A Flawed Person's Drug Problem Isn't a Moral Failing

By Dr. Lynn Webster, PNN Columnist

Rush Limbaugh was as controversial as he was politically influential. In fact, Nicole Hemmer, a research scholar at Columbia University, called Limbaugh "the man who created Donald Trump" and opined that Limbaugh created the political foundation that catapulted Trump to power.

In 2020, President Trump returned the favor by awarding Limbaugh the Medal of Freedom, our highest civilian honor, for his "decades of tireless devotion to our country."

But the Independent points out that Limbaugh also left behind a legacy of "divisiveness, cruelty, racism, homophobia, bigotry, and sexism." And Rolling Stone said the radio host "trafficked in bigotry and cruelty."

RUSH LIMBAUGH

It's hard to argue with either of those statements. To me, Limbaugh was a deeply flawed human being who caused harm. But some statements about him go too far.

When Limbaugh died this week after a lengthy battle with lung cancer, Mark Frauenfelder, editor of The Magnet, tweeted: "Rush Limbaugh, the sex tourist and drug addict whose four marriages, mockery of people after their deaths, and overt racism and misogyny made him a beloved icon of American conservatism, is dead at 70." 

That statement is troubling. Overt racism and misogyny are character flaws. Drug addiction, however, is not. It's unfortunate to see Limbaugh's detractors point to his well-documented problems with painkillers as moral failings. This supports my firm belief that our culture holds deeply negative views of people with addiction.  

History of Back Pain and Drug Use 

Limbaugh began abusing prescription painkillers after his spinal surgery in the 1990s. He was eventually arrested on drug charges — specifically, charges of fraud to conceal information to obtain prescriptions, also known as "doctor shopping." In exchange for having the charges dropped, Limbaugh agreed to undergo drug treatment and pay $30,000 in court costs. He posted $3,000 bail and was released.

I wrote about Limbaugh's prescription drug problem in my book, "Avoiding Opioid Abuse While Managing Pain." What we knew about Limbaugh's problem, as I said at the time, was that he abused large quantities of prescription opioids for several years; kept his abuse secret from family, friends and colleagues; entered a rehabilitation program twice, but relapsed each time; remained successful without a visible reduction in functioning while he used drugs; and was suspected of buying drugs illegally. 

What we didn't know, and perhaps now can never ascertain, is whether Limbaugh had an addiction or an undiagnosed psychiatric disorder (although some may argue his professional conduct was evidence of a disturbed personality). We also can't know whether his main motivation for using drugs was to control physical pain, to mask emotional pain or stress, to seek a "high," or some combination of those reasons.  

The answers to these questions — about his history of drug abuse, mental health and motivation — would have told us whether his opioid use disorder (OUD) was treatable with better pain control or, tragically, was an incurable disease.  

Limbaugh exemplifies the type of patient most physicians face when treating serious pain conditions. Sometimes, opioids fail to provide adequate relief for them. And, increasingly, patients cannot access the opioids they need due to misguided polices and regulations.   

How Society Views Addiction 

Some people may agree with Limbaugh's political and social views, and others may not. But conflating his drug abuse and associated illegal activities with the opinions he expressed about social issues harms people who suffer from the disease of addiction. It also makes it more difficult for people with severe pain to receive the care they deserve, whether their abuse is caused by addiction or, as is often the case, a symptom of undertreated pain. 

Many of those with addiction may not have the power or influence to bail themselves out of prison or pay tens of thousands of dollars in court costs. They may remain in prison for years and suffer the loss of their careers, reputations, homes and even their families.  

Generally, our society views people with addiction as flawed, weak and hopeless. We distance ourselves from those who have the disease, and we allow the criminal justice system to have jurisdiction over them, making it difficult or even impossible for them to receive treatment.  

We may never know why Rush Limbaugh made the choices he did. But, just as we would never think of berating him for falling victim to lung cancer, we also shouldn't chastise him for misusing painkillers. We may have a right to judge Limbaugh's behavior, but we cannot, in decency, judge his disease. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find Lynn on Twitter: @LynnRWebsterMD.

