NFL Players Tackle Pain with Regenerative Medicine

By A. Rahman Ford, Columnist

Several members of the Seattle Seahawks have opted for a regenerative medicine therapy called Regenokine to treat their pain and injuries, and the players believe it has made a big difference. 

The Seahawks were one of the NFL’s healthiest teams last season, ranking 5th out of 32 teams overall.  However, key players such as defensive back Earl Thomas and wide receiver Tyler Lockett had season ending injuries. Other players, like quarterback Russell Wilson and cornerback Richard Sherman, had nagging injuries that limited their effectiveness on the field. 

Unfortunately, serious injuries are all too common in the NFL.  According to NFL injury data, the incidence of anterior cruciate ligament (ACL) tears in the knee during the regular season has remained relatively consistent since 2012, with 36 reported in 2016. 

Likewise, the incidence of medial collateral ligament (MCL) tears has remained steady, with 143 incidents reported last season.  Suffice it to say, these injuries can require surgery, shorten playing careers and can be extremely painful, both physically and emotionally.

SEAHAWKS RECEIVER DOUG BALDWIN

Painkiller Use in the NFL

To cope with the pain, many NFL players resort to using opioid painkillers. According to the Washington Post, sealed court filings in a lawsuit filed by 1,800 former players asserted that the NFL violated federal law in prescribing painkillers to players.  Specifically, the players contended that the NFL disregarded DEA guidance on how to distribute controlled substances, and encouraged players to use powerful painkillers and anti-inflammatory drugs.  Team doctors who were deposed admitted to violating federal laws in prescribing painkillers. 

According to the filings, the average NFL team prescribed 5,777 doses of NSAIDs and 2,213 doses of controlled medications.  This amount averages to about 6-7 pain pills or injections per week per player. As a result, the players maintain that they suffered long-term organ and joint damage. 

In some cases, painkiller use in the NFL has led to addiction.  Hall of Fame quarterback Brett Farve, known for his durability and aggressive play, detailed how he would take 15 Vicodin at a time every day, and even resorted to asking teammates for their pills.

Regenerative Medicine as an Alternative to Existing Pain Therapies

In search of treatment options, several Seahawks traveled to England this year for a procedure known as Regenokine, or Orthokine.  The patented process was invented by Dr. Peter Wehling, Co-Director of the Center for Molecular Orthopaedics and Regenerative Medicine in Dusseldorf, Germany.  He, along with Klaus Wehling and biologist Dr. Julio Reinecke, founded the company Orthogen in 1993 to provide a joint-preserving alternative to traditional surgery. 

Orthokine works by using a patented syringe to incubate the “autologous conditioned serum” (ACS) in a patient's blood. In this phase, the blood is exposed to glass spheres, enriching the number of anti-inflammatory cytokines, interleukin agonists, and multiple growth factors.  After incubation, the blood is spun in a centrifuge to separate the solid components from the serum.  The ACS is later injected into the affected tissues. 

The therapy is not yet FDA approved, but is being offered by some clinics in the U.S. The cost of the procedure can vary.  Lloyd Sederer, MD, chief medical officer of the New York State Office of Mental Health, went to California in 2011 for ACS therapy of his arthritic knees and sore shoulders. He was charged $9,000 for the first joint and $3,000 for each subsequent joint.

Is the Treatment Effective?

Research on the effectiveness of the ACS/Orthokine/Regenokine treatment is scant but positive.  A 2015 study by Garcia-Escudero and Hernandez-Trilllos of 118 patients with unilateral knee osteoarthritis found significant improvements in pain over a two-year period.  These patients chose to forego surgery and instead opted for ACS and physiotherapy. 

A 2009 study had similar results with 376 osteoarthritis patients, concluding that the ACS therapy reduced pain and increased functional mobility for up to two years.  However, Rutgers et al. (2015) found no significant, long-term clinical improvement in 20 patients with osteoarthritis treated with ACS.  In 2009, Becker et al. used ACS successfully on patients with unilateral lumbar radiculopathy, or sciatica.  Ravi Kumar et al. (2015) replicated those results in 20 patients, leading the authors to conclude that “ACS can modify disease course in addition to reducing pain, disability and improving general health.”  In no study were there significant safety issues.

The reality is that interest in the therapy is largely driven by anecdotal, but promising evidence.  Dr. Sederer, who detailed his ACS treatment in an Atlantic article, was very happy with the results.  Seahawks linebacker K.J. Wright had ACS therapy to treat his nagging knee injury and told the Seattle Times he felt “1,000 percent better” than before.  Receiver Doug Baldwin, Defensive End Michael Bennett and several other Seahawks also traveled to Europe for ACS therapy.

Player reports have been so positive that Seahawks head coach Pete Carroll affectionately refers to receiving the therapy as “entering the circle.”  Other athletes have reported similar positive results, including MLB player Alex Rodriguez, NBA star Kobe Bryant and professional volleyball player Lindsay Berg.

Another Option in Tackling Chronic Pain

Overall, ACS/Orthokine/Regenokine therapy is very promising in treating pain.  However, the dearth of clinical data may cause some patients to choose a different option.  In addition, the cost – which is not covered by insurance – is likely prohibitive for most. 

To further complicate matters, there have been no published studies comparing the efficacy of ACS to other, better researched regenerative therapies such as platelet-rich plasma (PRP) therapy or stem cell therapy.  However, the good news for patients is that regenerative medicine alternatives to prescription painkillers are becoming more popular and more widely accepted.

A. Rahman Ford, PhD, is a lawyer and research professional who lives with chronic inflammation in his digestive tract. 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.

Rahman has received stem cell treatment and closely follows developments in regenerative medicine. He is not affiliated with any stem cell treatment provider.

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.

FDA Approves Advanced Spinal Cord Stimulator

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new spinal cord stimulator developed by Medtronic that can be managed, tracked and updated remotely on a Samsung Galaxy tablet.

The Intellis stimulator is designed for patients with chronic, intractable pain of the trunk and/or limbs.

