FDA Study Calls for More Aggressive Opioid Regulation

By Pat Anson, Editor

A new report commissioned by the U.S. Food and Drug Administration is calling for a sustained and coordinated national campaign to combat the opioid crisis, including more aggressive regulation of opioids by the FDA and a “cultural change” in the prescribing of opioid medication,

The report by a special committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) focuses primarily on restricting the supply of prescription opioids, not illicit opioids such as heroin and fentanyl, which are now driving the so-called opioid epidemic.

"The broad reach of the epidemic has blurred the formerly distinct social boundary between prescribed opioids and illegally manufactured ones, such as heroin," said committee chair Richard Bonnie, a Professor of Medicine and Law at the University of Virginia.

“This report provides an action plan directed particularly at the health professions and government agencies responsible for regulating them. This plan aims to help the millions of people who suffer from chronic pain while reducing unnecessary opioid prescribing. We also wanted to convey a clear message about the magnitude of the challenge. This epidemic took nearly two decades to develop, and it will take years to unravel."

The report estimates that at least 2 million people in the U.S. have an “opioid use disorder” involving prescription opioids -- meaning they are addicted to prescription painkillers -- and almost 600,000 have an opioid use disorder involving heroin.

Although opioid prescribing has been declining and the number of overdose deaths from prescription opioids has remained relatively stable in recent years, deaths from illicit opioids such as heroin have tripled in the past decade.

NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINES

The report claimed that many people who normally would use prescription opioids have transitioned to heroin because of the declining price of heroin and the introduction of abuse-deterrent formulations that make opioid medication harder to snort or inject. The Centers for Disease Control and Prevention (CDC) has said there is no evidence to support the theory that legitimate patients are transitioning to heroin.

"Evidence does not support the hypothesis that initiatives intended to reduce opioid prescribing increase illicit opioid-related overdose at a population level," Deborah Dowell, MD, of the CDC recently wrote in the Annals of Internal Medicine.

The NASEM committee recommended that further efforts be made to restrict the supply of opioid medication, even though there is “limited evidence” that steps taken so far are working and may, in fact, be harming patients.

“Although more research is needed, limited evidence suggests that state and local interventions aimed at reducing the supply of prescription opioids in the community may help curtail access. Importantly, however, none of these studies investigates the impact of reduced access on the well-being of individuals suffering from pain whose access to opioids was curtailed,” the report states.

The NASEM report also recommends broader insurance coverage of non-opioid treatments.and better education of physicians in pain management.

“The committee’s recommended changes to provider education and payer policy should be accompanied by a change in patient expectations with respect to the treatment and management of chronic pain. Attention is not being paid to educating the general public on the risks and benefits of opioid therapy, or the comparative effectiveness of opioids with nonopioid or nonpharmacologic therapies,” the committee said.

The committee also recommended that the FDA conduct a full review of currently approved opioids and that it consider “public health considerations” in all of its regulatory decisions. Such a policy would require the agency to not only consider the safety and efficacy of opioids for legitimate pain needs, but also their impact on addicts and the illicit drug market.

“I was encouraged to see that many of NASEM’s recommendations for the FDA are in areas where we’ve already made new commitments,” FDA commissioner Scott Gottlieb, MD, said in a statement.  “Among these important new actions is our work to ensure drug approval and removal decisions are made within a benefit-risk framework that evaluates not only the outcomes of opioids when used as prescribed, but also the public health effects of the inappropriate use of these drugs.”

Last month the FDA asked that the opioid painkiller Opana ER be removed from the market, not because it was harming legitimate pain patients, but because addicts were abusing it and spreading infectious diseases through infected needles. It was the first time the agency has taken steps to remove an opioid from the market.

“These are just some of the important efforts we have underway. But to make a meaningful impact, this epidemic must be addressed as a public health emergency, and requires an all-of-the-above approach. As underscored in the NASEM report, the scope of this epidemic is so large, it’s going to require a coordinated effort that includes federal, state, and local partners,” Gottlieb said.

The NASEM study was funded by the FDA.

Free Programs That Help Pay for Prescription Drugs

By Barby Ingle, Columnist

I decided to write about the high cost of prescription drugs because I am personally experiencing it and also hearing from other patients who cannot afford their medications. I found a program that can help and wanted to make sure that this information gets out to others who need proper, cost-contained, and timely access to care.

Last year I had my first experience with abandoning a prescription at the pharmacy. I developed asthma symptoms and was given a first-time script for a bronchodilator inhaler medication. My primary care provider gave me 2 free samples in his office and warned me that getting the inhaler could be expensive.

When I went to pick it up the first time, I learned that my insurance co-pay was more than $100. I am doubly insured through a group health plan/PPO through my husband’s insurance, as well as having Medicare as my secondary. If I am having trouble financially with my co-pays, then I know others must be as well.

I just couldn’t afford the inhaler and told them to put it back on the shelf. That was when my Walgreens pharmacist suggested that I Google a free savings program like WellRx and see if they had any discounts for the medication I needed.

I did find a discount card online at WellRx.com that helped save on the inhaler and I was able to fill the script after all. I would have never thought of doing something like this without the suggestion of my amazing pharmacist. The WellRx savings program works well for insured people with high out-of-pocket costs like me.

I have faced this situation two more times, one with a medication I was taking daily for years. The co-pay went up so high that without a savings card, I would not be able to pay for it.

The other medication I had to abandon because I couldn’t afford it, even though the savings program provided 50% off what my insurance was going to cover. Nevertheless, it was worth the look to see if I could find a discount. My provider had to substitute the medication for a different one that I could afford, although I am not sure if it worked as well as the one he originally prescribed.

I know how awful and embarrassing it feels to have to abandon a medication at the pharmacy, while you work to come up with a way to pay for it and know that you may never be able to pick it up. Now, I have my pharmacist price the medication through insurance and the WellRx program to see which is less expensive.

Recently a study was published in the Annals of Internal Medicine that showed a direct correlation between the amount of a patient’s out-of-pocket cost and the likelihood of a prescription being abandoned. They concluded that when patients have a co-pay of over $50 they are four times more likely to abandon their prescription than patients who only owe $10.

Leaving a prescription at the pharmacy and failing to follow a doctor’s instructions can lead to major health challenges, such as a condition worsening, increased side effects and symptoms, therapeutic failure, increased medical costs, and in some cases even death. A 2008 Harvard prescription study suggested that opiates, anti-platelets and statins were the least likely to be abandoned, while insulin and proton pump inhibitors were more likely to be left behind.

This is not a new issue for pharmacies, but it has become more common over the past few years. Besides cost, some other reasons for abandoning medications at the pharmacy include e-prescriptions, drug strength, taking the medication for the first time, and not understanding why the medication was prescribed.

But for me and many others, it all comes down to cost. Studies show that the higher the patient’s responsibility financially, the greater the risk of prescription abandonment. The second highest reason for abandonment is younger customers who are wary about the trying a new medication.

