6 Reasons Opioids Get More Attention Than Alcohol

By Janice Reynolds, Guest Columnist

Every day we hear how the “opioid crisis” is spiraling out of control.  Some even claim it is the worst health crisis to ever hit our country.  The response has largely been to restrict access to opioid pain medications and to sue the pharmaceutical companies that produce them.

But what is the real crisis? The elephant in the room that everyone conveniently ignores?

I believe opioids are being used to cover-up and distract from the real addiction crisis, which is alcohol abuse. 

Alcoholic beverages have been with us for thousands of years and are an important part of everyday life. Alcohol consumption has been increasing in the U.S. since the late 1990's and today about 57 percent of Americans drink alcohol at least once monthly, far more than consume opioids. Drinking to excess is usually frowned upon, but has long been treated as socially acceptable, even by the Puritans:

Drink is in itself a good creature of God, and to be received with thankfulness, but the abuse of drink is from Satan, the wine is from God, but the Drunkard is from the Devil.                                                                                                                                                        --  Increase Mather, Puritan clergyman in “Wo to Drunkards” (1673)

Alcohol is the fourth leading cause of preventable death in the in the United States. In 2015, over 30,000 Americans died directly from alcohol induced cases, such as alcohol poisoning and cirrhosis of the liver. 

There are another 88,000 deaths annually from alcohol related causes, including motor vehicle accidents, homicide, suicide, and incidents of poor judgement – such as going out in subzero weather and freezing to death, and infants dying after being left in hot cars by drunk fathers.

Many harms also occur that usually do not result in death, such as alcohol-related sexual assault or date rape, fetal alcohol syndrome, and fetal alcohol spectrum disorders. The World Health Organization reports that alcohol contributes to more than 200 diseases and injury-related health conditions, including alcohol dependence, cirrhosis, cancers, and injuries.

So why is alcohol ignored and the so-called opioid epidemic is hyped? Here are six reasons:

1) Many people drink alcohol. They may only drink “socially” and need a glass of wine or beer to relax, enjoy a sporting event or socialize at a party. Alcoholic beverages are an integral part of mealtime for many people.   

We also have functional alcoholics who are secret addicts.  As a nurse for over 20 years, it was not uncommon for me to have a patient begin to go through withdrawal after 48 hours in the hospital. Usually they deny drinking alcohol or admit to one drink a night. There is also denial by the medical profession about the dangers posed by alcohol, such as addiction specialists who differentiate between heavy drinkers and alcoholics.

Research frequently ignores alcohol entirely. A recent study looked at health conditions linked to Alzheimer’s disease and mentioned obesity, high blood pressure, diabetes and depression. Alcohol was not even considered, even though it has been shown in valid studies to damage brain cells.

2) Alcohol is BIG business.  Profits are immense and generate tax revenue.  Profits for breweries, distilleries and related businesses far outstrip what pharmaceutical companies make from opioids.  We see these monies going not only to shareholders, but government, lobbyists and advertising.

No one complains about a full-page newspaper ad for a brand of vodka, but a commercial during the Super Bowl for medication to treat opioid induced constipation sparks outrage. And no one bats an eye when a story about Maine liquor stores dropping the price of hard liquor is on the same front page with another article on the opioid crisis.

When have you ever seen a stadium named after an opioid or even a pharmaceutical company? Yet we have Coors Field in Denver, Busch Stadium in Saint Louis, and Miller Park in Milwaukee.

3) Problems need scapegoats. In this case we have two scapegoats: people in pain and opioids.  

Prejudices against people in pain have long existed: “It’s all in your head” or “the pain can’t be that bad” are all too familiar. It could also be simple bigotry towards someone different or a lack of compassion. We used to call pain management “an art and a science,” now it is optional and politically driven medicine.

Opiophobia has a long history as well; fear of addiction, fear of respiratory depression, belief that opioids don’t work, and that people in pain are drug seekers. The “opioid epidemic” has opened the gateway for uncontrollable and irrational bigots.

Nearly all the interventions to curb drug overdoses have been directed at people in pain, who are not responsible for the illegal use of opioids. If all prescription opioids disappeared tomorrow, it would have nil effect on the opioid crisis. Addicts would just turn to heroin and illegal fentanyl (if they haven’t already). There are a boatload of ways to get high.

4) McCarthyism: In the 1950’s, Senator Joseph McCarthy went hunting for communists and many lives were ruined. Today, the term “McCarthyism” defines a campaign or practice that uses unfair and reckless allegations, as well as guilt by association. 

Politicians, the media and many doctors are afraid to say anything not endorsing the “opioid epidemic” or supporting people in pain, because it will be held against them.

5) Fear-mongering:  The spread of frightening and exaggerated rumors of an impending danger that purposely and needlessly arouses public fear.

We can see this in the psychological manipulation that uses scare tactics, exaggeration and repetition to influence public attitudes about opioids. This is exactly what Andrew Kolodny and Physicians for Responsible Opioid Prescribing (PROP) are doing, along with formally reputable organizations such as the Food and Drug Administration and professional medical associations.

6) The alphabet soup: The CDC, DEA, and the bureau of Alcohol, Tobacco and Firearms (ATF) have all played a part in distracting us from alcohol abuse.  Although it is a drug, alcohol is not usually covered by the DEA, but is handled by the ATF, which mainly concerns itself with alcohol licensing and collecting alcohol taxes.

