Lessons from ‘The United States of Opioids’

By Roger Chriss, PNN Columnist

Harry Nelson’s new book “The United States of Opioids: A Prescription for Liberating a Nation in Pain” looks closely and productively at the opioid overdose crisis. It comments on origins and causal factors, and offers pragmatic policy ideas for addressing it. The book is succinct and well-organized, designed for easy reading and reference.

Nelson starts with a dire description of addiction and overdose, calling the U.S. opioid crisis “American healthcare’s self-inflicted wound.” He then gives a brief history of opioids, explaining the three waves of the crisis, culminating in illicit fentanyl and “an increasing crackdown on physician overprescribing.”

Nelson touches on the history and science of opioids, then looks at causes of the crisis. These include not only Purdue Pharma and the Sacklers, but also drug distributors, retailers and health insurers. Institutional and regulatory failures on opioids are not ignored.

“The overarching problem when it comes to physician overprescribing has been insufficient training and education on how to prescribe opioids,” he writes. “The FDA approved these drugs and oversaw the data concerning the risks of their misuse, abuse, addiction, and overdose.”

But Nelson digs deeper, looking at the underlying social and cultural determinants that play into the longer term. He cites a 2018 University of Pittsburgh study that underscores that opioids are part of a broader trend in which abuse of multiple drugs and a rising drug overdose rate “that shows no signs of slowing, with sub-epidemics of different drugs over time.”

Unlike other books, Nelson writes in depth about how to address the crisis: “I believe that our attention should first be focused on a host of intersecting trends that point to suffering in America — parallel crises that include suicidality, anxiety, depression, and pain.”

He explores other options for pain management, from NSAIDs and nerve blocks to non-pharmacological techniques: “It is critical to push insurers and government programs to cover non-opioid treatment, even if it means spending more to achieve this priority.”

Nelson includes a whole chapter on cannabis and other alternative therapies for opioid addiction, in particular kratom and psychedelics. He is optimistic but tentative about cannabis: “Despite the potential to address health issues, consumers need to be cautious about both the claims and contents of cannabis products.”

He also looks at addiction treatment, including AA-type abstinence programs and medication-assisted therapy, and notes that “the biggest challenge in addiction treatment is the complexity of addiction itself.”

Nelson is highly critical of much of the response to the crisis to date: “When I think about the government and health system’s approach for taking on the opioid crisis, the thing that strikes me most is how much it feels tactical rather than strategic.”

Nelson condemns the rampant fraud and patient brokering in the recovery industry. But he also points out that addiction treatment itself needs improvement.

“We will know that addiction treatment has ‘arrived’ in terms of its integration into healthcare when we have relatively uniform professional and program licensure requirements from state to state — something seemingly decades away,” he wrote.

Nelson lists seven general recommendations for the crisis in his OPIOIDS acronym:

  • Outreach for prevention and early intervention

  • Physician improvements

  • Innovation in pain and addiction care

  • Overdose interventions

  • Interdiction off illicit opioids

  • Data analytics to better track the crisis

  • Strengthening access to addiction care

He emphasizes the value of harm reduction, improving social capital, and organizing prevention in schools and the workplace — instead of “stop gap” measures that do little beyond preventing fatal overdoses.

“The key to solving the opioid crisis lies in not being satisfied with tackling the overdose death issue, but in addressing two of the fundamental problems that got us here: the inadequate management of ongoing issues for people living with chronic pain, which overlaps with the second problem of people living with an opioid use disorder (OUD),” he writes.

Finally, Nelson gives a warning: “If we think about the opioid crisis as the ‘canary in the coal mine,’ it’s warning us that we need to address a much bigger, toxic set of problems.”

For all the book offers, it also has problems. Nelson overstates the number of people with opioid use disorder, misrepresents the complex nature of opioid initiation, and misconstrues the varied trajectory of heroin addiction. Most importantly, Nelson gives little attention to rising rates of cocaine and methamphetamine overdose deaths, and ignores that most overdoses involve multiple drugs.

“The United States of Opioids” offers a suite of tools and ideas for moving forward, a refreshing change from the many righteous rants or poignant laments about the crisis.

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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.

Gabapentinoids Raise Risk of Suicide and Overdose in Younger People

By Pat Anson, PNN Editor

Gabapentinoids – a class of nerve medication widely prescribed to treat chronic pain – increase the risk of suicide, overdose, traffic accidents and head or body injuries in younger people, according to a large new study published in The British Medical Journal.