Gabapentinoids Riskier for Surgery Patients

By Pat Anson, PNN Editor

Another study is casting doubt on the use of gabapentinoids such as Lyrica (pregabalin) and Neurontin (gabapentin) for pain relief during and after surgery.

Gabapentioids are a class of nerve medication originally developed to treat convulsions, but the drugs are increasingly being used as a trendy alternative to opioids for acute and chronic pain. Some U.S. hospitals are even using gabapentinoids for surgical pain and have phased out or reduced the use of opioids.

In an analysis of over 5 million adults admitted for major surgery in the U.S. from 2007 to 2017, researchers at Harvard Medical School found that using gabapentinoids with opioids increases the risk of overdose, respiratory depression and other adverse events. Researchers say the additional risk was “extremely low” and would result in one additional overdose for every 16,000 patients.

“Our findings add to the growing evidence that gabapentinoids can potentiate the respiratory depressant effects of opioids,” researchers reported in JAMA Network Open. “The events were rare… (but) patients receiving multimodal pain management therapy that includes gabapentinoids should be closely monitored for possible respiratory depression.”

The study did not examine whether gabapentiniods were effective in treating surgical pain or if they improved the analgesic effect of opioids.

In an editorial also published in JAMA Network Open, a pain management expert said more studies were needed to see if gabapentiniods were worth the additional risk.

“The evidence in support of the analgesic benefit of gabapentinoids combined with opioids for postoperative analgesia is equivocal; there is no real support that adding gabapentinoids to opioid pain relievers offers additive, much less synergistic, enhancements to pain control,” wrote Joseph Pergolizzi, Jr, MD, Chief Operating Officer of NEMA Research.  

“Considering that combination analgesic regimens generally reduce overall opioid consumption, this study is important because it shows that this may not necessarily translate to reducing opioid-associated adverse events. As combination analgesia gains traction for in-hospital acute painful conditions, such as postsurgical pain, it is important to be guided by evidence rather than intuition.”

No Significant Analgesic Effect

A recent study by Canadian researchers also found little evidence to support the use of gabapentinoids for surgical pain.

“No clinically significant analgesic effect for the perioperative use of gabapentinoids was observed. There was also no effect on the prevention of postoperative chronic pain and a greater risk of adverse events,” wrote lead author Michael Verret, MD, a resident at Laval University in Quebec City.  

These and other findings contradict guidelines published by the American Pain Society in 2016, which advocate “around the clock” use of gabapentin, pregabalin and other non-opioid drugs both before and after surgery.

The risk of becoming addicted or dependent on opioids after surgery is actually quite low. A 2016 study found that only 0.4% of elderly patients who were prescribed opioids for post-operative pain were still using them a year after their surgeries. Another study by Harvard researchers found that only 0.2% of surgery patients prescribed opioids were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Growing Concerns About Opioid Tapering

By Roger Chriss, PNN Columnist

A common belief about the opioid crisis assumes that patients develop a substance use disorder from taking opioid medication, and that many derive no long-term benefit from opioids and need to be tapered.

There is some truth to this, but reality is much more complicated.

First, not all patients who take opioids become addicted. The National Institute on Drug Abuse reports between 8 and 12 percent of patients prescribed opioids for chronic pain develop an opioid use disorder (OUD). Even that estimate may be too high, because the diagnosis of OUD is sometimes mistaken.  

In a recent study of 90 patients diagnosed with OUD at three Veterans Health Administration medical centers, physician Ben Howell and colleagues found that nearly a third of the diagnoses were probably wrong.

“Our study identified significant levels of likely inaccurate OUD diagnoses among veterans with incident OUD diagnoses. The majority of these cases reflected readily addressable systems errors,” researchers concluded. “If these inaccuracies are prevalent throughout the VHA, they could complicate health services research and health systems responses.”