The Intellis platform can track patient activity 24/7 on the Samsung Galaxy Tab S2 tablet, enabling physicians to personalize the settings for individual patients and monitor their progress using Medtronic’s Evolve software system. 

"The launch of the Intellis platform isn't just about a new device, but about combining cutting edge hardware with optimal therapy through the Evolve workflow to enable personalized, long-term pain relief," said Marshall Stanton, MD, president of Medtronic's Pain Therapies division.

“The Intellis platform was designed based on what is most important to patients and physicians. We considered the entire patient journey - starting with the primary goal of optimal pain relief and access to important diagnostic tools, like MRI, to ease of use with simplified programming, faster recharge and a smaller implant."

MEDTRONIC PHOTO

Spinal cord stimulators (SCS) are often considered the treatment of last resort for chronic back and leg pain, because the devices have to be surgically implanted near the spine and connected to batteries placed under the skin. The implants send electrical impulses into the spine to mask pain.

Some patients find the stimulators ineffective and have them removed. According to one study, only about half of patients who received a traditional SCS device have a 50 percent reduction in their back and leg pain. New technologies are being developed to make the devices smaller, more effective and easier to recharge.

Medtronic says Intellis is the world's smallest fully implantable SCS neurostimulator. Its battery can be fully recharged from empty to full in about one hour and physicians can estimate recharge intervals based on therapy settings. Software upgrades are also easier to get through Samsung Galaxy tablets.

"We are excited to partner with Medtronic in their aim to simplify programming, and streamline therapy management with the Intellis platform," said Dr. Dave Rhew, chief medical officer and head of Healthcare and Fitness for Samsung Electronics America. "Samsung's Galaxy tablets-secured by the HIPAA-ready Samsung Knox mobile security platform-will support future Medtronic therapies and over the air (OTA) software upgrades to ensure clinicians using Intellis have access to the most up-to-date solutions."

One of the first implantation procedures using the Intellis platform was performed at Duke University Medical Center.

"Chronic pain is challenging to manage. Having real-time data can provide more information about patients' quality-of-life changes. This platform represents a welcome new option for managing some kinds of chronic pain," said Lance Roy, MD, a pain medicine specialist at Duke University Medical Center.

Lady Gaga Denies ‘Making Up’ Her Chronic Pain

By Pat Anson, Editor

Lady Gaga has postponed the European leg of her “Joanne” concert tour, announcing in an Instagram post that “trauma and chronic pain have changed my life” and would keep her from performing for several weeks.

Last week the 31-year old entertainer also canceled a concert appearance in Brazil and revealed for the first time that she suffers from fibromyalgia.

“Lady Gaga is suffering from severe physical pain that has impacted her ability to perform," tour promoter Live Nation said in a statement. "She remains under the care of expert medical professionals who recommended the postponement."

Some critics have questioned the severity of Lady Gaga’s pain, claiming she used it as an excuse to postpone her tour or as a publicity stunt to promote “Gaga: Five Foot Two,” a Netflix documentary that shows her being treated for chronic pain.

scene from "gaga: five foot two"

Lady Gaga responded to the criticism with the lengthy post on Instagram.

“As I get stronger and when I feel ready, I will tell my story in more depth, and plan to take this on strongly so I can not only raise awareness, but expand research for others who suffer as I do,” she wrote.

“I use the word ‘suffer’ not for pity, or attention, and have been disappointed to see people online suggest that I'm being dramatic, making this up, or playing the victim to get out of touring. If you knew me, you would know this couldn't be further from the truth. I'm a fighter. I use the word suffer not only because trauma and chronic pain have changed my life, but because they are keeping me from living a normal life. They are also keeping me from what I love the most in the world: performing for my fans.”

The Live Nation statement said Lady Gaga would “spend the next seven weeks proactively working with her doctors.”  

The singer's European concerts were scheduled to begin Thursday in Barcelona, Spain and run through the end of October.  Fans were told to keep their tickets until the concerts were rescheduled.  Lady Gaga is still scheduled to perform during the second leg of her North American tour, which begins November 5 in Indianapolis.

Fibromyalgia is a poorly understood disorder characterized by deep tissue pain, fatigue, depression and insomnia. As many as 90 percent of fibromyalgia cases are diagnosed in women.

Lady Gaga also has chronic hip pain from synovitis, an inflammation of the joint that can be caused by overuse or injury. Her struggle with chronic pain reportedly began over a decade ago with physical and emotional trauma caused by a sexual assault.

“I have always been honest about my physical and mental health struggles. Searching for years to get to the bottom of them. It is complicated and difficult to explain, and we are trying to figure it out,” Lady Gaga wrote on Instagram.

“I am looking forward to touring again soon, but I have to be with my doctors right now so I can be strong and perform for you all for the next 60 years or more. I love you so much.”

New HIV Guidelines Discourage Use of Opioids

By Pat Anson, Editor

Opioid pain medication should not be considered as a first-line treatment for people living with HIV, even though chronic pain is a significant health problem that affects up to 85% of HIV/AIDS patients, according to new guidelines released by the Infectious Diseases Society of America.

The voluntary guidelines, the first to address treating chronic pain in HIV patients, urge physicians to begin with non-drug treatments such as cognitive behavioral therapy, yoga, physical therapy, hypnosis and acupuncture. Only when those treatments fail do the guidelines recommend medications such as gabapentin (Neurontin), pregabalin (Lyrica), anti-depressants, and medical cannabis.

The guidelines recommend against using opioids because of the risk of misuse, addiction and overdose. Opioid medication should only be considered as a second- or third-line therapy when other treatments prove to be inadequate.

"Opioids are never first-line," said the guidelines' lead author, Douglas Bruce, MD, chief of medicine at Cornell Scott-Hill Health Center, and associate clinical professor of medicine at Yale University.

“Additional clinical trials are needed to assess the effectiveness of the long-term use of opioids in neuropathic pain in PLWH (persons living with HIV). Although short-term use may provide some relief, these medications may be of limited success in chronic neuropathic pain.”

