Physical Therapy for Back Pain Lowers Healthcare Costs

By Pat Anson, Editor

If you have lower back pain and get it treated with physical therapy first, you are significantly less likely to later need opioid medication or high cost medical services, according to a new study in Health Services Research.

Researchers at the University of Washington and George Washington University analyzed health insurance claims for over 50 million people from 2009 to 2013, tracking patients who had a new diagnosis of lower back pain.

Compared with patients who saw a physical therapist later or not at all, those who saw a physical therapist first had an 89% lower probability of having an opioid prescription, a 28% lower probability of having an MRI or advanced imaging, and a 15% lower probability of having an emergency department visit. Their healthcare costs were also significantly lower for out-patient care, pharmacy and out-of-pocket expenses.

“We found important relationships among physical therapy intervention, utilization, and cost of services and the effect on opioid prescriptions," said co-author Ken Harwood, PT, a professor of physical therapy at George Washington University.

One unexpected finding is that patients who had physical therapy first had a 19% greater chance of being hospitalized.

“Having an in-patient hospitalization is not necessarily a bad outcome for a patient. PTs (physical therapists) provide care that aims to resolve LBP (lower back pain) by addressing musculoskeletal causes first, but if the problem does not get resolved, PTs may refer patients appropriately for more specialized care,” the study found.

One out of every four Americans will experience at least one day of lower back pain every three months. Researchers say about half will be treated with opioid medication, while physical therapy (12%), exercise (19%) and psychological therapy (8%) will be recommended far less often.    

"Given our findings in light of the national opioid crisis, state policymakers, insurers, and providers may want to review current policies and reduce barriers to early and frequent access to physical therapists as well as to educate patients about the potential benefits of seeing a physical therapist first," said lead author Bianca Frogner, PhD, a professor and health economist at the University of Washington Center for Health Workforce Studies.

Lower back pain is the world’s leading cause of disability, affecting about 540 million people at any given time. But there is little consensus on the best way to treat it.

A recent series of reviews appearing in The Lancet medical journal found that lower back pain is usually treated with inappropriate tests, risky surgeries and painkillers.

“The majority of cases of low back pain respond to simple physical and psychological therapies that keep people active and enable them to stay at work,” said lead author Professor Rachelle Buchbinder of Monash University in Australia. “Often, however, it is more aggressive treatments of dubious benefit that are promoted and reimbursed.”

FDA Continues Crackdown on Kratom Vendors

By Pat Anson, Editor

The U.S. Food and Drug Administration has stepped up its campaign against the herbal supplement kratom by sending warning letters to three distributors of kratom products – the latest effort in what appears to be a concerted government effort to stop all sales of the herb.

Front Range Kratom, Kratom Spot and Revibe are accused of illegally selling unapproved “drug products” and making unproven claims about kratom’s ability to treatment opioid addiction, chronic pain and other medical conditions.

The FDA and the Centers for Disease Control and Prevention have previously warned consumers not to consume any kratom products. The CDC said kratom was the “likely source” of a small salmonella outbreak, while the FDA alleged that kratom has opioid-like qualities and could lead to addiction and overdose.

“Despite our warnings that no kratom product is safe, we continue to find companies selling kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

“We cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction. Far from treating addiction, we’ve determined that kratom is an opioid analogue that may actually contribute to the opioid epidemic and puts patients at risk of serious side effects.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and started using the herb as an alternative to prescription drugs for treating chronic pain, anxiety, depression, and addiction.

Like most herbal and dietary supplements, there is little scientific research to support the use of kratom and it is not approved for any medical condition by the FDA. As a result, many kratom distributors are careful to avoid making unsubstantiated medical claims. Front Range Kratom, for example, currently has a clear disclaimer on its website stating that:

“Information on this website is not for health-related guidance. The products mentioned on this website are not intended to diagnose, prevent, treat or cure any diseases or health conditions. You need to consult with a medical practitioner for all issues with regards to your overall health.”

But even sharing customer testimonials about kratom is considered illegal marketing by the FDA. The agency alleges in its warning letter to Front Range Kratom that the website contained comments from new customers such as “Certainly kratom is useful for pain — myself and everyone else on the internet can attest to that.” Another customer wrote that “the two things I think kratom works the best for are pain and to help people get through some of the post acute withdrawl (sic) symptoms they get when they come off of their pain medications.”

Those testimonials from kratom users can’t be found on the website today.

“If people believe that the active ingredients in kratom have drug-like effects that can treat pain or addiction, then the FDA is open to reviewing that data under our new drug approval process,” said Gottlieb. “In the meantime, I promised earlier this year that the FDA would step up our actions against unapproved and unsafe products that are being deceptively marketed for the treatment of opioid addiction and withdrawal symptoms.”

FDA investigators are also monitoring the social media sites of kratom vendors. Last October, Kratom Spot shared on its Facebook page a CNN story about kratom as a possible treatment for pain and opioid addiction. The company only said the story was “positive news for kratom as... an all natural alternative.” But the FDA said that amounted to the illegal marketing of an unapproved drug.

“The claims on your website and social media sites establish that your kratom products are drugs…  because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease—in particular, for opiate withdrawal and addiction,” the warning letter states.

It probably didn’t help that Kratom Spot shared a picture on its Facebook page of hundreds of kratom orders being readied for shipment by another federal agency -- the U.S. Postal Service.

Kratom Spot, Front Range Kratom and Revibe were all given 15 days to respond to the warning letters, which state that “failure to correct violations may result in law enforcement action such as seizure or injunction.”

KRATOM SPOT/FACEBOOK

The threat of legal action can be all that it takes to drive a kratom vendor out of business. In February, the FDA forced  Divinity Products Distribution to recall and stop selling kratom products. The FDA said the company agreed to the “voluntary destruction” of its kratom products, even though there were no reports of illnesses associated with them.

Reducing Supply of Opioids Will Not Stop Drug Diversion

By Roger Chriss, Columnist

Drug diversion is a massive problem. It plagues the entire drug supply chain, from manufacturer through wholesaler and distributor, to drug stores and dispensaries, all the way to consumers. It is particularly important for opioid pain medications because of the ongoing opioid crisis.

