Pennsylvania Overdoses Soar, But Not from Painkillers

By Pat Anson, Editor

A new study by the U.S. Drug Enforcement Agency underscores the changing nature of the nation’s overdose crisis and the diminishing role played by opioid painkillers.

In an analysis of 4,642 drug related overdose deaths in Pennsylvania last year, the DEA found that over half of those deaths (52%) involved fentanyl or fentanyl related substances. In many cases, toxicology reports found multiple drugs in the bodies of those who died.

Heroin was the second most frequently identified drug (45%), followed by benzodiazepines (33%), a class of anti-anxiety medication, and cocaine (27%).  

Prescription opioid medication was the fifth most common type of drug found. Painkillers were involved in 25 percent of the Pennsylvania overdoses, while ethanol (alcohol) was ranked 6th at nearly 20 percent.

Overall, the number of overdoses in the state was 37 percent higher than in 2015, according to the DEA report. Pennsylvania's overdose rate was 36.5 deaths per 100,000 people, twice the national average.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine, and is available legally by prescription to treat severe chronic pain. In recent years however, illicit fentanyl has become a deadly scourge across the U.S. and Canada, where it is often mixed with heroin or used in counterfeit painkillers. Illicit fentanyl is believed to be involved in the vast majority of the fentanyl-related deaths in Pennsylvania.    

DRUGS INVOLVED IN PENNSYLVANIA OVERDOSES (2016)

SOURCE: DEA

The DEA report was prepared in conjunction with the University of Pittsburgh’s School of Pharmacy Program Evaluation Research Unit (PERU). Unlike other reports on overdose deaths, the PERU analysis excluded suicides and included toxicology reports, a methodology that is considered more reliable than the ICD codes traditionally used by the CDC and other federal agencies to determine the drugs involved in overdoses.

“The expertise of PERU in the analysis and interpretation of public health data, which is outside of the traditional scope of law enforcement intelligence analysis, resulted in the creation of this comprehensive report that can be used to implement effective strategies to address the overdose crisis,” said Gary Tuggle, Special Agent-in-Charge of DEA’s Philadelphia Field Division.

Perhaps the most striking aspect of the report was the presence of anti-anxiety drugs in so many of the overdoses, and the smaller role played by prescription opioids. Toxicology reports found opioid medication in 1,181 of the overdose deaths, with oxycodone involved in most of them.

Still, more Pennsylvanians died with Xanax (alprazolam) in their system than oxycodone (846 vs. 679). And the anti-anxiety drugs clonazepam (Klonopin), diazepam (Valium), oxazepam and lorazepam (Ativan) were also involved in hundreds of overdoses.

The existence of valid prescriptions was not analyzed in the DEA report, which did not assess whether medications were diverted or obtained fraudulently.

In 2016, approximately 13 people died of a drug-related overdose in Pennsylvania each day. 

Although painkillers were not involved in most of those deaths, efforts at fighting the overdose crisis are still largely focused on reducing access to legally prescribed opioid medication.

Last month, Independence Blue Cross, the largest health insurer in the Philadelphia area, said it would limit the prescribing of opioids in its network to just five days for acute pain. Independence already limits the quantity of opioids that physicians can prescribe. The company claims that policy has reduced "inappropriate" opioid use by its members by nearly 30 percent.

Deaths from prescription opioids in Philadelphia started declining in 2013, a year before Independence started limiting access to painkillers.

The Myth of the Opioid Addicted Chronic Pain Patient

By Roger Chriss, Columnist

Prescription opioid use for chronic pain does not usually lead to addiction or to the use of illicit opioids such as heroin. But media reports often say otherwise.

“Opioids can be so addictive that many people develop a desperate need for them even after the pain has subsided, or disappeared. So when they’re turned away by doctors and pharmacies, they look for a fix on the streets,” Fox News recently reported.

Public officials also confuse the issue.

“Most of our constituents with substance-use disorders began their path to addiction after forming dependencies to opioids prescribed as a result of an injury or other medical issue,’ Anne Arundel County Executive Steve Schuh wrote in a letter to Maryland doctors. ‘Their opioid dependence may have led to obtaining illegal street opioids like heroin, sometimes laced with fentanyl, after valid prescriptions ran out.’”

But this is not what usually happens.

“What the media has sometimes missed is that of those people who started with prescription opioids and then went on to use heroin, 75% never had a legal prescription for opioids. They were already stealing or buying the drugs illegally,” Judith Paice, PhD, RN, director of the Cancer Pain Program at Northwestern University told Medscape.