The DEA has been totally helpless to stop the influx of illegal opioids like heroin and illicit fentanyl, as well as thediversion of prescription medications. Their survival mechanism is to go after the legitimate use of opioids for pain.  They have become a terrorist organization that is driving providers out of pain management.

In order to cover-up the heavy cost of alcohol abuse, we have seen hysteria driven by politicians and the media. This has resulted in difficulty getting opioids prescribed for pain, skewered facts to support the “opioid epidemic,” the CDC’s opioid guidelines, and what I call the passive genocide of people in pain.

There are many different means by which genocide can be achieved and not all have to be active (murder or deportation). For our usage, genocide means “the promotion and execution of policies by a state or its agents which result in the deaths (real and figuratively) of a substantial portion of a group.” 

Our genocide is passive because it relies on the harmful effects of pain, suicide, withdrawal of treatment, excessive use of over-the-counter pain relievers, malpractice, and the total dismissal of the human rights of people with pain; as well as lies and falsehoods being held as truths to promote this genocide.

This is not to say that alcohol should be made illegal. Prohibition did not work because most people wanted alcohol and it lead to a huge criminal enterprise. It is to say prescription opioids should not be treated differently than other medications or alcohol.  And people in pain should not be used to further an agenda based on fallacious, unethical and immoral sensationalism. 

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them, including a regular one on cooking with pain. 

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

Pain Patients Need to Stop Demonizing Addicts

By Crystal Lindell, Columnist

Ok. Wait. Before you read the headline and send me hate mail, I just want to remind you guys that I am a pain patient. Just like you. So take a breath and let me explain.

So yes, the pain patient community needs to stop demonizing “addicts.” I know. I know. They make a great enemy. I mean, if it wasn’t for all those opioid addicts out there, we’d all be able to get the medications we need. Am I right?

But just as pain is complicated, so is addiction and so are opioids.

I recently wrote a column about my first time getting a lidocaine infusion, and it included a throwaway line about how I was hoping the treatment will help me get off opioids because, “I don’t actually love being high all the time.”

Dang. People were not happy I said that.

Apparently, there is this idea out there that if you are taking opioids like hydrocodone for legitimate physical pain, then you don’t get high from the medications. And if you are getting a high from them, then you’re an addict. The end.

Unfortunately, that’s not exactly how opioids work. There is no magic pill (yet) that we can take that relieves physical pain without also impacting our brains.  

Part of the problem that people seem to have a very specific idea about what the word “high” means. There’s a common trop in pop culture that shows addicts in tattered clothes, lying in an alley with their eyes rolled back in their heads. But that is far from the full picture.

When I take a hydrocodone, even a very small dose of 2.5 mg, I get more relaxed, a little tired, and my reactions are delayed. That’s also a version of getting high. And pretty much everyone else on even a low dose of opioids is likely having the same reaction.

Personally, I have found that when the drugs don’t have that impact on you, it usually means your body is getting used to them, and it will be that much harder to quit taking them.

Look, I get it. The current mood of the country is that opioids are evil and must be stopped. And for people suffering from horrific chronic pain, losing what is often the only treatment that actually works is horrifying. It’s easy to just point to the people causing all the opioid hysteria (the addicts) and blame them. But it’s more complicated than that.

Because when a Ohio sheriff refuses to carry the opioid overdose medication Narcan, it doesn’t just hurt addicts. It hurts pain patients who may accidentally overdose too.

And when addicts start out taking these drugs because of physical pain, what right do we have to attack them? We started taking them for the exact same reason.

I know that many pain patients find great comfort in separating the idea of addiction and physical dependence, but I have to tell you something that I learned when I took myself off morphine — the two aren’t actually all that different.

When you are on 60 mg of opioids a day for years at a time like I was and then stop taking them, your body doesn’t care why you started in the first place. And even if you can get through the first week of hellish withdrawal with horrible flu symptoms, panic attacks, insomnia and diarrhea, your brain could still crave the drug for as long as two years. It got used to having opioids, and has to rewire itself to function without it.

Pain patients often take opioids hoping it will alleviate their symptoms and make them feel normal again. But guess what? Addicts take them for the same reason. At a certain point, they need the drugs just to feel normal because their brain doesn’t work right without them anymore.

And, while pain patients start taking opioids for physical pain, many addicts usually started taking them to relieve pain as well — it’s just that their pain is emotional. But anyone who has ever suffered through a truly tragic loss or heartbreak can tell you that emotional pain can be just as awful as any physical pain. We all just want to feel better.

What Can We Do?

I truly believe that the government should not be involved in our health care decisions and I’m against many of the new regulations that try to limit what doctors can prescribe. Whether or not you should take opioids is a decision that should be made solely between you and your doctor. And I know that the reason many people take opioids is because there are no other effective treatment options available.

However, pretending that pain patients somehow have a different response to these medications than anyone else is naïve. And the sooner we recognize how intense the drugs are, the sooner we can actually start looking at realistic ways to help pain patients as well as addicts.

So how can we move forward? Well, legalizing marijuana everywhere would be a good first step, but even that won’t help everyone. We also need more research into pain treatments that actually work as realistic alternatives to opioids. We also must approach addiction with the same compassion we usually reserve for physical health problems. Addiction is a mental health issue, and the key word there is health.

