Opioid Addiction Rates Redux

By Roger Chriss, PNN Columnist

The Oklahoma opioid trial is garnering attention for what could be a pivotal role in determining the liability of Johnson & Johnson and other drug makers in the opioid crisis. A key point hinges on a seemingly simple question: What percentage of people on long-term opioid therapy develop addiction?

Dr. Timothy Fong, a UCLA psychiatrist and defense expert, refuted claims by prosecution witness Dr. Andrew Kolodny that people who take opioid pain medication over extended periods have a 25% chance of becoming addicted. Fong said other studies suggest that patients who take opioids over long periods might have addiction rates closer to 1 to 3 percent.  

There is an extensive literature on these estimates, including NIH studies and published research from leading experts. I covered some of them in a PNN column last year (see “How Common Is Opioid Addiction?”)

“The best and most recent estimate of the percentage of patients who will develop an addiction after being prescribed an opioid analgesic for long-term management of their chronic pain stands at around 8 percent,” NIDA director Nora Volkow, MD, told Opioid Watch.

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Why are there so many different estimates? There is an important distinction between the incidence and prevalence of a medical condition. Briefly, incidence represents the probability of occurrence of a given medical condition in a population within a specified period of time. In contrast, prevalence gives the proportion of a particular population found to be affected by a medical condition.

The distinction is not just semantics and is critical in epidemiology. As explained in Physiopedia, “incidence conveys information about the risk of contracting the disease, whereas prevalence indicates how widespread the disease is.”

Besides obvious difficulties in determining incidence (the necessary clinical trials will never receive approval) and measuring prevalence (the required public health monitoring is well beyond our current capability), we instead have to rely on proxy measures derived from prescription drug databases, medical records and surveys.

We also have to make decisions about the “specified period of time” when determining incidence and the assessment of the “medical condition’ for prevalence.

There is no universally agreed upon time frame for the development of addiction or opioid use disorder after opioid initiation, whether medical or non-medical. Similarly, the definition of opioid use disorder has evolved over the years.

Further, in many cases incidence and prevalence are calculated based on assumptions made by researchers. For instance, in an Annual Review of Public Health article co-authored by Dr. Kolodny, a 2010 study is cited that found 26% of chronic pain patients met the criteria for opioid dependence and 35% met the criteria for opioid use disorder. This seems to be the source of the 25% claim used by Kolodny in the Oklahoma opioid trial.

But the 2010 study doesn’t distinguish between incidence and prevalence. It is also not clear how many of the surveyed pain patients had an opioid use disorder diagnosis before the onset of medical opioid therapy.

A similar critique can be levied against the authors of a 1980 letter in The New England Journal of Medicine that claimed opioid addiction was rare in pain patients. Some have claimed publication of the letter helped launch the opioid crisis. 

The problem with all of these studies is that they are retrospective in nature, limited to a particular patient population, and constrained by the diagnostic criteria in use at the time. And the estimates derived from such studies do not necessarily implicate or exonerate Johnson & Johnson.

Moreover, it is possible that addiction rates have varied over time and were influenced by factors that were not yet understood or even known. For example, recent research has found an association between opioid overdoses and drug diversion among family and friends, cold weather, altitude above sea level, and medical cannabis legalization.

The NIH work that Dr. Volkow refers to in her Opioid Watch interview works to account for all of these factors. So as Volkow stated last year, the “best and most recent estimate" stands at about eight percent. Improved public health surveillance, epidemiological research, and patient monitoring may shift this number up or down, and will increase confidence in the estimate.

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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.

Overdoses Soar in 2 States Despite Fewer Rx Opioids

By Pat Anson, PNN Editor

New studies from two of the states hardest hit by the opioid crisis – Massachusetts and Pennsylvania -- are throwing a damper on recent speculation that drug overdoses may have peaked.  

Researchers at Boston Medical Center released a startling study that found nearly 5 percent of people over the age of 11 in Massachusetts have an opioid use disorder.

The Drug Enforcement Administration also admitted in a Joint Intelligence Report that reducing the supply of prescription opioids in Pennsylvania failed to reduce the state’s soaring overdose rate and may have even increased demand for counterfeit painkillers. Pennsylvania had 5,456 fatal overdoses in 2017, a 65% increase from 2015.  