The take away for me is that prescription discount cards and pharmaceutical coupons can increase medication compliance, improve patient health, and lower the cost of medical care. I know that by getting the cost down for my medications, I will be more likely to comply with my doctors’ instructions.

The WellRx program I used was free. I wasn’t sure how it was going to work the first time, but the pharmacist just said print the savings card and bring it back. He did the rest for me. He knew exactly how to ring it into their register and didn’t seem to bat an eye or look down at me for using a savings card. They also have an app for Apple and Android phones for those who prefer everything digital.

WellRx also allows you to compare what the price will be at different pharmacies in your area and to search for the best discounts. It is quick and easy, and their program is accepted at more than 60,000 pharmacies across the country. They offer an average savings of 45% off the prescription cost and some of their medications are eligible for savings of up to 80 percent.

Another resource that can help is the Partnership for Prescription Assistance, which helps uninsured and underinsured patients connect with hundreds of public and private assistance programs that provide free or low-cost prescription drugs.

LowestMed has a free mobile app that allows you to research and compare prescription prices at pharmacies in your area. You then show the discounted price on your phone to a participating pharmacy. The price you see is the price you pay.

I love being able to pass savings tips on to others. Prescription discount programs are a great tool not only for the chronically ill, but also for healthy people who have an unexpected medical problem and need help paying for their prescriptions.

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.

16 Senators Urge DEA to Lower Opioid Supply Again

By Pat Anson, Editor

Sixteen U.S. senators have sent a letter to the head of the Drug Enforcement Administration asking the agency to consider further cuts in the supply of hydrocodone, oxycodone and other opioid pain medication in 2018.

The DEA, which regulates that amount of controlled substances that can be manufactured each year, reduced the quota for Schedule II opioids by 25 percent or more in 2017 after receiving a similar letter last summer.  The supply of hydrocodone, one of the most widely used painkillers, was cut by 34 percent.

“We commend DEA on taking initial steps last year to lower production quotas for the first time in a generation,” the senators wrote to DEA acting administrator Chuck Rosenberg.

“However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.”

The letter, which was drafted by Illinois Democrat Dick Durbin, was signed by 15 other Democrats and one Independent: Senators Sherrod Brown (D-Ohio), Amy Klobuchar (D-Minn.), Edward J. Markey (D-Mass.), Joe Manchin (D-W.Va.), Dianne Feinstein (D-Calif.), Claire McCaskill (D-Mo.), Patrick Leahy (D-Vt.), Tammy Baldwin (D-Wisc.), Jeanne Shaheen (D-N.H.), Kirsten Gillibrand (D-N.Y.), Catherine Cortez Masto (D-Nev.), Maggie Hassan (D-N.H.), Richard Blumenthal (D-Conn.), Al Franken (D-Minn.) and Angus King (I-Maine).

Between 1993 and 2015, the senators say the DEA allowed production quotas for oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold.

Production quotas may have been rising, but opioid prescriptions have actually been falling for several years.  Last week the CDC released a report acknowledging that opioid prescribing in the U.S. has fallen by 18 percent since 2010.  

Many PNN readers have complained that since the 2017 quotas were adopted they now have trouble getting legitimate prescriptions filled because pharmacies do not keep enough pain medication in stock.

“My pharmacy has been trying to fill my pain medication for 6 days now,” wrote Karen. “So I call my pain management office and (they) don't know there is a shortage! Help us get our medication!”

“I am horrified by the absolute stupidity of these lawmakers who have no business making any decisions about my pain management!” wrote Tracey, who has been taking pain medication for 5 years. “All of the lawmakers said this would not affect those with already established chronic pain! Well guess what they lied!”

“I am writing to each one of these senators and letting them know how I feel on this issue. We need to vote these people OUT of office come election time, send them a powerful message. Although at this point the damage is already done. People like myself shouldn't have to consider suicide to end their constant pain,” wrote Jenny.

While many patients complain of shortages, the senators who signed the letter talk about states being “flooded” with opioids.

“Pharmaceutical companies have irresponsibly flooded states with millions and millions of opioids pills – enough, in fact, for every adult in America to have their own bottle,” Sen. King said in a statement. “And the consequences are both clear and dire: As the number of pills has grown, so has the drug epidemic. By scaling back the overabundance of these opioids, the DEA can help directly stem the tide of addiction while still also ensuring that those who suffer from chronic pain have the medication they need.”

Drug Maker Pays $35 Million Fine for Opioid Sales

By Pat Anson, Editor

A British drug maker has agreed to pay a $35 million fine to settle allegations that it failed to report suspiciously large orders in the U.S. for the opioid painkiller oxycodone.

In the settlement, Mallinckrodt refused to admit any wrongdoing and said it was paying the fine “to eliminate the uncertainty, distraction and expense of litigation.”

Federal prosecutors say the company failed to detect and notify the Drug Enforcement Administration of unusually large orders for oxycodone from U.S. pharmacies and pain clinics from 2008 to 2011.  

The government also alleged that Mallinckrodt failed to keep accurate records at a manufacturing facility in upstate New York, which resulted in discrepancies between the actual number of oxycodone tablets produced and the number of tablets reported by the company.

“Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street,” Attorney General Jeff Sessions said in a statement.

Prosecutors say the settlement includes a “groundbreaking parallel agreement” with the DEA, under which the company will analyze data it collects from customers down the supply chain to identify suspicious sales. The DEA maintains that drug makers need to go beyond a “know your customer” policy and should use all available data to “know your customer’s customer” to prevent opioid painkillers and other controlled substances from getting into the wrong hands.

“Mallinckrodt has agreed to do everything they can to help us identify suspicious orders in the future. And as a result of today's settlement, we are sending a clear message to drug companies: this Department of Justice will hold you accountable for your legal obligations and we will enforce our laws,” Sessions said.

"While Mallinckrodt disagreed with the U.S. government's allegations, we chose to resolve the legacy matter in order to eliminate the uncertainty, distraction and expense of litigation and to allow the company to focus on meeting the important needs of its patients and customers,” said Michael-Bryant Hicks, General Counsel, Mallinckrodt.

"We are proud of the fact that Mallinckrodt has long been an industry leader in actively combatting the serious issue of prescription drug abuse with a demonstrated record of meeting and exceeding the requirements of federal and state laws governing the manufacturing, sale and distribution of controlled substances.”

CVS to Pay $5 Million Fine

In a related story, CVS Health Corp agreed to pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone.

“The Company agreed to settle this matter to avoid the delay, uncertainty, inconvenience and expense of protracted litigation,” CVS said in a statement. 

The allegations resolved by the settlement were uncovered by a DEA investigation that began in 2012 after CVS self-reported thefts and losses of hydrocodone at five of its Sacramento-area pharmacies. Under the Controlled Substances Act, pharmacies are required to report any thefts or significant losses of controlled substances to the DEA.