In other words, the reality of opioid therapy for chronic painful conditions is quite different from what media coverage and public officials claim.

In fact, the majority of chronic pain patients never even receive opioid medications. Recent estimates state that between 8 and 11 million chronic pain patients receive an opioid prescription at some point in a given year, with only some of them taking opioids for pain control on a daily basis.

Although that is a large number, it is dwarfed by the National Institutes of Health’s estimate that 25.3 million Americans live with daily chronic pain and nearly 40 million have severe pain. That  includes people in hospice and other end-of-life care, as well as people enduring cancer pain.

Moreover, many of the chronic pain patients who receive daily opioid therapy get there only after having failed many other treatment options, including non-opioid drugs and physical therapy. Opioids are rarely the first choice for treating persistent pain conditions, especially in the wake of opioid prescribing guidelines from the CDC, Department of Veterans Affairs, and some states.

Chronic pain patients are carefully screened, scrutinized, and monitored. They are subjected to risk assessment using the Opioid Risk Tool, required to take urine and saliva drug tests, told to show their prescription bottles and have their pills counted, and given pain contracts to sign. Their prescriptions are verified at pharmacies and tracked through prescription drug monitoring programs. Opioid misuse in any form is readily detected and is far from common.

Therefore, it is a myth that opioid addiction or other forms of opioid use disorder starts with a prescription. Instead, it almost always begins at a young age with the misuse of other drugs, such as tobacco, alcohol and marijuana. About 90% of drug addiction starts during adolescence.

And although most people who are addicted to heroin have previously used prescription opioids, the opposite is not true. Most people on opioid therapy do not become addicted to prescription opioids, and most of the people who do become addicted do not transition to heroin.

But the myth confuses and conflates chronic pain and opioid addiction. And this is having real-world consequences, both for people on opioid therapy for chronic pain and for people with opioid use disorder.

For people on opioid therapy, the problems include forced medication tapers or even termination of therapy. Pain management is an essential part of a variety of diseases and disorders, from the neuropathy of arachnoiditis and multiple sclerosis, to the visceral pain of interstitial cystitis and porphyria, to the musculoskeletal pain of Ehlers-Danlos syndrome. The choice and dose of medication should be a clinical decision made between patient and physician, not a blanket determination made by a guideline, regulation or committee.

Further, chronic pain is fast becoming undertreated or even untreated, which can have major health consequences. Forcing people to live without good pain management only creates more medical problems. 

For people suffering from opioid use disorder, the addiction myth embodies the idea that it is just accidental chemistry. But as Maia Szalavitz explains in her book Unbroken Brain, addiction has three key components: “The behavior has a psychological purpose; the specific learning pathways involved make it become nearly automatic and compulsive; and it doesn’t stop when it is no longer adaptive.”

The perpetuation of this myth has resulted in people not getting effective care, because the focus is on the substance instead of the sufferer.

“If we don’t invest in people and we focus on drugs, we end up creating another polarizing conversation about substances and people will continue to fall through the cracks,” Dr. Joseph Lee of the Hazelden-Betty Ford Foundation told the Minnesota Post.

The myth of the opioid-addicted chronic pain patient needs to be banished before it causes more people to fall through the cracks.

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.

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.

PROP Founder Calls for Forced Opioid Tapering

By Pat Anson, Editor

Have you or a loved one been harmed by being tapered off high doses of opioid pain medication?

The founder of an anti-opioid activist group wants to know – or at least he posed the question during a debate about opioid tapering with colleagues on Twitter this week.

“Outside of palliative care, dangerously high doses should be reduced even if patient refuses.  Where exactly is this done in a risky way?” wrote Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP). 

“I’m asking you to point to a specific clinic or health system that is forcing tapers in a risky fashion. Where is this happening?”

It’s not an idle question. About 10 million Americans take opioid medication daily for chronic pain, and many are being weaned or tapered to lower doses -- some willingly, some not -- because of fears that high doses can lead to addiction and overdose.

Kolodny’s Twitter posts were triggered by recent research published in the Annals of Internal Medicine that evaluated 67 studies on the safety and effectiveness of opioid tapering. Most of those studies were considered very poor quality.

“Although confidence is limited by the very low quality of evidence overall, findings from this systematic review suggest that pain, function, and quality of life may improve during and after opioid dose reduction,” wrote co-author Erin Krebs, MD, of the Minneapolis Veterans Affairs Health Care System. 