It is well established that the non-medical use of pharmaceutical drugs is an increasing public health concern. Most pharmaceutical drugs used non-medically are obtained from family and friends. There is little to no organized crime involved. And importantly, doctor shopping is rare.

An under-appreciated issue here is scale. According to the DEA, less than 1 percent of legally prescribed opioids are diverted. The sharing or selling of individual prescription pills is small compared to the impact of diversion higher up in the supply chain. For instance, Effingham Health systems just agreed to pay a $4.1 million settlement as a result of a DEA investigation into reports that tens of thousands of oxycodone tablets were believed to have been diverted for four years.

Similar reports about large-scale diversion abound. The Associated Press reported incidents of diversion at about 1,200 VA facilities rose from 272 in 2009 to 2,926 in 2015.

And in 2013 Walgreens was charged $80 million for poor record-keeping and dispensing violations that let millions of doses of controlled substances to enter the black market.

In 2007, the Drug Enforcement Administration estimated that prescription drug diversion in the United States was a $25 billion-a-year industry. About one of every four thefts of methadone and OxyContin were attributed by the DEA to employee pilferage at pharmacies, hospitals and other healthcare facilities.

More recently, a 2017 survey by Porter Research, 96 percent of healthcare workers said drug diversion occurs frequently in healthcare. And 65 percent believe most diversion goes undetected.

Pill mills are even worse. In the book “American Pain,” journalist John Temple describes the impact of Florida pill mills on the east coast a decade ago.

“Florida pumped millions upon millions of doses of those narcotics—oxycodone, mostly—northward, not through a major criminal organization like the cartels of Mexico, but via thousands of individuals who streamed up and down Interstate 75 or flew from Tri-Sate Airport in Huntington, West Virginia, to Miami International, on a flight nicknamed the Oxy Express,” Temple wrote.

And none of this is remotely new. In the book “Dark Paradise,” historian David Courtwright explains: “Diversion from maintenance programs posed a real danger, given that perhaps half of all licitly manufactured barbiturates and amphetamines ended up on the black market.”

So the claim by Attorney General Jeff Sessions that "It’s a common sense idea: the more a drug is diverted, the more its production should be limited” is both simplistic and misguided.

Sessions is assuming that limiting production will reduce diversion. But economic theory suggests the opposite may be true. Reducing supply leads to scarcity, which generally increases value. This in turn may create stronger incentives to divert more opioids into the black market.

Moreover, there is no evidence that people who divert medication are aware of and responding to DEA production quotas. Instead, the consensus is that people divert what they need and think they can get away with. In other words, diversion is an exercise in what economists call the “Tragedy of the Commons,” in which individuals each use a collective resource for their own benefit without regard for the effects on others.

And Sessions’ idea implies that reducing production won’t have any effect on medical practice. But there is an abundance of evidence to the contrary. There is an ongoing shortage of injectable opioids at hospitals around the country. And despite claims to the contrary, opioid analgesics cannot always be replaced or substituted with other pain relievers.

Thus, more intelligent and nuanced approaches are needed. For instance, the NIH is sponsoring research to use advanced data analytics to detect drug theft and diversion in hospitals. Similar efforts at wholesalers, distributors, pharmacies and dispensaries are worth considering.

So while diversion is a major problem, it is neither new nor limited to individual consumers with prescriptions for opioids or other medications that have a street value or abuse potential. The seemingly obvious response of reducing supply could easily backfire. Instead, securing the entire supply chain, from manufacturer through distributor to point-of-sale to consumers, is a vital step in making sure that only the intended recipients of pharmaceutical drugs have access to them.

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.

What Every Patient Should Know About NarxCare

By Rochelle Odell, Columnist

Walmart and Sam’s Club recently announced that by the end of August their pharmacists will start using NarxCare, a prescription tracking tool that analyzes real-time data about opioids and other controlled substances from Prescription Drug Monitoring Programs (PDMP’s).

Recent studies question the value of PDMP’s, but 49 states have implemented them so that physicians, pharmacists and insurers can see a patient's medication history. Granted, there is a need for monitoring the select few who doctor shop and/or abuse their medications, albeit that number is only in the 2 percent range.

What is NarxCare? Appriss Health developed NarxCare as a “robust analytics tool” to help “care teams” (doctors, pharmacists, etc.) identify patients with substance use disorders. Each patient is evaluated and given a “risk score” based on their prescription drug history. According to Appriss, a patient is much more willing to discuss their substance abuse issues once they are red flagged as a possible abuser.

“NarxCare automatically analyzes PDMP data and a patient’s health history and provides patient risk scores and an interactive visualization of usage patterns to help identify potential risk factors,” the company says on its website.

“NarxCare aids care teams in clinical decision making, provides support to help prevent or manage substance use disorder, and empowers states with the comprehensive platform they need to take to the next step in the battle against prescription drug addiction."

Sounds great doesn't it? Except prescription drugs are not the problem and never really have been. Illicit drug use has, is, and will continue to be the main cause of the addiction and overdose crisis. 

Even the name NarxCare has a negative connotation. “Narx” stands for narcotics. And in today's environment, narcotics is a very negative word. NarxCare makes me feel like a narcotics police officer is just around the corner.

Each patient evaluated by NarxCare gets a “Narx Report” that includes their NarxScores, Overdose Risk Score, Rx Graph, PDMP Data and my favorite, the Red Flags. The scores are based on the past two years of a patient’s prescription history, as well as their medical claims, electronic health records and even their criminal history.

Ohio, Michigan, Indiana, Iowa, and several other states are using NarxCare to supplement their own PDMPs. And Walmart isn’t the only big retail company to adopt it. Kroger, Ralphs, Kmart, CVS, Rite Aid and Walgreens are already using NarxCare. There’s a good chance your prescriptions are already being tracked by NarxCare and you don’t even know it.

But NarxCare doesn’t just analyze opioid prescriptions. It also tracks other controlled substances, such as antidepressants, sedatives and stimulants. If a patient is on any combination of those drugs, their risk scores and their chances of being red flagged will be higher – even if they’ve been safely taking the medications for years.