Second, not all people who are tapered off prescription opioids improve. A new study in the Journal of Pain Research looked at 40 chronic pain patients who were tapered from an average daily dose of 80 MME (morphine milligram equivalent) down to 19 MME. The results were disappointing. There was only minor improvement in the patients’ cognitive function and no improvement in their quality of life, depression and anxiety.

There is at present no well-established approach to opioid tapering and little effort made to study patient outcomes.  In a recent paper, lead author Stefan Kertesz, MD, and colleagues say there is a “pill dynamic” approach to tapering that focuses on dose reduction alone.

"When a multi-faceted, complex health issue becomes a public health crisis, the desire to ‘solve’ or ‘mitigate’ takes hold with a momentum of its own. A crisis deserves no less. However, nationally adopted quality metrics have convinced some patients with pain that their survival and functioning are no longer concerns for the systems in which they receive care. This outcome is unacceptable," they concluded.

Patient Suffering and Suicides

The risks of forced opioid tapering are so urgent that nearly 100 physicians, academics and patient advocates recently published an open letter in the journal Pain Medicine warning of “an alarming increase in reports of patient suffering and suicides” caused by aggressive tapering:

“We therefore call for an urgent review of mandated opioid tapering policies for outpatients at every level of health care — including prescribing, pharmacy, and insurance policies — and across borders, to minimize the iatrogenic harm that ensues from aggressive opioid tapering policies and practices.

We call for the development and implementation of policies that are humane, compassionate, patient-centered, and evidence-based in order to minimize iatrogenic harms and protect patients taking long-term prescription opioids.”

The public health issue of opioid overdoses is complex, urgent and largely driven by street drugs, not pain medication. Opioid prescriptions are at 20-year lows, and the American Medical Association recently said it was “alarmed by an increasing number of reports of opioid-related overdoses, particularly from illicit fentanyl.”

And as National Institute of Drug Abuse director Nora Volkow, MD, stated in a recent blog post:

“Although deaths from opioids continue to command the public’s attention, an alarming increase in deaths involving the stimulant drugs methamphetamine and cocaine are a stark illustration that we no longer face just an opioid crisis. We face a complex and ever-evolving addiction and overdose crisis characterized by shifting use and availability of different substances and use of multiple drugs (and drug classes) together.”

Opioid tapering is no more a universal good than opioid prescribing was a universal evil. And opioid tapering will no more solve the overdose crisis than opioid prescribing alone caused it. Instead, opioid tapering may harm the very people it is intended to help, and it may not help the crisis that it is motivated by. Better public health policy and clinical practice are urgently needed.

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. 

Do Prescription Opioids Increase Social Pain and Isolation?

By Pat Anson, PNN Editor

Long-term use of opioid medication may increase social isolation, anxiety and depression for chronic pain patients, according to psychiatric and pain management experts at the University of Washington School Medicine.

In an op/ed recently published in Annals of Family Medicine, Drs. Mark Sullivan and Jane Ballantyne say opioid medication numbs the physical and emotional pain of patients, but interferes with the human need for social connections.

“Their social and emotional functioning is messed up under a wet blanket of opioids,” Sullivan said in a UW Medicine press release.

Sullivan and Ballantyne are board members of Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group. Ballantyne, who is president of PROP, was a member of the “Core Expert Group” that advised the CDC during the drafting of its controversial 2016 opioid guideline. She has retired as a professor of pain medicine at the university, while Sullivan remains active as a professor of psychiatry.

In their op/ed, Sullivan and Ballantyne say it is wrong to assume that chronic pain arises solely from tissue damage caused by trauma or disease. They cite neuroimaging studies that found emotional and physical pain are processed in the same parts of the human brain.  While prescription opioids may lessen physical pain, they interfere with the production of endorphins – opioid-like hormones that help us feel better emotionally.

“Many of the patients who use opioid medications long term for the treatment of chronic pain have both physical and social pain,” they wrote. “Rather than helping the pain for which the opioid was originally sought, persistent opioid use may be chasing the pain in a circular manner, diminishing natural rewards from normal sources of pleasure, and increasing social isolation.

