5 Things to Know About Epidural Steroid Injections

By Margaret Aranda, MD, Columnist

Some patients with neck and back pain report that their doctor requires them to get epidural steroid injections (ESI's) before they are prescribed opioid pain medication. Many do not realize that the procedure or any use of drugs for spinal injection is not FDA approved and is considered "off label."

Some patients benefit from ESI’s, while others gain no pain relief or suffer serious complications. In 2014, the FDA warned that injection of corticosteroids into the epidural space of the spine may result in rare but serious neurological events, including "loss of vision, stroke, paralysis, and death."  

A 2015 commentary by FDA scientists in The New England Journal of Medicine urged doctors to carefully select patients to identify those who might benefit from spinal injections and to minimize serious risks.

Probably the worst epidural steroid catastrophe was the 2012-13 outbreak of fungal meningitis, caused by contaminated steroids produced at the New England Compounding Center. As many as 13,000 patients nationwide were exposed to the fungus, mostly through epidural injection, resulting in 751 meningitis infections and at least 64 deaths.

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Let's take a step back to assess why epidural steroids may or may not be a good idea. The rationale behind the procedure comes from the anti-inflammatory effect of steroids on the nerves.

Chronic inflammation in nerves can lead to pain, numbness, and muscle weakness. Nerve injury causes microscopic changes in nerve anatomy, including tissue swelling or edema, an increase in fibrous tissue and, in the worst case, nerve death through something called Wallerian degeneration. In cases like traumatic brain injury or stroke, the nerve damage can be permanent.

There are now about 9 million epidural steroid injections performed annually in the U.S and the number of procedures appears to be growing.

During a standard epidural injection, the doctor may inject into the epidural space a contrast dye using x-ray guidance (fluoroscopy) to make sure the dye is going into the correct location.  Others may use a more blind approach, called the "loss of resistance" technique, with a syringe of air that injects itself into the epidural space as it enters. There is a "pop" when the needle penetrates the epidural space.

After the air or dye is injected and the needle located, a second syringe containing  the steroid is injected. Afterward, the patient is observed for signs of pain relief and complications.

Many studies show that about 50% of patients feel better. If there is no pain relief after one ESI, a second attempt is usually in order. If partial relief is exhibited, a series of three injections in two weeks may be performed.

There is controversy over the rate and frequency of epidurals for pain. Typically, a “cycle” of epidurals is done, but if there is no pain relief after two injections, some doctors recommend that a different treatment be used. Some patients report getting as many as two or three dozen epidurals in a single year.  Critics say that raises the risk of a misplaced needle causing “cumulative trauma” and serious complications such as adhesive arachnoiditis.

If you doctor recommends that you get an epidural steroid injection, here are five things you need to know:

1. Drugs Used: The two most common drugs for ESI are a local anesthetic (lidocaine or bupivacaine) and/or a corticosteroid (betamethasone, dexamethasone, hydrocortisone, methyl-prednisolone, triamcinolone). 

The local anesthetic offers immediate numbing and pain relief. It also verifies whether the injection was done in the right place and gives an idea of how the steroid may act to decrease inflammation. After the anesthetic wears off, the steroid kicks in for an effect that may last varying times, sometimes for a short period and sometimes forever.

Patients and doctors need to know whether there was immediate pain relief from the local anesthetic. The doctor should ask, "Does the pain feel better?" to assess the temporary anesthetic effect.

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If the answer is yes, then the steroid should provide more pain relief. If the answer is no, the steroid is much less likely to have any clinical effect. There is no indication to repeat the procedure if there is no decrease in pain. Doing so would unnecessarily expose a patient to serious complications or death.

2. Injection Sites: The most common injections are into the neck (cervical) and into the lower back (lumbar). Less commonly, epidural injections are placed into the upper back (thoracic) or to the bottom tip of the spine in the sacral area (caudal). The needle can go either straight into the middle of the spine (interlaminar), or enter from the left or right side (transforaminal). 