We need to take a hard look at how we treat addiction, and move into longer-term models that help people for years and include professional psychiatric help. Pretending someone can get over opioid withdrawal by solely going to Narcotic Anonymous meetings is like pretending someone can get over cancer by solely going to weekly support group meetings.

We also need to treat underlying mental health issues like the serious health problems they are, because when people get their clinical anxiety and depression treated correctly, they are less likely to try to self-medicate with drugs like opioids.

Perhaps the best thing pain patients can do is join the same team as the addicts we love to hate. Because if fewer people were abusing opioids, then maybe the government would stop trying to take them away from pain patients.

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

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

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

New Opioid Painkiller Has Less Abuse Potential

By Pat Anson, Editor

A new opioid medication being developed by Nektar Therapeutics for the treatment of moderate to severe chronic pain has significantly less abuse potential than oxycodone -- even at high doses – according to the results of a new clinical study.

The investigational oral drug – known as NKTR-181 -- is the first analgesic opioid designed to reduce side effects such as euphoria, which can lead to abuse and addiction.

In a small study involving 54 recreational drug users, NKTR-181 had significantly less “drug liking” than oxycodone in the first hours of use. The dosage given to the study participants ranged from a maximum therapeutic dose of 400mg of NKTR-181 to a “supratherapeutic” dose that was 3 to 12 times higher than common doses of oxycodone.

"It is clear from our new study results that NKTR-181 is highly differentiated in this respect from oxycodone, which is a choice drug of abuse.  Further, and critically important in the context of this public health emergency, NKTR-181's less rewarding properties and strong analgesia are inherent to its novel molecular structure and independent of any abuse-deterrent formulation,” said Ivan Gergel, MD, Senior Vice President and Chief Medical Officer of Nektar. 

“Many patients do not receive adequate pain relief because they fear taking conventional opioids, including abuse-deterrent formulations, because of their potential for abuse and addiction.  We believe NKTR-181 is a transformational pain medicine that should significantly advance the treatment of chronic pain and could be a fundamental building block in the fight against prescription opioid abuse.”

nektar therapeutics

In March, NKTR-181 received “fast track” designation from the Food and Drug Administration -- a status that allows for an expedited review of the drug – after Nektar reported positive results from a Phase 3 study of over 600 patients with chronic back pain.  Pain scores dropped by an average of 65% in patients taking NKTR-181 twice daily.

The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier, which slows its rate of entry into the brain – thus reducing the “high” or euphoric effect. Many pain sufferers say they do not get high or experience euphoria from opioid medication, but drug makers and regulators are working to develop painkillers with less risk of abuse and addiction.  

"Getting very high, very fast, is a mark of conventional high-risk, abused opioids," said Jack Henningfield, PhD, vice president at Pinney Associates and adjunct professor at The Johns Hopkins University School of Medicine. "NKTR-181 represents a meaningful advance in the treatment of pain as the first opioid analgesic with inherent brain-entry kinetics that avoids this addictive quality of traditional opioids. This prevents the rapid 'rush' that abusers seek during the critical period immediately after dosing. Importantly, these properties of NKTR-181 are inherent to its molecular structure and are not changed through tampering or route of administration." 

Because NKTR-181 produces less euphoria, Nektar believes it should be scheduled as a Class III or Class IV controlled substance, a less restrictive schedule than Class II medications, a category that includes oxycodone, hydrocodone and many other opioids.

Nektar is a research-based biopharmaceutical company that discovers and develops new drugs for which there is a high unmet medical need. It has a pipeline of new investigational drugs to treat cancer, auto-immune disease and chronic pain.

FDA Study Calls for More Aggressive Opioid Regulation

By Pat Anson, Editor

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

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

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

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

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

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

NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINES

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

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

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

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

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

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

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

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

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

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

The NASEM study was funded by the FDA.

From Bad to Worse: The Future of the Opioid Crisis

By Roger Chriss, Columnist

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

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

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

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

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

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

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

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

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

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

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

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

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Drug Maker to Stop Sales of Opana ER

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

Gabapentin Boosts High For Opioid Abusers

By Carmen Heredia Rodriguez, Kaiser Health News

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

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

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

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

CIERA SMITH (KAISER HEALTH NEWS)

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

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

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

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

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

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

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

‘Available To Be Abused’

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

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

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

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

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

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

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

(kAISER HEALTH NEWS)

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

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

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

Little Testing

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

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

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

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

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

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

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

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

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

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

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

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

Insurer Reports Soaring Rates of Opioid Addiction

By Pat Anson, Editor

The number of Blue Cross and Blue Shield (BCBS) customers diagnosed with opioid addiction has soared by nearly 500 percent in recent years, according to a new report that found only about a third of the addicted patients were getting medication assisted treatment.

The Health of America Report analyzed prescription data for over 30 million BCBS customers from 2010 to 2016. The report focused mainly on patients who use legally prescribed painkillers, while virtually ignoring addicts who use heroin, illicit fentanyl and other illegal opioids, who are now the driving force behind the nation’s opioid crisis.

"Opioid use disorder is a complex issue, and there is no single approach to solving it," said Trent Haywood, MD, senior vice president and chief medical officer for the Blue Cross Blue Shield Association, which represents 36 independent insurers that provide health coverage to over 100 million Americans.

“Opioid use disorder” is a broad and somewhat misleading term that includes illegal drug addicts, as well as chronic pain patients who take opioids responsibly, and develop a tolerance or dependence on them.