Nearly half of HIV patients suffer from neuropathic pain, likely due to inflammation or injury to the central or peripheral nervous system caused by the infection. Musculoskeletal pain, such as low-back pain and joint pain from osteoarthritis, is also common.

"It has been long known that patients with HIV/AIDS are at high risk for pain, and for having their pain inadequately diagnosed and treated," said Peter Selwyn, MD, co-chair of the guidelines and a professor at the Albert Einstein College of Medicine. “This is an aging population and the changing clinical manifestations of HIV, complexity of the disease and additional challenges related to substance abuse make treatment complicated. These guidelines help provide clarity in treating these patients."

The guidelines recommend that physicians consult with a palliative care or pain management specialist when HIV patients have an advanced illness or near the end of life.

"Because HIV clinicians typically are not experts in pain management, they should work closely with others, such as pain specialists, psychiatrists and physical therapists to help alleviate their patient’s' pain," said Bruce.

Restricting Opioid Doses Won’t Help the Overdose Crisis

By Roger Chriss, Columnist

As the overdose crisis worsens, new strategies and policies are being considered, including a recent petition to remove so-called high-dose opioids from the market.

The petition asks the FDA to ban opioid pills that, when taken as directed, would add up to a daily dose equivalent to more than 90mg of morphine. It is signed by leaders of several anti-opioid activist groups, including Physicians for Responsible Opioid Prescribing (PROP).

"The existence of these products implies that they're safe. They're not,” says Andrew Kolodny, MD, Executive Director and founder of PROP. "These are not medicines. These are lethal weapons that should be removed from the market.”

Before we start removing access to pain medication, it’s incumbent upon us to analyze the question of prescription opioid doses and what role, if any, they have in the overdose crisis.

First, higher doses of opioids are more dangerous. That is obvious, since most substances become dangerous at a sufficiently high dose, or as the Swiss physician Paracelsus supposedly said, “The dose makes the poison.” It is reasonable to conclude that higher doses of an opioid would be riskier.

But there is no inherent implication about safety in the existence of any substance. There is nothing "safe" about chemotherapy drugs, anti-seizure medication or anti-anxiety drugs, just as there is nothing safe about tobacco or alcohol.

Moreover, the opposite of safe is not necessarily dangerous, since something that is "dangerous" can still be clinically beneficial. Open heart surgery is dangerous, but beneficial to someone dying from heart disease.

Conspicuously absent from the signatories of the PROP petition are any physician groups or doctors involved in pain management. Asked to comment on the petition, the President of the Society of Palliative Care Pharmacists told Pharmacy Times that while she agreed that opioid abuse is an urgent concern, she dose not believe that removing high-dose opioids from the market would be the best way to combat the overdose crisis.

“Let’s put our efforts together in an interdisciplinary approach and train providers to accurately assess their patients rather than pulling certain drugs from the market, because there may be cancer patients or others who are truly benefiting from these high-dose opioids,” said Rabia Atayee, PharmD.

The petition argues that people who currently take high-dose opioid medication can simply take two or more lower-dose pills. This would supposedly reduce the risk of overdose when high-dose pills are stolen or diverted.

“Removing UHDU (ultra-high dosage unit) orally-administered opioids from the market will result in patients having to swallow more tablets or capsules. But this is unlikely to result in a significant inconvenience or hardship for patients,” the petition states.

In other words, there would be a trade off. The risk of an overdose would be lower for a person who gets an opioid analgesic from a friend to deal with severe pain. But a person with a disorder like achalasia that impairs swallowing or a GI disorder that impairs absorption may be harmed by having to take more pills.

Unintended Consequences

The strength of the arguments is only one factor here. The unintended consequences of this petition should also be considered. One obvious effect would be an increase in the total number of pills, which would exacerbate concerns about over-prescribing. There would be more pills to steal or divert, and more potential problems in securing the opioid supply chain from manufacturer to pharmacy, a major source of diverted pills that often goes unremarked and unpunished.

Another likely effect is increased activity on the black market. In 2010, when Purdue Pharma brought out its abuse deterring form of OxyContin, some abusers started switching to illegal drugs, including heroin. An uncomfortable outcome of this well-intentioned change is that a public health policy meant to prevent abuse and addiction may have made the overdose crisis worse.

A similar outcome could result from this petition: Drug abusers who are intent on having a high-dose opioid pill may shift to street drugs.

Another possible outcome is that opioid doses keep getting smaller and smaller. If a daily dose of pills containing 90mg of a morphine equivalent (MME) is considered “dangerous,” then what about 80 MME? Or 70 MME? If the changes recommended in this petition do not work, will we try more restrictions in doses and prescribing? Clear measures of the success or failure of the proposal should be defined in a petition like this one, but they are not.

We already have vast quantities of data about the opioid crisis. According to the CDC, opioid prescribing peaked in 2010 and has been in decline ever since, yet overdose rates keep rising. 

The average daily dose of opioids started falling even earlier, in 2006. By 2015, it had declined to nearly 48 MME -- well below the dose sought in the petition.

AVERAGE DAILY PER CAPITA MORPHINE EQUIVALENT DOSE (MME)

Source: CDC/QuintilesIMS

In other words, reducing the amount and dose of prescription opioids is inversely correlated with the number of overdoses. Of course, correlation is not causation, but the negative correlation does not bode well for the effects of this petition. Based on this data, the best we can reasonably hope for is small benefits on the margins of the overdose crisis, at the expense of people who benefit from high-dose prescription opioids.

And this petition will do nothing to improve treatment for people suffering from opioid use disorder or to reduce the risks of people overdosing on heroin or illicit fentanyl. These are key features of the opioid crisis, and a policy that claims to beat addiction without addressing them should be greeted with skepticism.

Instead of new restrictions, perhaps the CDC and state guidelines can be updated to include recommendations that physicians and pharmacists discuss with patients the safe storage and disposal of opioid medications.

Before we ban a medication for having too much of a chemically active ingredient for people who abuse it, we should do whatever we can to ensure that the people who benefit from it are not harmed.

To make a comment on the PROP petition to the FDA, click here.

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.