In general, the closer the injection is placed to the head, the greater the risk of serious complications if the needle accidentally hits a nerve or artery, an air bubble causes an embolism, or if the injection goes into the spinal fluid.

3. Minor complications: Adverse events can occur within minutes or up to 48 hours after an injection. Minor complications are generally not life-threatening and usually go away with little to no treatment.

Some patients get an "epidural headache" when the needle is inserted too far into the dura, causing a leak of cerebrospinal fluid. This is a stressful and painful headache, but it usually completely resolves. Other minor complications include facial flushing, fainting, hypertension (high blood pressure) and increased pain.

4. Serious complications: No one really knows the complication rate of epidural steroid injections, due to under-reporting by doctors and the lack of standard guidelines.

Normally, the steroid will flow into the epidural space above and below where it was injected, but it can also flow into unintended places like the subdural or intrathecal spaces, cranial nerves, brain stem, and lower midbrain.

For example, if the injection accidentally goes into the spinal fluid, the procedure becomes a spinal block, not an epidural block. This may lead to potentially life-threatening complications. If this happens during an injection to the neck, it can spread upward, toward the top of the head and into the brain, leading to serious complications. 

Severe complications from an injection can include arachnoiditis, allergic reactions, stroke, brain edema, cauda equina syndrome, seizures, vasculitis, blindness, and death.

5. Off-Label Use: The FDA places epidural steroids in the category of "off-label" use that falls within the practice of medicine and is not FDA-approved. The FDA requires all glucocorticoid steroid warning labels to state:

The safety and effectiveness of epidural administration of corticosteroids have not been established and corticosteroids are not approved for this use… serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids.”

The FDA website also warns patients to seek emergency medical attention if they experience any unusual symptoms, such as loss of vision or vision changes, tingling in the arms or legs, sudden weakness or numbness, dizziness, severe headache or seizures.

If you have concerns regarding the use of epidural steroid injections, talk to your doctor.

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Dr. Margaret Aranda is a Stanford and Keck USC alumni in anesthesiology and critical care. She has dysautonomia and postural orthostatic tachycardia syndrome (POTS) after a car accident left her with traumatic brain injuries that changed her path in life to patient advocacy.

Margaret is a board member of the Invisible Disabilities Association. She has authored six books, the most recent is The Rebel Patient: Fight for Your Diagnosis. You can follow Margaret’s expert social media advice on Twitter, Google +, Blogspot, Wordpress. and LinkedIn.

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.

CVS to Limit Opioid Prescriptions

By Pat Anson, Editor

CVS Health has announced plans to further restrict the filling of opioid prescriptions at its pharmacies by limiting the dose and initial supply of opioid medication to seven days. It was not immediately clear how the new policy would impact customers who refill 30-day opioid prescriptions at CVS or those who receive high doses.

The company said it would “give greater weight” to the Centers for Disease Control and Prevention's opioid prescribing guideline, which discourages doctors from prescribing opioids for chronic pain.

“The CDC Guideline should become the default approach to prescribing opiates, a scenario in which physicians would have to seek exceptions for those patients who need more medication or longer duration of therapy,” Troyen Brennan, MD, CVS’ Chief Medical Officer wrote in a post on Health Affairs Blog.

But the new CVS policy actually goes beyond the voluntary recommendations of the CDC guideline, which was only intended to give advice to primary care physicians who treat chronic pain.

Beginning February 1, CVS will limit all initial opioid prescriptions for acute pain to seven days. For both acute and chronic pain, opioid doses must not exceed 90mg morphine equivalent units and patients will be required to try immediate release formulations, before using extended release opioids.

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The policy will apply to all 90 million CVS customers enrolled in commercial, employer or Medicaid health plans. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide.

In announcing the policy, CVS rejected complaints that it and other healthcare providers were adopting a “heavy-handed, cookie cutter” approach to patient care – decisions best left between a patient and their doctor.

“To be sure, prescriber autonomy and respect for the physician-patient relationship are of paramount importance. However, there is little evidence to show that past opioid prescribing habits are necessary or appropriate, and there is a great deal of evidence that they have produced significant harm,” said Brennan.

