Over 600 Arrested in Healthcare Fraud Sweep

By Pat Anson, Editor

Over 600 doctors, nurses, pharmacists and other medical providers have been arrested in what the U.S. Justice Department is calling its largest healthcare fraud investigation.

Most of the charges involve false claims for opioid prescriptions or addiction treatment that resulted in $2 billion in fraudulent billings to Medicare, Medicaid and other health insurers. Many of the arrests occurred weeks or months ago, and were apparently lumped together by federal agencies to make the crackdown on healthcare fraud appear to be the "largest ever." 

“This is the most fraud, the most defendants, and the most doctors ever charged in a single operation -- and we have evidence that our ongoing work has stopped or prevented billions of dollars’ worth of fraud,” said Attorney General Jeff Sessions.

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Federal officials also announced that they have excluded 2,700 individuals from participating in Medicare, Medicaid and other federal health programs, including 587 providers excluded for conduct related to opioid diversion and abuse. 

“Health care fraud is a betrayal of vulnerable patients, and often it is theft from the taxpayer,” said Sessions.  “In many cases, doctors, nurses, and pharmacists take advantage of people suffering from drug addiction in order to line their pockets. These are despicable crimes.”

A $106 million scheme uncovered in Florida alleged there was widespread fraudulent urine drug testing at a substance abuse treatment center. The owner, medical director and two employees at the sober living facility allegedly recruited patients and paid kickbacks to them for participating in bogus drug tests.

In California, an attorney at a compounding pharmacy allegedly paid kickbacks and offered incentives such as prostitutes and expensive meals to two podiatrists in exchange for bogus prescriptions written on pre-printed prescription pads. Once the fraudulent prescriptions were filled, about $250 million in false claims were submitted to federal, state and private insurers.

In Texas, a pharmacy chain owner, managing partner and lead pharmacist were accused of using fraudulent prescriptions to fill bulk orders for over one million hydrocodone and oxycodone pills, which the pharmacy then sold to drug couriers for millions of dollars. 

“Healthcare fraud touches every corner of the United States and not only costs taxpayers money, but also can have deadly consequences,” said FBI Deputy Director David Bowdich.  “Through investigations across the country, we have seen medical professionals putting greed above their patients’ well-being and trusted doctors fanning the flames of the opioid crisis.”

Since becoming Attorney General, Sessions has shown a particular interest in opioid prescriptions -- once urging pain patients to “tough it out” and take aspirin instead.

Last August, Sessions ordered the formation of a new data analysis team, the Opioid Fraud and Abuse Detection Unit, to focus solely on opioid-related health care fraud.  Five months later, Sessions launched a Justice Department task force targeting manufacturers and distributors of opioid medication, as well as physicians and pharmacies engaged in the “unlawful” prescribing of opioids.

As PNN has reported, the data mining of opioid prescriptions -- without examining the full context of who the medications were written for or why – can be problematic. Last year the DEA raided the offices of Dr. Forest Tennant, a prominent California pain physician, because he had “very suspicious prescribing patterns.” Tennant only treated intractable pain patients, many from out-of-state, and often prescribed high doses of opioids to patients because of their chronically poor health -- important facts that were omitted or ignored by DEA investigators. Tennant has not been charged with a crime, but announced plans to retire after the DEA raid.

Sessions has also proposed a new rule that would allow the DEA to punish drug makers if their painkillers are diverted or abused. If approved, the agency could reduce the amount of opioids a company would be allowed to produce, even if the drug maker had no direct role in the diversion.

Most overdoses are not linked to opioid pain medication, but are more likely associated with illicit fentanyl, heroin, anti-anxiety drugs or antidepressants.

My Opioid Dependency Turned into Addiction

By Jim Best, Guest Columnist

When I was in my early 40’s, I had an accident at work that injured the discs in my lower back. I tried physical therapy, but after three months of little improvement they performed a discectomy.