Don't Forget Chronic Pain Patients During Disasters

By Janice Reynolds, Guest Columnist

With the recent hurricanes in Florida and Texas, there was an Associated Press story you may have seen. 

Titled “Hurricanes Drive Addiction Issues into Public Square,” it dealt with the plight of people addicted to alcohol, tobacco, pills or heroin when disaster strikes.  While the article was not the “yellow press” we often see in the coverage of opioid medication, it did err by the sin of omission.

People with all sorts of health problems suffer during a natural disaster. Not only did the AP story not mention this, I didn’t see it covered elsewhere in the national news.

People living with pain are likely to be the ultimate casualties.  Anxiety and stress increases pain levels, and some pain sufferers will be difficult to evacuate. 

Most critical is the loss of treatment.  If a patient is taking opioids as part of their pain plan, they may not be able to take their medication with them (when leaving in a hurry) and getting a new prescription or even someone willing to fill it would likely be impossible. 

In a shelter, theft would be a worry.  This applies to non-opioid medication as well.  Non-pharmaceutical interventions might also be unavailable.  If pain was already poorly managed -- as it often is -- it would be even worse.

As we know, pain has many harmful side effects that lead to other health emergencies, including suicide. People in pain during a disaster are going to be even more vulnerable than usual.

a hurricane harvey evacuee (texas national guard photo)

All chronic health problems are affected by natural disasters.  In the aftermath of Hurricane Katrina in 2005, thousands of cancer patients had their treatment disrupted.  Records were lost and many did not know their treatment protocol or where they were in it.  Some did not even know the type of cancer they had.

Of course, medication for other conditions was lost as well. People living with heart conditions, diabetes, kidney failure, AIDS, high blood pressure, COPD, multiple sclerosis, Alzheimer’s and many other chronic health issues need special medications or treatments. For many, pain is a part of their disease as well.

Patients in hospice or nursing homes are especially vulnerable. Eight elderly nursing home residents in Florida died this week in sweltering heat when the facility they were in lost its air conditioning during Hurricane Irma.

The media has an ethical obligation to address the problems of natural disasters related to chronic health problems, especially for chronic pain, and not just limit their concern to addicts.  It is the right thing to do.

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country on pain management and co-authored several articles in medical journals. Janice lives with persistent post craniotomy pain and is active with The Pain Community.

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.

Strong Support for Cannabis Rx in Comments to FDA

By Pat Anson, Editor

The Food and Drug Administration may have gotten more than it bargained for when it asked for public comments about the medical value and abuse potential of 17 different drugs.

The agency wound up getting over 6,400 comments in the Federal Register, the vast majority of them from people advocating for cannabidiol (CBD) -- one of the active ingredients in medical marijuana.  

Unlike tetrahydrocannabinol (THC), the substance in marijuana that makes people high, CBD-based oils and medications relieve pain, and are increasingly being used to treat a variety of medical conditions.  

“CBD's are not a way to get high as THC is. These oils have so many beneficial uses for anxiety, stress, pain, joint issues, muscular issues, arthritis, seizures, Parkinson's, cancer,” wrote Tami Camp in her public comment. “We need natural herbs, not man-made poisons!”

“CBD helps me with my chronic nerve pain, in a way that prescription medications can't match,” wrote Jason Turgeon.

“I've been consistently using CBD oil now for three months and have noticed an uptick in my moods, a reduction of joint pain, and my sleeping cycles at night have improved as my sleep is deeper and I wake up feeling refreshed,” wrote Kerry Meier.

Public opinion polls show that these are not isolated comments or marijuana supporters trying to game the system by flooding the Federal Register with comments. A recent poll by CBS News found 85% of Americans favor medical marijuana use.

drug policy alliance photo

But while medical cannabis may be legal in 29 states and the District of Columbia, marijuana is still classified as an illegal Schedule I controlled substance by the Drug Enforcement Administration, right alongside heroin and LSD.

The FDA opened the cannabis can of worms at the behest of the World Health Organization (WHO), which is not only reviewing the safety and effectiveness of CBD, but 16 other drugs -- including pregabalin, tramadol, ketamine, and several chemical cousins of fentanyl, a synthetic opioid blamed for thousands of overdose deaths. 

WHO is seeking input from the FDA on whether international restrictions should be placed on any of the drugs. Under the Controlled Substances Act, the FDA was required to seek public comment in the Federal Register before responding to WHO -- perhaps not anticipating the overwhelmingly positive response that CBD would get. 

“Cannabidiol should not be restricted because CBD is not addictive, nor does it have the potential for abuse nor should it be tied to hallucinogenic drugs. Therefore, no international restrictions should be placed on CBD,” wrote Steve Easterly.

“For cannabis to be scheduled as a class I drug is ludicrous especially when the entire prohibition of cannabis was based on lies,” wrote Mike Copple. “What a shameful spectacle that we the people still have to argue about the usefulness of the cannabis plant. Cannabis has and continues to help me in many ways both physically and mentally.”

“I want cannabis to be legalized and available for over the counter sale. I have known several people who have benefited for various conditions from anxiety, depressions, MS, arthritis and epilepsy,” wrote Nancy Scott-Puopolo.

The public comment period ended on Wednesday. You can look at other responses in the Federal Register by clicking here. 

Mixed Reviews of Lyrica

There were only a few dozen comments about pregabalin (Lyrica), a prescription medication that millions of Americans take for fibromyalgia, neuropathy and other chronic pain conditions. As PNN has reported, WHO is investigating reports that pregabalin is being abused by addicts.

“Patients are self-administering higher than recommended doses (of pregabalin) to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness,” WHO told the FDA..

The public comments about pregabalin were mixed at best.

“I have been on several medications prior to being switched to Lyrica about six months ago. I actually feel nothing while taking the drug, and assume you would indeed have to take lots to maybe feel high,” wrote Mary. “Not sure if it helps my fibromyalgia or not since I still have lots of pain.”

“I take pregabalin in Lyrica form twice a day currently for nerve pain and fibromyalgia. I cannot accurately express the relief this has brought me,” wrote Renee.

