I feel about the current classification of these substances. We all know it only takes one person to essentially ruin things for everyone else. As a result, most people think this kind of stuff only causes harm and chaos.  No one is suggesting that anybody should go to their local drug dealer and score a bag of whatever -- we’re discussing potential. It all boils down to the science and our focus here is solely medicinally related.

Much like we've been exploring the use of CBD without THC, we are moving forward with learning more about these other substances -- potentially without the psychedelic or hallucinogen properties. Perhaps they're needed to induce relief. And if that is the case, in what micro-dosage could this possibly be prescribed in a safe, effective way?     

Although I am not using them, I've known others who’ve had successful results. In the proper way and for the right reasons, I have also chosen to advocate for them, as there seems to be far less complications with more natural options than those from the pharmaceutical realm. Each approach has its rightful place and there's no one-size-fits-all for everyone. 

Mia Maysack lives with chronic migraine, cluster headaches and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook support group, and Peace & Love Enterprises, a wellness coaching practice focused on holistic health.

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.

Elite Hospitals Offering Unproven Stem Cell Treatments

By Liz Szabo, Kaiser Health News

The online video seems to promise everything an arthritis patient could want.

The six-minute segment mimics a morning talk show, using a polished TV host to interview guests around a coffee table. Dr. Adam Pourcho extols the benefits of stem cells and “regenerative medicine” for healing joints without surgery. Pourcho, a sports medicine specialist, says he has used platelet injections to treat his own knee pain, as well as a tendon injury in his elbow. Extending his arm, he says, “It’s completely healed.”

Brendan Hyland, a gym teacher and track coach, describes withstanding intense heel pain for 18 months before seeing Pourcho. Four months after the injections, he says, he was pain-free and has since gone on a 40-mile hike.

“I don’t have any pain that stops me from doing anything I want,” Hyland says.

The video’s cheerleading tone mimics the infomercials used to promote stem cell clinics, several of which have recently gotten into hot water with federal regulators, said Dr. Paul Knoepfler, a professor of cell biology and human anatomy at the University of California-Davis School of Medicine.

But the marketing video wasn’t filmed by a little-known operator. It was sponsored by Swedish Medical Center, the largest nonprofit health provider in the Seattle area.

Swedish is one of a growing number of respected hospitals and health systems—including the Mayo Clinic, the Cleveland Clinic and the University of Miami—that have entered the lucrative business of stem cells and related therapies. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best, Knoepfler said.

Hospitals say they’re providing options to patients who have exhausted standard treatments. But critics suggest the hospitals are exploiting desperate patients and profiting from trendy but unproven treatments.

The Food and Drug Administration is attempting to shut down clinics that hawk unapproved stem cell therapies, which have been linked to several cases of blindness and at least 12 serious infections. Although doctors usually need preapproval to treat patients with human cells, the FDA has carved out a handful of exceptions, as long as the cells meet certain criteria, said Barbara Binzak Blumenfeld, an attorney who specializes in food and drug law at Buchanan Ingersoll & Rooney in Washington.

Hospitals like Mayo are careful to follow these criteria, to avoid running afoul of the FDA, said Dr. Shane Shapiro, program director for the Regenerative Medicine Therapeutics Suites at Mayo Clinic's campus in Florida.

‘Expensive Placebos’

While hospital-based stem cell treatments may be legal, there’s no strong evidence they work, said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics who has published a series of articles describing the size and dynamics of the stem cell market.

“FDA approval isn’t needed and physicians can claim they aren’t violating federal regulations,” Turner said. “But just because something is legal doesn’t make it ethical.”

For doctors and hospitals, stem cells are easy money, Turner said. Patients typically pay more than $700 a treatment for platelets and up to $5,000 for fat and bone marrow injections. As a bonus, doctors don’t have to wrangle with insurance companies, which view the procedures as experimental and largely don’t cover them.

“It’s lucrative. It’s easy to do. All these reputable institutions, they don’t want to miss out on the business. It preys on people’s desperation.”

— Dr. James Rickert

“It’s an out-of-pocket, cash-on-the-barrel economy,” Turner said. Across the country, “clinicians at elite medical facilities are lining their pockets by providing expensive placebos.”

Some patient advocates worry that hospitals are more interested in capturing a slice of the stem-cell market than in proving their treatments actually work.