Krebs was an original member of the “Core Expert Group” – an advisory panel that secretly helped draft the CDC opioid prescribing guidelines with a good deal of input from PROP. She also appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which coincidentally is the fiscal sponsor of PROP. 

Curiously, while Krebs and her colleagues were willing to accept poor quality evidence about the benefits of tapering, they were not as eager to accept poor evidence of the risks associated with tapering. 

“This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health symptoms,” wrote Krebs.

But the risk of suicide is not be taken lightly, as we learned in the case of Bryan Spece, a 54-year old chronic pain sufferer who shot himself to death a few weeks after his high oxycodone dose was abruptly reduced by 70 percent.  Hundreds of other pain sufferers at the Montana clinic where Spece was a patient have also seen their doses cut or stopped entirely.

Spece’s suicide was not an isolated incident, as we are often reminded by PNN readers.

“A 38 year old young lady here took a gun and put a bullet in her head after being abruptly cut off of her pain medication,” Helen wrote to us. “Her whole life ahead of her. This is happening every day, it just isn't being reported.”

“I too recently lost a friend who took his own life due to the fact that he was in constant pain and the clinic he was going to cut him off completely,” said Tony.

“I have been made to detox on my own as doctors who were not comfortable giving out these meds would take me off, not wean me,” wrote Brian. “Was a nightmare. Thought I was gonna die. No, I wanted to die.”

“In the end when you realize that you’re not going to get help and that you have nothing left, suicide is all you have,” wrote Justin, who is disabled by pain and no longer able to work or pay his bills after being taken off opioids. “I don't want to hurt my family. I don't want to die. However it is the only way out now. I just hope my family and the good Lord can forgive me.”

Patient advocates like Terri Lewis, PhD, say it is reckless to abruptly taper anyone off high doses of opioids or to aim for artificial goals such as a particular dose. She says every patient is different.

“There is plenty of evidence that persons treated with opiates have variable responses - some achieve no benefit at all.  Some require very little, others require larger doses to achieve the same benefit,” Lewis wrote in an email to PNN.

“It is an over-generalization to claim that opiates are lousy drugs for chronic pain. Chronic pain is generated from more than 200 medical conditions, each of which generate differing patterns of illness and pain generation. For some, it may be reflective of its own unique disease process. We have to retain the ability to treat the person, not the label, not to the dose.”

Patient ‘Buy-in’ Important for Successful Tapering

And what about Kolodny’s contention that high opioid doses should be reduced even if a patient refuses? Not a good idea, according to a top CDC official, who says patient “buy-in” and collaboration is important if tapering is to be successful.

“Neither (Kreb’s) review nor CDC's guideline provides support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources,” wrote Deborah Dowell, MD, a CDC Senior Medical Advisor, in an editorial in the Annals of Internal Medicine.  “Clinicians have a responsibility to carefully manage opioid therapy and not abandon patients in chronic pain. Obtaining patient buy-in before tapering is a critical and not insurmountable task.”

The CDC guideline also stresses that tapering should be done slowly and with patient input.

“For patients who agree to taper opioids to lower dosages, clinicians should collaborate with the patient on a tapering plan,” the guideline states. “Experts noted that patients tapering opioids after taking them for years might require very slow opioid tapers as well as pauses in the taper to allow gradual accommodation to lower opioid dosages.”

The CDC recommends a "go slow" approach and individualized treatment when patients are tapered.  A "reasonable starting point" would be 10% of the original dose per week, according to the CDC, and patients who have been on opioids for a long time should have even slower tapers of 10% a month.

The Department of Veterans Affairs takes a more aggressive approach to tapering, recommending tapers of 5% to 20% every four weeks, although in some high dose cases the VA says an initial rapid taper of 20% to 50% a day is needed. If a veteran resists tapering, VA doctors are advised to request mental health support and consider the possibility that the patient has an opioid use disorder.

Have you been tapered at a level faster than what the CDC and VA recommend? Let us know by leaving a comment below.

If you think you were tapered in a risky way, you can let Dr. Kolodny know at his Twitter address: @andrewkolodny.

Safeway Fined $3 Million for Painkiller Thefts

By Pat Anson, Editor

Safeway has agreed to pay a $3 million fine to settle allegations that it failed to timely report the theft of tens of thousands of hydrocodone tablets from pharmacies in Alaska and Washington state. The company also agreed to a compliance agreement with the Drug Enforcement Administration to ensure such lapses do not happen again.