“We see firsthand the impact of the alarming and rapidly growing epidemic of opioid addiction and misuse,” said Larry Merlo, CEO of CVS Health. 

“With this expansion of our industry-leading initiatives, we are further strengthening our commitment to help providers and patients balance the need for these powerful medications with the risk of abuse and misuse.”

 

Opioids Have Been Costly for CVS

Patient safety may not be the only factor behind CVS’ decision to limit opioid prescriptions. In recent years, the company has been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

As PNN has reported, CVS recently agreed to pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the painkiller hydrocodone by employees.

In 2016, CVS also paid a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged opioid prescriptions. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores. Another forger obtained over 200 prescriptions for hydrocodone and methadone by forging the name of an emergency room physician.

And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

As a result of these and other fines, CVS pharmacists were already under pressure to be wary of filling opioid prescriptions. Many started calling doctors to make sure the prescriptions were legitimate and some even refused to fill the prescriptions of longtime customers.

Alcohol Sales Continue

CVS was widely praised for its decision to stop selling cigarettes a few years ago, a move that cost the company $2 billion in lost tobacco sales.  According to Marketplace, the company has also removed transfats from its branded food products and reduced displays of candy near its cash registers.

The healthier offerings apparently do not apply to alcohol, however, a substance that causes far more addiction, death and health problems than opioid medication. This week an advertising flier for CVS stories in California prominently displays a selection of inexpensive beer, wine and hard liquors.

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CVS did not respond to a query from PNN about whether it intends to limit the amount and frequency of alcohol purchases, as it is planning to do for opioid pain medications.    

CVS Health (NYSE: CVS) stock has fared poorly in the past year and company insiders have sold nearly $100 million in shares. Among the sellers, according to Barrons, was CEO Merlo – who has sold $26 million in shares so far in 2017, including $20 million in September alone.

Is Medical Marijuana Causing More Fatal Crashes?

By Rochelle Odell, Columnist

Medical marijuana’s role in fatal auto accidents is a subject that’s rarely addressed by those who support full legalization of cannabis. But I found numerous articles about it online and all show there is cause for concern.

An NBC News story warned that “Pot Fuels Surge in Drugged Driving Deaths” back in 2014, the year after Colorado became the first state to legalize recreational marijuana:

“During each shift at her drive-through window, once an hour, Cordelia Cordova sees people rolling joints in their cars. Some blow smoke in her face and smile.

Cordova, who lost a 23-year-old niece and her 1-month-old son to a driver who admitted he smoked pot that day, never smiles back. She thinks legal marijuana in Colorado, where she works, is making the problem of drugged driving worse.”

“Drugged driving” is a term I had not heard before. Police agencies and medical professionals usually refer to it as driving under the influence or operating a vehicle while intoxicated. It is a perfect description, not only for marijuana, but for any substance that alters your ability to safely operate a vehicle.

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The NBC News story quotes researchers at Columbia University, who looked at toxicology reports on over 23,000 dead drivers in six states were medical marijuana was legal. Cannabis was detected in the bodies three times more often in 2010 than in 1999.  

"This trend suggests that marijuana is playing an increased role in fatal crashes, said Dr. Guohua Li, co-author and director for Injury Epidemiology and Prevention at Columbia University Medical Center.

But alcohol was the most common mind-altering substance detected, appearing in the blood of nearly 40 percent of the drivers who died in 2010.

Research on this subject can be somewhat contradictory. A second study at Columbia found that states with medical marijuana laws had an 11 percent decrease in traffic fatalities. They also found there were fewer alcohol related accidents, suggesting that some younger drivers were substituting marijuana for alcohol.

Marijuana, like opiates and alcohol, should never be consumed by someone intending to drive. Even cannabidiol (CBD) based medications, which marijuana supporters tout as safe, may contain trace amounts tetrahydrocannabinol (THC), the chemical ingredient in cannabis that makes people high.