Sales of the two main gabapentinoids, pregabalin (Lyrica) and gabapentin (Neurontin), have tripled in recent years in the United States, where they are often promoted in prescribing guidelines as safer alternatives to opioids.

A team of researchers followed nearly 192,000 people enrolled in the Swedish Prescribed Drug Register who filled prescriptions for gabapentinoids on at least two consecutive occasions from 2006 to 2013. That information was compared to data in the Swedish Patient Register, which collects information on hospital admissions and outpatient care, as well as the Swedish Cause of Death Register.

Over the study period, researchers found that patients taking gabapentinoids had higher rates of suicide or suicidal behavior (5.2%), unintentional overdose (8.9%), traffic accidents (6.3%) and head or body injuries (36.7%) than the general population.

The risks were strongest for people who were prescribed pregabalin and were most pronounced among adolescents and young adults aged 15 to 24.  Patients aged 55 and older taking gabapentinoids were not at greater risk.

Researchers believe the drugs may have more impact on younger people because they have faster metabolisms, which could lead to withdrawal problems that affect their impulsivity and emotions.

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“Overall, gabapentinoids seem to be safe for a range of outcomes in older people. However, the increased risks found in adolescents and young adults prescribed gabapentinoids, particularly for suicidal behaviour and unintentional overdoses, warrant further research,” said lead author Seena Fazel, MD, of the University of Oxford in England.

“If our findings are triangulated with other forms of evidence, clinical guidelines may need review regarding prescriptions for young people, and those with substance use disorders. Further restrictions for off-label prescription may need consideration.”

Pregabalin is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries; while gabapentin is approved for epilepsy and post-herpetic neuralgia. Both drugs are also widely prescribed off-label to treat back pain, depression, migraine and other chronic conditions.

Gabapentinoids are increasingly being used recreationally by addicts who have found the medications enhance the effects of heroin and other opioids. The drugs were recently classified as controlled substances in the UK.

Gabapentin is not currently scheduled as a controlled substance by the DEA, while Lyrica is classified as a Schedule V controlled substance, meaning it has low potential for addiction and abuse.  

A recent clinical review found little evidence the drugs should be used off-label to treat pain and that prescribing guidelines often exaggerate their effectiveness. The CDC’s controversial opioid guideline, for example, calls gabapentin and pregabalin “first-line drugs” for neuropathic pain.

“Despite documentation that these drugs were promoted improperly for off-label treatment of pain, the recent rapid increase in prescribing of gabapentinoids suggests a persisting sense among clinicians that gabapentinoids are highly effective pain medications,” wrote Christopher Goodman, MD, and Allan Brett, MD, of the University of South Carolina School of Medicine.

“Guidelines and review articles have contributed to this perception by often uncritical extrapolation from FDA-approved indications to off-label use.”

Prescription Opioids Play Minor Role in Massachusetts Overdoses

By Pat Anson, PNN Editor

Two new studies in Massachusetts – one of the states hardest hit by the overdose crisis – highlight the role of multiple substances in most overdose deaths and how limiting the supply of prescription opioids has failed to reduce the number of drug deaths.

Researchers at Boston Medical Center's Grayken Center for Addiction analyzed toxicology reports on nearly 2,250 fatal overdoses involving opioids in Massachusetts between 2014 and 2015. Overdose data in Massachusetts is considered more reliable because it is one of the few states to extensively use toxicology testing.

Only 9 percent of the deaths in Massachusetts involved prescription opioids alone. Most of the overdoses (72%) involved illicit fentanyl or heroin, while one in five (19%) involved a combination of heroin, fentanyl or prescription opioids.

Other substances such as alcohol, marijuana, stimulants (cocaine and methamphetamine) and non-opioid medications (benzodiazepines and gabapentin) were also frequently involved.

“Using multiple substances, in addition to opioids, is the rule rather than the exception for opioid-related deaths,” researchers reported in the journal Drug and Alcohol Dependence.

“Our study draws attention to the heterogeneity of the problem at hand and that there is not a one-size-fits-all approach to addressing the overdose epidemic, which is increasingly driven by polysubstance use.”

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Over half of the Massachusetts overdoses involved someone with a diagnosed mental illness. Homelessness and a recent incarceration also raised the risk of a fatal overdose involving both opioids and stimulants.