The BCBS report found that patients who filled prescriptions for high doses of opioids had much higher rates of opioid use disorder than those on lower doses. Women aged 45 and older had higher rates of the disorder than men. Women of all ages were also more likely to fill an opioid prescription.

The BCBS report found that patients who filled prescriptions for high doses of opioids had much higher rates of opioid use disorder. Women aged 45 and older had higher rates of the disorder than men. Women of all ages were also more likely to fill an opioid prescription.

Less than one percent of BCBC customers (0.83%) were diagnosed with opioid use disorder in 2016, a rate much higher than in 2010 (0.14%). The rise was attributed to “an increased awareness of the disorder,” suggesting that doctors were simply more likely to diagnose opioid addiction then they were in 2010.    

While the diagnosis of opioid use disorder rose by 493 percent during the study period, there was only a 65 percent increase in the number of BCBS customers who were prescribed addiction treatment drugs such as Suboxone (buprenorphine).

BCBS customers in the South were more likely to be diagnosed with opioid use disorder. Alabama led the nation with a diagnosis rate of over 1.6 percent, twice the national average.

The report noted that New England leads the nation in the use of medication-assisted treatments, even though the region has lower levels of opioid use disorder than other parts of the country. In Massachusetts, 84% of BCBS customers diagnosed with addiction were getting treatment with medication.

That prompted Blue Cross Blue Shield Association of Massachusetts to issue a press release claiming the state was “ahead of the nation when it comes to combating the opioid epidemic.” The insurer was one of the first in the country to take steps to significantly reduce access to opioids by its customers. As a result, only 2% of Blue Cross Blue Shield members in Massachusetts are receiving high doses of opioids, far less than the national average of 8.3 percent.

However, restricting access to pain medication has failed to stop a surge in opioid overdoses in Massachusetts, most of which are now caused by illicit fentanyl.  Over 2,000 people died of opioid overdoses in Massachusetts last year, almost three times the number of deaths in 2012, when Blue Cross Blue Shield began restricting access to painkillers.

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

Prescription opioids were involved in only 9% of the overdose deaths in Massachusetts at the end of 2016. In addition, the most recent report from the state's prescription drug monitoring program identified only 264 of the 288,519 people receiving Schedule II opioids as having “activity of concern” that could indicate they were misusing the drugs. That minuscule rate of 0.0915% hardly suggests that legitimate pain patients are the source of Massachusetts’s drug problem.

This week the largest health insurer in the Philadelphia area, Independence Blue Cross, announced plans to limit the prescribing of opioids in its network to just five days for acute pain -- making it one of the first insurers in the country to adopt such a strict limit.

The Wrong Opioid War

By Roger Chriss, Columnist

The opioid crisis continues to worsen, with rising rates of addiction and overdose deaths. The 2016 CDC opioid prescribing guidelines and earlier state guidelines in Washington and Oregon have not helped. Government interventions, from increased physician surveillance to reduced opioid manufacturing quotas by the DEA, are not working.

And the reason is simple: they are fighting the wrong opioid war.

The American Society of Addiction Medicine (ASAM) reports that opioid addiction rates have doubled in the past decade to the current estimate of 2 million opioid addicts and another 500,000 heroin addicts.

It’s a myth that prescription painkillers are the leading cause of addiction. According to the National Institute of Drug Abuse (NIDA), “use of most drugs other than marijuana has stabilized over the past decade or has declined."

As can be seen in the chart below, overall prescription drug abuse was virtually flat between 2002 and 2013, the most recent year data is available. Significant increases were seen for marijuana, starting in 2007 with state-level legalization, and for illicit drugs like heroin.

NATIONAL INSTITUTE OF DRUG ABUSE

“Although heroin use in the general population is rather low, the numbers of people starting to use heroin have been steadily rising since 2007. This may be due in part to a shift from abuse of prescription pain relievers to heroin as a readily available, cheaper alternative,” says NIDA Director Nora Volkow, MD.

If opioid addiction were starting with medical opioids prescribed to adults for acute pain or persistent pain disorders, we’d be seeing a rise in prescription drug abuse and addiction, with a high percentage of addicts found among people on opioid therapy. But in fact this is not happening.

So the question becomes: When does opioid addiction start?

At a very young age, usually. There were over 2.8 million new users of illicit drugs in 2013, according to NIDA, or about 7,800 new users per day. Over half (54%) of these new users were under 18 years of age.

The National Center on Addiction and Substance Abuse reports that 90% of all drug addiction starts in the teens. Other studies tell us that opioid medications are rarely the first drug young people misuse, and that early signs of addiction start with alcohol, marijuana and tobacco use.

Further, Pain Medicine News reports that research at Boston Children’s Hospital found that “if a patient reaches the age of 25 years without misuse, the odds of that patient ever becoming an opioid misuser are much lower.” Thus, opioid abuse almost always starts during adolescence, a time when medical treatment with opioids is rare.

According to NIDA, 6.5 million Americans aged 12 or older used prescription drugs non-medically in 2013. The source of these drugs is usually not a doctor or a drug seeking patient.  Doctor shopping is rare, occurring in about 1 out of 143 patients. And according to ASAM, “most adolescents who misuse prescription pain relievers are given them for free by a friend or relative.”

The medical use of opioid drugs for persistent pain disorders is conspicuous by its absence. That is because pain patients are a statistically insignificant part of the opioid crisis. As Maia Szalavitz reported in Scientific American, “regulatory efforts will fail unless we acknowledge that the problem is actually driven by illicit—not medical—drug use.”