“To make matters worse, the people who need and want opioids the most, and who choose to use them over the long term, tend to be those with the most complex forms of chronic pain, containing both physical and social elements. We have called this process ‘adverse selection’ because these are also the people who are also at the greatest risk for continuous or escalating opioid use, and the development of complex dependence.”

Sullivan and Ballantyne say doctors need to recognize that when patients have both physical and social pain, long-term opioid therapy is “more likely to harm than help.”

“We believe that short-term opioid therapy, lasting no more than a month or so, will and should remain a common tool in clinical practice. But long-term opioid therapy that lasts months and perhaps years should be a rare occurrence because it does not treat chronic pain well, it impairs human social and emotional function, and can lead to opioid dependence or addiction,” they wrote.

Angry and Depressed Patients

It’s not the first time Sullivan and Ballantyne have weighed in on the moods and temperament of chronic pain patients. In a 2018 interview with Pain Research Forum, for example, Ballantyne said patients often have “psychiatric comorbidities” and become “very angry” at anyone who suggests they shouldn’t be on opioids.

“I’ve never seen an angry patient who is not taking opiates. It’s people on opiates who are angry because they’re frightened, desperate, and need to stay on them. And I don’t blame them because it is very difficult to come off of opiates,” she said.

In a 2017 interview with The Atlantic, Sullivan said depression and anxiety heighten physical pain and fuel the need for opioids. “People have distress — their life is not working, they’re not sleeping, they’re not functioning,” Sullivan said, “and they want something to make all that better.”

JANE BALLANTYNE MARK SULLIVAN

In a controversial 2015 commentary they co-authored in the New England Journal of Medicine, Sullivan and Ballantyne said chronic pain patients should learn to accept pain and get on with their lives, and that relieving pain intensity should not be the primary focus of doctors. The article infuriated both patients and physicians, including dozens who left bitter comments.

“Great job. I will be going into the coffin business thanks to these believers that people should suck it up. How NEJM even recognizes these people as doctors and not quacks is beyond me,” wrote a family practice physician.

“I take just enough narcotic pain meds to cut the edge off of my pain to be coherent enough to love my wife and respond to your constant misinformation,” wrote a patient.

Ballantyne and Sullivan’s op/ed in Annals of Family Medicine has yet to produce a similar response, either pro or con. The article was submitted to the journal over a year ago, but is only being published now.

Ballantyne disclosed in her conflict-of-interest statement that she has been a paid consultant in opioid litigation lawsuits, while Sullivan disclosed that he provided expert testimony for the states of Maryland and Missouri.

Other PROP board members have also found a lucrative sideline testifying in lawsuits. The organization is currently conducting a fundraiser to hire a new Executive Director to “take PROP's work to the next level.”

Can Cannabis Be Used to Treat Opioid Addiction?

By Pat Anson, PNN Editor

Canadian researchers – with funding from U.S. taxpayers – are proposing a novel treatment for opioid use disorder: Cannabis.

In a paper published in the journal Drug and Alcohol Dependence, researchers from the University of British Columbia (UBC) and the BC Centre on Substance Use (BCCSU) say cannabis could help people being treated for opioid addiction by reducing their risk of exposure to illicit fentanyl and other street drugs.

The finding is based on urine drug tests of 819 people being treated for opioid addiction in Vancouver, BC, the first major city in North America to experience an outbreak of fentanyl-related overdoses. Addiction treatment usually involves taking opioid agonist drugs (OATs) such as buprenorphine or methadone.

The researchers found that over half the participants (53%) tested positive for fentanyl, suggesting they were still using street drugs. Those who tested positive for THC -- the psychoactive compound in cannabis -- were about 10 percent less likely to have fentanyl in their urine.