"As a provider, these findings indicate a pressing need to address and treat not just opioid use disorder, but other substances that patients are misusing," said lead author Joshua Barocas, MD, an infectious disease physician at BMC. "To truly make a difference in reducing opioid overdose deaths, we must tackle issues such as homelessness and access to mental health services. This means not only investing in treatment but also implementing tailored programs that address the specific barriers to accessing care."

Opioid Prescriptions Down 39% since 2015

The number of opioid prescriptions has declined significantly in Massachusetts over the last four years, according to a recent report from the state’s Department of Public Health. In the first quarter of 2019 there were over 518,000 prescriptions filled for Schedule II opioids such as hydrocodone and oxycodone – a 39% decline from the first quarter of 2015.

But the decrease in prescriptions has failed to make much of a dent in Massachusetts’ opioid overdose rate, which peaked in 2016 with 2,100 deaths and remains stubbornly high.  

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

In 2018, nearly nine out of ten opioid-related deaths (89%) in the state involved illicit fentanyl, with cocaine (39%), heroin (32%), and benzodiazepines (40%) such as Xanax also commonly found.

Only about ten percent of the overdose deaths in the fourth quarter of 2018 involved prescriptions opioids, virtually unchanged from the 2014-2015 study.

Heroin and Fentanyl Fueling Veteran Overdoses, Not Rx Opioids

By Pat Anson, PNN Editor

The U.S. Department of Veterans Affairs has taken a number of steps in recent years to reduce opioid prescribing for military veterans and their families. In 2015, the VA adopted the CDC opioid guideline before it was even finalized. Two years later, the agency adopted a clinical practice guideline for VA doctors that strongly recommends against prescribing opioids to patients for more than 90 days.

Both measures were intended to address “mounting concerns about prescription drug abuse and an overdose epidemic among veterans.”

But a new study has found that the “epidemic” of opioid overdoses among veterans is not fueled by prescriptions opioids – but by heroin, illicit fentanyl and other synthetic opioids obtained on the black market.

Researchers at the University of Michigan and VA Ann Arbor Healthcare System reported in the American Journal of Preventive Medicine that overdose deaths from all opioids increased by 65 percent for veterans from 2010 to 2016. But when then looked closer at prescription data on nearly 6,500 veterans who died, they found an unexpected trend.

"The percentage of veterans who had received an opioid pain prescription in the year before their opioid overdose death dropped substantially over this time period," says lead author Allison Lin, MD, an addiction psychiatrist at the VA Ann Arbor.

In 2010, half of the veterans who died of any opioid overdose had filled an opioid prescription in the three months before they died, and two-thirds had filled a prescription in the last year.

But by 2016, only a quarter of those who overdosed had filled an opioid prescription in the last three months, and 41 percent had done so in the past year.

At the same time, the death rate from heroin or from taking multiple opioids nearly quintupled, and the death rate from synthetic opioids such as fentanyl rose more than five-fold.

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“Interventions on opioid overdose prevention have often focused on those receiving opioid prescriptions; if we're only screening for risk in that population, this shows we will miss a lot," said Lin. "We really have to think about opioid overdose prevention and substance use disorder treatment more broadly, to determine where the greatest unmet need is, increase treatment access and accessibility, and improve outcomes."

The VA provides health services to 6 million veterans and their families. Over half the veterans being treated at VA facilities suffer from chronic pain, as well as other conditions that contribute to it, such as depression and post-traumatic stress disorder.

A 2016 study of veterans found a strong link between heroin use and the non-medical use of prescription opioids. Having a long-term prescription for opioids to treat chronic pain was not found to be a significant risk factor for heroin use.

Record Decline in Opioid Prescriptions

By Pat Anson, PNN Editor

Often lost in the debate over opioid medication is that prescriptions for the drugs have been falling for years — a trend that appears to be accelerating. The volume of prescription opioids dispensed in the U.S. last year fell 17 percent, the largest annual decline ever recorded, according to a new study by the health analytics firm IQVIA. Opioid prescriptions have dropped 43% since their peak in 2011.

“Decreases in prescription opioid volume have been driven by changes in clinical use, regulatory and reimbursement policies and legislation, all of which have increasingly restricted prescription opioid use since 2012,” the report found.

The biggest drop was in high dose opioid prescriptions of 90 MME (morphine milligram equivalent) or more, which account for 43% of the decline. Low dose prescriptions of 20 MME or less have remained relatively stable, falling just 4 percent.