Federal agencies and state governments by and large have not recognized this. And we are witnessing the consequences. The CDC reports that overdose deaths for heroin and illicit fentanyl have been rising rapidly since 2010, while overdose deaths involving commonly prescribed opioids have been almost flat.

Moreover, a significant percentage of the overdose deaths are suicides. The CDC classified 10% of the overdose deaths in 2015 as suicides. Florida’s Medical Examiners Commission came up with even more startling numbers, classifying 20% of the state’s oxycodone deaths and 31% of its hydrocodone deaths as suicides.  

"Hidden behind the terrible epidemic of opioid overdose deaths looms the fact that many of these deaths are far from accidental. They are suicides," says Dr. Maria Oquendo, President of the American Psychiatric Association.  

The opioid crisis is about illicit drug use. Policies that fail to recognize that fact will end up fighting the wrong war, with consequences that are becoming all too common.

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.

VA Study Could Lead to More Cuts in Opioid Prescribing

By Pat Anson, Editor

A new study by a prominent think tank could give further ammunition to the Department of Veterans Affairs to reduce access to opioid pain medication in its healthcare system.

Researchers at the RAND Corporation studied data from nearly 32,500 patients who were treated at VA facilities in 2007 and were identified as having an opioid use disorder. The goal was to identify “quality measures” that could help reduce the death rate of addicted patients.

The researchers found that deaths were much lower among patients who were not prescribed opioids or anxiety medications, those who received counseling, and patients who had regular visits with a VA physician. They estimate the number of deaths could be reduced by a third if all three quality measures were adopted. 

"This is a very large drop in mortality and we need to conduct more research to see if these findings hold up in other patient care settings," said Dr. Katherine Watkins, a physician scientist at RAND and lead author of the study published in the journal Drug and Alcohol Dependence.

"But our initial findings suggest that these quality measures could go a long way toward improving patient outcomes among those who suffer from opioid addiction."

The findings suggest that a key to reducing mortality is to minimize the prescribing of opioid medication and benzodiazepines to veterans with opioid addiction. Benzodiazepines are a class of psychiatric medication used to treat anxiety disorders.

Because lower death rates were also associated with counseling and quarterly visits with a VA physician, researchers concluded that addicted patients benefit from making a connection with a caregiver, who can identify changes in their behavior and potential for relapse.

Surprisingly, patients in the study who were prescribed addiction treatment drugs such as Suboxone (buprenorphine) did not have lower death rates.

"We know from other research that medication-assisted therapy can help people stay off drugs, get jobs and lead more-productive lives," Watkins said. "But in this study, the treatment strategy was not associated with lower mortality."

The VA has already taken a number of measures to reduce opioid prescribing, including a new guideline that strongly recommends against prescribing opioids for chronic pain. VA physicians are also being urged not to prescribe opioids long-term to anyone under the age of 30. The guideline recommends exercise and psychological therapies such as cognitive behavioral therapy as treatments for chronic pain, along with non-opioid drugs such as gabapentin.

“We’ve been working on this now for seven years and we’ve seen a 33 percent reduction in use of opioids among veterans, but we have a lot more to do. We have a lot we can learn,” Secretary of Veterans Affairs David Shulkin told a White House opioid commission earlier this month. "At the VA, my top priority is to reduce veteran suicides. And when we look at the overlap with substance abuse and opioid abuse, it’s really clear.”

According to a recent VA study, an average of 20 veterans die each day from suicide, a rate that is 21 percent higher than the civilian population.  Veterans also suffer from high rates of chronic pain, depression and post-traumatic stress disorder.

Opioid Addiction Linked to Range of Health Problems

By Pat Anson, Editor

An extensive new analysis of insurance claims has found that patients being treated for opioid addiction are much more likely to suffer from a wide range of other health problems, including hepatitis C, HIV, bronchitis, fibromyalgia and chronic pain.

The large study by Amino – a healthcare information company – looked at 205 million private health insurance claims involving patients with “opioid use disorder,” a loosely defined diagnosis that includes both mild and severe forms of “problematic” opioid use. The diagnosis does not distinguish between prescription opioids used therapeutically and illegal opioids such as heroin that are used recreationally.

In just four years, Amino found a 6-fold increase in the number of Americans diagnosed with opioid use disorder, from 241,000 in 2012 to 1.4 million 2016.  

Amino also found that patients with opioid use disorder were significantly more likely to be diagnosed with diseases linked to substance abuse and intravenous drug use, including hepatitis C, HIV, alcoholism and mental health issues.

“Behavioral health issues like alcoholism and binge drinking were 8.4x and 5x more frequently diagnosed among patients who were also diagnosed with opioid use disorder, while mental health issues like suicidal ideation and post traumatic stress disorder were 6.9x and 4.2x more frequently diagnosed,” wrote Amino researcher Sohan Murthy.

Murthy and his colleagues also found many diagnoses related to pain, including chronic regional pain syndrome (CRPS), herniated disc, failed back syndrome, stenosis and fibromyalgia.

Stanford psychiatrist Anna Lembke, MD, a board member of Physicians for Responsible Opioid Prescribing (PROP), told Amino there is a high risk for addiction even when opioids are prescribed for a “bonafide” medical use.