The surgery was successful and I had very little pain until a year later, when I re-injured the same area. I was taken to the hospital in an ambulance and a neurosurgeon decided I needed emergency surgery and performed a laminectomy. This time, the pain came back after less than six months. I was in constant pain (most days rated somewhere between a 6-8) and unable to work. 

The next ten years included numerous trips to various providers, including pain specialists. I was evaluated by orthopedists and neurologists, and informed I was not a good candidate for spinal fusion surgery due to my overall body structure. They took more than a dozen MRI’s and I was subject to painful spinal injections on a regular basis.

I was also given a discogram, which is an extremely painful diagnostic procedure involving the insertion of needles into the spinal discs. The pain was so severe from this procedure that I passed out. The results were “inconclusive.”

During those ten years I was also introduced to opiate medication. They started me off on Vicodin and I was eventually prescribed OxyContin by my regular doctor. I took relatively small doses to start, but it didn’t take too long before I was being prescribed larger and larger doses.

What I didn’t know was that the more I took, the more I thought I needed. This is known as opioid-induced hyperalgesia, a syndrome in which people can become hypersensitive to painful stimuli due to prolonged use of opioids.

Although at the time I was sure that had nothing to do with my case, now I see where it made perfect sense and I should have ceased my opiate use immediately. However, I continued to use for five additional years. 

JIM BEST

JIM BEST

An important part of my story concerns my addiction to alcohol, which I stopped using in 2005. I was a stalwart member of AA up until 2015, when I had a relapse. I never really discussed my use of painkillers with other people because I was afraid they would think I might have a problem with pills. Of course, they would have been correct, but I fooled myself into thinking I was okay.

That is part of the self-delusion of any kind of drug use, but perhaps more so with opiates because they were prescribed by a doctor and because I felt I had a legitimate reason for using them -- a rationalization I maintained even when I was using far more than prescribed.

Looking back, I do not believe I should have ever been prescribed opioid medication due to my addictive personality. I don’t blame the doctor who prescribed them to me. I would tell her horrible stories of not being able to get out of bed without the pills, or how some days all I could do was sit in a chair and cry. I believe that as a physician (as well as a caring and compassionate human being), she was concerned with my pain and truly thought she was doing what was in my best interest.   

It’s important to make one fact clear: I was in pain. Although I certainly hyperbolized my symptoms to my doctor, girlfriend and a few others, I did have daily chronic pain. And I was dependent on the drugs to provide some modicum of relief.

There came a time, however, when the dependency turned into an addiction. I literally could not function without large doses of the drugs. I also began to abuse them by taking more than prescribed and taking them in non-prescribed methods such as snorting.

The end of my use came when I got busted by my doctor. She caught me in one of the myriad of lies I had to tell because I would run out of pills before the next prescription was due. She gave me a script for 10 Xanax and basically told me good luck.

I went through withdrawal for a few days and then, after almost ten years of sobriety, I started to drink again. Eventually, I ended up in treatment. I admitted to the counselors at the treatment center that opioids were also “sort of a problem.” Luckily, they saw through the lie and I was put on Suboxone. I still take the Subs because they help with the pain and I don’t have the urge to use anymore.

I still experience daily pain. Some days it is bad enough that I have to be very careful with how much I exert myself. But I manage to get by without the pills.

As an aside, I feel like the current restrictions being put on opioid medications are too extreme. Not everyone that takes them has a problem and by restricting them, as many states currently are, they are making life very difficult for the ones using them responsibly.

What other people do is their business. For myself, taking such medications is no longer an option. I hope this story helps someone. 

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Jim Best lives in Minnesota.

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.

The Other Victims of the Opioid Epidemic

By Katie Burge, Guest Columnist

Imagine the fear, frustration, helplessness and anger you might feel upon learning that your doctor cannot treat you to the best of his or her ability because they’re afraid of being arrested. 

I don't have to imagine that because I am a chronic pain patient with a degenerative spinal condition, plus severe osteoarthritis and fibromyalgia; each of which cause severe chronic pain 24/7. Combined, they can make simple tasks like getting dressed in the morning sheer torture.