“I have tried many, many medications. When I tried Lyrica, the side effects were horrible. I couldn't even lift my head without severe dizziness and the room spinning,” said Lora Berry.  

“I take Lyrica and all I got from it was fatter,” said Debra Winegar. “CBD oil is wonderful. Take a few drops under the tongue and I'm good to go. Narcotics are needed when my pain is out of control. I'm tired of waiting to be pain free. Legalize pot now!”

Will the FDA now report to WHO that thousands of American citizens want CBD-based medications fully legalized?  The FDA notice in the Federal Register only notes that public comments “will be considered” when the FDA prepares its scientific and medical evaluation. The FDA report to WHO is due September 30.

Living With an Invisible Monster

By Marcie Ann Dillard, Guest Columnist

I live with an invisible monster that consumes both body and mind. A monster that steals the ability of children, mothers, fathers and grandparents to sit, stand or walk. A monster that consumes finances, destroys friendships, marriages and families.

I say invisible monster because when I speak these three letters -- RSD --- which stand for Reflex Sympathetic Dystrophy, I am faced with the blank stares of the ignorant.

What is such a thing I myself in 47 years of living had never heard of? How could I have not known of this monster that stalks me like a crouching lioness after a simple leg fracture?

She pounced suddenly and fiercely, feeling her teeth, her bite sink into my body, setting my flesh on fire in moments. Now in the grasp of a beast that respects no one, she sinks her claws deeper. Her death grip no one will ever escape.

Going from doctor to doctor, I can feel her but she goes unseen even after dozens of MRIs, CT scans and x-rays. The searing unseen pain forces me to look for freedom from what I now understand to be the most painful disease known to man.

I begged for those sworn to help me to release me from her grasp, but ignorance -- mine and theirs -- gave her time to continue her devastation.

I marched through this life boldly; a mother, wife and business owner, never giving a thought to the day that would end. Then that day came. The only evidence often of her existence was the life stealing pain, and the integrity of my words lost among strangers.

The skeptical looks of the medical community as I once again describe the effect her grasp has on my body.

Through the tears of pain and hopelessness, the joy of living is veiled in agony. The blank stares of loved ones when I choose to be honest about what I daily experience. Self-confidence fades, the beat of the drum I confidently marched to become unclear, self-worth gone, as one by one the things that made me Marcie Ann become painfully impossible feats.

She never stops chewing my flesh, the nerve twitches and the muscle spasms a constant reminder that I remain helpless prey to a ruthless predator.

If I spoke these six letters -- CANCER -- I would be met with the sympathy of the community. Not to offend those who suffer from that monster or have suffered a loss to it, but perhaps someone would run a marathon in my honor or host a fundraiser to help me secure lifesaving treatment.

If I said it was a terminal illness there would be no misunderstanding of the impending outcome. But with chronic, progressive and incurable pain, the well of sympathy quickly dries.

Silent suffering.

In this lifetime, the lioness will never deliver her final blow and end my suffering .

Marcie Ann Dillard lives in Washington state. She was diagnosed with Reflex Sympathetic Dystrophy in 2012, two years after her symptoms began.

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.

Vitamin D Levels May Help Predict Risk of MS

By Pat Anson, Editor

Vitamin D levels in the blood may help predict whether a person is at risk of developing multiple sclerosis, according to a large new study published online in the journal Neurology.

The findings provide the best evidence to date that low levels of Vitamin D may be a contributing factor to multiple sclerosis (MS), a chronic and incurable disease which attacks the central nervous system.

“There have only been a few small studies suggesting that levels of vitamin D in the blood can predict risk,” said study author Kassandra Munger, ScD, of the Harvard T.H. Chan School of Public Health in Boston. “Our study, involving a large number of women, suggests that correcting vitamin D deficiency in young and middle-age women may reduce their future risk of MS.”

Munger and her colleagues analyzed a database derived from blood samples taken during prenatal testing of over 800,000 Finnish women. Using hospital and prescription records, they were able to identify 1,092 of those women who were later diagnosed with MS. They were compared to a control group of 2,123 women who did not develop the disease.

Of the women who developed MS, 58% had deficient blood levels of vitamin D, compared to 52% of the women who did not develop the disease.

Deficient blood levels of vitamin D were defined as fewer than 30 nanomoles per liter (nmol/L). Insufficient levels were 30 to 49 nmol/L and adequate levels were 50 nmol/L or higher.

Researchers found that with each 50 nmol/L increase in vitamin D in the blood, the risk of developing MS later in life decreased by 39 percent. In addition, women who had deficient levels had a 43% higher risk of developing MS than women who had adequate levels.

“More research is needed on the optimal dose of vitamin D for reducing risk of MS,” said Munger. “But striving to achieve vitamin D sufficiency over the course of a person’s life will likely have multiple health benefits.

"Our results further support and extend those of previous prospective studies of (Vitamin D) levels in
young adults and risk of MS, and suggests that many individuals are exposed to an increased MS risk that
could be reduced by broad population-based programs to prevent vitamin D deficiency."

Participants in the study were primarily white women, so the findings may not be the same for other racial groups or men. Also, while the blood samples were taken an average of nine years before MS diagnosis, it is possible some women may have already had MS when their blood was drawn and were not yet showing symptoms of the disease.

MS causes numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain. Symptoms begin with a series of irregular relapses, and after about 20 years MS worsens into a secondary progressive stage of the disease.

Low blood levels of vitamin D – known as the “sunshine vitamin”-- have previously been linked to an increased risk of developing MS. Danish researchers found that MS patients who spent time in the sun every day during the summer as teenagers developed the disease later in life than those who spent their summers indoors.

Ultraviolet rays in sunlight are a principal source of Vitamin D, which has a wide range of positive health effects, such as strengthening bones and inhibiting the growth of some cancers.

Pam Bondi to Join Trump Opioid Commission

By Pat Anson, Editor

Less than three weeks before its final report is due, President Trump’s opioid commission is getting a new member --   Florida Attorney General Pam Bondi.