“What I thought was really interesting was the correlation with failed back syndrome. Perhaps failed back syndrome is a risk factor for developing an opioid use disorder—and that could be part of the reason why this community experiences such chronicity and lack of improvement. This is a subgroup that’s especially vulnerable to opioid misuse,” Lembke said.

"Failed back syndrome" is a diagnosis used to describe patients who do not respond or whose pain grows worse after spinal surgery, injections or other "interventional" procedures. Ironically, these same procedures are often promoted as "non-opioid" treatments for chronic back pain.

Amino notes in the study that the data does not make a "causal" link between different diagnoses, meaning the study doesn't conclude that opioid use disorder causes hepatitis C or HIV. However, the FDA recently asked that Opana ER be removed from the market  because the painkiller was associated with outbreaks of hepatitis C, HIV and other diseases spread by intravenous drug use; indicating that health problems other than abuse and addiction are now being used by the agency as a rationale to limit the sale of opioids.

Amino found that geography is often a major factor in the diagnosis of opioid use disorder. The study found a disproportionate number of patients with opioid use disorder in Appalachia and Florida, suggesting that doctors in regions with a history of opioid abuse may simply be more likely to make the diagnosis.  Kentucky alone had 9 of the top 10 counties for doctors treating a high volume of patients with opioid use disorder.

Addiction Treatment Initial Focus of Opioid Commission

By Pat Anson, Editor

President Trump’s commission on drug addiction and the opioid crisis held its first public meeting today, a two-hour session focused largely on expanding access to addiction treatment.

Chaired by New Jersey Governor Chris Christie, the commission is expected to make interim recommendations to the president in the next few weeks on how to combat drug abuse, addiction and the overdose epidemic, which is blamed for the deaths of nearly 60,000 Americans last year. A final report from the commission is due by October 1.

It is not clear yet how much of a role opioid prescribing and pain medication will play in the commission’s work. Most of its five members have publicly blamed overprescribing for causing the opioid epidemic.

“No offense, but that is where this came from,” said Massachusetts Gov. Charlie Baker, a commission member.

“The opioid crisis is ruining lots of people’s lives and lots of families across America," David Shulkin, Secretary of Veterans Affairs told the commission. "At the VA, my top priority is to reduce veteran suicides. And when we look at the overlap between substance abuse and opioid abuse, it’s really clear.

“We’ve been working on this for seven years and we’ve seen a 33 percent reduction in use of opioids among veterans, but we have a lot more to do.”

Shulkin did not mention that veteran suicides have soared during that period, and are now estimated at 20 veterans each day.

“We also need to look at pharmaceutical companies making generic drugs more tamper resistant and looking at making drugs that do not cause addiction,” said North Carolina Gov. Roy Cooper, a commission member.

Commission member Patrick Kennedy, a former congressman who has battled substance abuse himself, said there has been a “historic discrimination” against mental health and addiction treatment.

“I’m excited by the chance to kind of push for ways that we can hold insurance companies more accountable, so that the public sector doesn’t have to pick up the tab. Because its taxpayers that are picking up the tab when insurance companies continue to push folks with these illnesses off into the public system,” Kennedy said. “This is a cost shift that is a windfall for insurance companies if they can get rid of people who have mental health or addiction issues.”

Limits on Opioid Medication Not Working

“Let me be blunt. Today there is not nearly enough drug treatment capacity in America to help most of the victims of the epidemic,” said Mitchell Rosenthal, MD, who founded Phoenix House, a nationwide chain of addiction treatment centers.

“Most terrifying is the reality that nothing we are doing today has been able to halt the spread of opioid addiction. Controlling prescription opioid medication has not done so. Prescription monitoring programs, strict limits on the number of pills physicians can prescribe, and the CDC pain management guidelines seem to have capped usage of prescribed opioid medications. But overdose deaths from heroin and highly potent synthetics like fentanyl have gone through the roof.”

One activist called for wider adoption of the CDC opioid guidelines and rigid enforcement if doctors don’t follow them. Gary Mendell, the CEO and founder of Shatterproof, a non-profit focused on preventing addiction, said each state should be held accountable and federal funding reduced to states if their prescribing exceeds a certain level.

“If every primary care doctor in this country followed the CDC guideline, you would cut by more than half, instantly, the number of new people becoming addicted,” said Mendell, whose son committed suicide after years of struggle with addiction. “We need a goal for the country. Divide it up by 50 states, a proper goal developed by the CDC, and then we need to publicize it and hold people accountable. Just like you would do in any business.”

Patrick Kennedy is a member of Shatterproof's board of advisors, and Andrew Kolodny, MD, founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP) is a member of its "opioid overdose advisory board."

No pain patients or pain management experts testified before the commission or were appointed to the panel.

Watch below for a replay of today's meeting:

FDA to Review All Abuse Deterrent Opioids

By Pat Anson, Editor

A week after asking that Opana ER be taken off the market, the head of the Food and Drug Administration has ordered a review of all opioid painkillers with abuse deterrent formulas to see if they actually help prevent opioid abuse and addiction.

The move is likely to add to speculation that the FDA may seek to prevent the sale of other opioid painkillers.

“We are announcing a public meeting that seeks a discussion on a central question related to opioid medications with abuse-deterrent properties: do we have the right information to determine whether these products are having their intended impact on limiting abuse and helping to curb the epidemic?” FDA commissioner Scott Gottlieb, MD, said in a statement.