Pain patients are the other victims of the so-called opioid epidemic, the ones the media usually don’t mention unless they're blaming us for other people's drug usage. 

Patients are being forced to live in agony and, as a result, increasingly lose their lives due to catastrophic medical events, such as stroke, heart attack and even suicide.

These can all be triggered by the physical, mental and emotional pressures of trying to survive with inadequately treated chronic pain.

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Why?  Because politicians and bureaucrats (who refuse to admit the government is completely impotent at controlling the proliferation of illicit drugs) have managed to sell the public on the ridiculous premise that refusing medically necessary medication to one group of people will somehow alter the behavior of another group, and handily end America's drug crisis.

This approach simply does not work. Torturing vulnerable pain patients by refusing them life-giving medication will never make the slightest dent in the illegal drug trade because, sadly, people who want to get high will find something somewhere that will enable them to do so. 

Also, most of the prescription opioids that people abuse DO NOT come from doctors or pain patients. Less than one percent of legally prescribed opioid medication is diverted.  People in true pain are not going to suffer additionally by sharing or selling their medication. And doctors are not as careless with their prescription pads as the powers-that-be would like you to think.  

Nonetheless, the entities that control doctors’ licenses to prescribe opioids have yielded to political pressure by ordering doctors to either cut back on pain medication to the point that it's ineffective or stop opioid treatment altogether, regardless of patient need or outcome.

Inadequately treated chronic pain has stolen a great deal of my independence and quality of life, and though I hate the idea of taking pain medication at all, my greatest desire is to simply be able to fully participate in my own life again.  I will never be pain free, but I long to be able to play with my grandchildren, go to the theater or sit through an entire movie (and still be able to walk back to my car).

The mainstream media is also responsible for the ridiculous narrative that opioids have no legitimate clinical use and are immediately addictive. The result of this bias and hyperbole is that most folks believe outlawing the legitimate medical use of opioids can only be a good thing. Society teaches us that pain is somehow shameful.  We must “suffer in silence” and learn to control our pain without complaint or medical intervention. 

With such an abundance of myth and misinformation, it's no small wonder that actual facts about pain tend to get lost in the mix. Please allow me to share a few:

First, many overdose deaths are made to sound as though they were caused by a single prescription or even a single dose of opioids, when they are actually the result of a mixture of different medications, street drugs and alcohol. 

Second, chronic pain affects more Americans than heart disease, cancer and diabetes combined.  And studies have repeatedly shown that less than 4% of those who take opioid medication for pain become addicted.  They might develop a dependence or tolerance, but that occurs with many medications.

Physical “dependence” simply means that, if a drug or substance is stopped abruptly, the body will react by exhibiting withdrawal symptoms.  “Tolerance” occurs over time, as the dosage of some drugs might need to be adjusted as the body grows tolerant to its effects. Neither of these conditions is unique to opioids, nor are they necessarily indicative of addiction -- which is characterized by compulsive drug seeking behavior and use, despite harmful consequences.

Personally, I believe the question of addiction simply comes down to motive.  If your primary motive in taking opioids is to get high, you might be a drug addict.  If your only motive is pain relief and once that relief is achieved you do not increase the dose, you are not a drug addict.

Drug abuse is a complex social issue that has no easy fixes.  It should not, however, be confused with the medical management of chronic pain.  All life is precious and should be valued and protected, but not at the expense of others.

So, the next time your favorite TV show has a story line about someone going to the hospital and being transformed into a raving drug addict, or you hear yet another biased news story about opioids, do something about it.  You can help save lives by contacting the source of those fallacies and insisting that they tell the whole truth about the opioid crisis. Call them. Write a letter. Send an email.

We desperately need your voice, your prayers, your empathy and your compassion.

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Katie Burge lives in south Mississippi, which she calls a “a veritable wasteland” for pain treatment. 

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.

Do Anti-Opioid Ads Hammer Home Wrong Message?

By Pat Anson, Editor

People who take opioid pain medication are often accused of bad behavior – such as stealing, selling and diverting their drugs. Or being lost in a haze of opioid addiction.