"These new findings suggest that cannabis could have a stabilizing impact for many patients on treatment, while also reducing the risk of overdose," said lead author Eugenia Socías, MD, a clinician scientist at BCCSU. "With overdoses continuing to rise across the country, these findings highlight the urgent need for clinical research to evaluate the therapeutic potential of cannabinoids as adjunctive treatment to OAT to address the escalating opioid overdose epidemic."

Socias and her colleagues say cannabis may play an important role in keeping people in addiction treatment programs. Previous research at BCCSU found that drug users initiating OAT who used cannabis daily were about 21 percent more likely to be retained in treatment after six months than non-cannabis users. People who stay in treatment face much lower risks of dying from an overdose, acquiring HIV or suffering other harms of drug use.

‘Gateway Drug’

The research at UBC and BCCSU was funded, in part, by grants from the U.S. National Institute on Drug Abuse, which is part of the National Institutes of Health (NIH).

The NIH has taken a dim view of cannabis in the past, calling marijuana a “gateway drug” for some users, particularly adolescents. A 2015 study funded by NIH found that nearly a third of those who use marijuana develop some degree of marijuana use disorder.

“Whether smoking or otherwise consuming marijuana has therapeutic benefits that outweigh its health risks is still an open question that science has not resolved,” said Nora Volkow, MD, Director of the National Institute on Drug Abuse.

Public health officials in British Columbia have proposed some controversial solutions to the opioid crisis, including decriminalization of all illicit drugs. A treatment center in Vancouver currently provides diacetylmorphine -- prescription heroin – to drug users to keep them from using street heroin that is often laced with fentanyl, a synthethic opioid that is 50 to 100 times more potent than morphine.

The Canadian Institutes of Health Research recently approved funding for a pilot study in Vancouver to evaluate cannabis as an adjunct therapy to OAT.

"Scientists are only just beginning to understand the role cannabis might play in supporting people's well-being, particularly those who use other substances," said co-author M-J Milloy, PhD, the Canopy Growth professor of cannabis science at UBC. "This study will help us understand if and how cannabis might have a role in addressing the overdose crisis."

A Little Shop of Horrors: VA Opioid Guideline for Veterans

By Richard Lawhern, PNN Contributor

As a volunteer patient advocate and healthcare writer, I read a very large volume of scientific and policy literature. And as a 21-year military veteran myself, I am particularly interested in Veterans Administration policies for treatment of chronic pain. Thus I reviewed with interest the VA’s 2017 Clinical Practice Guideline for Opioid Therapy for Chronic Pain.  

I also checked with a medical professional who practices in the VA hospital system to verify that the “guidance” of this document is still in force. It is. 

In my view, the VA opioid guidance is a “little shop of horrors” guaranteed to drive patients into medical collapse, and in some cases suicide. These direct quotes from the VA guideline should illustrate my concerns:

• “Since [2010], there has been growing recognition of an epidemic of opioid misuse and opioid use disorder (OUD) in America, including among America’s Veterans…. At the same time, there is a mounting body of research detailing the lack of benefit and severe harms of [long-term opioid therapy].”

• “We recommend against initiation of long-term opioid therapy for chronic pain.”

• “We recommend alternatives to opioid therapy such as self-management strategies and other non-pharmacological treatments.”

• “If prescribing opioid therapy for patients with chronic pain, we recommend a short duration… Consideration of opioid therapy beyond 90 days requires re-evaluation and discussion with patient of risks and benefits.”

• “We recommend against long-term opioid therapy for pain in patients with untreated substance use disorder.”

• “If prescribing opioids, we recommend prescribing the lowest dose of opioids as indicated by patient-specific risks and benefits…. There is no absolutely safe dose of opioids.”   

• “As opioid dosage and risk increase, we recommend more frequent monitoring for adverse events including opioid use disorder and overdose… Risks for opioid use disorder start at any dose and increase in a dose dependent manner. Risks for overdose and death significantly increase at a range of 20-50 mg morphine equivalent daily dose.” 