There are several other ways a patient can be red flagged, such as having multiple doctors or pharmacies. But what if you moved and changed physicians? What if you had the same physician for many years and he/she retired or moved away? What if your pharmacy refused to fill your prescription and you had to go pharmacy hunting every month? What if you had dental surgery and your dentist placed you on a short-term pain medication?

Unfortunately, the NarxCare scores do not reflect any of that. How can raw data on prescription medications be an indicator of abuse? I believe there is some merit in tracking and weeding out the rare abuser, but NarxCare doesn't factor in all the “what if’s” that can happen to law-abiding and responsible patients. 

As pain patients, we need to be acutely aware of the negative impact this analytics tool can have. Many of us have already been required to sign pain contracts, take drugs tests, and undergo pill counts. In 2019, Medicare will adopt policies making it even harder for patients to get high doses of opioid medication. Some insurers are already doing it. We're already being policed enough as it is.

I intend to ask my physician, pharmacist and case manager if they utilize NarxCare. So should you. If they say yes, ask them why. Ask your doctor if they believe you are at risk for substance use disorder. Why is their judgement and treatment of you being second guessed by anyone?

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.

TV Host Tries Stem Cell Therapy for Chronic Back Pain

Reality TV star Tarek El Moussa – host of HGTV’S “Flip or Flop” – recently posted photos on Instagram detailing his experience with stem cell therapy. 

El Moussa has a history of back injuries causing severe pain. He lost 50 pounds while recovering from one back injury and was taking “large amounts of pain meds to try and help the pain.” 

“Truthfully those meds really affected my mental and physical state and changed who I was,” El Moussa posted.

When he recently injured his back again and could “barely walk,” El Moussa decided stem cell therapy was a better option. In one photo of the stem cell procedure, El Moussa shows a 12-inch needle being inserted into his lower back to remove fat cells, a procedure similar to liposuction.

TAREK EL MOUSSA

“I believe they put over 1,000,000 stem cells back in my body after the lipo. It's wild seeing the technology and future of medicine,” he wrote.

A post shared by Tarek El Moussa (@therealtarekelmoussa) on May 9, 2018 at 7:24pm PDT

A post-operative photo shows El Moussa’s discolored and bruised lower back three days later. He said he was still “a little sore” but that his back was “actually feeling better!” He’s hoping for a “major improvement” from the procedure in a few weeks.

El Moussa’s therapy involved a controversial stem cell product known as stromal vascular fraction (SVF).  It’s the same product at the center of two lawsuits recently filed by the Department of Justice on behalf of the FDA against stem cell clinics in Florida and California.

What is Stromal Vascular Fraction?

SVF uses autologous stem cells derived from a patient’s own body, including adipose (fat) cells obtained through liposuction.  When injected back into the body, these stem cells stimulate the immune system, have anti-inflammatory properties, and promote the development of new blood vessels. All help to heal injured tissues.

For clinicians, the attraction of SVF is that the procedure is “point of care” or delivered at the time of care.  In theory, this would exempt the therapy from FDA rules for stem cell products under the “same surgical procedure” exception.  The FDA, however, doesn’t agree with that interpretation and has yet to approve SVF use. It considers the procedure unproven and experimental. But that hasn’t stopped dozens of stem cell clinics from offering SVF therapy.

SVF generally has a good safety profile.  Potential risks of SVF therapy include lack of standardization of SVF products and terminology, unwanted tissue differentiation, poor cell handling and insufficient data on dose versus effect. 

Evidence regarding the clinical efficacy of SVF in treating painful conditions is limited.  Jaewoo Pak, MD successfully treated patients with knee osteoarthritis.  Their pain scores, functional ability and cartilage regeneration were all improved through SVF therapy.  Pak also achieved success in treating meniscus tears and osteoarthritis of the hip.  

In 2015, three researchers for the Cell Surgical Network (who are defendants in the FDA lawsuits) reported on their treatment of 1,524 patients with SVF who lived with painful conditions such as osteoarthritis.  About 25% of the patients showed evidence of new cartilage formation in their joints and 80% had a significant reduction in pain.  The beneficial effects of SVF were sustained for well over six months and some for several years.  The researchers also reported success in treating neurodegenerative diseases, with 80% of the patients with interstitial cystitis showing pain reduction.

Despite the controversy and lawsuits, El Moussa and thousands of other patients are willing to give SVF therapy a try. We’ll keep you updated on his progress.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

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

FDA Approves Injectable Migraine Drug

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a monthly self-injected drug for the prevention of migraine in adults.

Aimovig (erenumab) is the first FDA-approved migraine treatment in a new class of drugs – known as fully human monoclonal antibodies -- that target receptors in the brain where migraines are thought to originate. It blocks the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks.

"The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine," said Sean Harper, MD, executive vice president of Research and Development for Amgen, which shares the licensing rights to Aimovig with Novartis.

The effectiveness of Aimovig for the prevention of migraine was evaluated in three clinical trials, which found that patients experienced one to 2.5 fewer migraine days per month compared to those who took a placebo. The most common side effects were irritation at the injection site and constipation. 

Like many specialized drugs used to treat chronic conditions, Aimovig comes with a hefty price tag. Amgen says the drug will cost about $6,900 a year, or $575 for each monthly dose.

Out-of-pocket costs will vary for patients depending on their insurance. Amgen has a co-pay program for Aimovig that could reduce the cost to as little as $5 per month for eligible patients.

The company says Aimovig will be available to patients within one week.

"Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success," said Stewart  Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School. "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy – with a discontinuation rate of two percent due to adverse events – and experienced sustained migraine prevention."

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraine than men.

About one-third of migraine sufferers can predict the onset of a migraine because it is preceded by an aura – a sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision. People with migraine tend to have recurring attacks, triggered by stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet.

Amgen and Novartis expect Aimovig to be approved in the European Union in the next few months. Amgen holds the sales rights for Aimovig in the United States, Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world.

A Funeral for My Health

By Crystal Lindell, Columnist

I want to have a funeral for my health. I want to go abroad and throw its ashes into the sea while wearing a beautiful black dress and Jackie O sunglasses to hide my tear-stained eyes.