While opioid prescriptions have fallen significantly, addiction and overdose rates continue to soar, fueled in large part by illicit fentanyl, heroin and other black market opioids.

“We saw many more people receiving medication-assisted treatment (MAT) for opioid addiction. Our research shows new therapy starts for MATs increased to 1.2 million people in 2018, nearly a 300 percent increase compared with those seeking addiction help in 2014,” said Murray Aitken, IQVIA senior vice president.

“This is an important indicator of the effects of increased funding and support for treatment programs to address addiction.”

A recent report by the Bipartisan Policy Center estimates the federal government spent nearly $11 billion since 2017 subsidizing the addiction treatment industry, much of it spent on MAT drugs such as buprenorphine (Suboxone).

Drug maker Indivior recently reported the buprenorphine market had double digit growth in the first quarter of 2019, and that “growth continues to be driven primarily by Government channels.”

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Hydrocodone Prescriptions Drop

For the 7th consecutive year, prescriptions fell for hydrocodone-acetaminophen combinations such as Vicodin, Lortab and Norco. Once the #1 most widely dispensed drug in the nation, hydrocodone now ranks fifth, behind drugs used to treat thyroid deficiency, high blood pressure and high cholesterol.

Only 68 million prescriptions for hydrocodone were dispensed last year, half the number that were filled in 2011.

U.S. HYDROCODONE PRESCRIPTIONS (MILLIONS)

Source: IQVIA

Due to fears about addiction and overdose, hydrocodone was reclassified by the DEA as a Schedule II controlled substance in 2014, requiring new prescriptions for every refill.

“My hydrocodone has been cut in half and my pain is out of control. I feel like a criminal, like I am committing a crime each time I pick up my prescription. I now have to visit my doctor once a month to receive my script,” one patient told us.

“I was prescribed hydrocodone over the last couple of decades for severe chronic pain with very positive effects. Now I am unable to carry out a lifestyle for a man my age, I'm basically done/finished.  My way of life is over,” a disabled veteran wrote.

“Stop denying the patients that have real pain. I don’t use it to get high. Hydrocodone is the only thing that has helped my back pain. I’ve tried a lot of things but nothing helps. It frees me of enough of the pain that I can function like a normal person,” another patient said.

The shift away from hydrocodone and other opioids has benefited pharmaceutical companies that make non-opioid medications such as Neurontin (gabapentin) and Lyrica (pregabalin).  Prescriptions for gabapentin reached 67 million last year – nearly the same as hydrocodone.

These trends have yet to show much benefit for pain patients, who increasingly report their pain is poorly treated. In a recent PNN survey of nearly 6,000 patients, over 85% said their pain and quality of life are worse since the release of the CDC opioid prescribing guideline. One in five say they are hoarding opioid medication because they fear losing access to it in the future.

More Overdoses Blamed on Kratom

By Pat Anson, PNN Editor

A new analysis by the Centers for Disease Control and Prevention lists the herbal supplement kratom as the cause of death in at least 91 overdoses in the U.S. from 2016 to 2017.  Multiple substances were involved in the vast majority of those cases, with over half of the deaths also linked to fentanyl, a synthetic and potent opioid that has become a scourge on the black market.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever. In recent years kratom has grown in popularity in the U.S. as a treatment for chronic pain, addiction, depression and anxiety.  

Although kratom is not an opioid, public health officials have warned that it has “opioid-like” qualities, can be addictive and is not approved for any medical condition.

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In the new study, CDC researchers analyzed over 27,000 fatal overdoses in 27 states between July 2016 and December 2017. Kratom was determined to be the cause of death by a medical examiner or coroner in 91 overdoses, with multiple substances detected in all but seven of them.

Heavy Drug Use

Most of those who died were apparently heavy drug users. In nearly 80 percent of the kratom-involved deaths, the decedents had a prior history of substance misuse and 11% had survived a previous overdose.  Fentanyl or fentanyl analogs were co-listed as a cause of death in 56% of the kratom-involved deaths. Heroin was co-listed in about a third of the kratom cases, followed by benzodiazepines (22%), a class of anti-anxiety medication, prescription opioids (20%) and cocaine (18%).