My VA colleague, who asked not to be identified, offers the following observations concerning VA policies in treating pain. This is paraphrased to protect the physician from retaliation:   

“The VA simply does not allow me the flexibility I need to manage my patients’ pain. All that is said about honoring our veterans and all the expressions of pride in the level of care the VA provides veterans thus ring hollow. The VA exhibits far greater pride in the percent reduction in opioid prescriptions it has been able to achieve, even giving out awards to physicians who make particularly large contributions to this effort.”

Let’s also compare these highly restrictive policies with a June 2020 letter from the American Medical Association to the CDC’s Chief Medical Officer on the pending revision of the 2016 CDC guideline:

• “We can no longer afford to view increasing drug-related mortality through a prescription opioid-myopic lens.”

• “Some patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than guidelines or thresholds put forward by federal agencies.”

• “A CDC Guideline only focused on ‘opioid prescribing’ will perpetuate the fallacy that by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end.”

• “The CDC Guideline has been misapplied as a hard policy threshold by states, health plans, pharmacy chains, and PBMs.”

• “It is clear that the CDC Guideline has harmed many patients — so much so that in 2019, the CDC authors and HHS issued long-overdue … clarifications that states should not use the CDC Guideline to implement an arbitrary threshold.”  

The AMA recommended that the CDC should advocate explicitly for the repeal of all federal and state legislation that places hard limits on opioid prescribing.  Another recommendation is that physicians should treat both chronic pain and opioid addiction among the few patients who deal with both issues.  Discharging these patients or forcibly tapering them should no longer be automatic.

AMA is also on public record with the position that so-called “high prescriber” letters issued by prosecutors and state Prescription Drug Monitoring Programs (PDMPs) constitute a witch hunt against physicians and their sickest patients, and is a violation of legal due process.  

Not addressed by either the AMA or the VA is the reality that there are presently no field-tested tools that reliably evaluate quantitative risk of opioid tolerance, dependence or addiction in individual patients. 

As Nora Volkow, MD, and Thomas McMillan, PhD, of the National Institutes of Health wrote in The New England Journal of Medicine:  

“Unlike tolerance and physical dependence, addiction is not a predictable result of opioid prescribing. Addiction occurs in only a small percentage of persons who are exposed to opioids — even among those with pre-existing vulnerabilities... Older medical texts and several versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) either overemphasized the role of tolerance and physical dependence in the definition of addiction or equated these processes (DSM-III and DSM-IV).

However, more recent studies have shown that the molecular mechanisms underlying addiction are distinct from those responsible for tolerance and physical dependence, in that they evolve much more slowly, last much longer, and disrupt multiple brain processes.”  

A further complicating factor for the VA is that we now know beyond any reasonable contradiction that their attempt to restrict opioid prescribing is unsupported by science. 

There is no relationship between rates of opioid prescribing versus rates of overdose-related mortality. The demographics simply don’t work:  Although they have the highest rate of opioid prescribing for pain, seniors over age 62 have the lowest rates of overdose-related mortality.  Youths under age 19 receive the fewest number of opioid prescriptions, but have three to six times higher overdose mortality relative to seniors.

It is arguable that the VA guideline is just as fatally flawed as the CDC guideline, and is responsible for significant numbers of patient medical collapses and suicides among veterans.  Both documents fail conclusively on grounds of both medical science and medical ethics and both should be withdrawn immediately.

Richard “Red” Lawhern, PhD, has for over 20 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  Red is co-founder of The Alliance for the Treatment of Intractable Pain.

Prescription Opioid Use at 20-Year Lows

By Pat Anson, PNN Editor

Prescription opioid use in the United States is expected to decline for the ninth consecutive year in 2020, with per capita consumption of opioid medication falling to its lowest level in two decades, according to a new report by the IQVIA Institute, a data analytics firm.

Although fewer opioids are being prescribed, U.S. drug overdose deaths have reached record levels, driven largely by illicit fentanyl and other streets drugs, not pain medication.