Now pain patients are being depicted as self-destructive maniacs so hopelessly hooked on opioids they'll do anything for their next high.

Four government-sponsored ads released this week by the White House feature young people who deliberately and violently injure themselves to get opioid medication.

All four ads are cringe worthy.

Kyle smashes his hand with a hammer.

Chris breaks his arm by slamming a door on it.

Joe breaks his back when he crawls underneath a car and lets it fall right on top of him.

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“They gave me Vicodin after my knee surgery," says Amy in the 4th ad. "They kept prescribing it, so I kept taking it.  I didn’t know it would be this addictive. I didn’t know how far I’d go to get more."

Amy then unbuckles her seat belt and drives her car into a garbage dumpster.

“Opioid addiction can happen after just five days. Know the truth, spread the truth,” an announcer solemnly warns.

The White House Office of National Drug Control Policy partnered with the Ad Council and the Truth Initiative to launch “The Truth About Opioids” campaign. The four 30-second ads are based on real life stories.

“After testing 150 different messages, we are all excited to launch four hyper-realistic ads that show true stories — not fictionalized and not embellished — true stories of four young adults who took extreme measures to get more prescription pills in order to feed their addiction,” said White House counselor Kellyanne Conway.

“The goal is for other young adults to see these ads and ask themselves how they can prevent their lives and others’ lives from going down a similar path.  We hope these ads will spark conversation to educate teens and young adults to talk to their doctors about alternatives to opioids.”

The White House was vague about when and where the ads will run, and dodged questions about how much the campaign will cost taxpayers. Most of the productions costs and airtime are being donated by Facebook, YouTube, Google, NBCUniversal and other media partners.

Like the CDC’s recent Rx Awareness Campaign, the four commercials focus exclusively on opioid prescriptions, while ignoring the rising death toll taken by illicit fentanyl and heroin. It is also rare for anyone to become addicted to opioid medication after a few days, as the ads suggest.

A recent report by the Substance Abuse and Mental Health Services Administration (SAMHSA) warned that fentanyl and other black market opioids are now involved in more fatal overdoses than opioid medication. Drugs used to treat depression and anxiety are also linked to more deaths than painkillers. SAMHSA said that “widespread public health messaging is needed” about the rapidly changing nature of the overdose crisis.

Why then the continued focus on pain medication?  

“The fact is that the greatest amounts of misuse are happening among 18- to 24-year-olds.  Almost 6 million young people a year get prescribed opioids.  They are initiated into this.  And we know that most long-term heroin addiction starts among young people through a first experience with opioids.  So that is what we’re focusing on here because there is great need,” said Robin Koval, CEO and President of Truth Initiative.

But a recent study of high school heroin users found that most abuse a wide variety of substances – not just painkillers. Alcohol was the most common drug abused, followed by marijuana, ecstasy, LSD and other psychedelics, cocaine, amphetamines and tranquilizers. 

“The Truth About Opioids” campaign makes no mention of those other drugs.

"It may be inadequate to focus on heroin and opioid use in isolation,” said lead author Joseph Palamar, PhD, a  professor of population health at NYU School of Medicine. "A deeper understanding of how heroin users also currently use other drugs can help us to discern better prevention measures."

I Wasn’t Looking for Addiction, I Wanted Pain Relief

By Denise Pascal, Guest Columnist

Five botched back operations, a cracked pubic bone and fibromyalgia led me to OxyContin 20 years ago.

I stayed with my doctor for 15 of those years, voluntarily titrating my dosage down from an initial 280mg of OxyContin a day to only 40mg.

Last June, my doctor suddenly decided to take me off opioids. I was given 6 WEEKS to get off Oxy with nothing for my pain or the effects of rapid titration off opioids. 

I now have to fight for my prescription lidocaine patches (which insurance doesn’t cover), my nightly Ambien and two lousy valiums for panic attacks.

My body is completely confused. Everyday feels like I am moving through mud. The pain is indescribable. Everyday things I could do last year on Oxy are gone. I can’t grocery shop. I can’t walk my dog. If something falls on the floor, it stays there because I can’t bend from the knees due to osteoarthritis.