“It’s lucrative. It’s easy to do. All these reputable institutions, they don’t want to miss out on the business,” said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. “It preys on people’s desperation.”

In a joint statement, Pourcho and Swedish defended the online video.

“The terminology was kept simple and with analogies that the lay person would understand,” according to the statement. “As with any treatment that we provide, we encourage patients to research and consider all potential treatment options before deciding on what is best for them.”

But Knoepfler said the guests on the video make several “unbelievable” claims.

At one point, Dr. Pourcho says that platelets release growth factors that tell the brain which types of stem cells to send to the site of an injury. According to Pourcho, these instructions make sure that tissues are repaired with the appropriate type of cell, and “so you don’t get, say, eyeball in your hand.”

Knoepfler, who has studied stem cell biology for two decades, said he has never heard of “any possibility of growing eyeball or other random tissues in your hand.” Knoepfler, who wrote about the video in February on his blog, The Niche, said, “There’s no way that the adult brain could send that kind of stem cells anywhere in the body.”

The marketing video debuted in July on KING-TV, a Seattle station, as part of a local lifestyles show called “New Day Northwest.”

Although much of the show is produced by the KING 5 news team, some segments—like Pourcho’s interview—are sponsored by local advertisers, said Jim Rose, president and general manager of KING 5 Media Group.

After being contacted by KHN, Rose asked Swedish to remove the video from YouTube because it wasn’t labeled as sponsored content. Omitting that label could allow the video to be confused with news programming. The video now appears only on the KING-TV website, where Swedish is labeled as the sponsor.

“The goal is to clearly inform viewers of paid content so they can distinguish editorial and news content from paid material,” Rose said. “We value the public’s trust.”

Increasing Scrutiny

Federal authorities have recently begun cracking down on doctors who make unproven claims or sell unapproved stem cell products.

In October, the Federal Trade Commission fined stem cell clinics millions of dollars for deceptive advertising, noting that the companies claimed to be able to treat or cure autism, Parkinson’s disease and other serious diseases.

In a recent interview Scott Gottlieb, the FDA commissioner, said the agency will continue to go after what he called “bad actors.”

With more than 700 stem cell clinics in operation, the FDA is first targeting those posing the biggest threat, such as doctors who inject stem cells directly into the eye or brain.

“There are clearly bad actors who are well over the line and who are creating significant risks for patients,” Gottlieb said.

“Products are being promoted that aren’t providing any proven benefits and where patients are paying out-of-pocket.”

— Scott Gottlieb, FDA Commissioner

Gottlieb, set to leave office April 5, said he’s also concerned about the financial exploitation of patients in pain.

“There’s economic harm here, where products are being promoted that aren’t providing any proven benefits and where patients are paying out-of-pocket,” Gottlieb said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said there is a broad “spectrum” of stem cell providers, ranging from university scientists leading rigorous clinical trials to doctors who promise stem cells are “for just about anything.” Hospitals operate somewhere in the middle, Marks said.

“The good news is that they’re somewhat closer to the most rigorous academics,” he said.

The Mayo Clinic’s regenerative medicine program, for example, focuses conditions such as arthritis, where injections pose few serious risks, even if that’s not yet the standard of care, Shapiro said.

Rickert said it’s easy to see why hospitals are eager to get in the game.

The market for arthritis treatment is huge and growing. At least 30 million Americans have the most common form of arthritis, with diagnoses expected to soar as the population ages. Platelet-rich plasma (PRP) injections for arthritis generated more than $93 million in revenue in 2015, according to an article last year in The Journal of Knee Surgery.

“We have patients in our offices demanding these treatments,” Shapiro said. “If they don’t get them from us, they will get them somewhere else.”

Doctors at the Mayo Clinic try to provide stem cell treatments and similar therapies responsibly, Shapiro said. In a paper published this year, Shapiro described the hospital’s consultation service, in which doctors explain patients’ options and clear up misconceptions about what stem cells and other injections can do. Doctors can refer patients to treatment or clinical trials.

“Most of the patients do not get a regenerative [stem cell] procedure,” Shapiro said. “They don’t get it because after we have a frank conversation, they decide, ‘Maybe it’s not for me.’”