“National retailers that distribute massive amounts of controlled substances have a responsibility to comply with recordkeeping regulations because these regulations are specifically designed to prevent dangerous drugs from being diverted into the community and abused,” said U.S. Attorney Phillip Talbert.

In addition to paying the $5 million fine, CVS also agreed to a compliance plan for 168 its pharmacies in California, under which pharmacy staff would be provided with better training and monitoring.

“CVS Health is committed to the highest standards of ethics and business practices, including complying with all federal and state laws governing the dispensing of controlled substance prescriptions and is dedicated to helping reduce prescription drug abuse and diversion,” the company said. 

This is certainly not the first time CVS has been accused by the federal government of failing to comply with the Controlled Substances Act.

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

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.

And in 2010, the DEA fined CVS $75 million for the improper selling of cold medicines in California and Nevada. The cold medicines contained pseudoephedrine, an ingredient that can be used to make methamphetamine.

9 out of 10 Patients Prefer Cannabis Over Opioids

By Pat Anson, Editor

A survey of nearly 3,000 medical marijuana users has found that 9 out of 10 patients prefer cannabis over opioid medication when managing their chronic pain. A similar number prefer cannabis over non-opioid pain relievers such as Tylenol or Advil.

The survey was conducted by researchers at the University of California Berkeley and HelloMD, a website that links patients to doctors in California and New York that prescribe medical marijuana. The survey was administered by email to a HelloMD database of cannabis patients who were asked how marijuana affected their consumption of opioids and other pain relievers.

Eighty percent of those surveyed said that cannabis was more effective at relieving pain than opioid medication and 97 percent said they decreased their opioid use when using cannabis. The latter finding supports previous research that found use of prescription pain medication declining in states where medical marijuana is legal.

“The results of our study were striking, showing 97% of people were able to decrease the amount of opioids that they used in conjunction with cannabis use. This was more than double the amount shown in any previous studies conducted,” said Perry Solomon, MD, Chief Medical Officer of HelloMD.

DRUG POLICY ALLIANCE

“The (study) clearly showed that chronic pain is one of the medical conditions that cannabis can be used for with great efficacy. Our study not only supports this but also goes further in that the clear majority of patient’s state that they prefer it. Hopefully this will awaken the public, medical professionals and legislatures to the fact that there is a safe, non-addictive product available to help fight the opioid epidemic, and that is cannabis.”

Other key findings from the survey of medical marijuana users:

• 93% said they prefer cannabis to opioids
• 92% said cannabis' side effects were more tolerable than side effects from opioids
• 90% said cannabis works well with non-opioid pain relievers
• 96% said they need fewer non-opioid pain relievers when using cannabis
• 89% said cannabis was more effective than non-opioid pain relievers

"With cannabis not only becoming more accepted in the mainstream but also coming in a variety of preparations, some of which are nonintoxicating, more people are looking at cannabis as a viable treatment for everyday ailments such as muscle soreness and inflammation,” wrote Amanda Reiman, PhD, of UC Berkeley and the Drug Policy Alliance, lead author of the study published in the journal of Cannabis and Cannabinoid Research.

“Participants in this study overwhelmingly supported the notion that they would be more likely to use cannabis as a substitute for pain medication if it were less stigmatized and more available, suggesting that there are populations of people who could benefit from this practice but are shying away due to the stigma and legal restrictions related to cannabis use.”

The survey should not be considered a scientific study on the effectiveness of cannabis, because participants were self-selected and reported their perceptions about cannabis use, as opposed to an objective measurement by a third party. There was also no control group of pain patients who only had access to opioids and other pain relievers.

A small study last year by the University of Michigan found that nearly two-thirds (64%) of medical marijuana patients reported a reduction in their use of prescription pain medications.

A 2014 study published in JAMA Internal Medicine found that opioid overdoses declined by nearly 25 percent in states where medical marijuana was legalized.

From Bad to Worse: The Future of the Opioid Crisis

By Roger Chriss, Columnist

The opioid crisis is getting worse. STAT News is predicting that “opioids could kill nearly half a million people across America over the next decade as the crisis of addiction and overdose accelerates.” The Guardian calls it “this generation’s AIDS crisis.”

There are three developments now at work that are likely to determine the future direction of the opioid crisis: Illicit drugs coming from China and Mexico; healthcare reform and funding for addiction treatment; and the White House Commission on Combating Drug Addiction and the Opioid Crisis, chaired by New Jersey governor Chris Christie.  

With opioid prescriptions dropping since 2010, heroin and illicit fentanyl are now the main drivers of the opioid crisis. The U.S. is trying to get China to shut down illicit labs and stop the shipment of fentanyl and other synthetic opioids to Mexican drug cartels. But The Globe and Mail warns that “hoping Chinese police and border officials can solve the problem is unlikely to be an effective strategy.”

The New York Times reports illicit drugs can also be obtained online over the “dark web” and attempts to block overseas shipments of such drugs have met with little success so far.

In the U.S. Senate, the GOP healthcare bill would allocate $2 billion to addiction treatment, but CNN reports that “those on the front lines say the bill won't help the opioid crisis -- and very well could make matters worse.” The reason, says Politico, is that “throwing a pile of cash at addiction won’t make it go away.”

Presidential advisor Kellyanne Conway echoes that belief, warning that “money alone hasn’t solved the problem. Obamacare spent billions of dollars and where are we?”

“It takes money and it also takes a four letter word called will,” she told ABC News, a comment that infuriated addiction treatment supporters.

Two Republican senators want to boost funding for addiction treatment to $45 billion, but experts say even that amount of money would be inadequate because it doesn’t provide for the treatment of other healthcare problems – like HIV and hepatitis C – that many addicts have.

Addiction treatment was the focus of the first meeting of the White House Opioid Commission, which was appointed by President Trump to come up with solutions to the opioid crisis.  During last month’s meeting, Mitchell Rosenthal, MD, founder of the addiction treatment chain Phoenix House, warned that “nothing we are doing today has been able to halt the spread of opioid addiction. Controlling prescription opioid medication has not done so.”

The commission has until October 1 to present its recommendations to President Trump, but the panel has already missed one deadline for an interim report and postponed its second meeting until next week.

As you can see, there are no easy solutions. The opioid crisis is a perfect storm of increasingly available illicit drugs, very limited and costly treatment resources, and virtually no early detection or prevention. We can’t simply legislate, regulate or incarcerate our way out.

Nothing less than a comprehensive and coordinated national response will end the crisis. We need early intervention and preventative education, long-term treatment of opioid addiction using medication-assisted therapy, and careful and humane oversight of prescription opioids that doesn’t take them away from patients who need them. What we will get remains to be seen.

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.

PROP Urges Members to Oppose FDA Opioid Strategy

By Pat Anson, Editor

An anti-opioid activist group has sent an “Urgent Action Request” to it members, asking them to oppose plans by the Food and Drug Administration to give new guidance to health care providers about prescribing opioid pain medication.