“I’m actually pleased that they are recognizing that when kratom is present in a decedent, it is usually with other substances. Instead of blaming kratom as the cause of death, it points to polysubstance use,” said Jane Babin, PhD, a molecular biologist and patent attorney. “If someone takes a lethal dose of fentanyl plus kratom, it is unreasonable to conclude that kratom was the cause of death.  The same could be said of a lethal dose of fentanyl plus anything else – cannabis, coffee, Tylenol, etc.  This is the same situation in many ‘opioid related’ deaths, where multiple substances are present.”

Babin has worked as a consultant to the American Kratom Association, an advocacy group of kratom vendors and consumers. She has disputed previous reports of kratom overdoses – attributing them to faulty lab tests and inexperienced coroners.

“When a coroner can’t find an obvious physical cause of death, they pin the death on kratom even though they don’t have a link between the cause and manner of death and what is known about kratom pharmacology,” Babin wrote in an email to PNN. “I think the bigger question that CDC and FDA need to address is why do these people take so many different substances, including prescription medications?  

“The answer is not simple and there is no quick fix.  It is easier to blame kratom or opioids and focus on those instead of addressing the complex problems of pain, mental illness and the circumstances of life that lead people to take multiple substances.  At least they ‘look’ like they are doing something.”

It was another CDC report in July 2016 that laid the groundwork for an attempted ban on kratom. The report called kratom "an emerging public health threat" due to a modest increase in the number of kratom-related calls to poison control centers. The following month, the Drug Enforcement Administration tried to schedule kratom as a controlled substance, something the agency backed away from after a public outcry.

Last week the Food and Drug Administration released a laboratory analysis that found dangerous levels of heavy metals in over two dozen kratom products. However, the agency did not consider the finding significant enough to order a recall. Kratom has never been listed as dangerous substance in the DEA’s annual National Drug Threat Assessment.

Study Finds 90% of Medicare Patients Have Little Risk of Opioid Overdose

By Pat Anson, PNN Editor

Current methods used to identify Medicare patients at high risk of overdosing on prescription opioids target many people who are not really at high risk, according to a team of researchers who found that over 90% of patients have little to no risk of overdosing.

"The ability to identify such risk groups has important implications for policymakers and insurers who currently target interventions based on less accurate measures,” said lead author Wei-Hsuan "Jenny" Lo-Ciganic, PhD, a professor of pharmaceutical outcomes and policy at the University of Florida, who reported her findings in JAMA Network Open.  

Lo-Ciganic and her colleagues at the University of Pittsburgh, Carnegie Mellon University and University of Utah studied health data on over half a million Medicare beneficiaries who filled one or more prescriptions for opioids between 2011 and 2015. The researchers identified which patients overdosed and then used machine-learning algorithms to analyzed their demographics and health records.

The computer models developed three risk groups that predict which patients are at risk of overdosing over a 12 month period.

  • Low risk patients (67.5%) have 0.006% risk of overdose

  • Medium risk patients (23.3%) have 0.05% risk of overdose

  • High risk patients (9.1%) have 1.77% risk of overdose  

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Put another way, out of 100,000 Medicare patients in the low risk group, six would have an overdose; while there would be 1,770 overdoses in a high risk group of the same size.

Not surprisingly, the computer models found that high doses of opioids and a prior history of substance abuse significantly raise the risk of an overdose. So does a person’s age, disability status and whether they are co-prescribed benzodiazepines. Patients who live in certain states (Florida, Kentucky or New Jersey) are also at higher risk.

Top 10 Predictors of Opioid Overdose

  1. Total MME (morphine milligram equivalent)

  2. History of substance or alcohol abuse

  3. Average daily MME

  4. Age

  5. Disability status

  6. Number of opioid refills

  7. Resident state

  8. Type of opioid

  9. Number of benzodiazepine refills

  10. Drug use disorders  

The study found that the machine-learning algorithms the researchers developed performed well in predicting overdose risk and in identifying patients with a low risk. Machine learning is an alternative analytic approach to handling complex interactions in large data.  It can discover hidden patterns and generate predictions in clinical settings. Based on their findings, the researchers concluded that their approach outperformed other methods for identifying risk used by the Centers for Medicare and Medicaid Services.

"Machine-learning models that use administrative data appear to be a valuable and feasible tool for identifying more accurately and efficiently individuals at high risk of opioid overdose," says Walid Gellad, MD, a professor of medicine at the University of Pittsburgh and senior author on the study. "Although they are not perfect, these models allow interventions to be targeted to the small number of individuals who are at much greater risk."