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“Implementation of legislation influencing prescription opioid prescribing has resulted in a decrease in availability; however, a corresponding decrease in demand is less certain,” the DEA report found.

“Practitioners may be offering non-opioid alternatives to pain management to their patients, but this is most likely due to increased scrutiny of prescribing habits, as well as legislated changes, not due to requests from patients seeking non-opioid products.”

Prescription opioids were involved in only 20% of Pennsylvania’s overdoses. Most of the deaths involve a combination of illicit drugs such fentanyl, heroin, cocaine and counterfeit medication.

“The increasing presence of counterfeit opioid CPDs (controlled prescription drugs) in Pennsylvania is an indicator of strong demand for opioid CPDs in the illicit market. Traffickers use substances such as heroin, fentanyl, and tramadol to create tablets that look like the opioid CPDs most commonly purchased on the street (e.g., oxycodone 30 milligram tablets). The tablets are often exact replicas with the shape, coloring, and markings consistent with authentic prescription medications,” the report found.

The DEA said heroin and fentanyl could be found in 97% of Pennsylvania’s counties and called the city of Philadelphia a “wholesale market” for illicit drugs from China and Mexico.

Opioid Use Disorder in Massachusetts

Illicit fentanyl is also blamed for a soaring number of fatal overdoses in Massachusetts, where researchers used a new method to estimate how many people have opioid use disorder (OUD).  

Instead of relying on insurance claims for addiction treatment, researchers used a database that links information from 16 state agencies on other forms of healthcare use. Researchers were then able to identify patients who have OUD and estimate those who have the disorder but aren't seeking treatment. Individuals with substance use disorders are often less likely to seek medical care or be insured. Many are also reluctant to admit they have a drug problem.  

"There are many people with opioid use disorder who do not encounter the health care system, which we know is a barrier to understanding the true impact of the opioid epidemic," said Joshua Barocas, MD, an infectious disease physician at Boston Medical Center, who was lead author of the study published in the American Journal of Public Health.

Barocas and his colleagues found the prevalence of opioid use disorder in Massachusetts rose from 2.72% in 2011 to 4.6% in 2015. People between the ages of 11 and 25 experienced the greatest increase in OUD – a demographic much younger than a typical chronic pain sufferer, who is usually middle aged.

In 2012, Massachusetts was one of the first states where insurers and healthcare providers took steps to reduce the supply of prescription opioids – measures that have yet to have any meaningful impact on the state’s overdose rate.  

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

Massachusetts was also one of the first states to use toxicology screens from coroners and medical examiners to get a more accurate assessment of the drugs involved in overdoses.

According to the most recent report from the first quarter of 2018, nearly 90% of Massachusetts overdoses involve fentanyl, 43% percent involve cocaine, 42% involve benzodiazepines and 34% involve heroin. Prescription opioids were involved in only about 20% of the Massachusetts overdoses, the same rate as Pennsylvania.

Preliminary estimates released by the CDC last week show a modest 2.3% nationwide decline in opioid overdoses from September 2017 to March 2018. Over 48,000 people died from opioid overdoses during that period, with most of those deaths involving illicit fentanyl, heroin and other street drugs.

Addiction to Rx Opioids Falling

By Pat Anson, Editor

A new report from health insurance giant Blue Cross Blue Shield highlights a little-known and rarely reported aspect of the opioid crisis: Addiction to opioid pain medication is declining, not increasing.

Blue Cross Blue Shield (BCBS) said 241,900 of its members were diagnosed with opioid use disorder (OUD) in 2017, a rate of 6.2 for every 1,000 BCBS members. The rate fell to 5.9 in 1,000 members in 2017, a decline of nearly 5 percent. The insurer said it was the first drop in the eight years BCBS has tracked diagnoses of OUD.

"We are encouraged by these findings, but we remain vigilant," said Trent Haywood, MD, senior vice president and chief medical officer for BCBS said in a statement.

"More work is needed to better evaluate the effectiveness of treatment options and ensure access to care for those suffering from opioid use disorder."