The DEA learned of the hydrocodone thefts at Safeway pharmacies in North Bend, Washington and Wasilla, Alaska in April 2014, months after Safeway discovered the pills were stolen by employees. Under federal law, pharmacies are required to notify the DEA of the theft or significant loss of any controlled substance within one business day of the discovery of the theft or loss.

A DEA investigation of the case was later widened to review practices at all Safeway pharmacies nationwide between 2009 and 2014.  The investigation revealed a “widespread practice” of Safeway pharmacies failing to timely report missing or stolen controlled substances. 

“At this crucial juncture in our efforts to combat abuses of prescription drugs, it is imperative that pharmacies notify DEA immediately when drugs are stolen or missing.  A quick response to such reports is one of the best tools DEA has in stopping prescription drug diversion,” said DEA Special Agent in Charge Keith Weis.

As part of the settlement, Safeway will close a pharmacy in Belmont, CA and will suspend filling prescriptions for controlled substances for four months at a pharmacy in North Bend, WA.

“Safeway cooperated fully with government investigators throughout the investigation and remains an active partner with the DEA, local law enforcement and the communities it serves in the fight against prescription drug abuse, including the abuse of opioids,” the company said in a statement.  “Since early 2015, the Company has significantly enhanced its controlled substance monitoring program and implemented a variety of improved policies and procedures to enforce compliance with the Controlled Substances Act.”

Safeway is the latest in a string of pharmacy operators that have been fined for failing to comply with the Controlled Substances Act.

Last week CVS Health Corp agreed pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone. In January, Costco paid nearly $12 million to settle allegations that its pharmacies filled invalid prescriptions and failed to maintain accurate records at two central fill locations in Sacramento, California and Everett, Washington.

“We call on all participants in drug distribution to carefully monitor their practices to stem the flow of narcotics to those who should not have them,” said U.S. Attorney Annette L. Hayes.  “Pharmacies have a key role to play in making sure only those with legitimate prescriptions receive these powerful and potentially addictive drugs, including by timely reporting losses of those drugs.  Failure to do so hamstrings DEA’s investigative abilities and frustrates some of our best methods at curbing abuse.” 

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.

Full Court Press on Opioid Pain Medication

By Pat Anson, Editor

A full court press is a defensive basketball tactic in which a team applies relentless pressure on an opponent the entire length of the court.

This past week felt like a full court press against prescription opioids, with government regulators, politicians, and even economists weighing in on the opioid crisis – almost all of them pointing a finger of blame at pain medication.

Where to begin?

On Tuesday, sixteen U.S. senators wrote a letter to the head of the Drug Enforcement Administration asking the agency to make further cuts in the production of hydrocodone, oxycodone and other opioid pain medications in 2018. The DEA has already reduced the supply of Schedule II opioids by 25 percent or more in 2017.

The letter, which was signed by 15 Democrats and one independent -- many from states where deaths from heroin and illicit fentanyl have eclipsed those from painkillers -- doesn’t even mention the role of illegal drugs in the overdose crisis, pinning the blame solely on pain medication.

“In order to effectively combat this raging crisis, stakeholders -- especially our federal oversight agencies -- must use every tool available to prevent the flood of addictive narcotic painkillers onto the market that can result in misuse, abuse, and diversion,” said the letter.

On Thursday, the Food and Drug Administration signaled that it was prepared to use some of those tools. An FDA funded report by the National Academies of Sciences, Engineering, and Medicine called for a national campaign to combat the opioid crisis, including more aggressive regulation of opioid medications and a “cultural change” in the way they are prescribed.

At the same time, the report warned that the illicit and prescription drug markets are "intertwined" and that "regulatory efforts designed to reduce harms associated with the use of prescription opioids may be contributing to
increased heroin use."

FDA commissioner Scott Gottlieb, MD, welcomed the report with a lengthy statement that completely ignored the role of heroin and illicit fentanyl in the opioid crisis.

“I’ve asked my FDA colleagues to take a fresh look at some key features of the agency’s regulation of opioids, including provider education, benefit-risk assessment in the pre- and post-market setting, and steps we can take to reduce overall exposure to these drugs,” Gottlieb said.