CDC: Opioid Prescriptions Drop in 3 of 4 U.S. Counties

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has released another study documenting how prescriptions for opioid medication have fallen dramatically in recent years. The study partially credits the CDC’s own guideline for the drop in opioid prescribing, but makes no mention of the suffering and suicides of pain patients who’ve been cut off from opioid medication.

Researchers at the CDC’s National Center for Injury Prevention and Control – which developed the agency’s controversial 2016 guideline -- looked at opioid prescribing trends nationally from 2015 to 2017.

They found significant declines in high dose opioid prescribing and in the average daily dose, which fell from 48.1 MME (morphine milligram equivalent) to 45.2 MME, a 6% decline. The guideline recommends that doses not exceed 90 MME except in rare instances.

Nearly 3 out of 4 counties experienced a reduction of 10% or more in the amount of opioids prescribed – the counties colored green in the map below. Relatively few counties, primarily in the Midwest and northern Rockies, had a 10% or more increase in opioid prescribing – counties that are marked in orange.

JAMA INTERNAL MEDICINE

JAMA INTERNAL MEDICINE

“The reduction in opioid prescribing that began in 2012 has accelerated in the United States. The amount of opioids prescribed decreased an average of 10.0% annually with reductions in 74.7% of counties from 2015 to 2017,” CDC researchers reported in JAMA Internal Medicine.

“Recent reductions could be related to policies and strategies aimed at reducing inappropriate prescribing, increased awareness of the risks associated with opioids, and release of the CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016. Despite reductions in prescribing, opioid overdose rates continue to increase and are driven largely by illicitly manufactured fentayl.”

A similar CDC study in 2018 also documented a decline in prescriptions, but made no effort to measure the guideline’s impact on patients and whether it had improved the quality of their pain care or worsened it.  There is only a brief acknowledgement that both studies are limited by “the inability to determine the appropriateness of opioid prescriptions” -- a belated and backhanded admission by the CDC that its guideline is built on the false premise that it knows what an appropriate dose is.

Had the CDC looked in its own Twitter feed touting the latest study, it could have found insight from patients on the guideline’s effect on the quality of pain care.

“Yea this is why my wife has been bedridden for over 2 YEARS now as her doctor does NOT BELIEVE in pain medication.  And when we call all the other practices in the area its more of the same response. Either we don't prescribe opioids or we don't take pain patients,” one poster wrote.

“Let's not forget skyrocketing suicide and patients turning to the streets for relief. Good job you now have a #OpioidCrisis of your own making,” another poster wrote.

“When the numbers of a drug are more meaningful than the human lives they help. So caught up in numerical reduction people who once had managed pain are forced to suffer or #SuicideDueToPain. I guess this makes you folks very proud, to kill off the disabled,” said another.

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“And here we see the CDC touting what they think is a great thing. Ironically of course they are likely NOT tracking how many patients committed suicides after being forcibly tapered for no medical reason,” said Dave Wieland, a pain patient and advocate.

“And you can bet they are NOT tracking how many patients who had been able to work on their stable medication dosage, have now been forced to apply for disability after having their medication also taken away for no medical reason. Oh yea that's right the CDC doesn't care about those things.”

When the CDC released its guideline nearly 3 years ago, it pledged to “revisit this guideline as new evidence becomes available" and to evaluate its impact on doctors and patients.

How has the CDC guideline affected you? As the third anniversary of the guideline approaches, PNN is conducting a new survey of patients and healthcare providers. Is the guideline working as intended?

Click here to take the survey, which should only take a few minutes.

Overdose Crisis Will Worsen, But Not Due to Rx Opioids

By Pat Anson, PNN Editor

The opioid crisis will “substantially worsen” in coming years and could result in the overdose deaths of over a million Americans by 2025, according to an eye-opening new study. Because most of the deaths will involve illicit opioids, researchers say limiting the supply of prescription opioids will have only a “modest” effect in reversing the trend.      

The study, published in JAMA Network Open, is based on mathematical models developed by a team of researchers at Harvard Medical School, Boston University School of Medicine, Pennsylvania State University and other academic institutions.

“Our study also highlights the changing nature of the epidemic. The opioid crisis is expected to worsen in the next decade owing to multiple factors,” said lead author Jagpreet Chhatwal, PhD, a researcher at Massachusetts General Hospital.