I am not an active proponent of medical marijuana, although I realize there are those who benefit from its use. But cannabis is not always the "magic bullet" when it comes to pain relief, and not all pain patients support it.

I tried CBD medication for three weeks and it did nothing for my pain. Being asthmatic precludes me from smoking or vaping, and I have been told using edibles in the amount required to achieve pain relief would require a large amount. Medical marijuana is also costly and can be cost prohibitive for those of us on fixed incomes.

I did vote for full legalization last year when it was on the California ballot. I also believe those who buy it from medical marijuana dispensaries have a right to know where it is cultivated, along with what pesticides, fertilizers or other harmful substances may have been used in its cultivation. People are going to use marijuana whether it is legal or illegal, so state and federal governments should legislate accordingly.

Studies show that Colorado, Oregon and Washington State have all seen an increase in car crashes since they fully legalized marijuana, although the number of fatal crashes has remained about the same. A recent analysis by the Denver Post found the number of drivers in Colorado who tested positive for marijuana after fatal crashes has risen by 145 percent since 2013.

Like everything else, we can draw our own conclusions from these statistics. I only ask that readers who are medical marijuana users check your state’s laws before smoking or vaping, consuming CBD, or ingesting the popular edibles.

THC is a known psychoactive and can affect your ability to safely operate a vehicle. CBD can also show up in toxicology reports and will reflect on the driver if they’re involved in an accident. Please educate yourself and be sober from any substance, legal or illegal, before driving.

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Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

Trump Opioid Commission Delays Final Report

By Pat Anson, Editor

The chairman of President Trump’s Commission on Combating Drug Addiction and the Opioid Crisis has asked for – and apparently been granted – a one month delay in releasing the panel’s final report.

In a letter posted on the White House website, New Jersey Gov. Chris Christie said the commission’s “research and policy development are still in progress,” and that he was extending the deadline from October 1 to November 1.

Christie said the opioid commission would hold its third public hearing September 27 at the White House. A notice published in the Federal Register indicates the meeting will focus on pain management and the diversion of opioid pain medication.

“The meeting will consist of statements to the Commission from invited government, nonprofit, and business organizations regarding Innovative Pain Management and Prevention Measures for Diversion followed by discussion of the issues raised,” the statement says. No list of attendees is included.

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Christie’s letter also says the opioid commission will visit an Ohio medical center to learn about “innovative pain management strategies” and will meet in New Jersey with representatives of the pharmaceutical industry “to talk about partnership opportunities with the National Institutes of Health and the Food and Drug Administration.”

Until now the focus of the opioid commission has been on treating opioid addiction. An interim report released in July recommends increased access to addiction treatment, mandatory education for prescribers on the risks and benefits of opioid medication, 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 or providing different forms of pain management.

Bondi Joins Commission

Another possible sign of a shift in the commission’s direction is the recent appointment of Florida Attorney General Pam Bondi to the panel. Bondi is now listed as member of the commission on the White House website,  although there has been no official announcement by the Trump administration. She is the fifth politician appointed to the six member panel.

Bondi played a prominent in shutting down on 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 street drugs like heroin and illicit fentanyl. Many pain patients in Florida still have trouble finding pharmacies willing to fill their opioid prescriptions.

Bondi recently joined other state attorneys general in asking pharmaceutical companies for information about their marketing, production and distribution of opioids.

“Florida citizens continue to become addicted to opioids and die daily -- meanwhile, prescription drug manufacturers, distributors and the medical profession all point fingers at each other as the cause of this national crisis,” Bondi said in a statement. “This far-reaching multistate investigation is designed to get the answers we need as quickly as possible. The industry must do the right thing. If they do not, we are prepared to litigate.”

Bondi also recently joined the National Association of Attorneys General in asking the insurance industry to do more to reduce opioid prescriptions and combat opioid abuse.

“Insurance companies can play an important role in reducing opioid prescriptions and making it easier for patients to access other forms of pain management treatment. Indeed, simply asking providers to consider providing alternative treatments is impractical in the absence of a supporting incentive structure,” the attorneys general said in a letter to an insurance industry trade group.