Bondi is a longtime supporter of the president, served as a member of his transition team, and was once rumored to be the next head of the White House Office of National Drug Control Policy. There was speculation back in March that Bondi would be named to the opioid commission, but it was not until last week that the White House confirmed it was President Trump's "intent to appoint" Bondi to the panel, which currently has five members.

Curiously, Bondi’s office blamed New Jersey Gov. Chris Christie, the chair of the opioid commission, for the six month delay in getting her on board. Both Bondi and Christie are lame ducks serving out their final months in elected office.

“The President always intended for the Attorney General to be on the Commission – however, Governor Christie choose (sic) to begin the Commission with only himself and four others,” Whitney Ray, Bondi’s spokesman, said in an email.

“The announcement (of Bondi's appointment) is protocol before the Executive Order is signed next week. The Attorney General will continue to work with President Trump, General Kelly, Kellyanne Conway and other leaders to combat the national opioid epidemic.“

Bondi's spokesman also reportedly said that the October 1 deadline for the commission to release its final report would be extended. No such announcement has been made and the White House website still doesn’t list Bondi as a commission member.

FLORIDA ATTORNEY GENERAL PAM BONDI

The Trump administration has also yet to issue an official declaration that the opioid crisis is a national emergency – something the President said he would do over a month ago.  

"The opioid crisis is an emergency, and I am saying, officially right now, it is an emergency. It's a national emergency. We're going to spend a lot of time, a lot of effort and a lot of money on the opioid crisis,” Trump said on August 10.

Bondi played a prominent in shutting down Florida’s pill mills several years ago, but critics say she has been slow to acknowledge that the opioid crisis has shifted away from prescription painkillers to heroin and illicit fentanyl.

“The problem is Bondi isn't doing enough about the heroin epidemic,” the Miami Sun Sentinel said in an editorial.  “Considering that Bondi was once touted as a potential Trump drug czar — and infamously failed to investigate Trump University after receiving a major donation from Trump — it's no surprise that she was named to the commission. But she's still living off her reputation from the pill mill crack down.

“In fact, if you Google Bondi and heroin, by far the most you'll read about is when she slammed a drug dealer for stamping Trump's name on a batch of heroin. You won't find any solutions to our crisis.”

In a recent interview with WMBB-TV, Bondi warned that drug dealers were putting heroin and illicit fentanyl into counterfeit medications.

"It's a national epidemic and it truly affects everyone, and parents need to really warn their kids, their teens, adults need to know, never take a pill from someone you don't know, even if they say it is a Tylenol, an Advil or an aspirin. Don't take anything from someone who you don't know," said Bondi.

The initial focus of Trump's opioid commission has been on educating, preventing and treating opioid addiction. An interim report released by the commission in July recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioids, and increased efforts to detect and stop the flow of illicit fentanyl into the country.

There are no specific recommendations aimed at reducing access to prescription opioids, although they could be added to the commission’s final report.

In addition to Gov. Christie, commission members include Gov. Charlie Baker of Massachusetts, Gov. Roy Cooper of North Carolina, Bertha Madras, PhD, a professor of psychobiology at Harvard Medical School, and Patrick Kennedy, a former Rhode Island congressman. No pain patients, pain management experts or practicing physicians were appointed to the panel.

Learning How to Live with Chronic Pain

By Barby Ingle, Columnist

When I became so debilitated by chronic pain and doctors could not figure out what was going on, I could no longer hold my life together. It was a minor auto accident that triggered crazy symptoms that didn’t make sense to me or my doctors.

When the first symptoms of Reflex Sympathetic Dystrophy (RSD) began, I thought I was being ridiculous. The pain was overwhelming. It took all of my attention and energy just to be able to focus. It felt a burning fire in my face, neck and shoulder, and my skin became discolored. I also started having balance issues and falling.

I remember at a practice I was working with a male cheerleader and we did a stunt. Everyone around us was yelling, “Coach, stand up straight. What are you doing?”

I kept saying I was straight, but then I looked down. I didn’t even know how he was holding me up in the air. I was in the weirdest position; legs bent, leaning forward, arms not in the right place. Until I saw what my body was doing I had no idea what everyone was so upset about. 

I was coaching, heading to counseling appointments, chiropractors and neurologists, and sleeping in my office or wherever I could find a place to sleep. It wasn’t solid sleep. It was for 20 to 45 minutes at a time. I was overwhelmed physically and emotionally, not being able to coach like I wanted, but still trying not to let my team members down.

I wish I could go back and help them understand what I was going through. I wish I had let go of my job sooner so that they could have had a better year. I didn’t know that what I was dealing with was not going to be as easily overcome as endometriosis was. That was a struggle that made me believe everything was just a challenge that I could get past. Not this time. It was going to take years, financial strain, and learning new life skills. I just didn’t know it. 

I was no longer able to handle my dream job of coaching cheer and dance at a Division I-A university. My business started to crumble and eventually closed. My husband stopped supporting me emotionally and physically. I didn’t have the energy to take care of me and him any longer. One good thing that came from it was that after our separation he found God, and was baptized into the Catholic Church the next Easter.

The biggest reason our marriage fell apart was he had me feeling that it was all in my head, and tried to convince my family and our friends of the same. My psychologist and psychiatrist both told me he was wrong. What I had was situational depression and they assured me what I was going through was normal. They had faith in me and helped me get faith back in myself. 

We began marriage counseling before the accident because of our struggling relationship, but that was no longer an issue because the relationship was over. We were divorced within 3 months of filing for separation. Now I needed help getting my new life in order and to continue counseling, until I felt I had the life tools I needed to be the best me I could be.  

I rated the physical pain I had from the accident in the beginning as a level ten. I did not think I could take anything worse. But as each surgery or procedure was performed and the pain only worsened, I wanted sometimes to have that first pain back.

As our bodies get “used to the pain,” it sometimes gets easier to manage and deal with. With each additional trauma and spread of RSD, the pain I thought was unbearable becomes a livable level. But I wasn’t living.