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“First, the number of individuals using illicit opioids is expected to increase substantially. Second, unlike historical trends where prescription opioid use has served as a path to heroin use, more people are directly initiating opioid use with illicit opioids. Third, there has been a rapid increase in illicit opioid lethality, likely mainly driven by the infiltration of the heroin supply with the highly potent synthetic opioid fentanyl.”

Under a “base-case” scenario, with the opioid crisis stabilizing by 2020, researchers project that over 700,000 Americans will die from opioid overdoses from 2016 to 2025. Nearly 80 percent of the deaths will involve fentanyl, heroin and other illicit opioids. Overdoses involving prescription opioids would decrease by about 10% during that period.

JAMA NETWORK OPEN

JAMA NETWORK OPEN

A “pessimistic” scenario developed by researchers is even more jaw dropping. If the opioid crisis does not stabilize until 2025, they project over 1.2 million Americans will die from overdoses. Over 88% of the deaths will involve illicit opioids.

In either scenario, efforts to reduce the misuse of opioid medication, such as limiting the dose and supply of prescription opioids, will only reduce the number of overdose deaths by 3 to 5 percent.

“State and local governments have instituted several interventions aimed at preventing individuals from exposure to prescription opioids, including a recently proposed goal to lower opioid prescriptions by one-third in the coming 3 years,” said Chhatwal.

“Our study does not devalue these efforts and it is possible that their effect could improve over time, which may ultimately yield a substantial benefit in the long term. However, given the large number of individuals who have already engaged in prescription opioid misuse or illicit opioid use, our study indicates that prevention efforts, in isolation, are unlikely to have the desired level of effect on opioid overdose deaths the near term.”

The researchers say a strong, multi-pronged approach is needed to reduce overdoses, including greater scrutiny of patients for signs of opioid use disorder (OUD).

"It could include implementation of screening for OUD in all relevant health care settings, improving access to medications for OUD such as methadone and buprenorphine, increasing OUD training programs at medical and nursing schools, improving access to harm-reduction services, and controlling the supply of illicit opioids,” they concluded.

Another recent study also predicts that reducing the supply of prescription opioids will have little effect on the overdose rate and could lead to increased use of heroin.   

Doctors Call Probe of Opioid Deaths a ‘Witch Hunt’

By Cheryl Clark, Kaiser Health News

The Medical Board of California has launched investigations into doctors who prescribed opioids to patients who, perhaps months or years later, fatally overdosed.

The effort, dubbed “the Death Certificate Project,” has sparked a conflict with physicians in California and beyond, in part because the doctors being investigated did not necessarily write the prescriptions leading to a death. The project is one of a kind nationally, although a much more limited program is operated by North Carolina’s board.

So far, the board has launched investigations into the practices of about 450 physicians and referred the names of 72 nurse practitioners, physician assistants and osteopathic physicians to their respective licensing boards.

To date, the regulators have formally accused at least 23 doctors of negligent prescribing, and more accusations are expected. Some of the accusations, like one 63-page document filed against Dr. Frank Gilman, a San Diego internist, detail hundreds of prescriptions for one patient over four years, most of them by him. Gilman did not respond to a request for comment.

The project, first reported by MedPage Today, has struck a nerve among medical associations. Dr. Barbara McAneny, the American Medical Association president and an Albuquerque, N.M., oncologist whose cancer patients sometimes need treatment for acute pain, called the project “terrifying.” She said “it will only discourage doctors from taking care of patients with pain.”

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Using terms such as “witch hunt” and “inquisition,” many doctors said the project is leading them or their peers to refuse patients’ requests for painkiller prescriptions — no matter how well documented the need — out of fear their practices will come under disciplinary review.

The influential California Health Care Foundation also has pushed back against the project, saying it could harm patients.

Unusually aggressive for the board, the program is a reaction to the by now well-known phenomenon of physicians overprescribing opioids. Nationally, a host of policy changes and educational efforts have driven down the rate of opioid prescriptions in recent years.

The goal of California’s program, quietly launched four years ago, is not necessarily to link a doctor’s specific prescription to a specific patient’s death — although many of the cases do — but to find doctors whose patterns of prescribing are so dangerous they may lead to patients’ ultimately fatal addictions.

Sometimes a doctor was earmarked for investigation even though the cause of death included multiple drugs prescribed by many physicians, or suicide by overdose, board documents indicate.

Kimberly Kirchmeyer, executive director of the Medical Board of California, defended the project. She said the effort has found patterns of “gross negligence,” incompetence and excessive prescribing.