Lots of Hype, Little Proof

Although some hospitals boast of high success rates for their stem cell procedures, published research doesn’t back up those claims, Rickert said.

The Mayo Clinic website says that 40 to 70 percent of patients “find some level of pain relief.” Atlanta-based Emory Healthcare claims that 75 to 80 percent of patients “have had significant pain relief and improved function.” In the Swedish video, Pourcho claims “we can treat really any tendon or any joint” with PRP.

The strongest evidence for PRP is in pain relief for arthritic knees and tennis elbow, where it appears to be safe and perhaps helpful, said Dr. Nicolas Piuzzi, an orthopedic surgeon at the Cleveland Clinic.

But PRP hasn’t been proven to help every part of the body, he said.

PRP has been linked to serious complications when injected to treat patellar tendinitis, an injury to the tendon connecting the kneecap to the shinbone. In a 2013 paper, researchers described the cases of three patients whose pain got dramatically worse after PRP injections. One patient lost bone and underwent surgery to repair the damage.

“People will say, ‘If you inject PRP, you will return to sports faster,’” said Dr. Freddie Fu, chairman of orthopedic surgery at the University of Pittsburgh Medical Center. “But that hasn’t been proven.”

A 2017 study of PRP found it relieved knee pain slightly better than injections of hyaluronic acid. But that’s nothing to brag about, Rickert said, given that hyaluronic acid therapy doesn’t work, either. While some PRP studies have shown more positive results, Rickert notes that most were so small or poorly designed that their results aren’t reliable.

In its 2013 guidelines for knee arthritis, the American Academy of Orthopaedic Surgeons said it is “unable to recommend for or against” PRP.

“PRP is sort of a ‘buyer beware’ situation,” said Dr. William Li, president and CEO of the Angiogenesis Foundation, whose research focuses on blood vessel formation. “It’s the poor man’s approach to biotechnology.”

Tests of other stem cell injections also have failed to live up to expectations.

Shapiro published a rigorously designed study last year in Cartilage, a medical journal, that found bone marrow injections were no better at relieving knee pain than saltwater injections. Rickert noted that patients who are in pain often get relief from placebos. The more invasive the procedure, the stronger the placebo effect, he said, perhaps because patients become invested in the idea that an intervention will really help. Even saltwater injections help 70 percent of patients, Fu said.

A 2016 review in the Journal of Bone and Joint Surgery concluded that “the value and effective use of cell therapy in orthopaedics remain unclear.” The following year, a review in the British Journal of Sports Medicine concluded, “We do not recommend stem cell therapy” for knee arthritis.

Shapiro said hospitals and health plans are right to be cautious.

“The insurance companies don’t pay for fat grafting or bone-marrow aspiration, and rightly so,” Shapiro said. “That’s because we don’t have enough evidence.”

Rickert, an orthopedist in Bedford, Indiana, said fat, bone marrow and platelet injections should be offered only through clinical trials, which carefully evaluate experimental treatments. Patients shouldn’t be charged for these services until they’ve been tested and shown to work.

Orthopedists—surgeons who specialize in bones and muscles—have a history of performing unproven procedures, including spinal fusion, surgery for rotator cuff disease and arthroscopy for worn-out knees, Turner said. Recently, studies have shown them to be no more effective than placebos.

Misleading Marketing

Some argue that joint injections shouldn’t be marketed as stem cell treatments at all.

Piuzzi said he prefers to call the injections “orthobiologics,” noting that platelets are not even cells, let alone stem cells. The number of stem cells in fat and bone marrow injections is extremely small, he said.

Patients are attracted to regenerative medicine because they assume it will regrow their lost cartilage, Piuzzi said. There’s no solid evidence that the commercial injections used today spur tissue growth, Piuzzi said. Although doctors hope that platelets will release anti-inflammatory substances, which could theoretically help calm an inflamed joint, they don’t know why some patients who receive platelet injections feel better, but others don’t.

So, it comes as no surprise that many patients have trouble sorting through the hype.

Florida resident Kathy Walsh, 61, said she wasted nearly $10,000 on stem cell and platelet injections at a Miami clinic, hoping to avoid knee replacement surgery.

When Walsh heard about a doctor in Miami claiming to regenerate knee cartilage with stem cells, “it seemed like an answer to a prayer,” said Walsh, of Stuart, Florida. “You’re so much in pain and so frustrated that you cling to every bit of hope you can get, even if it does cost you a lot of money.”