Gottlieb said the FDA would meet with “external thought leaders” on July 10th and 11th to assess abuse deterrent formulas, which usually make medications harder for addicts to crush or liquefy for snorting and injecting. He did not identify who the thought leaders were.

“Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof. These drugs can still be abused, particularly orally, and their use can still lead to new addiction,” Gottlieb said. “Nonetheless, these new formulations may hold promise as one part of a broad effort to reduce the rates of misuse and abuse. One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations.”

In a surprise move last week, the FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing concerns that the oxymorphone tablets are being liquefied and injected. It’s the first time the agency has taken steps to stop an opioid painkiller from being sold.

“I am pleased, but not because I think that this one move by itself will have much impact,” Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP) told Mother Jones. “I’m hopeful that this signals a change at FDA—and that Opana might be just the first opioid that they’ll consider taking off the market. It’s too soon to tell.”

Opana was reformulated by Endo in 2012 to make it harder to abuse, but addicts quickly discovered they could still inject it. The FDA said Opana was linked to serious outbreaks of HIV, Hepatitis C and a blood clotting disorder spread by infected needles.

Endo has yet to respond to the FDA request. If the company refuses to stop selling Opana, the agency said it would take steps to require its removal from the market by withdrawing approval.

“The request to voluntarily remove the product is one thing, but it comes with a lot of other questions that are unanswered,” Endo CEO Paul Campanelli reportedly said at an industry conference covered by Bloomberg. “We are attempting to communicate with the FDA to find out what they would like us to do.”

Patient advocates say it would be unfair to remove an effective pain medication from the market just because it is being abused by addicts.

“The FDA is following a political agenda, rather than its mandate to protect the public health,” said Janice Reynolds, a retired oncology nurse who suffers from persistent pain. “Depriving those who benefit from the use of Opana ER to stop people from using it illegally is ethically and morally wrong.”

Sales of Opana reached nearly $160 million last year. The painkiller is prescribed about 50,000 times a month.

"This is something that could potentially apply to other drugs in the future, as it may signal a movement by the FDA to start taking products off the market that don't have strong abuse-deterrent properties," industry analyst Scott Lassman told CorporateCounsel.com.

The FDA put drug makers on notice four years ago that they should speed up the development of abuse deterrent formulas (ADF).  Acting on the FDA's guidance, pharmaceutical companies spent hundreds of millions of dollars developing several new opioid painkillers that are harder to chew, crush, snort or inject.

Were they worth the investment? Not according to a recent study funded by insurers, pharmacy benefit managers and some drug makers.

The Institute for Clinical and Economic Review (ICER), a non-profit that recommends which medications should be covered by insurance and at what price, released a report last month that gave ADF opioids a lukewarm grade when it comes to preventing abuse.

“Without stronger real-world evidence that ADFs reduce the risk of abuse and addiction among newly prescribed patients, our judgment is that the evidence can only demonstrate a ‘comparable or better’ net health benefit (C+),” the ICER report states.

The insurance industry has been reluctant to pay for ADF opioids, not because of any lack of effectiveness in preventing abuse, but because of their cost. A branded ADF opioid like OxyContin can cost nearly twice as much as a generic opioid without an abuse deterrent formula.  According to one study, OxyContin was covered by only a third of Medicare Part D plans in 2015. Many insurers also require prior authorization before an OxyContin prescription is filled.  

Trump Opioid Commission to Hold First Meeting

By Pat Anson, Editor

The pain community will get its first glimpse this month at how the Trump administration may address the nation’s opioid crisis, when the president’s new Drug Addiction and Opioid Commission holds its first two meetings.

The commisison's first meeting will be held Friday June 16, followed by a teleconference on Monday June 26. Both meetings are open to the public.

Details on how to watch or listen to the meetings can be found in the Federal Register, here and here.

Chaired by New Jersey Governor Chris Christie, the commission will make recommendations to the president later this year on how to combat drug abuse, addiction and the overdose crisis, which is blamed for over 50,000 deaths in 2015.

The White House says the commission will “work closely” with President Trump’s son-in-law and senior advisor, Jared Kushner.

“I made a promise to the American people to take action to keep drugs from pouring into our country and to help those who have been so badly affected by them. Governor Christie will be instrumental in researching how best to combat this serious epidemic and how to treat those it has affected,” Trump said in a statement.  

The public can submit written comments to the commission by emailing the Office of National Drug Control Policy at commission@ondcp.eop.gov.

“I'd really like to see the commission recognize that addressing opioid use disorders through increasing access to treatment and through attempting to reduce the supply of opioids (both legal and illegal) will only go so far, and that, to be truly successful, they also must address inadequacies in the way we treat pain,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, which represents pain management physicians.

“Unless and until we reach a point where we can truly implement the kind of integrative pain care called for by every guideline and highlighted in the National Pain Strategy, we are going to be unable to succeed in addressing both of the public health crises we are encountering.”

Twillman helped draft and submit a letter to the commission signed by 73 different medical and patient advocacy groups calling for more federal funding of pain research and treatments.

“This longstanding underinvestment in pain research has resulted in a limited number of safe and effective chronic pain treatments, and according to the FDA, a field that is 'strikingly deficient' in high-quality evidence to assess risks and benefits of current treatments,” the letter states. “As a result, even highly knowledgeable health care providers are left without clear guidance, and may spend months to years with their patients experimenting with treatments in the hope of finding relief.”