“I understand their frustrations,” she said of the complaining doctors, “but we do have to continue our role with consumer protection.”

She noted that part of the point of the project is to educate doctors and, through probation requirements, change the behavior of those who prescribe excessively.

“That’s education that could potentially save patients in the future,” said Kirchmeyer, whose agency licenses some 141,000 doctors.

Some consumer groups consider the board’s bold effort to find overprescribing doctors not aggressive enough.

“It’s long overdue,” said Carmen Balber, executive director of the nonprofit Consumer Watchdog. The board should investigate opioid-related deaths that occurred more recently, she said: “They need to get their act together and speed things up.”

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The agency thus far has looked at deaths only in 2012 and 2013 in which opioids were confirmed as a cause or contributing cause. It matched the names of the dead with the prescription drugs they filled, which are listed in the state’s prescription database. The database also shows the names of the doctors who prescribed to them. Physician experts reviewed those doctors’ prescribing history and selected those who appeared to prescribe drugs heavily.

Some doctors said they were especially angered that the letters they received concerned prescriptions they wrote as long as nine years ago.

McAneny, of the AMA, noted that prescribing practices now deemed unacceptable came out of public policies years ago that “compelled doctors to treat pain more aggressively for the comfort of our patients.” Also, payers have measured quality of care by whether their patients answered surveys about whether their pain was well-controlled.

“We’re [already] doing a lot of education to undo the damage” from those policies, she said.

Similarly, Dr. David Aizuss, a Los Angeles ophthalmologist who is president of the California Medical Association, said state and federal guidelines that took effect in 2014 and 2016 impose much more stringent prescribing precautions than “what was going on six or seven years ago.”

Many insurance plans and pharmacies in recent years have restricted dosages and durations of certain painkillers a physician may prescribe at one time.

Afraid to Prescribe

The crackdown on doctors has created fear, said Dr. Robert Wailes, a pain medicine specialist in Encinitas and chair of the California Medical Association’s Board of Trustees.

“What we’re finding is that more and more primary care doctors are afraid to prescribe and more of those patients are showing up on our doorsteps,” he said.

Officially, the CMA stops short of saying the medical board should stop the project, perhaps to avoid any perception that the association condones overprescribing. But it has asked the board to hire an independent reviewer to assess the criteria the board is using to decide which physicians to investigate, and whether physicians in certain specialties or regions of the state are being targeted more than others.

Dr. Ako Jacintho, a San Francisco addiction medicine specialist, was notified by the board that he was in trouble over a year ago. A patient for whom he had prescribed methadone fatally overdosed in 2012. The letter said “a complaint” had been filed against him, and asked him to respond to the allegations or, if he delayed, face a citation or fine of $1,000 per day. (The medical board can file its own complaints against a doctor.)

The letter said the patient had died of “acute combined methadone and diphenhydramine intoxication.” Jacintho had refilled the patient’s prescription for methadone the day before but said a 10-milligram pill was not a toxic dose. And he said he never prescribed diphenhydramine, the antihistamine sold as Benadryl.

“The only way he would have died was if he had not taken it as directed, or had mixed it with a medication that was not prescribed,” Jacintho said.

As of Dec. 21, Jacintho was still waiting to hear if he would face a formal accusation.

Last year, the board rewrote those letters in a less accusatory tone — describing the “review” as routine — although it still threatens doctors with $1,000 fines.

In a much smaller subset of cases, it finds problems that result in formal accusations that can result in discipline, such as public reprimands or restrictions on a physician’s ability to practice.

You can’t even begin to understand how disrupting and upsetting this is. It’s not just a threat on your license; it’s a threat that you’ve not been a good physician.
— Dr. Paul Speckart

Despite its designation as a “Death Certificate Project,” the California effort has not focused only on doctors whose patients died. In an unknown number of overdose cases, the board has sent letters to living patients asking them to authorize their doctors to relinquish their medical records to the board, adding that those documents would otherwise be subpoenaed.

Dr. Paul Speckart, a San Diego internist, said three of his patients last year received board letters that seemed to question his quality of care when all he did was try to relieve their well-documented pain. The board has not filed any accusations against him.

“You can’t even begin to understand how disrupting and upsetting this is,” Speckart said. “It’s not just a threat on your license; it’s a threat that you’ve not been a good physician.”

This story was produced by Kaiser Health News, which publishes California Healthline, a service of the California Health Care Foundation.