The injections eased her pain for only a few months. Eventually, she had both knees replaced. She has been nearly pain-free ever since. “My only regret,” she said, “is that I wasted so much time and money.”

Kaiser Health News (KHN) is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

What About Pain Patients Who Don’t Get Better?

By Roger Chriss, PNN Columnist

The standard narrative of the opioid crisis focuses on pain management run amok. From duped doctors drugging patients into dependency to pill mills pumping painkillers into vulnerable communities, the narrative assumes chronic pain is a treatable ill.

“Looking back it’s clear that using opioids to treat chronic pain — backaches, bum knees and the like — might well be considered the worst medical mistake of our era,” wrote Haider Warraich, MD, in a recent opinion piece in The New York Times.

But what about the people who don’t get better?

There is a world of difference between “bum knees” and major diseases and disorders. From ankylosing spondylitis to sickle-cell disease, sometimes the diagnosis is permanent and the clinical course is progressive and degenerative. Care for such conditions is supportive and palliative. Affected people do not get better.

This distinction, between conditions like low back pain that often improve or resolve on their own versus progressive and degenerative conditions like Charcot-Marie-Tooth disease or multiple sclerosis, is often overlooked.

Patients treated with analgesic therapy, opioid or otherwise, are often judged on their level of improvement.

“Despite the limited improvement of clinical outcomes, most patients keep their long-term opioid prescriptions. Our results underscore the need for changes in clinical practice and further research into the effectiveness and safety of chronic opioid therapy,” concludes a study of chronic pain patients recently published Pain Medicine.

Left unsaid is anything specific about the study’s 674 patients’ diagnoses or expected clinical outcome. There was a tacit assumption that the patients should have improved and stopped taking opioids, an expectation that therapy should have been restorative and not just palliative. There is also an implication that non-restorative therapy is somehow inferior and not getting better is in effect a failure.

Often, however, that “failure” is the best that modern medicine can offer. Treatment does not necessarily mean clinical improvement and sometimes it doesn’t even mean halting progression of a disease. Instead, it may be about improving patient safety, such as the use of balance training for people with Meniere’s disease or peripheral neuropathy in the feet, or about improving activities of daily living, such as the use of assistive technology for people with muscular dystrophy or Ehlers-Danlos syndrome.

The list of chronic, progressive and degenerative disorders is long. The very complexity of the human body makes for a vast number of points of failure, from genetic mutations that cause inborn errors of metabolism to immune system dysfunction causing rheumatoid arthritis or lupus. There is the aftermath of chemotherapy, surgery and trauma, too.

MalaCards Human Disease Database has almost 20,000 gene-based disease entries. The National Organization for Rare Disorders includes over 1,000 diseases in its database. Though each condition may be rare, the total number of affected people reaches into the millions in the United States.

A common thread in current coverage of the opioid crisis is that people with chronic pain can and will get better, especially if they stop taking opioids. But a recent study of patients who stopped opioid therapy shows mixed results.

“Half of the former opioid users reported their pain to be better or the same after stopping opioids; however, 47% of the sample reported feeling worse pain since stopping their opioids,” researchers found. “As the pendulum swings from pain control to drug control, we must ensure that the response to the opioid epidemic does not cause harm to individuals with chronic pain.”

There is tendency not to see chronic pain patients as individuals and to lump them all together into one group. This may explain the mixed results in many recent studies on pain management, including on medical cannabis. The patients’ diagnoses and expected clinical outcome are often ignored, which in turn leads to overlooking the value of a therapy that may seem ineffective but is actually helpful.

The reality of long-term pain management for chronic, progressive and degenerative conditions is that there are no great options. It's all trade-offs, risks and benefits, and a careful balancing of medical needs. Sometimes there is little if any improvement. But if you're facing a lifetime of chronic pain, that little bit can still be worth a lot.

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.

Do You Know How To Say No?

By Ann Marie Gaudon, PNN Columnist

Such a tiny word. Such a powerful one. For toddlers and teenagers, saying “No” comes easily. Then something changes. Some of us as adults would rather stick pins in our eyes than say no to anyone. That’s a problem. An even bigger problem if you suffer from chronic pain

You likely know the drill. Your body is screaming in flared pain -- red flags for rest and self-care. But you don’t say no to your neighbour who needs help with a chore. You don’t say no to babysitting your nieces at the last minute. You don’t say no to that extra job your boss asks you to stay late for. 