The initial draft of the guideline for Prescriber Education for Extended-Release and Long-Acting Opioids Risk Evaluation and Mitigation Strategies – more simply known as REMS -- warns prescribers at length about the risk of overdose, addiction and the “epidemic of prescription opioid drug abuse.” But Physicians for Responsible Opioid Prescribing (PROP) doesn’t think the draft goes far enough.

“The current draft is seriously flawed,” wrote PROP founder and Executive Director Andrew Kolodny, MD, in an email to supporters urging them to leave a comment in the Federal Register before the public comment period on the REMS guideline ends on Monday, July 10.

“Please post a comment about the draft on the FDA federal docket. FDA is required to review the comments and tally them. If FDA receives enough critical comments, there is a good chance they'll improve the document.” 

Kolodny’s email provides a “sample comment” for PROP members to use, urging the FDA to adopt an upper dose limit on opioids, mention the “lack of evidence supporting long-term opioid use” and provide a list of pain conditions for which opioids are “inappropriate” – such as fibromyalgia and chronic headache.

Until now, the REMS draft guideline – an update to a similar guideline released in 2012 – has drawn little public attention. Less than 300 comments have been made in the Federal Register, most of them focused on whether acupuncture and chiropractic care should be included as alternative treatments to opioids. 

The 10-page guideline warns doctors repeatedly about using caution when prescribing opioids, but it stops short of setting an artificial ceiling on doses, such as those recommended last year by the Centers for Disease Control and Prevention and an even tougher guideline recently adopted by the Departments of Veterans Affairs and Defense (VA/DOD).

“We believe the REMS curriculum should be based on the CDC guideline and the VA/DOD guideline,” wrote Kolodny and other PROP board members in a letter to FDA commissioner Scott Gottlieb, MD. “The CDC and VA/DOD guideline warn against prescribing high doses of opioids and specifically recommend against doses greater than 90mg morphine equivalents. The Blueprint omits this critical topic.”

“I don't agree that the new blueprint is inconsistent with recommendations from other government agencies. For one thing, there is a specific statement in the blueprint that HCPs (health care providers) should know about the CDC guideline and other guidelines regarding safe opioid prescribing,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, an organization of pain management providers.

“Let me also point out that PROP's call for inclusion of ‘an upper dose limit consistent with recommendations from other federal agencies’ perpetuates the myth that the CDC guideline contains such an upper dose limit. CDC was very clear when it issued the guideline that it should be considered to contain recommendations, not limits.”

The REMS guideline not only does not endorse a specific limit on opioids, it recommends that “a comprehensive treatment plan should be developed and customized to the needs of the individual patient.”  The focus on individualized patient care is something else that PROP takes issue with.

“Since the purpose of the Blueprint is to teach more cautious prescribing the focus should be first and foremost on when to use opioids for acute and chronic pain, and secondly, on how to use opioids as safely as possible. The Blueprint does not need to teach how to make a pain diagnosis, or what alternatives there are to opioids, both of which should be considered beyond the scope of REMS,” wrote Kolodny his his letter. “Until opioids are prescribed more cautiously it will not be possible to bring the opioid addiction epidemic under control.”

But opioids are being prescribed more cautiously and have been since 2010, as we learned from a new CDC study. Yet the nation’s opioid crisis continues to worsen, fueled by heroin, illicit fentanyl, counterfeit painkillers, and failed strategies to control the crisis by denying many pain patients their only form of treatment.   

To see the FDA’s draft REMS guideline, click here. To leave your own comment on the Federal Register, click here.

Are You Still Hoping for a Cure?

By Rochelle Odell, Columnist

As a 25 year survivor of Complex Regional Pain Syndrome (CRPS/RSD), I ask myself all the time if I have lost hope, become too cynical and if reality has finally hit home.

Yes to all three, unfortunately. And I don't like that.

For most chronic pain conditions, there is usually hope for a cure. But for some there is no hope at all -- people just have to learn to live with the outcome and hope there are doctors who know how to treat it accordingly.

When viewing the main CRPS/RSD websites and support groups, hope for a cure is a common thread. But in reality for me and others like me who have lived with this insidious monster for far too long, there truly is no hope. Medical treatment and modalities have changed little in the 25 years I have battled this disease and that concerns me.

Why haven't greater strides been made? Possibly because researchers and scientists just do not fully understand the human brain yet. Until there is a complete understanding of the mechanics of this disease and others like it, hope ends there.

I recently learned from a friend that her physician, a general practitioner, had little respect for anesthesiologists who treated post-surgical pain and how he felt a patient wasn't treated appropriately. So I looked into when pain management became its own medical specialty.

Pain management became the first sub-specialty of anesthesia in 1993, the same year that I was diagnosed with CRPS/RSD. Most pain management specialists are anesthesiologists, but neurologists and psychiatrists can also become board certified in pain management. The training is long and arduous, but they are among the highest paid in the medical profession.  

When my treatment began, my first pain management physician was still learning and I was his all too cooperative guinea pig. I just wanted the CRPS/RSD pain in my left foot to go away. Would I go down that path again? Never.

My outcome may have been much better without all the “minimally invasive” procedures that were attempted. It started with epidural blocks and progressed from there. The more procedures that were done, the faster the CRPS/RSD spread and the worse the pain became. 

I often wonder where the term “minimally invasive” began. Even though doctors may not go deeply into the body, just by going into our spine or brain for whatever reason, they are venturing into the very nerve fiber of every patient. That is not minimal.

I have read where researchers, scientists and even some pain management physicians now believe that all those minimally invasive procedures may in the end do more harm than good.  Do I believe it?  Absolutely!  But that's just me -- although many long term CRPS/RSD patients will admit that it was wrong for them too.  Most just do not go around talking about this other dark side of the pain. 

There are times I want to scream at a patient: DON'T DO IT! EXPLORE ALL YOUR OPTIONS FIRST. AND ABOVE ALL EDUCATE YOURSELF!

But I don't, I temper my tongue.

Many of us don't believe our physicians as we are rushed through an appointment. We may be allotted only about 10-15 minutes. If you haven't written down your questions and concerns first, you soon realize you are sitting in the exam room with your mouth open as the doctor leaves, telling you to pick up your prescription at the front desk, schedule your next appointment or, worse yet, that they will be unable to treat you any longer. 

This type of inadequate treatment, with your pain increasing and no end in sight, is where cynicism soon develops.  It is also when reality hits you smack in the face and you start to question yourself. What in the hell am I doing here?

When clinical trials are started, they are aimed at a specific group of people, often in the early stages of a disease. There is often a large exclusion list, such as those of us who have had CRPS/RSD for many years. New treatments are not being investigated or developed for us, so the standard nerve blocks, injections, surgical procedures and implants are utilized. And now, because of the opioid crisis, more patients than ever are being dropped.