I want to take a week off work and forget to shower while everyone brings me casseroles. And I want all of my friends and family to acknowledge what I’ve lost with slideshows and poorly written eulogies that succeed in making everyone cry.

I want to drink too much wine in a vain attempt to numb the pain, and maybe even take up smoking and a few bad men.

I want to sit around with lipstick stained coffee cups late at night telling stories about how amazing it was — my health.

How it let me lead so many youths on mission trips to far-off places. How it let me fall in love so many times. How it let me shower without pain, lured me into believing I would be immortal, and how it allowed me to travel the world.

I want to take all the time I need to figure out how the hell I’m going to live the rest of my life without it. How I will find love, be independent, and survive all of my physical limitations.

And I want the planet to just stop turning for one second while I catch my breath and adjust to the fact that world is a different place than it was.

The obituary would read as follows:

Crystal Sue Lindell’s health died after a 5-year long battle with her body. Her health was 34.

News about the loss came via email from her doctor when he confirmed her worst fears: She likely had hypermobile Ehlers Danlos syndrome (EDS) -- a diagnosis that meant that she would not only never get better, she would likely continue to get worse.

Her health is survived by her body, which will, unfortunately, carry on, in immense pain, despite the loss.

There is no cure for EDS, and as such, her health is completely dead.

She looks forward to seeing her beautiful health again one day in the afterlife, where she hopes it will be waiting for her among the stars.

In lieu of flowers, Crystal asks that donations be made to EDS Awareness, a non-profit online resource for the EDS community.

Crystal Lindell is a journalist who lives in Illinois. She eats too much Taco Bell, drinks too much espresso, and spends too much time looking for the perfect pink lipstick. She has hypermobile EDS. 

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.

FDA Uncovers Errors in Opioid Database

By Pat Anson, Editor

The U.S. Food and Drug Administration has identified potentially serious errors in a database of opioid sales maintained by IQVIA - a private company that provides data to the federal government on the volume of drugs sold by manufacturers and wholesalers to pharmacies and hospitals.

The FDA said the errors “raise serious questions” about the reliability of IQVIA’s database, which is used by the Drug Enforcement Administration to set opioid production quotas for drug makers. In the last two years, the DEA has reduced opioid production quotas by as much as 45 percent, claiming there was less demand for opioids and that the market was oversupplied with them.

“When we discover irregularities or inconsistencies in the data we use, we take such deficiencies very seriously,” the FDA said in a statement. "The FDA uses these data to assist the DEA in determining the medical and research needs for Schedule I and II controlled substances in the U.S. for the upcoming year."

The FDA believes the error was caused when IQVIA incorrectly converted into kilograms the amount of prescription fentanyl contained in transdermal skin patches and other fentanyl products. As a result, FDA researchers believe the company overestimated the amount of fentanyl sold in the U.S. in the last five years by over 20 percent.

“This error caused IQVIA to overestimate the total amount of fentanyl distributed into the marketplace,” the FDA said. “As a result of this work, we identified additional data quality issues related to several other controlled substances with similar weight-based conversion factors, including oxymorphone and hydrocodone. These additional errors raise serious concerns about systemic issues with IQVIA’s data and quality control procedures.”

Fentanyl is a potent synthetic opioid that is used to treat severe chronic pain and acute pain in patients recovering from surgery and trauma. There is currently a nationwide shortage of intravenous fentanyl and other opioids that has forced some hospitals to postpone surgeries or use other pain medications that are less effective.   

FDA Commissioner Scott Gottlieb, MD, called on IQVIA to immediately hire an independent, third party auditor to conduct a review of its database. Gottlieb said he would brief members of Congress about the data issues and their potential impact on public health.

IQVIA was formed in 2016 after the merger of IMS Health and Quintiles, two prominent healthcare research firms. The company released a statement saying it identified the problems in its opioid database last month and notified customers.  

“Recently, we made a correction to a kilogram conversion measurement in the United States IQVIA National Sales Perspective (NSP) market research service affecting reported measurements for transdermal patches in the opioid market,” the company said. “IQVIA’s internal processes had already identified the measurement conversion issue prior to the FDA’s notification. We notified our clients about this measurement conversion issue in April of this year. Ongoing steps have been undertaken to correct this measurement conversion issue.

“We stand behind our data methodologies. We value our long-standing relationship with the FDA. We take the FDA’s concerns seriously and will continue working with the FDA to resolve these concerns to its satisfaction.”

If confirmed, the database errors would be the second admission by federal agencies this year that their analysis of opioid prescriptions relied on faulty data. In March, four researchers in the CDC’s ironically named Division of Unintentional Injury Prevention acknowledged that many overdoses involving illicit fentanyl and other synthetic black market opioids were erroneously counted as prescription drug deaths.

Overdose Crisis Boosts Organ Donations

By Pat Anson, Editor

Drug overdose deaths have reached unprecedented levels in the United States, with over 63-thousand people dying in 2016 from overdoses involving antidepressants, illicit fentanyl, heroin, prescription opioids and other drugs.

Those deaths have led to an unexpected gift for thousands of Americans who needed organ transplants. Researchers at University of Utah Health and Brigham and Women's Hospital say there has been a steady increase in the number of organs available for transplantation – due in large part to the escalating overdose crisis. They documented an 11-fold increase in the proportion of organ donors who died of drug overdoses from 2000 to 2016.

"We were surprised to learn that almost all of the increased transplant activity in the United States within the last five years is a result of the drug overdose crisis," said Mandeep Mehra, MD, medical director of the Heart and Vascular Center at Brigham and Women's Hospital and lead author of a research letter published in The New England Journal of Medicine.

Mehra and his colleagues examined transplantation records and found no significant change in the recipients' chance of survival when the organ donation came from an overdose victim. The survival rate of 2,360 patients after receiving a heart or lung transplant from donors who died from overdoses was no different than those who received organs from donors who died from gunshot wounds, asphyxiation, head injuries or stroke.

There has long been a stigma against using donated organs from overdose victims because the organs may be damaged due to reduced oxygen supply that may occur during an overdose. There are also fears the organs could be infected with HIV, hepatitis or other communicable diseases due to high rates of intravenous drug use by overdose victims. As a result, some organs harvested from overdose donors are discarded.