The inability to say no is directly linked to our need for approval from others. Why do we crave their positive opinion? There are many reasons, but for our purposes let’s just talk about chronic pain patients and some of the reasons we can’t say no.

The consequences of unrelieved pain can include but are not limited to:  depression, anxiety, impaired function, financial distress, sleep and appetite disturbances, identity erosion, social isolation, relationship conflict, demoralization, and feelings of helplessness and hopelessness. They can all disconnect you from your family, friends, work and social life.

In a herculean attempt not to relinquish “who we were” before the pain, we don’t say no. Our hearts scream out: “I’m still a son/daughter! I’m still a partner! I’m still a parent! I’m still a good friend! I’m still a valued employee!”  We instinctively try to stay in the group in order to survive. We must be accepted and approved at all costs!

What are the personal costs of not saying no?

Anxiety

We only have so much time and energy, and yours is steadily eroded by other people’s demands. You may begin to experience anxiety attacks. Constant worrying and catastrophizing can lead to heart palpitations, sweating, headaches and other physical manifestations.

Depression

Constantly giving in to the demands of others and consistently falling behind in your own life can lead to feelings of low self-esteem, a major contributor to depression. If you spend your time catering to others without focusing on your owns needs, you can lose track of what you want and who you really are. This loss of identity feeds into anxiety and depression.

Relationship Breakdown

In the beginning, saying yes all the time may be appealing to you and to others. But as time goes by hidden resentments may surface or you may feel manipulated.

If you cannot say no, you’re not being honest about your feelings for fear of hurting someone else’s. You may not even be honest about how much pain you are in.

Honesty is a cornerstone of healthy relationships. Saying yes when you truly want to say no isn’t being honest – to yourself or anyone else.

Stress

Too much stress isn’t healthy and can be devastating to pained bodies. It’s exhausting trying to please everyone all of the time. Exhausted bodies are stressed bodies. You’re more likely to experience low grade colds or illness, have trouble sleeping, and feel more pain.

The inability to say no is problematic to your mental and physical well-being. It serves no one – not you or others – to be consistently saying yes when your body says no. You are not being true to yourself or to them.

Others cannot see your pain or understand what your needs are, so they are not given a chance to respect them. It’s really a lose-lose situation.

How does a pain sufferer get themselves out of this unrelenting pattern? Here are four tips I’ve learned:

1. Make Your Pain Visible

If you were in a wheelchair, your disability and limitations would be obvious. But when your pain is invisible, others may need to be educated. It’s time to fess up about what you are capable of and what you are not. Your health demands it.

You’ve likely heard this before: If you don’t take care of yourself first, you will never be able to take care of others. Think of the flight attendant teaching us how to use our oxygen masks in case of emergency. You always put your own mask on first to get the oxygen you’ll need to help others. It’s just like that with pain. When your body says no, it becomes you first.

Some people feel shame in telling others that they suffer from chronic pain. They feel broken or weak and don’t want others to know. This is an erroneous self-belief. It creates an invisible boundary between yourself and the rest of the world.

You = bad, broken. Everyone else = good, whole.

This is emphatically untrue. You are not different from the rest of the world. Everyone suffers in some way, shape or form. It may not be from physical pain, but it will be from something else.

It may not be the easiest conversation you ever have, but it’s one of the most important ones.  Some folks provide educational material about their pain condition to help explain how debilitating it can be. You might be pleasantly surprised when you give people a chance to understand. They may embrace you with compassion, respect your limitations and treat you accordingly – just as you would for a loved one.

If you don’t say no and make your pain visible, they’ll never see the authentic you. They only see a façade: You wearing a “yes” mask. Is that fair to either of you? 

2. Create Boundaries  

When you’re learning how to say no, it’s easy to get caught off guard so be prepared. Sometimes well-meaning loved ones will try to coax or guilt you into doing something you really don’t want to do. Have a narrative ready. It could be something like, “I know I look fine, but my joints are hurting so much it’s getting hard to move. I’m just exhausted and I need your support right now.”