Richard Martin, a retired Nevada pharmacist disabled by chronic back pain, says the first item on the commission’s agenda should be to withdraw and re-write the CDC’s opioid guideline, which discourages physicians from prescribing opioids for chronic pain.

“Since the Guideline was released, there are now tens of thousands of non-cancer pain patients on long term opioid prescription therapy who are being INVOLUNTARILY tapered down or off of their pain medications.  This has resulted in patients being under treated, left to suffer with debilitating pain.  Some of these patients have had their opioid medications abruptly discontinued throwing them into withdrawal,” Martin wrote in an email to the commission.

“There now abounds significant anecdotal evidence and significant documented media reports, that these patients who have been involuntarily tapered down or off their opioid medications, are committing suicide due to the intense pain that has resulted.” 

Background of Commission Members

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

Gov. Christie, who lost a close friend to painkiller addiction, has seen his home state of New Jersey ravaged by the opioid crisis, with 1,600 overdose deaths in 2015.  Christie championed a new state law that limits opioid prescriptions for acute pain to just five days.  

Gov. Cooper supports similar legislation now under consideration in North Carolina.  Over 1,100 North Carolinians died from opioid overdoses in 2015, with prescription opioids involved in about half of them.

Gov. Baker’s home state of Massachusetts lost over 2,000 people to opioid overdoses in 2016, most of them caused by heroin and illicit fentanyl. Baker apparently got an inside track on the commission when he discussed the opioid crisis with Ivanka Trump while sitting next to her during a National Governors Association dinner.

Bertha Madras recently authored an editorial in JAMA Psychiatry in which she claimed that prescription opioids “remain a primary driver of opioid-related fatalities” and called on the medical community to limit the supply of opioid medication.

Patrick Kennedy has battled substance abuse issues since he was teenager, including addiction to the painkiller OxyContin. He now works for Advocates for Opioid Recovery, a non-profit funded in part by Braeburn Pharmaceuticals, which makes an implant that dispenses the addiction treatment drug buprenorphine.

New Drug Testing Guideline Warns Against Fraud

By Pat Anson, Editor

A new guideline on the use of drug testing by the American Society of Addiction Medicine (ASAM) warns against expensive and unnecessary tests that have led to “unethical and/or fraudulent activities.”

The ASAM is a professional society that represents over 4,300 physicians and specialists in addiction treatment. Its new guideline – the first attempt to set national standards for clinical drug testing – could also influence primary care providers and pain management specialists who are increasingly testing their patients for opioid misuse.  

"Drug testing is a valuable tool for supporting patients in addiction treatment, and this comprehensive set of recommendations should prove useful to providers in a variety of addiction treatment settings," said Margaret Jarvis, MD, Chair of ASAM's Quality Improvement Council.

The new guideline, developed by an 11-member expert panel, is published in the Journal of Addiction Medicine.

“ASAM is acutely aware that this document will be released in a context where a lack of clarity about the appropriate use of drug testing has led not only to inconsistent clinical practice, but also unethical and/or fraudulent activities,” the guideline says.

“One of the purposes of this document is to clarify appropriate clinical use of drug testing and, in so doing, shine a light on drug-testing practices that are clearly outside of these boundaries. The delineation of appropriate treatment practices will confer multiple benefits; most importantly, it will improve patient care. At the same time, it will reduce waste and fraud.”

Drug testing has grown into a multi-billion dollar industry – what some call “liquid gold” – largely because so many doctors who treat addicts and chronic pain patients require them to submit to urine drug screens. Many experts consider the “point-of-care” immunoassay tests widely used in doctors’ offices unreliable because they often give false negative or false positive results.

Several drug testing laboratories have also paid heavy fines to settle fraud and kickback charges after they bilked Medicare, Medicaid, private insurers, and patients for unnecessary and expensive lab tests. The practice was so egregious that the Department of Health and Human Services issued a Special Fraud Alert in 2014 to warn physicians not to accept any payments, referrals, rent or reimbursements from drug testing companies.

The new ASAM guidelines say drug tests "should be widely used in addiction treatment settings," but warn that negative or positive findings about a patient’s use of drugs do not necessarily mean they have a substance use disorder. A patient who consumes poppy seeds, for example, could have a positive finding for morphine.

“The list of potential sources of false positives is too extensive to list here, but a few noted examples include; cough suppressants resulting in positive opioid results, ephedrine in cold medicine resulting in positive result for amphetamines, and antidepressants resulting in positive opioid results,” the guideline says.

“There are known limitations to urine immunoassays for opiate use and providers should be cautious when interpreting their results. Providers should carefully review the testing report produced by the laboratory to ensure they understand which opiates and opioids a test is capable of detecting.”

The ASAM’s expert panel said there was no “magic formula” to determine how often a patient should be drug tested. Testing should be done at least weekly at the beginning of addiction treatment, according to the guideline, and at least monthly in patients in stable recovery. Testing should be performed on a random schedule, when possible.

The guideline also cautions physicians not to be confrontational with patients if a test has an unexpected finding.

“Drug testing should function as a therapeutic tool, so a provider's response to test results should not be confrontational. This approach can perpetuate an ‘us versus them’ mentality that reduces the effectiveness of drug testing to support recovery,” the guideline says.

The ASAM guideline also advises physicians on other issues such as urine tampering, patient confidentiality, practitioner education, and how to select reliable tests and laboratories.