But researchers say those risks can be minimized with modern testing.

"I feel hopeful that doctors across the country will read this and feel confident that organs that pass the required tests are safe for transplant," said Josef Stehlik, MD, medical director of the Heart Transplant Program at University of Utah Health. "This awareness is especially important when organ procurement professionals have to decide on use of potential donors with this high-risk history."

The United Network for Organ Sharing requires organ recipients to be made aware of the circumstances of higher risk donations, so they can decide whether or not to accept it. There are nearly 115,000 Americans currently waiting for an organ donation, including many who have been on the waiting list for years.

"We must look to new ways to increase organ donor recovery by concentrating on greater use of marginal organs or by expanding the suitable donor pool by using new technologies to improve organ function before the transplant takes place," Mehra said.

A similar study recently published in the Annals of Internal Medicine also found an increase in the proportion of organ donors who died from an overdose. In 2000, only 1.1% of donors were overdose victims. By 2017, that grew to 13.4 percent.

"For people waiting on an organ transplant right now, I would like to think that our studies bring them hope that they could receive a transplant and have more donors that could help them," Dr. Christine Durand, a professor of medicine and oncology at Johns Hopkins University, told CNN. "We have an obligation to optimize the use of all organs donated. The donors, families and patients waiting deserve our best effort to use every gift of life we can."

Are You ‘Paingry’ About Your Pain?

By Ann Marie Gaudon, Columnist

I’ve learned the hard way how you can stress anyone at all. Put these three factors in their life: Uncertainty, lack of information, and loss of control. Chronic pain patients are slammed with all three.

The stress can manifest itself in a variety of ways -- including anger -- and pain patients have a lot to be angry about. I’ve heard it called “paingry” -- which might even be cute if pain didn’t have the capacity to obliterate lives. People in pain typically experience greater anger than others because they carry the burden of many frustrations related to work, finances, relationships, health care systems, limitations, losses, etc.

We all tend to resort to anger to protect ourselves because someone or something has done us wrong. We protect ourselves from feeling what is “underneath the anger” which is emotional pain and feelings of vulnerability. Pain patients often have these feelings in spades. Anger is a natural, adaptive, emotional response when we feel threatened. It is the “fight” in the fight-flight-freeze response.

It’s no surprise that for chronic pain patients, anger arousal is associated with greater pain intensity, muscle tension, and interference with function and relationships.

So is anger regulation, whether it’s expressed in an outburst of anger (blowing up) or inhibited as anger (stuffing it down).  Blowing up won’t help you, but it will make you untouchable. You don’t want to be touched and nobody wants to touch you either.

Stuffing it down merely buries problems, which won’t go away and can lead to seething anger. These things are bad for everyone’s health and worse if you have chronic pain.

If you’ve got chronic pain, you’re going to be frustrated a lot of the time and acceptance of your condition becomes important. However, even learning acceptance can spark anger. You may think, “Why should I have to accept this? What have I done to deserve it?”

Understand Your Anger

Ironically, getting angry is not the problem. The real problem is a lack of awareness that anger is building into destructive ways of expressing that anger, and poor resolutions when we blow up in anger.

Here’s my message to all chronic pain patients: Don’t waste your anger, put it to work for you.

Understanding your anger is important. It is not caused by anything outside of you but is a response – sometimes not even conscious – that you make based on your interpretation of events. Feeling betrayed by your body? Doctors underestimating your pain? Suspected of malingering at work? Hard up for finances? Relationships breaking down? Denied or restricted medications? Stigmatized and discriminated against because you need opioid pain medication?

I don’t know about you, but I’ve come to loathe the phrase “drug seeking behavior” in reference to a legitimate pain patient because it’s so misguided. “Pain relief seeking behavior”? Now you’re talking.

Anger is an assertion of your most basic rights as an individual. Angry feelings need to be validated or acknowledged by yourself and others in order to move on to problem solving. You’re going to need a commitment to optimal pain management and to process your anger in a healthy way. The question then becomes, “How am I going to live with this in the best way possible?”

What Is Anger Telling You?

Anger and other raw emotions can be considered warning signs to things that we care about. Feeling enraged about your life with chronic pain can be a signpost that you value health, a productive life, want to be cared about authentically, and that you are not being treated fairly. If we didn’t experience anger, we wouldn’t have the message. It is a very healthy and necessary emotion to help us protect ourselves.

What is your anger telling you? If you misunderstand the message or do not act on it, your body will react and your pain will be escalated. Know that. It’s also crucial that you look for primary emotions. Those will be the underlying the hurt, vulnerability, and feelings of unfair treatment. They can be quite uncomfortable for a lot of folks.

Think of an iceberg. The much smaller top portion that you can see is the anger. What is not so obvious is the much larger mass underneath the water. That is your emotional pain and what you need to process and feel for all its worth. You need to acknowledge the entire iceberg; really get to the bottom of it. Secondary emotions like anger are often not helpful, especially if it leads to rage. Use your anger as a tip off that you need to look deeper to alleviate your distress.

Plenty of chronic pain patients need help with anger because they have so much to be angry about. See a therapist. There are many questions you will need to address. “Is there any unfair treatment in my life? Am I being honest and authentic about how I really feel? Are my needs being met? What is my message and what needs to be changed?”

You can get help becoming aware of your emotions on your way to accepting them. You can learn to take actions guided by these emotions – and put them to work for you.

If you’re a pain patient with no history of mental illness, yet you find yourself damned angry, breathe easier. You couldn’t be more normal. Pathologizing you with a mental health disorder and treating it with medication will not help you with your anger. Get help to listen to your inner dialogue.  See anger as a useful emotion. It’s telling you something that needs tending to.

I have a simple but effective strategy. It doesn’t involve diagnoses, medication, or creating spaces between myself and another person. Rather, I lean in and rely on empathy, respect and compassion for a fellow human being who is clearly overwhelmed with torment. Quietly and gently I ask, “Is it okay if we talk about your suffering?” The floodgates open. Know that is normal too.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for 33 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website.