BCBS attributes much of the decline to a 29% drop in opioid prescriptions for its members since 2013.  A longtime critic of opioid prescribing hailed the findings as a sign of change.

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"It means that there's light at the end of the tunnel," psychiatrist Andrew Kolodny, MD, the founder and executive director of Physicians for Responsible Opioid Prescribing (PROP) told BuzzFeed.

"Unfortunately though, the genie is out of the bottle," said Kolodny, a former medical director of the addiction treatment chain Phoenix House. "Millions of Americans are now struggling with opioid addiction. Unless we do a better job of increasing access to effective treatment, overdose deaths will remain at record high levels and we'll have to wait for this generation to die off before the crisis comes to an end."

Admissions for Addiction Treatment

The BCBS numbers should be taken with a grain of salt, since they include all types of opioid addiction, including those linked to heroin, illicit fentanyl and prescription opioids. A more accurate way to track addiction to opioid medication would be admissions to publicly-funded treatment facilities for “non-heroin opiates/synthetic abuse” – a category that excludes heroin, but includes hydrocodone, oxycodone, fentanyl and other painkillers.

A database maintained by the Substances Abuse and Mental Health Services Administration (SAMHSA) shows that treatment admissions for prescription opioids peaked in 2011 at 193,552 admissions and fell to 121,363 by 2015 – a significant decline of over 37 percent. It seems likely that admissions for painkiller abuse have fallen even further since 2015, as opioid prescriptions have continued to plummet, and more pain patients are abandoned or denied treatment.

The SAMHSA data also reveals another trend: While the number of people seeking treatment for painkiller, alcohol and marijuana abuse has declined, admissions to treatment facilities for heroin addiction have soared. In 2010, there were 270,564 admissions in which heroin was identified as the primary substance of abuse. By 2015, that number had grown to 401,743 admissions – an increase of nearly a third.

ADMISSIONS TO ADDICTION TREATMENT FACILITIES

SOURCE: SAMHSA

Admissions for heroin addiction now surpass those for other substances, yet much of the nation’s spending and law enforcement resources remain targeted on opioid prescriptions. Many public health officials also cling to the myth the heroin epidemic was triggered by opioid overprescribing, even though heroin admissions outnumber painkiller admissions by a 3 to 1 margin.

“Epidemiological data show that as widely prescribed opioids became less accessible due to supply side interventions, heroin use skyrocketed,“ psychiatrist Nora Volkow, MD, director of the National Institute on Drug Abuse, recently told OpioidWatch.  Volkow was an early supporter of the CDC opioid guideline, one of the first supply side interventions, a strategy that she now characterizes as "naive."

“Expecting that declines in rates of prescribed opioids could, by themselves, stem the tide of the opioid crisis is naïve and an oversimplification of the complex nature of the crisis," Volkow said. "Legitimate questions have been raised about whether some pain patients might now be undertreated, and whether tightened prescribing practices over the last few years has contributed to the surge in overdose deaths from heroin and especially fentanyl.”

A recent study by SAMHSA found that deaths linked to illicit fentanyl and other synthetic opioids surpassed overdoses involving pain medication in 2016.  The study also found that drugs used to treat depression and anxiety are involved in more overdoses than any other class of medication.

What is Opioid Use Disorder?

By Rochelle Odell, Columnist

You’ve probably heard or seen the phrase “Opioid Use Disorder.”  It’s a broad term currently being used to describe not only opioid addiction, but patterns of behavior that might be a sign of addiction or could lead to it.

If that sounds like they’re putting the cart before the horse, it’s because they are.

In order to understand Opioid Use Disorder, one must understand the government's stance on opioids. The National Institute on Drug Abuse – which is part of the National Institutes of Health (NIH) – lays it out in a recently revised statement on the opioid crisis:

“Every day, more than 90 Americans die after overdosing on opioids. The misuse of and addiction to opioids--including prescription pain relievers, heroin and synthetic opioids such as fentanyl--is a serious national crisis that affects public health as well as social and economic welfare."

Notice how they lump prescription pain relievers in with heroin and illicit fentanyl?  The more I research, the more I find this common thread of illogical thinking. The government consistently lumps pain medication in with illicit drugs.