“Reflex” is any process in your body that automatically goes haywire. “Sympathetic” is your sympathetic nervous system, which makes you feel like you are on fire and you can’t put it out. “Dystrophy” is the loss of muscle and bone, which left me in a wheelchair for many years.

As an athlete, it was difficult to understand how working out and pushing myself were making me worse, but it was. Pushing myself too far taught me that it can cause damage. I realized that doing this was creating further damage to my body and pain pathways. I learned that trying smarter is more important than trying harder.

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.

Do Half of Americans Really ‘Misuse’ Drugs?

By Pat Anson, Editor

One of the nation’s largest drug testing companies has released a study claiming that over half of Americans who are prescribed medication show signs of drug misuse, including potentially dangerous drug combinations.

In 2016, Quest Diagnostics found that 52% of patient test results were “inconsistent” with their prescribed medications. That was an improvement over the rate found in 2011, when 63% of samples were inconsistent.

The Quest report, titled "Prescription Drug Misuse in America: Diagnostic Insights in the Growing Drug Epidemic," is based on an analysis of 3.4 million laboratory tests performed between 2011 and 2016.

Many of the specimen samples came from patients being treated in pain management and addiction treatment clinics, which are not representative of the population as a whole.

Like previous studies of its kind, Quest broadly defines what constitutes drug “misuse” – a misleading term many people associate with abuse, addiction and diversion. Nearly a quarter of the patients (23%) with inconsistent results had no drugs detected in their system, which simply means they were not taking medications as directed.

The other 77% tested positive for illegal drugs or for a medication they were not prescribed.

"Over the past several years, federal and state government, clinician organizations, public health advocates and providers have all launched campaigns to educate the public about the perils of prescription drug misuse, which hypothetically should have yielded a significant rate of improvement. Yet our study shows that every other American tested for possible inappropriate use of opioids and other prescription drugs is potentially at risk," said F. Leland McClure, PhD, director of medical affairs at Quest Diagnostics.

"This finding is rather shocking, and speaks to the challenges of combating the nation's drug misuse epidemic."

Are the results really all that shocking? Or were they ginned up to hype the so-called epidemic? Consider some of the reasons a patient may not take a drug or have an inconsistent test result:

• Patient didn't like side effects from a medication
• Pain or other symptoms have subsided, so medication is not needed
• Patient skipped a dose
• Patient cannot afford a medication
• Patient can’t find a pharmacy willing to fill their prescription
• Patient may be a “rapid metabolizer” of a medication
• Physician may not be aware another doctor prescribed a drug
• Inaccurate drug test

The latter is a very real problem in the drug testing industry. As PNN has reported, “point-of-care” urine tests widely used by pain management and addiction treatment doctors to screen patients for illicit drug use are wrong about half the time, often giving false positive or false negative results for drugs like marijuana, oxycodone and methadone. 

The Quest study identified some disturbing and encouraging trends in drug use.

It wasn't opioids but benzodiazepines – a class of anti-anxiety medication that includes Xanax – that were most likely to be misused by adults over the age of 25.  Marijuana was most likely to be misused by people aged 18 to 24.   Opioids were second in both age groups.

Quest researchers found a striking decline in drug misuse among adolescents 10 to 17 years of age. The inconsistency rate for adolescents dropped from a whopping 70% in 2011 to 29% in 2016. Amphetamines and attention deficit disorder drugs were most likely to be abused by adolescents.

Among nearly 34,000 patient samples tested for opioids, alcohol and benzodiazepines, more than 20% were positive for opioids and benzodiazepines, 10% were positive for alcohol and opioids, and 3% were positive for all three.  Any combination of these drugs raises the risk of respiratory depression and overdose.

Misuse rates were higher for men and women of reproductive age (58%) than in the general study population (52%). The findings are significant because opioid and benzodiazepine use may decrease male fertility and, if taken during pregnancy, increase the risk of birth defects and other health concerns.

Quest is one of several drug testing laboratories that have been fined millions of dollars for paying kickbacks to physicians and patients for medically unnecessary tests.  Recent guidelines adopted by the American Society of Addiction Medicine warn doctors about ordering expensive drug tests that have led to “unethical and/or fraudulent activities.”

A Pained Life: The “I Dunno” Answer

By Carol Levy, Columnist.

“I dunno.”

That phrase feels like the bain of my existence. Most of us have heard it.

My brain stimulator implant is experimental.  I was told I'm just the 13th person in the world to get it. It was in for over 20 years, but recently stopped working. Until it failed, I had not been aware just how much benefit the stimulator had given me. I was still unable to work -- the eye pain from my trigeminal neuralgia is too bad -- but I was able to do a lot more things before the pain became unbearable. Once the stimulator failed, I was back to where I was originally,

I asked my neurosurgeon “Why did it fail?”

He shrugged his shoulders. “I dunno.”

As it failed, I was getting some horrific “tic-like” pains. My pain doc ascribed them to anaesthesia dolorosa (phantom pain). They were very different in intensity and sensation from the usual pain. They were odd spontaneous sensations, usually an intense itch in a small area under my nose (an area that was not a part of my trigeminal neuralgia).

Neither my neurosurgeon nor my pain doc could explain why this was happening. My feeling was that maybe the sensory cortex, where the implant was placed, might be remembering the stimulation and causing the pain.

When I asked, they gave the same answer. "I dunno.”

I searched the internet for a sensory cortex specialist. I found one and sent off an email. “Does the sensory cortex remember?” I asked, explaining about the implant, where it was, what it was supposed to, and the weirdness of the pain.

He was very kind and replied almost immediately. “I dunno.”

The “'opioid epidemic” has harmed many people in the chronic pain community, who either no longer have access to opioid medication or the amount that had been helping. I talk to these people and read what they write in support groups.  

“My doctor reduced the amount of opioids I was on,” they say. Now they can’t work, clean their homes, take care of their children, or go on disability. Others say their doctor now refuses to write any more prescriptions for a medication they were taking for years.  

Invariably, the end of the conversation with the doctor is pretty consistent. “What am I supposed to do now?”

“I dunno.”