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

FDA Commissioner Listening to Chronic Pain Patients

By Pat Anson, Editor

Chronic pain sufferers have long complained that they rarely get a seat at the table when important decisions are being made about opioid medication.

Last year President Trump’s opioid commission held five public hearings without ever inviting a patient, patient advocate or pain management physician to testify.  The Centers for Disease Control and Prevention also ignored the pain community in 2015 when it secretly drafted its opioid prescribing guideline, relying instead on the advice of addiction treatment specialists and anti-opioid activists.

Now there is a hopeful sign that at least one federal agency is starting to listen to patients about the worsening quality of pain care in the U.S.

The Food and Drug Administration is seeking comments from patients only on the challenges they face finding treatment and on the effectiveness of opioids and other types of pain medication. Patients are invited to submit their comments by mail or in the Federal Register, and to attend a public meeting on July 9. Click here for more details.

The meeting is the latest in a series of step ordered by FDA Commissioner Scott Gottlieb, MD, to get more public input on how to deal with the opioid crisis.  In January, dozens of pain patients and their advocates expressed their concerns to the FDA’s Opioid Policy Steering Committee.

“We’ve heard the concerns expressed by these individuals about having continued access to necessary pain medication, the fear of being stigmatized as an addict, challenges in finding health care professionals willing to work with or even prescribe opioids, and sadly, for some patients, increased thoughts of or actual suicide because crushing pain was resulting in a loss of quality of life,” Gottlieb wrote in an online blog.

“We’re focused on striking the right balance between reducing the rate of new addiction while providing appropriate access to those who need these medicines. In some medical circumstances, opioids are the only drugs that work for some patients. This might include patients with metastatic cancer or severe adhesive arachnoiditis.”

SCOTT GOTTLIEB, MD

Gottlieb also signaled that the FDA is considering the development of prescribing guidelines for specific chronic pain conditions – not the one-size-fits-all approach taken by the CDC.

“We believe such guidelines could encourage the use of an appropriate dose and duration of an opioid for some common procedures and promote more rational prescribing, including that patients are not being under prescribed and patients in pain who need opioid analgesics are not caught in the cross hairs,” he wrote.

“In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren’t over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.”

Although Gottlieb has angered some in the pain community with his crackdowns on kratom and stem cell clinics, he does appear to have a sympathetic ear for pain sufferers. In 2012, a full five years before becoming FDA commissioner, Gottlieb warned that heavy-handed enforcement actions by the DEA were interfering with patient care.  

“This approach is burdening a lot of innocent patients, including those with legitimate prescriptions who may be profiled at the pharmacy counter and turned away. Others have in effect lost access to care, because their doctors became too wary to prescribe what their patients need,” Gottlieb wrote in a prophetic column published in The Wall Street Journal.

To leave a public comment for the FDA in the Federal Register, click here. Comments will be accepted until September 10, 2018.

The Search for a Chronic Pain Gene

By Roger Chriss, Columnist

The book “Chasing Men on Fire: The Story of the Search for a Pain Gene” by Yale University neuroscientist Stephen Waxman, MD, describes the hunt to understand and treat a rare neuropathic disorder called erythromelalgia – also known as burning man syndrome.

Inherited erythromelalgia is a rare painful neuropathy that causes severe burning pain and skin redness. Attacks are periodic and commonly triggered by heat, pressure, mild activity, exertion, insomnia or stress. The burning pain occurs in small fiber sensory nerves.

The book includes 13 research papers by Waxman and his team that illustrate the the process of discovering that the gene SCN9A is responsible for erythromelalgia, as well as idiopathic small fiber neuropathy. Waxman shows considerable understanding of the plight of people with these disorders.

“Since their neurological examinations were often normal, the complaints of patients with small fiber neuropathy -- which occurred without physical signs of disease of the nervous system that can be seen by the physician -- were, in the past, often dismissed as being of little consequence, or as having a psychological origin,” he wrote.

But the disorders are genetic. And understanding them has wide-ranging potential value. These mutations, once identified in families with rare inherited diseases, can teach us important lessons about other medical conditions.

Waxman cites the famous example of familial hypercholesterolemia, a rare metabolic dysfunction whose understanding led to the development of statin drugs.

Waxman’s work suggests that similar advances may be possible for other neuropathic pain disorders. Waxman and his research team found that “neuropathic pain reflects dysfunction of the nervous system and can occur when DRG [dorsal root ganglion] neurons take on a life of their own and generate pain signals even in the absence of a noxious stimulus or inflammation.”

Eventually, Waxman was able to show that one change in the genetic code for this gene was responsible. In other words, erythromelalgia and inherited small fiber neuropathy are the result of genetic mutations – debunking the theory that patients with these disorders have psychological issues.

“Surprisingly, despite their history of chronic pain, on psychological testing we found that only two subjects displayed signs of moderate anxiety and depression,” Waxman explains.

Rigorous clinical testing confirmed these ideas. Waxman and his team began by doing human studies on erythromelalgia, then moved on to small fiber neuropathy in 2010. They found evidence that genetic mutations may contribute to disorders of pain signaling. Understanding the exact pathophysiology of these painful neuropathies opens the door to new and more effective treatments.

“Identification of specific molecules that play key roles in axonal injury might provide a basis for therapies that would prevent, or slow, the degeneration of axons, thus halting or slowing the progression of peripheral neuropathy,” Waxman wrote.

The first drug tried was the sodium channel blocker carbamazepine. Pre-clinical studies in people confirmed that it does have a protective effect. Additional work using a research drug nicknamed “771” shows similar promise.

Research into leveraging this hard-won knowledge is ongoing. This work could ultimately lead to new treatments for a wide range of neuropathic disorders, including trigeminal neuralgia, diabetic neuropathy, and phantom limb pain.

The book “Chasing Men on Fire” amply illustrates the challenges of medical research and the importance of even seemingly small genetic variations in chronic neuropathic disorders. And it reminds us that rare disorders often provide invaluable insight into human disease and dysfunction that can benefit us all.

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.