Here’s another example from the NIH: 

“In 2015, more than 33,000 Americans died as a result of an opioid overdose, including prescription opioids, heroin, and illicitly manufactured fentanyl, a powerful synthetic opioid.

That same year, an estimated 2 million people in the United States suffered from substance use disorders related to prescription opioid pain relievers, and 591,000 suffered from a heroin use disorder.”

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Substance use disorders “related” to pain relievers? Heroin use disorder? That got me wondering how many drug “disorders” there are.

According to the Substance Abuse and Mental Health Services Administration (SAMSHA), there are six major substance use disorders. Nearly 93,000,000 Americans have a substance use disorder of some kind:

1) Alcohol Use Disorder (AUD): About 17 million Americans have AUD. According to the CDC, alcohol causes 88,000 deaths a year. 

2) Tobacco Use Disorder: Nearly 67 million Americans use tobacco. According to the CDC, cigarette smoking causes more than 480,000 deaths a year.

3) Cannabis Use Disorder: Over 4 million Americans meet the criteria for a substance use disorder based on their marijuana use. No estimate is provided on the number of deaths caused by marijuana, if any.

4) Stimulant Use Disorder:  This covers a wide range of stimulant drugs that are sometimes used to treat obesity, attention deficit hyperactivity and depression. The most commonly abused stimulants are amphetamine, methamphetamine and cocaine. Nearly 2 million Americans have a stimulant use disorder of some kind.

5) Hallucinogen Use Disorder: This covers drugs such as LSD, peyote and other hallucinogens. About 246,000 Americans have a hallucinogen use disorder.

6) Opioid Use Disorder: Again, this covers both illicit opioids and prescription opioids. In 2014, an estimated 1.9 million Americans had an opioid use disorder related to prescription pain relievers and 586,000 had a heroin use disorder (notice the SAMSHA numbers are somewhat different from what the NIH tells us).

But what exactly is Opioid Use Disorder?  Does it mean 2.5 million Americans are addicted to opioids?

No.

The diagnostic codes used to classify mental health disorders were revised in 2013 to cover a whole range of psychiatric symptoms and treatments. Two disorders – “Opioid Dependence” and “Opioid Abuse” -- were combined into one to give us “Opioid Use Disorder.” Few recognized at the time the significance of that change, it's impact on pain patients, or how it would be used to inflate the number of Americans needing addiction treatment.

Elizabeth Hartley, PhD, does a good job explaining what Opioid Use Disorder is in an article for verywell.

Hartley wrote that Opioid Use Disorder can be applied to anyone who uses opioid drugs (legal or illegal) and has at least two of the following symptoms in a 12 month period:

  • Taking more opioids than intended
  • Wanting or trying to control opioid use without success
  • Spending a lot of time obtaining, taking or recovering from the effects of opioids
  • Craving opioids
  • Failing to carry out important roles at home, work or school because of opioid use
  • Continuing to use opioids despite relationship or social problems
  • Giving up or reducing other activities because of opioid use
  • Using opioids even when it is unsafe
  • Knowing that opioids are causing a physical or psychological problem, but using them  anyway
  • Tolerance for opioids.
  • Withdrawal symptoms when opioids are not taken.

The last two criteria will apply to almost every chronic pain patient on a prescription opioid regimen. So might some of the others. Most of us develop a tolerance for opioids, and if they are stopped or greatly reduced, we will experience withdrawal symptoms.  We simply cannot win for losing. 

If you learn your physician has diagnosed you with Opioid Use Disorder, be sure to ask them what criteria were used and why was it selected. Ask if you should see a doctor more knowledgeable about diagnostic codes and psychiatric disorders. 

Remember, knowledge is power. Take this information with you on your next visit to the doctor if you suspect you have been diagnosed with Opioid Use Disorder and your medications have been cut or reduced.

I hope what I have written helps you further understand exactly what we are facing and why. To be honest, it makes me want to wave the white flag, but I know that cannot happen.  We have to fight. Fight for proper care for a chronic disease or condition we didn't ask for or want. We can’t live the rest of our lives in severe, debilitating pain when effective treatment is available.  

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

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

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

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.

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.