Or perhaps something like: “Sorry, I cannot help with that because I’m in a pain flare today and need to take care of myself. I’d really like to help when I am able to, so next time around, ask me again.”

Boundaries for support from other people need to be firm. If not, you risk no one taking you or your pain seriously.

3. Simplify Your Social Life, But Don’t Abandon It  

What about social occasions? How do you handle an impromptu invitation from a friend when your body is telling you to stay put? Living as well as possible with chronic pain is all about constant adaptations.

Perhaps there is something you could attend if someone else did all of the driving?

Maybe you can go to a potluck dinner, but your contribution is store-bought?

Loved ones want to get together for a meal? Dining out is a terrific choice because there’s no cooking or clean up involved.

Can’t keep up with your friends at the gym? Let them run on their treadmills or go to cardio class while you walk around the track. You can all meet up later for a stretch and a green tea.

Family wants to go bowling, which is something you’re not physically capable of? No need to miss out. Let them bowl as you sit and chat with them as they take their turns. You might be pleasantly surprised your inner circle is just happy to have you there and that they’ve come to understand your limits

4. Yes, But…

How do you RSVP to an invitation when you have no idea how you will feel at that time?

How about this: “Thanks, I would love to come but there is a chance that it may be a flared pain day for me. Can I confirm with you the day of, if that’s okay?” This is a regular of mine.

It may turn out to be a low pain day, in which case I’m attending.  If it’s a medium pain day, I’ll put my psychotherapy tools to work and go. If it’s a very high pain day, I am staying home.  

Framing it this way makes it much easier for me to bow out at the last minute. I do this both socially and with work-related meetings. If I’m not able to make it, we re-book so they know I really do want to attend, I just need to be well enough to do it.

There are some very special and rare occasions where I will say yes even if my body says no, such as a wedding or special birthday event. In that case, I will not book myself for anything or anyone for a couple of days after so that I can fully recover.

Say no when necessary. Simplify and adapt to your needs when necessary. You first. It’s not selfish, it’s self-compassion. Chronic pain patients could all use more of that. Seek help if you need some.  Most therapists are well-versed in self-compassion.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, 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 represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Doctors Say Guidelines Exaggerate Effectiveness of Lyrica and Neurontin

By Pat Anson, PNN Editor

There is little evidence that gabapentin (Neurontin) and pregabalin (Lyrica) should be used off-label to treat pain and prescribing guidelines often exaggerate their effectiveness, according to a new clinical review in JAMA Internal Medicine.

Gabapentin and pregabalin belong to a class of nerve medication known as gabapentinoids. The drugs were originally developed to prevent seizures, but their use has tripled over the past 15 years as more doctors prescribed them for a variety of chronic pain conditions. It is a common practice for doctors to prescribe drugs “off label” for treatments that are not FDA-approved.

“Gabapentinoids have become frequent first-line alternatives in patients with chronic pain from whom opioids are being withheld or withdrawn, as well as in patients with acute pain who traditionally received short courses of low-dose opioid,” wrote Christopher Goodman, MD, and Allan Brett, MD, of the University of South Carolina School of Medicine.

“The evidence to support off-label gabapentinoid use for most painful clinical conditions is limited. For some conditions, no well-performed controlled trials exist.”

Gabapentin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder.  Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries, but it is also widely prescribed off-label to treat other types of pain.

The drugs are sold by Pfizer under the brand names Lyrica and Neurontin. The company has paid nearly $1 billion in fines for misleading and improper marketing of the drugs for off-label use.

“Despite documentation that these drugs were promoted improperly for off-label treatment of pain, the recent rapid increase in prescribing of gabapentinoids suggests a persisting sense among clinicians that gabapentinoids are highly effective pain medications,” the doctors wrote.

“Guidelines and review articles have contributed to this perception by often uncritical extrapolation from FDA-approved indications to off-label use.”

Goodman and Brett say the wording in many medical guidelines “reinforces an inflated view of gabapentinoid effectiveness” by falsely claiming the drugs should be used to treat all types of nerve pain.

“Another example is the 2016 guideline on opioid prescribing from the U.S. Centers for Disease Control and Prevention, which states broadly that gabapentin and pregabalin are first-line drugs for neuropathic pain, without further detail or specification,” they wrote. “Even for treatment of diabetic neuropathy (for which pregabalin is FDA approved and gabapentin is off-label), guideline conclusions tend to exaggerate effectiveness.”