Often we ask our physicians why we have the disorders we have, what are the standard treatments, and if they might help us. Too often we get the “I dunno” answer.

I am not sure what it is about pain vs. so many other health conditions, but “I dunno” seems to be the answer too many times for too many of our questions.

As long as pain is a distant cousin to cancer, diabetes and other “major” health problems, we will be the proverbial 4th cousin twice removed. The medical community and government will be happy to just pat us on the head, say “I dunno” and hope we disappear.

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

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

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

Researchers Question Value of Brain Imaging

By Pat Anson, Editor

An international team of researchers is recommending against the use of brain imaging as a diagnostic test for chronic pain, saying the tests are “inappropriate and unethical.”

"It's not possible at this point in time to say with any degree of certainty that a person does or does not have chronic pain based on brain imaging," said Karen Davis, PhD, senior scientist at the Krembil Research Institute and a professor at the University of Toronto.

"The only way to truly know if someone is in pain is if they tell you because pain is subjective and it is a complex experience. No brain scan can do that."

In recent years, technological advances in brain imaging have led to an increased use of functional magnetic resonance imaging (fMRI) to search for brain-based biomarkers for chronic pain.

Demand for brain imaging is also growing for legal purposes, including the development of a potential “lie detector” test for chronic pain.

"Use of such tools would be inappropriate and unethical," said Davis. "This technology is not foolproof. There are vast issues of variability between people and even within a person at different times. As a result, brain imaging must not be used as a lie detector for chronic pain."

Davis and her colleagues say brain-based biomarkers should only be used to supplement -- not replace -- a patient’s own reports of pain, even if testing is improved and valid protocols developed. Their recommendations were published in the journal Nature Review: Neurology.

"We are working towards biomarkers for chronic pain, but the goal is not as a lie detector test but rather to help provide personalized pain treatment options for patients," Davis. “People outside of the field of imaging might be disappointed, but the fact of the matter is the technology cannot be used to support or dispute a claim of chronic pain."

According to a 2015 study at the University of Michigan, one in eight visits to a doctor for a headache or migraine end up with the patient going for a brain scan. Often a doctor will order an fMRI to ease a patient’s fear that they may have a brain tumor or some other serious health problem. Doctors may also order a test to protect themselves in case of a lawsuit. About 1 to 3 percent of brain scans of patients with repeated headaches identify a cancerous growth or aneurysm.

University of Michigan researcher Brian Callaghan, MD, identified 74 neurological tests and procedures that are often unnecessary. Many involve the use of imaging.

“The two biggest areas that might be done more than they should are imaging for low back pain and imaging for headaches,” Callaghan said. “It’s a big problem and it costs a lot of money – we’re talking a billion dollars a year on just headache imaging.”

Other researchers believe brain imaging can be used as a valuable diagnostic tool. In a small study at the University of Colorado Boulder, researchers used fMRIs to discover a “brain signature” that identifies fibromyalgia with 93 percent accuracy. They found three neurological patterns in the brain that correlate with the pain hypersensitivity typically experienced with fibromyalgia.

Lady Gaga: Chronic Pain Patients Shouldn’t Feel Alone

By Pat Anson, Editor

It’s rare for a celebrity to talk openly their health problems, but Lady Gaga is speaking up about her battle with fibromyalgia and chronic hip pain. 

During a news conference at the Toronto Film Festival promoting her Netflix documentary Gaga: Five Foot Two, Lady Gaga fought back tears as she described how “liberating” it was for the film to cover her decade-long struggle with chronic pain.

“There is an element and a very strong piece of me that believes pain is a microphone. My pain does me no good unless I transform it into something that is. So I hope people watching it who do struggle with chronic pain know that they're not alone. It's freeing for me ... and I want people that struggle with it to hear me,” the 31-year old entertainer said.

“There is a degree of self-deprecation and shame with feeling in pain a lot. And I want people that watch it — that think there's no way I live (with chronic pain) because they see me dance and sing and don't think that could possibly be — to know I struggle with things like them. I work through it and it can be done. We have to stick together. I don't have to hide it because I'm afraid it's weak.”

In a teaser for the film, there are shots of Lada Gaga wincing in pain as she receives injections on a surgical table. 

"It was incredibly hard, on a basic fundamental human level, to be near someone experiencing pain like that. There's nothing you can do, beyond filming," said director Chris Moukarbel.

"I felt I needed to continue to roll. She was very aware of people struggling with similar chronic pain. She's not even sure how to deal with it.”

a scene from "GAGA: Five FOOT TWO"

“It's a part of me, and I'm grateful to Chris for caring. The compassion is overwhelming. That's why it makes me emotional. It's very touching,” Lady Gaga said.

The singer’s struggle with chronic pain reportedly began with physical and emotional trauma from a sexual assault. She later suffered a hip injury, but hid her pain from fans and her own staff until she required surgery in 2013. The singer now reportedly suffers from synovitis, an inflammation of the joint that can be caused by overuse or injury.

“I hid my injury until I couldn’t walk,” Lady Gaga told Arthritis Magazine in March. “I had a tear on the inside of my joint and huge breakage.

Lady Gaga also recently acknowledged that she has pain from fibromyalgia.

"I wish to help raise awareness & connect people who have it," she wrote in a Tweet.

"Thought ice helped #Fibromyalgia. I was wrong & making it worse. Warm/Heat is better. Electric Heated Blanket, Infrared Sauna, Epsom Baths."

Last November, Lady Gaga posted on Instagram an image of herself sitting in a sauna wrapped in an emergency blanket. Months later, she set aside her pain and soared around a stadium during a spectacular halftime show at theSuper Bowl.  

The singer told reporters in Toronto she was going to take a break from performing and  “slow down for a moment, for some healing.”  That prediction came true days later when she cancelled plans for a concert in Brazil because of severe pain.

"I was taken to the hospital its not simply hip pain or wear & tear from tour, I'm in severe pain. I'm in good hands w/ the very best doctors," she wrote on Twitter. "Brazil, I'm devastated that I'm not well enough 2 come to Rock In Rio. I would do anything 4 u but I have to take care of my body right now."