Treating a CRPS/RSD patient has so many variables. What works for one, doesn't work for the other, and what worked yesterday may not work the next day. Treating us has to be a nightmare for any physician.

I do have hope for patients who are newly diagnosed with CRPS/RSD, absolutely. But at this point in time, unless medical advances are developed, they soon will be walking down the same path so many of us long time pain patients or on, when hope is dashed, and cynicism and reality make a grand entrance.

I get tired of hearing the word “hope” as it has no meaning for me. Yet we are continually told to hope for a cure, to be brave, and to develop a positive attitude. Am I all doom and gloom? Not yet. I still smile and laugh.

But when alone in the dark, when reality hits me once again, I cry. 

Rochelle Odell lives in California. She lives 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.

Drug Maker to Stop Sales of Opana ER

By Pat Anson, Editor

Endo International has agreed to voluntarily remove Opana ER from the market, one month after the Food and Drug Administration said safety risks posed by the pain medication outweigh its benefits. Opana ER is the brand name for Endo’s extended release opioid painkiller oxymorphone.

“Endo International continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse,” the company said in a statement.

“Endo reiterates that neither the FDA's withdrawal request nor Endo's decision to voluntarily remove Opana ER from the market reflect a finding that the product is not safe or effective when taken as prescribed.”

If Endo had not agreed to stop Opana sales, the FDA would have taken steps to require its removal by withdrawing approval for the drug. The company said it would work with the FDA to remove Opana “in a manner that looks to minimize treatment disruption for patients” and to give patients time to consult with doctors about other alternative painkillers.

The FDA action is the first time the agency has taken steps to stop an opioid painkiller from being sold. Opana was reformulated by Endo in 2012 to make it harder to abuse, but addicts quickly discovered they could still inject it. The FDA said Opana was linked to serious outbreaks of HIV, hepatitis C and a blood clotting disorder spread by infected needles.

Next week the FDA will meet with “external thought leaders” to review the effectiveness of other painkillers made with abuse deterrent formulas, which make medications harder for addicts to crush or liquefy for snorting and injecting.

FDA commissioner Scott Gottlieb, MD, has hinted the agency could take other painkillers off the market.

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Gottlieb said last month.

“I’m hopeful that this signals a change at FDA—and that Opana might be just the first opioid that they’ll consider taking off the market. It’s too soon to tell,” Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP) told Mother Jones.

Endo said it will incur a pre-tax impairment charge of $20 million in the second quarter of 2017 to write-off the remaining book value of Opana.  Sales of Opana reached nearly $159 million in 2016.

CDC: Opioid Prescribing Peaked in 2010

By Pat Anson, Editor

The Centers for Disease Control and Prevention admitted something today that most doctors and pain patients could have told the agency several years ago: prescriptions for opioid painkillers are declining.

In its newest Vital Signs report, the CDC analyzed prescription drug data compiled by QuintilesIMS from 2006 to 2015, and found that opioid prescribing in the U.S. peaked in 2010.  More recent data indicates the downward trend continued in 2016.

The CDC's new report undermines one of the main reasons behind the agency’s 2016 opioid prescribing guidelines, which falsely claimed that “opioid prescriptions per capita increased from 2007 to 2012,” when, in fact, they actually declined (see chart below).  

“Overall, opioid prescribing in the United States is down 18 percent since 2010,” said CDC Acting Director Anne Schuchat, MD.  

But even with that downward trend in prescribing, the CDC maintains opioid doses are still too high and contributing to the nation’s overdose crisis.

“Despite these overall declines, the bottom line remains we still have too many people getting opioid prescriptions for too many days at too high a dose,” said Schuchat. “In addition, the dramatic increase we’ve been seeing in heroin overdose is another tragic consequence of exposing too many people to prescription opioids, since most people who use heroin started off with misusing prescription opioids.”

Schuchat did not explain how her theory could account for the fact that heroin overdoses were increasing at a time when opioid prescriptions were declining. The association between heroin use and prescription painkillers is a common misconception at best, and a misleading half-truth at worst.

While many heroin users start out with painkillers (as well as tobacco, marijuana, alcohol and other drugs), most obtain their opioids illegally through friends, relatives and the black market. Heroin use by patients who are legally prescribed painkillers is actually quite rare, although the CDC's acting director makes it sound like one of the leading causes of overdoses.

"We're now experiencing the highest overdose drug death rates ever recorded in the United States, driven by prescription opioids and illicit opioids like heroin and illicitly manufactured fentanyl," Schuchat said.

Contrary to its own prescribing guideline, the CDC found that the average per capita daily morphine equivalent dose (MME) has been in decline for nearly a decade, from 59.7 MME per capita in 2006 to 48.1 MME in 2015.

The latter dose is well below the highest recommended limit of 90 MME in the CDC guidelines.

AVERAGE DAILY PER CAPITA MORPHINE EQUIVELANT DOSE (MME)

Source: CDC/QuintilesIMS

The CDC also found a wide variation in prescribing practices around the country, with six times more opioids per resident dispensed in the highest-prescribing counties than in the lowest-prescribing ones.

Many of the high-prescribing counties are in rural, economically depressed areas such as Appalachia, where there are high rates of disability, suicide and unemployment; suggesting that the so-called "opioid epidemic" is actually more of an epidemic of despair. Other factors associated with high rates of opioid prescribing are a high percentage of white residents, high rates of uninsured or Medicaid recipients, and high rates of patients with diabetes and arthritis.

Gabapentin Boosts High For Opioid Abusers

By Carmen Heredia Rodriguez, Kaiser Health News

ATHENS, Ohio — On April 5, Ciera Smith sat in a car parked on the gravel driveway of the Rural Women’s Recovery Program here with a choice to make: go to jail or enter treatment for her addiction.

Smith, 22, started abusing drugs when she was 18, enticed by the “good time” she and her friends found in smoking marijuana.

She later turned to addictive painkillers, then anti-anxiety medications such as Xanax and eventually Suboxone, a narcotic often used to replace opioids when treating addiction.

Before stepping out of the car, she decided she needed one more high before treatment. She reached into her purse and then swallowed a handful of gabapentin pills.

CIERA SMITH (KAISER HEALTH NEWS)

Last December, Ohio’s Board of Pharmacy began reporting sales of gabapentin prescriptions in its regular monitoring of controlled substances. The drug, which is not an opioid nor designated a controlled substance by federal authorities, is used to treat nerve pain. But the board found that it was the most prescribed medication on its list that month, surpassing oxycodone by more than 9 million doses. In February, the Ohio Substance Abuse Monitoring Network issued an alert regarding increasing misuse across the state.

And it’s not just in Ohio. Gabapentin’s ability to tackle multiple ailments has helped make it one of the most popular medications in the U.S. In May, it was the fifth-most prescribed drug in the nation, according to GoodRx.