Many patients who take gabapetinoids have side-effects such as dizziness or drowsiness, and there are an increasing number of reports that the drugs are being abused and sold on the street.   

Goodman and Brett have sounded the alarm before about the drugs, warning in a 2017 commentary in the The New England Journal of Medicine that “gabapentinoids are being prescribed excessively.”

They say doctors should do a better job warning patients about the side effects of gabapentinoids and the drugs should be stopped if a patient reports little or no benefit.  They also think medical guidelines should be revised to stop the promotion of gabapentinoids for any pain labeled as neuropathic.

Mice and Mozart: Can Music Make Pain Meds More Effective?

By Pat Anson, PNN Editor

Wolfgang Amadeus Mozart is widely considered the most gifted and prolific composer in the history of classical music. Mozart composed over 600 symphonies, concertos and operas, and many remain popular two centuries after his death.

WOLFGANG AMADEUS MOZART

Were he alive today, Mozart would probably be flattered to learn that his music is being studied as a pain reliever.  And amused that some of his most devoted listeners are mice.

Music therapy won’t cure chronic pain, but there’s a growing body of evidence that it helps distract and alleviate pain and anxiety. Mozart’s “Sonata for Two Pianos” has been found to be particularly helpful in treating patients with epilepsy.

Researchers at the University of Utah took that theory a step further, to see if music can decrease pain and improve the effectiveness of ibuprofen and cannabidiol (CBD), the non-psychoactive compound found in marijuana.

"We know these drugs work without music but they can produce toxicity and adverse effects," said senior author Grzegorz Bulaj, PhD, an associate professor in medicinal chemistry at University of Utah Health. “The holy grail is to combine the right drug with this new paradigm of music exposure, so we do not need as much drug for analgesic effects."

‘Music is Like DNA’

Bulaj and his colleagues selected some of Mozart’s compositions and arranged them on a playlist for laboratory mice. That’s right, mice. Humans were not part of the study.

The playlist was made up of two faster-paced allegro sections separated by a slower adagio section — with “Sonata for Two Pianos” played multiple times. The goal was to “balance arousal” and “minimize any potential stress on the mice.”

"Music is like DNA. We had musicians analyze sequences of several Mozart pieces to optimize the playlist," Bulaj said. "This was exciting but challenging to integrate these musical analyses into neuropharmacology."

The mice were divided into two groups (five to eight mice in each group), with a control group exposed to ambient noise, while mice in the music group listened to the Mozart playlist three times a day for 21 days.

Both groups were given ibuprofen, CBD and two epilepsy drugs. The mice received one sub-optimal dose of each drug and then put through a series of inflammatory pain tests in the laboratory.

When combined with music, ibuprofen reduced inflammation in the mice by 93 percent compared to ibuprofen alone. Mice exposed to Mozart and CBD had a 70 percent reduction in inflammation compared to CBD with no music. Researchers say they were unable to evaluate the effectiveness of music with epilepsy drugs.

"There is emerging evidence that music interventions can alleviate pain when administered either alone or in combination with other therapies," said first author Cameron Metcalf, PhD, a research assistant professor in Pharmacology and Toxicology at University of Utah Health. "I was particularly excited to see reduced swelling in the inflammatory pain model."

According to Metcalf, medications currently available to treat inflammation do not show such a robust response. "It is exciting to think of what this might mean for the anti-inflammatory effects of music interventions and where the research may take us next," he said.

Mice hear at different frequencies than humans, and the effect of music volume or duration remains unclear. So is the type of music. Is Mozart a better pain reliever than Beyonce? We don’t know. Also unclear is whether any of these results can be duplicated in people. But Bulaj believes future studies should explore the pairing of music with pain relievers.

"If we could package music and other non-pharmacological therapies into mobile apps and deliver them with drugs and it works, it will be better than drugs alone," Bulaj said. "It is exciting to find new ways to improve pain treatments."

Mozart didn’t need an app or mice to figure that out. “Music, even in situations of the greatest horror, should never be painful to the ear but should flatter and charm it,” he wrote to a friend.

The study findings are published online in the journal Frontiers in Neurology.