“Insurance companies thus are in a position to make a very positive impact in the way that providers treat patients with chronic pain.”

In addition to Bondi and Christie, opioid 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.

The Trump administration has still not officially declared that the opioid crisis is a national emergency – something the President said he would do in August.  

CDC Releases More Faulty Research About Opioids

By Pat Anson, Editor

A new study by researchers at the Centers for Disease Control and Prevention estimates that opioid overdoses have shaved two and a half months off the average life span of Americans – a somewhat misleading claim because the study does not distinguish between legally obtained prescription opioids and illegal opioids like heroin and illicit fentanyl.

The research letter, published in the medical journal JAMA, looked at the leading causes of death in the U.S. from 2000 to 2015. Overall life expectancy rose during that period, from 76.8 years in 2000 to 78.8 years in 2015, largely due a decline in deaths from heart disease, cancer, stroke, diabetes and other chronic health conditions.

But deaths due to Alzheimer’s disease, suicide, liver disease, drug poisoning and opioid overdoses rose, collectively causing a loss of 0.33 years in life expectancy – most of it due to opioids.

“This loss, mostly related to opioids, was similar in magnitude to losses from all the leading causes of death with increasing death rates,” wrote lead author Deborah Dowell, MD, of the CDC’s National Center for Injury Prevention and Control.

“U.S. life expectancy decreased from 2014 to 2015 and is now lower than in most high-income countries, with this gap projected to increase. These findings suggest that preventing opioid related poisoning deaths will be important to achieving more robust increases in life expectancy once again.”

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Dowell was also one of the lead authors of the CDC’s 2016 opioid prescribing guidelines, which discourage physicians from prescribing opioids for chronic pain. She and her two co-authors in the JAMA study --  both of them CDC statisticians -- do not explain why they failed to distinguish between black market opioids and legal prescription opioids, a dubious use of statistics akin to lumping arsonists in the same category as smokers or Boy Scouts learning to build campfires.  

They also fail to even mention the scourge of heroin and illicit fentanyl sweeping the country, which now accounts for the majority of opioid overdoses in several states.  

But Dowell and her co-authors don't stop there. The say the actual number of deaths caused by opioids is “likely an underestimate” because information on death certificates is often incomplete and fails to note the specific drug involved in as many as 25% of overdose deaths. This is another disingenuous claim, because it fails to explain why the data on the other 75% of overdoses is faulty too. 

Epidemic of Despair

Other researchers have also tried to explain the disturbing decline in American life expectancy – which began over adecade ago for middle-aged white Americans. Princeton researchers Anne Case and Angus Deaton were the first to document that trend,  when they estimated that nearly half a million white Americans may have died early because of depression, chronic pain, suicide, alcohol and drug abuse, and other health problems – an epidemic of despair linked to unemployment, poor finances, lack of education, divorce and loss of social connections.

The evidence was right there for Deborah Dowell and her co-authors had they looked for it. The JAMA study found that over 44,000 Americans committed suicide in 2015, a 66% increase from 2000, and over 40,000 died from chronic liver disease or cirrhosis, another 66% increase. Opioid overdoses during that same period rose to 33,000 deaths. 

Which is the bigger epidemic?

As PNN has reported, the CDC ignored early warnings from its own consultant that the agency’s opioid guidelines were being viewed as “strict law rather than a recommendation,” causing many doctors to stop prescribing opioid pain medication. Chronic pain patients also feel “slighted and shamed” by the guidelines, and are increasingly suicidal or turning to street drugs. We’ve also reported that the CDC has apparently done nothing to study the harms or even the possible benefits the guidelines have caused since they were released 18 months ago.

Instead of going back in time and selectively mining databases to fit preconceived notions about opioids, perhaps it is time for the CDC to take a giant step forward and see what its opioid guidelines have actually done.

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

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.

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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

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"

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.

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"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.

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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.

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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)

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.

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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

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.