Gabapentin is approved by the Food and Drug Administration to treat epilepsy and pain related to nerve damage, called neuropathy. Also known by its brand name, Neurontin, the drug acts as a sedative. It is widely considered non-addictive and touted by the federal Centers for Disease Control and Prevention as an alternative intervention to opiates for chronic pain. Generally, doctors prescribe no more than 1,800 to 2,400 milligrams of gabapentin per day, according to information on the Mayo Clinic’s website.

Gabapentin does not carry the same risk of lethal overdoses as opioids, but drug experts say the effects of using gabapentin for long periods of time or in very high quantities, particularly among sensitive populations like pregnant women, are not well-known.

As providers dole out the drug in mass quantities for conditions such as restless legs syndrome and alcoholism, it is being subverted to a drug of abuse. Gabapentin can enhance the euphoria caused by an opioid and stave off drug withdrawals. In addition, it can bypass the blocking effects of medications used for addiction treatment, enabling patients to get high while in recovery.

Athens, home to Ohio University, lies in the southeastern corner of the state, which has been ravaged by the opioid epidemic. Despite experience in combating illicit drug use, law enforcement officials and drug counselors say the addition of gabapentin adds a new obstacle.

“I don’t know if we have a clear picture of the risk,” said Joe Gay, executive director of Health Recovery Services, a network of substance abuse recovery centers headquartered in Athens.

‘Available To Be Abused’

A literature review published in 2016 in the journal Addiction found about a fifth of those who abuse opiates misuse gabapentin. A separate 2015 study of adults in Appalachian Kentucky who abused opiates found 15 percent of participants also misused gabapentin in the past six months “to get high.”

In the same year, the drug was involved in 109 overdose deaths in West Virginia, the Charleston Gazette-Mail reported.

Rachel Quivey, an Athens pharmacist, said she noticed signs of gabapentin misuse half a decade ago when patients began picking up the drug several days before their prescription ran out.

“Gabapentin is so readily available,” she said. “That, in my opinion, is where a lot of that danger is. It’s available to be abused.”

In May, Quivey’s pharmacy filled roughly 33 prescriptions of gabapentin per week, dispensing 90 to 120 pills for each client.

For customers who arrive with scripts demanding a high dosage of the drug, Quivey sometimes calls the doctor to discuss her concerns. But many of them aren’t aware of gabapentin misuse, she said.

Even as gabapentin gets restocked regularly on Quivey’s shelves, the drug’s presence is increasing on the streets of Athens. A 300-milligram pill sells for as little as 75 cents.

(kAISER HEALTH NEWS)

Yet, according to Chuck Haegele, field supervisor for the Major Crimes Unit at the Athens City Police Department, law enforcement can do little to stop its spread. That’s because gabapentin is not categorized as a controlled substance. That designation places restrictions on who can possess and dispense the drug.

“There’s really not much we can do at this point,” he said. “If it’s not controlled … it’s not illegal for somebody that’s not prescribed it to possess it.”

Haegele said he heard about the drug less than three months ago when an officer accidentally received a text message from someone offering to sell it. The police force, he said, is still trying to assess the threat of gabapentin.

Little Testing

Nearly anyone arrested and found to struggle with addiction in Athens is given the option to go through a drug court program to get treatment. But officials said that some exploit the absence of routine exams for gabapentin to get high while testing clean.

Brice Johnson, a probation officer at Athens County Municipal Court, said participants in the municipal court’s Substance Abuse Mentally Ill Program undergo gabapentin testing only when abuse is suspected. Screenings are not regularly done on every client because abuse has not been a concern and the testing adds expense, he said.

The rehab program run through the county prosecutor’s office, called Fresh Start, does test for gabapentin. Its latest round of screenings detected the drug in five of its roughly 238 active participants, prosecutor Keller Blackburn said.

Linda Holley, a clinical supervisor at an Athens outpatient program run by the Health Recovery Services, said she suspects at least half of her clients on Suboxone treatment abuse gabapentin. But the center can’t afford to regularly test every participant.

Holley said she sees clients who are prescribed gabapentin but, due to health privacy laws, she can’t share their status as a person in recovery to an outside provider without written consent. The restrictions give clients in recovery an opportunity to get high using drugs they legally obtained and still pass a drug test.

“With the gabapentin, I wish there were more we could do, but our hands are tied,” she said. “We can’t do anything but educate the client and discourage” them from using such medications.

A stone painted with the phrase “Perfect Imperfection” is among the inspirational messages along the sidewalk leading to the main entrance of the Rural Women’s Recovery Program. (Carmen Heredia Rodriguez/KHN)

Smith visited two separate doctors to secure a prescription. As she rotated through drug court, Narcotics Anonymous meetings, jail for relapsing on cocaine and house arrest enforced with an ankle bracelet, she said her gabapentin abuse wasn’t detected until she arrived at the residential recovery center.

Today, Smith sticks to the recovery process. Expecting a baby in early July, her successful completion of the program not only means sobriety but the opportunity to restore custody of her eldest daughter and raise her children.

She intends to relocate her family away from friends and routines that helped lead her to addiction and said she will help guide her daughter away from making similar mistakes.

“All I can do is be there and give her the knowledge that I can about addiction,” Smith said, “and hope that she chooses to go on the right path.”

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

‘Catastrophizing’ Doesn’t Mean Pain Is All in Your Head

(Editor’s Note: Last month we published a story about pain “catastrophizing,” and how a new study showed that women who have negative or emotional responses to pain are more likely than men to be prescribed opioid medication. Several readers were offended by the study, as well as our story, feeling they belittled women and their ability to handle pain.

The two co-authors of the study, which was published in the journal Anesthesiology, kindly agreed to address some of these concerns and further explain their research.)

By Yasamin Sharifzadeh and Beth Darnall, PhD, Guest Columnists

Thank you for taking the time to share your thoughts and ideas about our recently published paper on opioid prescription and pain catastrophizing. We would like to address a few concerns brought up and to clarify some of the statements made in our publication.

First and foremost, our study analyzed pain catastrophizing, which has a different and more nuanced definition than terms such as complaining or worrying, that are commonly used to describe it.

Pain catastrophizing is measured via a 13 question survey, with specific subsets used to assess varying aspects of the way we emotionally approach pain. This term is not meant to downplay or discredit pain or its associated emotions. In fact, we use it to better understand the many manifestations of pain.

But for some people, the term “catastrophizing” is offensive. We hear those negative responses, but in clinic, when the term is described, many patients will say:  “I do that!  That is totally me.”  So while not everyone is offended by the term, some people are. It’s important to know that catastrophizing does not mean that pain is all in your head, or your fault, or that you did anything wrong.

Our nervous systems are hardwired to respond to pain with alarm. It is actually an acquired skill to learn to disengage one’s attention to pain and develop strategies that counteract this agitation in the nervous system. Otherwise, it can set us up to have greater distress and pain. This is true for everyone, but for some people the alarm in the nervous system rings louder. 