Be the Best You

By Barby Ingle, Columnist

Recently Melania Trump unveiled her "Be Best” campaign, which focuses on the well-being of children, their use of social media, and preventing opioid abuse and bullying. The First Lady wants to promote healthy living, kindness and respect so that children are better prepared physically and emotionally to face the challenges of tomorrow.

“It remains our generation’s moral imperative to take responsibility and help our children manage the many issues they are facing today, including encouraging positive social, emotional, and physical habits,” she said.

Those are admirable goals. But I strongly believe that we need to make tomorrow the best it can be for everyone – including the pain community. The same challenges the First Lady sees for children are faced by everyone who is living in pain, disabled or is a caregiver for someone in pain.

Since 2012, I have been losing too many friends to suicide who are not being adequately treated or who don’t have access to proper and timely care. Instead of society stepping up and helping, I have seen the bullies (in our community and in the general public) berate and beat down people in pain who want to live, thrive and succeed despite the challenges they face. Pain patients are committing or attempting suicide at an alarming rate.

We can make a difference if we use our voices to encourage positive social, emotional and physical well-being. By living with purpose and exuding positive attitudes, pain patients will be better equipped to deal with the physical and emotional challenges we face.

In recent years, I have been happy to see many pain patients and caregivers use their voices to speak out and work to create the change we need. We have begun to see our stories and efforts get some attention in the local and national media.

Although we are just scratching the surface, we are making change happen. We have to continue creating that change with hope, resilience and strength more than ever.

I get many calls and emails from patients who have been poorly treated in their search for pain care, threatened on social media, and criticized for trying to show the plight of pain sufferers and their lack of access to effective treatment.

I have seen firsthand how this lack of compassion has affected both pain patients and addicts, who together make up more than a third of our society. Some addicts are stepping up and saying what is happening to pain patients because of sweeping measures to prevent opioid abuse is not right, compassionate or ethical. 

I hope that the efforts of both the pain and addiction communities will show the administration and Congress that we need to work on both the pain epidemic and the lack of access to proper and timely pain care.  I hope you will join in these efforts in your own way. It shouldn’t matter where we live, how rich or poor we are, or what our health is like. We should have less stigma and more compassion for the suffering. 

Ordinary people can do extraordinary things. Let’s make it our mission to have our own “Be Best” campaign. This doesn’t mean being perfect or making change in one day. It means recognizing areas where change is needed and coming up with solutions. A place to start is understanding and sharing core beliefs that we can agree on. There are four beliefs as a pain patient that I subscribe to:

1. Chronic pain is a real and complex disease that may exist by itself or be linked with other medical conditions. 
2. Effective pain care requires access to a range of treatment options, many of which are currently being denied. 
3. Chronic pain is an unrecognized public health crisis with devastating personal and economic impact.
4. Allowing people to suffer with unmanaged pain is immoral and unethical. 

These goals were agreed on two years ago by over 70 healthcare and advocacy organizations in a letter to Congress urging it to implement the National Pain Strategy. Isn’t it time we started acting on that?

I believe that we can agree on actionable solutions that promote better well-being for all. I look forward to hearing your thoughts on tools and skills that will improve the social, emotional and physical health of pain patients. We need more than pain organizations to make these changes. We need patients, families, caregivers, providers and the public to help us solve the challenges we face as a pain community.

We have a purpose to be your best you. What is it that you can do to be your best?  

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.

Childhood Trauma Linked to Adult Pain

By Pat Anson, Editor

If you experienced physical or emotional trauma as a child – like a major illness, abuse or your parents’ divorce – you are more likely to experience pain as an adult, according to researchers at Penn State.

Their findings -- published in the Journal of Behavioral Medicine – add to previous research suggesting there’s a link between adult physical pain and childhood trauma or adversity.

"Pain is the number one reason people seek health care in the United States," said co-author Jennifer Graham-Engeland, PhD, a professor of biobehavioral health at Penn State. “We need more insight into pain and the phenomenon that can make pain both better or worse."

The researchers surveyed a diverse group of 265 adults who lived in a housing cooperative in the Bronx, New York.  All reported at least one form of trauma or adversity as children or adolescents. Some reported as many as seven.

A traumatizing event that left a person scared for years was the most common adversity (44%), followed by parental divorce (31%), a major illness or accident requiring hospitalization (24%), parental substance abuse (24%), sexual abuse (23%), parental unemployment (21%), a child’s removal from the home (10%) and physical abuse (10%).

Participants were also asked about their current mood, sleep patterns, optimism, how in control of their lives they felt, and if they recently felt pain.

Those who experienced more adversity or trauma as children were more likely to have mood or sleep problems as adults -- which in turn made them more likely to have physical pain. But the connection to pain was weaker in those who felt more optimistic and resilient.

"The participants who felt more optimistic or in control of their lives may have been better at waking up with pain but somehow managing not to let it ruin their day," said Ambika Mathur, a graduate student in biobehavioral health. "They may be feeling the same amount or intensity of pain, but they've taken control of and are optimistic about not letting the pain interfere with their day. They're still performing their work or daily activities while doing their best to ignore the pain."

The researchers found that childhood or adolescent adversity was strongly associated with more physical pain in adulthood, which could be partially explained by feelings of anger, depression or anxiety -- as well as poor sleep.

"Basically what's happening is mood and sleep disturbances are explaining the link between early life adversity and pain in adulthood," Mathur said. "The findings suggest that early life trauma is leading to adults having more problems with mood and sleep, which in turn lead to them feeling more pain and feeling like pain is interfering with their day."

The researchers also found that people who felt more optimistic or resilient didn't have as strong of a connection between trouble sleeping and pain interfering with their day. This suggests that childhood adversity can be overcome and doesn't necessarily sentence anyone to a lifetime of pain.

"This study does build on a body of research showing a connection between early life adversity and pain, but also that some people can achieve resilience," said Graham-Engeland. “Some people can be relatively resilient to adverse effects in the longer term, while others have a harder time."

Recent studies have also linked childhood trauma to adult migraine and fibromyalgia.

Major Depression Increasing

Pain sufferers aren't the only ones dealing with anxiety or depression. According to a new report from Blue Cross Blue Shield, major depression affects more than 9 million Americans who are commercially insured.