‘Extreme Amount’ of Opioids Prescribed

Also on Thursday, the Department of Health and Human Services’ Office of Inspector General (OIG) published a widely cited and inflammatory report claiming that over half a million Medicare beneficiaries were receiving high doses of prescription opioids.  The estimate is based on the premise that a daily morphine equivalent dose (MME) greater than 120 mg is a “high amount” and a dose of 240 mg or more is an “extreme amount.”

Those would be high doses for most pain patients, but not for Rick Martin, a retired Nevada pharmacist disabled by severe chronic back pain. Martin says he needs up to 300 mg (MME) of opioids daily just to be able to stand and walk for any length of time.

“I am really really incensed about the OIG using the word ‘extreme’ in defining people who take greater than 240 MME/day.  This is shouting fire in the movie theater,” Martin wrote in an email to PNN. “Patients who have long term persistent pain are where they are due to the medical community failing to correctly diagnose and treat what is causing the pain in the first place.  

“So in the OIG's eyes, not only am I a chronic pain patient on long term monitored opioid prescription medications, I am now considered EXTREME ! What a degrading moniker that is. In 6 months, I'll be called an EXTREME OPIOID ABUSER.  That's the next level to come down the pike.”

Like the senators’ letter to the DEA and the FDA study, the OIG report virtually ignores the illegal drug trade, instead blaming patients and providers for the opioid crisis. The report estimates that 400 doctors have “questionable” prescribing practices and 22,000 Medicare beneficiaries are doctor shopping.

“The extreme use of opioids and apparent doctor shopping described in this study put beneficiaries at risk and may indicate that opioids are being prescribed for medically unnecessary purposes and then diverted for resale or recreational use. It may also indicate that beneficiaries are receiving poorly coordinated care,” the report says.

On Thursday, the Justice Department also announced a nationwide crackdown on health insurance fraud and the illegal distribution of prescription opioids. Over 400 people were arrested nationwide, including many doctors, nurses and healthcare providers.

"While today is a historic day, the Department's work is not finished. In fact, it is just beginning. We will continue to find, arrest, prosecute, convict, and incarcerate fraudsters and drug dealers wherever they are,” warned Attorney General Jeff Sessions.

Opioid Crisis Affecting Job Market

Surprisingly, it was left to economists to take a more nuanced view of the opioid crisis – noting there are many other factors involved besides pain medication

Federal Reserve chair Janet Yellen told the Senate Banking Committee that economic despair was one reason that the labor force participation rate remains stubbornly low, despite declines in the unemployment rate.

“Unfortunately this is likely tied to the opioid crisis, the problems that many communities have. We’ve seen an increase in death rates due to despair, suicide, drugs in these communities,” Yellen said, adding that the United States is "the only advanced nation that I know of where in these communities we're actually, especially among less-educated men, seeing an increase in death rates partly reflecting opioid use."

Yellen was reacting in part to a Goldman Sachs report  which blamed opioids of all kinds – both legal and illegal – for keeping millions of Americans unemployed during their prime working years.

“Use of both legal prescription pain relievers and illegal drugs is part of the story of declining prime-age participation, especially for men,” economist David Mericle wrote in a research note that attributed a spike in overdoses to “heroin and illicit fentanyl users, most of whom previously used prescription opioids but switched to these cheaper, more accessible drugs.”

Trump Opioid Commission Delays Report

Curiously silent during a week full of opioid news was the White House Office of National Drug Control Policy, which quietly postponed the second meeting of President Trump’s Opioid Commission.  A notice published in the Federal Register Friday said the commission’s second meeting has been postponed until July 31, the second time the meeting has been rescheduled.  No explanation for the delay was given.

Also delayed was the commission’s interim report on how the federal government should address the opioid crisis, which is now over a month overdue.

At the commission’s first meeting in June, testimony was taken only from government officials and addiction treatment advocates. Pain management experts and patient advocates were not asked to appear, nor are they represented on the commission itself.

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.

16 Senators Urge DEA to Lower Opioid Supply Again

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

Drug Maker Pays $35 Million Fine for Opioid Sales

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

CVS to Pay $5 Million Fine

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

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

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

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

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

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

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

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

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

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

From Bad to Worse: The Future of the Opioid Crisis

By Roger Chriss, Columnist

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

PROP Urges Members to Oppose FDA Opioid Strategy

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Drug Maker to Stop Sales of Opana ER

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

CDC: Opioid Prescribing Peaked in 2010

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

AVERAGE DAILY PER CAPITA MORPHINE EQUIVELANT DOSE (MME)

Source: CDC/QuintilesIMS

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

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