We sometimes use “negative mindset” as a way to describe difficulties in disengaging from attention to pain or focusing on worsening pain or worst-case scenarios. The science is clear on how our thoughts, attention, and emotions impact pain and pain treatment response.

Whatever the term used to describe this specific form of pain-related distress, it is highly predictive of response to various pain treatments. For this reason, it is important that we identify it and treat it. Not addressing these issues would be neglectful, given the degree to which one’s mindset can undermine treatment response and contribute to suffering.

Men and Women Catastrophize

We also wish to clarify some of the findings of the study. We found that men and women, in a general sample of chronic pain patients, had similar levels of pain catastrophizing. In other words, men and women do not significantly differ in their pain-related emotions. Also, consistent with previous peer-reviewed work, we found that women reported higher than average pain levels.

We took our robust analysis a few steps further to show that in women, pain-related emotions played a bigger role in the likelihood of having an opioid prescription than it did in men. Again, this is not saying that pain catastrophizing played no role in opioid prescribing for men -- just that it had a higher effect in women despite equal levels of pain catastrophizing between the sexes.

Overall, we view our study as a stepping-stone towards an improved understanding of both the physical and emotional manifestations of pain.

Pain catastrophizing is a unique term that describes just one of many ways that we can look at pain-related emotional distress, and it is not meant to discount pain in any way. Rather, it validates the importance of treating pain comprehensively in order to attain better results.

We hope that this study helps people with pain look at pain from many angles and work with their physician to find the solution that works best for them.

Yasamin Sharifzadeh is lead author of the study. She is a second year medical student at Virginia Commonwealth University.

Beth Darnall, PhD, is senior author of the study.  She is a clinical associate professor at Stanford University School of Medicine and author of 3 books:    "Less Pain, Fewer Pills," "The Opioid-Free Pain Relief Kit," and a forthcoming book entitled “Psychological Treatment for Chronic Pain.”

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

What It’s Like to Get a Lidocaine Infusion

By Crystal Lindell, Columnist

So I’m kind of annoyed at the wellness people out there for making the word “infusion” sound like something vitamin-related that rich people get at the spa right before a couple’s massage and a facial.

That is not what an infusion is. At least, that’s not what a lidocaine infusion is. It’s also not a shot. That seems to come up at lot. Everyone thinks I went into the hospital, got a quick shot in the arm, and then went to Chipotle. Again, that is incorrect.

I recently got my first lidocaine infusion at the recommendation of my pain specialist and my primary care doctor. They were hoping it would help me with the daily pain I have on my right side from what they think is intercostal neuralgia —  basically I always feel like I have a broken rib.

I was really apprehensive about trying it though, and the only reason I agreed to do it was because my primary care doctor strongly encouraged me to try it and I trust him. We’ve been through some stuff together and he has always seemed to have my best interest at heart.

He said of the like five people he knew who tried it, all had found success with it. I’m pretty sure he also is hoping to get me off opioids because it’s a huge hassle for him to write a hydrocodone script these days — all sorts of government regulatory boards are involved and he has to check a drug database every time to make sure I’m not coming up with a red flags. But I get that — I don’t actually love being high all the time either.

The way the lidocaine infusion was explained to me was not super encouraging though. Basically, they give you an IV at the hospital infusion center, and you have to sit there for an hour while they slowly pump the medication into your system. Then, at least for the first visit, you have to sit there for another hour after that and get a saline solution to keep the line open. Then they do a blood test and send you home. Also, you have to bring someone with you the first time, in case you can’t drive home afterward.

If it works, you have to go in every month and do it again.

The doctors told me that they don’t even really know why lidocaine infusions work because the effects seem to last longer than the drug should even be in your system. But they think it somehow blocks pain signals in your body.

On a personal note, I was apprehensive because I spend most days dreaming of living in Paris, and I didn’t want to be dependent on something that I’d have to do monthly and that might not even be available in France. In fact, Paris is why I want to get off the hydrocodone in the first place. It’s harder to get opioids over there.

But, like I said, my PCP was all about this infusion, so I decided to do it. They told me I could expect things like numbness and tingling in my fingers, toes and my mouth, a metallic taste, lightheaded, and a feeling of cotton in my mouth.

And, depending on how it went, I also might get nauseous and dizzy. But, they made it sound like all the side effects would go away as soon as they stopped the infusion, and that I should be fine as soon as it was over.

They did not tell me I would feel like I had been drugged.

I mean, I guess, looking back, feeling lightheaded is kind of along those lines, but the feeling is way more intense than that. At least it was for me.

I brought my mom and sister with me, and thank God I did, because the whole thing ended up being a lot more traumatic than I was expecting.

When they started the infusion I was actually FaceTiming my best friend, who said she could literally see the effects of the lidocaine on me in the span of one sentence. My speech got slower, my head got heavy and I could not think clearly.

“I... don’t... think... I.... can..... talk....... anymore,” I told her. 

“Yeah, I know,” she said before wishing me luck and hanging up the phone. 

I don’t know why I was not expecting such an intense reaction, but I wasn’t. About 10 minutes in, I literally started crying for no reason. And the reason I know I had no reason to cry is that I remember telling everyone around me that I didn’t know why I was crying. 

When I started getting really nauseous, they did stop the infusion and give me some graham crackers, which helped. But as soon as they started again the drugged feeling came back. 

The nurse at the infusion center said a lot patients describe it as having too many cocktails. So it’s past that fun one-or-two-glasses-of-wine stage, but just shy of the blackout-drunk stage. Add in that it all feels like it’s happening against your will, and it’s not exactly a fun two hours.

Also, my legs turned to jelly, and I couldn’t think clearly at all. I was literally so naïve going in that I honestly thought I might be able to get some work done while they were doing the infusion. I was not. All I could manage was lying on my back, asking everyone around me if my lips were swollen, and closing my eyes. 

Overall, it was a lot more like going into the hospital for a small procedure than I was expecting it to be — traumatic, time consuming and hard on my body.

When they finished everything, they just let me get up and walk out of the hospital, but I should have had a wheelchair. My legs did not seem to work at all and my brain was in a fog. I felt like how people in action movies look when they’ve been drugged and kidnapped against their will. 

I was hoping to go home and sleep it off, but I woke up the next day still feeling pretty drunk. All told, it took about 15 hours after the infusion before I felt like I had my brain back. 

Did It Work?

Of course, none of this really matters. What really matters is whether or not this thing worked. And I have to tell you it did — for about six days. 

Then, on day seven I woke up at 1 a.m. feeling like someone was stabbing my ribs and I remembered how much chronic pain sucks. I spent the whole day on hydrocodone trying to get my pain under control. 

Those first six days were glorious though.  I would literally wake up pain free. Healthy even. And I got so much done around the house. I did the dishes, I vacuumed. I went for walks without any pain at all. My body felt like it did before I ever had intercostal neuralgia. It was incredible.