For ten months I have had diarrhea, my brain is totally confused, and even simple tasks like paying bills are overwhelming. THIS IS YOUR BRAIN NOT ON DRUGS.

DENISE PASCAL

DENISE PASCAL

My withdrawal cost me almost $5 thousand in out-of-pocket expenses from visits to random specialists to manage my symptoms, prescriptions, and people I have had to hire to do simple errands.

This is what happens to those of us left with no family who can’t function. I am over 62 and have been legally disabled since 42. I wasn’t looking for an addiction, I was looking for relief. We were caught in a net by people who abused a drug that gave us some semblance of normalcy.

Suicide enters my thoughts often now. I can’t stand the pain. And just maybe that was the desired end result of this false narrative. 

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Denise Pascal lives in New Mexico.

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.

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."

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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?

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

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

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.

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"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."

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.

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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.

Rx Drug Monitoring Not Reducing Opioid Abuse

By Pat Anson, Editor

Prescription drug monitoring programs (PDMPs) have long been promoted as a critical tool in the fight against opioid abuse and overdoses. PDMP’s in 49 states and the District of Columbia allow physicians and pharmacists to consult a prescription drug database to see if patients might be “doctor shopping” or selling their opioid medication.

But a new study has found little evidence that PDMPs are working and that they may in fact be driving some patients to the black market for cheaper drugs such as heroin.

Researchers at Columbia University's Mailman School of Public Health and University of California, Davis, analyzed 17 studies that looked at the effectiveness of PDMPs. Their findings are published online in the Annals of Internal Medicine.

“Evidence that PDMP implementation either increases or decreases nonfatal or fatal overdoses is largely insufficient, as is evidence regarding positive associations between specific administrative features and successful programs. Some evidence showed unintended consequences,” wrote lead author David Fink, MPH, a doctoral candidate in epidemiology at the Mailman School of Public Health.

What were those unintended consequences? Three studies that looked at heroin related overdoses found a “statistically significant” increase in heroin deaths after PDMPs were implemented.

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"This suggested to us that heroin substitution may have increased after PDMP-inspired restrictions on opioid prescribing," says Silvia Martins, MD, a professor of epidemiology at Mailman and co-senior author. "We therefore caution that programs aimed at reducing prescription opioids should also address the supply and demand of illicit opioids."

Researchers believe that efforts to reduce doctor shopping and the diversion of prescription opioids may have backfired.

“A reduction in black market prescription opioids, although generally viewed as positive, also may generate unanticipated outcomes. For example, an ethnographic study of high-risk users in Philadelphia and San Francisco found that key drivers of the progression from prescription opioid to heroin use are the rising cost of the ‘pill habit’ and heroin’s easy availability and comparatively lower cost,” Fink said.

Heroin overdoses also rose after Purdue Pharma introduced a new and more expensive abuse deterrent formulation of OxyContin in 2010. According to one study, each death that was prevented by OxyContin's reformulation “was replaced with a heroin death.”

Fink and his colleagues say more studies are needed to examine the true effectiveness of PDMPs, which can vary widely from state to state.

Doctor Shopping Rare

Missouri is the lone state that has not adopted a statewide PDMP and one family physician would like to keep it that way.

In an unpublished study, John Lilly, DO, claims that PDMPs are not working because doctor shopping is rare to begin with. In 2016, doctor shopping was responsible for only 1.7% of all misused opioid prescriptions. The rest are stolen, borrowed or bought on the black market, or misused by the patients they were prescribed to.

“The prescription drug monitoring programs will never catch the remaining 98.3 percent of the problem. That is why the death rate has not decreased despite 49 states having an operational PDMP,” Lilly wrote.  “There is now an alternative to prescription drugs that is easier to obtain and more powerful. Illicit fentanyl is now the preferred opioid and the PDMPs have absolutely no effect on its rapid rise. I would not be surprised if prescription opioid deaths start to fall, not due to the effectiveness of the PDMPs, but due to market competition from illicit fentanyl.”