Diagnoses of major depression have risen by 33 percent since 2013. The rate is rising even faster in millennials (up 47%) and adolescents (47% for boys and 65% for girls).

In most cases, major depression coincides with a chronic or behavioral health condition. People diagnosed with depression are three times more likely to suffer from pain related disorders and injuries, and seven times more likely to have a substance use disorder.

It's worth noting that a recent study by the Substance Abuse and Mental Health Services Administration (SAMHSA) found that medications used to treat depression, anxiety and other mental health disorders are now involved in more overdoses than opioid pain medication.

Over 25,000 overdoses in 2016 were linked to "psychotherapeutic" medications such as antidepressants, benzodiazepines, anti-psychotics, barbiturates and attention deficit hyperactive disorder (ADHD) drugs such as Adderall. Deaths linked to psychotherapeutic drugs have risen by 45 percent since 2010.

Over 17,000 Americans died in 2016 from overdoses involving prescription opioids.

Growing Abuse of Gabapentin

By Christine Vestal, Stateline

Doctors who are cutting back on prescribing opioids increasingly are opting for gabapentin, a safer, non-narcotic drug recommended by the Centers for Disease Control and Prevention.

By doing so, they may be putting their opioid-using patients at even greater risk.

Recently, gabapentin has started showing up in a substantial number of overdose deaths in hard-hit Appalachian states. The neuropathic (nerve-related) pain reliever was involved in more than a third of Kentucky overdose deaths last year.

Drug users say gabapentin pills, known as “johnnies” or “gabbies,” which often sell for less than a dollar each, enhance the euphoric effects of heroin and when taken alone in high doses can produce a marijuana-like high.

Medical researchers stress that more study is needed to determine the role gabapentin may have played in recent overdose deaths. However, a study of heroin users in England and Wales published last fall concluded that combining opioids and gabapentin “potentially increases the risk of acute overdose death” by hampering breathing and reversing users’ tolerance to heroin and other powerful opioids.

Kentucky last year classified gabapentin as a controlled substance, making it harder for doctors to prescribe it in copious quantities and for long durations. The new classification also allows police to arrest anyone who illicitly sells the drug, although the state’s drug control chief, Van Ingram, said that was not the intent of the new law.

In the last two years, Illinois, Ohio, Massachusetts, Minnesota, Tennessee, Virginia and Wyoming also have moved to control the flow of gabapentin by requiring doctors and pharmacists to check a prescription drug database before prescribing it to patients to make sure they aren’t already receiving gabapentin, or some other medication that interacts with it, from another physician.

In a statement to Stateline, Pfizer communications director Steven Danehy said, “Reports of misuse and abuse with this class of medicines are limited and typically involve patients with a prior history of substance abuse, including opioids.”

The drugmaker also pledged to “continue working with regulatory authorities and health officials to evaluate and monitor the safety of these medicines.”

Prescribed for Many Conditions

Approved by the FDA in 1993 for the treatment of epilepsy and the nerve pain associated with shingles, gabapentin is sold by Pfizer under the brand name Neurontin. A generic form of the drug has been available since 2004 and is now sold by several other companies as well.

Gabapentin is now one of the most popular prescription drugs in the United States, according to the New England Journal of Medicine. It was the 10th-most-prescribed medication in 2016. Its more expensive cousin, pregabalin, sold as Lyrica and also made by Pfizer, was the eighth best-selling.

Many doctors recommend gabapentin to patients for a long list of disorders, including hot flashes, migraines, restless leg syndrome, fibromyalgia, and neuropathic pain associated with diabetes and spinal injuries. Some doctors also prescribe it for anxiety and insomnia.

Now, research is underway to determine whether gabapentin may be effective as a treatment for alcoholism.

Already, it is widely used to ease the symptoms of drug and alcohol detoxification. And addiction specialists routinely use gabapentin to manage pain in people who are either addicted or at risk of addiction to opioids and other substances.

Alone, high doses of gabapentin have not been found to affect breathing. The vast majority of gabapentin deaths, about 4 in 5, also involved opioids, according to the journal Addiction.

People who stop taking the medication abruptly, however, can suffer withdrawal symptoms such as trembling, sweats and agitation.

In February, Food and Drug Administration director Scott Gottlieb said the agency was reviewing the misuse of gabapentin and, for now, had determined no action was necessary. Similarly, the CDC has not issued a warning about gabapentin, nor has the Drug Enforcement Administration.

(Editor's note: the CDC opioid guidelines recommend gabapentin without any mention of the risk of abuse or overdose associated with the drug, or of possible side effects such as weight gain, anxiety and mood disorders.)

Early Signs of Abuse

In Kentucky, Ingram said it has been clear to police and pharmacists for the last three or four years that gabapentin was becoming an increasingly popular street drug. “People were seeking early refills, claiming they lost their prescriptions and openly conducting transactions in parking lots outside of drug stores,” he said.

But since it wasn’t a controlled substance, nothing was done about it. That’s likely to start changing with the new law, he said.

“Misuse of gabapentin is just one more collateral effect of the opioid epidemic,” said Caleb Alexander, an epidemiologist at Johns Hopkins University who has been studying the heroin and prescription drug epidemic. When one drug becomes less available, drug users historically seek out alternatives, he said. “What is most surprising is the sheer magnitude of its use.”

The share of Appalachian drug users who reported using gabapentin to get high increased nearly 30-fold from 2008 to 2014, according to a 2015 study in the American Journal of Psychiatry.

Paul Earley, an addiction doctor practicing in Georgia and a board member of the American Society of Addiction Medicine, said, “We knew that a small subset of our addiction patients would abuse gabapentin.” But he said it wasn’t until 2016, when Ohio sounded an alarm about the drug’s association with overdose deaths, that addiction doctors started taking the problem more seriously.

“For years, we considered gabapentin to be ‘good for what ails you,’” Earley said. “But I’m much more cautious than I used to be. If there’s anything we’ve learned from the opioid epidemic, it’s that we need to rethink how we prescribe drugs we once assumed were safe.”

This is story is republished with permission by Stateline, an initiative of The Pew Charitable Trusts.