Today is day eight, and I haven’t taken any hydrocodone yet, but it’s early and who knows how I will feel later. 

Maybe day seven was just a fluke. Maybe it was the weather related, or maybe it was because I ate too much sugar and it spiked my inflammation. I don’t know. I’m seeing my pain specialist again in a couple weeks, and we’ll decide at that time if another infusion makes sense for me. I hoping she will tell me that the more infusions you get the longer they last, but I have no idea if that’s the case. 

Whether or not it makes sense for you is another matter altogether. It depends on what type of pain you have, what types of drugs you are already on, and what your feelings are on being drugged.

I will leave you with this though. The nurse at the infusion center said they are getting way more patients for lidocaine infusions for chronic pain and she thought it was directly related to the push to get people off opioids.  The nurse also admitted that the lidocaine doesn't work for everyone, and she was seeing lots of patients who had been managing their pain with things like hydrocodone for decades suddenly being forced to get off them. She said it was hard to watch patients suddenly lose access to drugs that had been helping them. 

But, she also said that for some patients the lidocaine infusions were life changing and a miracle. 

Pain is complicated and how we treat it has to be complicated as well if it’s going to be effective. Maybe lidocaine can help some people, but maybe opioids are the only thing that help others. And maybe, as most of us already know, everyone is different. 

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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

From Hopeless to Helping Others

By Jory Pradjinski, Guest Columnist

My chronic pain journey began when I injured my back in 1987, while I was managing an auto repair shop.

I was trying to remove a large pallet from a delivery truck and the pallet was placed sideways in the truck. Another guy and I had to use a large crowbar to leverage the pallet 90 degrees so it could be removed. We had done this many times before. However, when I was ready to turn the pallet I felt something pop in my low back and I ended up in the emergency room. I had herniated my L5-S1 disc.

The doctors tried different types of treatments, but nothing worked. So in 1989, I had to go through back surgery with a fusion. That first fusion didn’t work and I ended up having a second and third, which also failed. Finally, the fourth and fifth fusions were successful.

There were a grand total of five fusions, plus two follow-up procedures, over the course of 7 years before my L5-S1 level was fused. But I continued to have pain that just kept getting worse.

I lost support early on after my second failed fusion, which left me feeling isolated. I knew my family and friends couldn’t understand. With no support system, I retreated into myself and experienced depression, anxiety, post-traumatic stress disorder, dissociative amnesia and a year of suicidal thoughts. I had a hard time keeping a job due to failing concentration levels and extreme pain. I went on disability.

JORY PRADJINSKI

The Transition to Alternative Treatments

In 2006, while I was still having treatments on my back, I was rear ended at a stop light by an inattentive driver of a pickup truck going 50 mph. The accident affected my C5-C6 and C6-C7 discs, gave me a severe concussion, traumatic brain injury and a bruised skull (which I will have the rest of my life). I tried traditional medicine, but it failed to relieve the pain in my arms and hands. My doctor referred me to chiropractic and massage care, which relieved the pain somewhat.

In 2013, I fell face first at home after tripping on a cord. This dislodged my L4 vertebra. I went to an orthopedic surgeon who said they don’t do surgeries for that anymore. That was a welcoming statement to hear. After several months of rest and pain management, the vertebra went back into place. The surgeon then referred me to a chiropractor and several months later I changed to my current chiropractor, which was the best thing I ever did.

She helped me believe in what might be possible. If it hadn’t been for that fall, I don’t believe I would be where I am today because she gave me the hope and treatment that I needed. There truly was a silver lining in this situation.

I worked on reducing my weight, realizing the extra weight was adding to my pain levels, and ended up losing 57 pound. I did not use any special diet or exercise, just changed what I ate. Then, I had to get off the pain medications. I was up to 60mg OxyContin twice a day, plus oxycodone for breakthrough pain. I went through 5 months of withdrawal from the OxyContin.

The changes in my body from the chiropractic adjustments helped me get off the pain medications. The weight loss and getting the medications of out my system also had big impacts on my body. Along the way, I started getting massage therapy, dry needling, supplements, a natural muscle relaxer, an anti-inflammatory, and an herb for pain relief. It was a tough journey during this transition..

Founding ‘Hope Instilled’

I kept having the repeated thought in my head that this is not the way my life should be. I started to think, “I’m here for a reason. I must have experienced all these things for a reason.”

That's when I came up with the idea of Hope Instilled, a non-profit that provides resources and support to people living with chronic pain and illness. Having survived with no support network during my own journey, I wanted to help others with peer-to-peer support groups, which are often a missing link in pain management programs.

We are now building support forums on our website which allow anonymity for members. This also allows us to create different forum topics. We are looking to connect with local pain treatment centers and clinics. Our Facebook group has grown to include members from around the world. All the growth we've experienced came through word of mouth.

I have a positive and optimistic attitude towards life now. There are experiences I’ve endured which have made me enjoy rainy days as much as sunny days. Because I’m alive each day is a blessing.

When we find out we’re not alone there is some healing which begins deep inside. Throughout my journey, no one reached out to me and pulled me up. No one encouraged me to keep going. I was totally alone and survived alone. I look to do my best to help others not face a similar path.

Jory Pradjinski is a chronic pain survivor and the founder of Hope Instilled. Jory is a strong advocate for speaking up and speaking out about chronic pain, chronic illness and mental health conditions.

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.

Cannabis Formula Just as Effective as Migraine Drug

By Pat Anson, Editor

An experimental medication made from marijuana is just as effective as a widely used pharmaceutical drug in the treatment and prevention of migraine, according to two new studies by Italian researchers.

In the first study, a research team led by Dr. Maria Nicolodi found that combining two cannabinoids, tetrahydrocannabinol (THC) and cannabidiol (CBD), in a 200mg dose reduced acute pain by 55 percent in a group of 48 migraine sufferers. The medication, which was taken orally, contained 19% THC and 9% CBD.

In a second phase of the study, researchers then gave a group of 79 chronic migraine patients either the 200 mg THC-CBD combination or a 25mg dose of amitriptyline – a tricyclic antidepressant commonly used to treat migraine.

After three months of daily treatment, researchers found that the group taking the THC-CBD combination had a 40.4% reduction in migraine attacks, which was slightly better than the amitriptyline group (40.1%). 

The cannabinoids reduced migraine pain intensity by an average of 43.5 percent. Female patients also reported a decline in stomach ache, colitis and musculoskeletal pain.

"We were able to demonstrate that cannabinoids are an alternative to established treatments in migraine prevention,” said Nicoldi, who recently presented her findings at the 3rd Congress of the European Academy of Neurology in Amsterdam.

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

Previous research has also found that cannabis is effective in treating migraines. A 2016 study by the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of Colorado found that inhaled and ingested cannabis significantly reduced the number of headaches in a group of migraine sufferers. Inhalation appeared to provide the fastest results, while the edible cannabis took longer to provide pain relief.