If PDMP's were effective, Lilly says states that have them would see a decline in opioid overdoses. But in 2016, West Virginia had the highest opioid death rate in country -- over three times higher than Missouri's -- which ranked 25th.

Missouri’s Governor ordered the creation of a statewide PDMP last year, but the state legislature has so far resisted efforts to fund it. Critics say it doesn’t give doctors the necessary tools to prevent overprescribing, but allows law enforcement to track and prosecute physicians and pharmacists.  A spokesman for the Missouri State Medical Association called the program a “witch hunt against physicians.”

Broader Public Health Campaign Needed for Drug Crisis

By Pat Anson, Editor

Overdose deaths in the United States involving illicit fentanyl and other synthetic opioids have surpassed those linked to prescription opioids, according to new research published in JAMA.  Researchers say drugs used to treat depression and anxiety are also involved in more overdoses than opioid pain medication.

The study by researchers at the Substance Abuse and Mental Health Services Administration (SAMHSA) mirrors a similar report released by the CDC in March. The findings further demonstrate how federal and state efforts to combat the overdose crisis are wrongly focused on prescription pain medication as the primary cause of the overdose crisis.

“These findings underscore the rapidly increasing involvement of synthetic opioids in the drug overdose epidemic and in recent increases in overdose deaths involving illicit and psychotherapeutic drugs," wrote lead author Christopher Jones, PharmD, SAMHSA.

“Lack of awareness about synthetic opioid potency, variability, availability, and increasing adulteration of the illicit drug supply poses substantial risks to individual and public health. Widespread public health messaging is needed.”

Over 19,400 overdoses were linked to synthetic opioids in 2016, while 17,087 deaths involved opioid pain medication.

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Synthetic opioids such as fentanyl are far more potent than other opioids such as oxycodone. Fentanyl is prescribed legally for severe pain, but illicit fentanyl has become a scourge on the black market, where it is often mixed with heroin and cocaine or used in the manufacture of counterfeit medication. It is assumed that illicit fentanyl and its chemical cousins account for the vast majority of deaths caused by synthetic opioids.  

Another key finding of the SAMHSA study is that psychotherapeutic drugs used to treat depression, anxiety and other mental disorders are now involved in more overdoses than any other class of medication. They include antidepressants, benzodiazepines, anti-psychotics, barbiturates and attention deficit hyperactive disorder (ADHD) drugs such as Adderall.

DRUGS INVOLVED IN 2016 OVERDOSES

Over 25,000 overdoses in 2016 involved psychotherapeutic drugs.

That compares to nearly 13,900 deaths linked to the medications in 2010, an increase of 45 percent.

"I think what you're seeing in the data in the last couple of years is that the illicit drug supply has become substantially more dangerous than it has been, and there's this level of unpredictability and lack of awareness of what are exactly the substances that people are using that are contributing to the overdose risk," Jones told Medscape.

That lack of awareness is due in part to poorly designed public health messaging. For example, last year the CDC launched a public relations campaign in 14 states that focused exclusively on warning of the risks associated with prescription opioids. Fentanyl, heroin and other drugs commonly involved in overdoses are not addressed in the Rx Awareness campaign because the CDC didn't want to risk “diluting” its primary message.

Specificity is a best practice in communication, and the Rx Awareness campaign messaging focuses on the critical issue of prescription opioids. Given the broad target audience, focusing on prescription opioids avoids diluting the campaign messaging,” the CDC said.  

SAMHSA researchers say nearly 80 percent of the synthetic opioid overdoses in 2016 involved multiple drugs, indicating that many of the decedents are abusing a wide variety of substances. The most commonly involved drugs were another opioid (48%), heroin (48%), cocaine (22%), prescription opioids (21%), benzodiazepines (17%), alcohol (11%), psychostimulants (5%) and antidepressants (5%).

About 20 percent of the death certificates did not specify the type of drug involved, so the number of reported overdoses are likely underestimated.