In the past year alone, IQVIA estimates there was a 17 percent decline in the amount of prescription opioids dispensed in morphine milligram equivalent (MME) units. The decrease is being driven by changes in prescribing policy, government regulation and insurance reimbursement policies, as well as disruptions in healthcare caused by the COVID-19 pandemic.

In the early stages of the pandemic, IQVIA researchers say there was a 44% decline in the number of new patients prescribed opioids, likely the result of providers and patients canceling non-emergency visits, dental appointments and elective surgeries. As the economy reopened in early summer and healthcare visits resumed, opioid prescribing for pain returned to baseline levels, as did prescriptions for addiction treatment drugs.

“The opioid epidemic has captivated the country for a decade, although it lost attention this year in the face of the COVID-19 pandemic. Patients with chronic pain and addiction have also been affected by disruptions to life and healthcare during COVID, when hospitals, doctors’ offices, and drug treatment facilities were closed,” Murray Aitken, Executive Director IQVIA Institute for Human Data Science, said in a statement.

“While the human toll of the opioid epidemic is being addressed differently across the country, efforts in managing prescription opioids and in supporting medication-assisted treatment are showing measurable progress in many states.”

Prescription opioid use peaked in 2011 and has been in steep decline ever since. By the end of 2020, IQVIA projects per capita annual opioid consumption to fall to 298 MME, nearing a level last seen in 2000.

SOURCE: iqvia iNSTITUTE

“Based on usage in the mid-1990s, it may be difficult to reduce current prescription opioid levels further, as pain medications are necessary for some patients, including cancer patients, until other non-addictive or disease-modifying treatments are available,” the IQVIA report found.

Over the past decade, the greatest decline in prescription opioid use has been in the highest risk categories. Prescriptions written for 90 MME or more per day – a level considered risky by the CDC – have fallen by 70 percent since 2011.

Co-prescribing of opioids with benzodiazepines – an anti-anxiety medication – is also falling rapidly. The number of patients taking both drugs has declined from 86 million in 2016 to less than 60 million in 2020. Opioids and benzodiazepines both slow respiration, and patients who take them in combination are believed to be at higher risk of an overdose.

Overdoses Still Rising

Despite the historic decline in prescription opioid use, U.S. overdose deaths hit a record high last spring, according to a new report from the CDC.  For the 12 months ending in May 2020, over 81,000 people died of a drug overdose.

"This represents a worsening of the drug overdose epidemic in the United States and is the largest number of drug overdoses for a 12-month period ever recorded," the CDC said in a health advisory, adding that the deaths were largely driven by illicit fentanyl, heroin, cocaine and psychostimulants such as methamphetamine. Opioid pain medication is not even mentioned in the CDC report.

“The disruption to daily life due to the Covid-19 pandemic has hit those with substance use disorder hard,” CDC director Robert Redfield said in a statement. “As we continue the fight to end this pandemic, it’s important to not lose sight of different groups being affected in other ways. We need to take care of people suffering from unintended consequences.”

Some federal agencies haven’t gotten the message and continue to blame opioid medication and prescribers for the nation’s overdose epidemic.

A new report released this week by the Office of Inspector General (OIG) for Health and Human Services warns that thousands of Medicaid patients in six Appalachian states are being prescribed “harmful amounts” of opioids. The report also identifies 19 physicians with “questionable prescribing practices” and said they will be referred to law enforcement.  

“OIG, along with its law enforcement partners, will review the prescribers with questionable prescribing patterns for possible investigation. OIG will also refer the beneficiaries at serious risk for opioid misuse or overdose to their respective State Medicaid agencies for review and possible followup to ensure that they are receiving appropriate care,” the report states.

“Further, we encourage States to provide greater access to data from prescription drug monitoring programs, including sharing these data with State Medicaid agencies. We also encourage States to analyze data to help identify patients who may be at risk and to promote appropriate opioid prescribing practices.”

AMA ‘Greatly Concerned’ By Rising Number of Opioid Overdoses

By Pat Anson, PNN Editor

The American Medical Association is once again urging states, regulators and policymakers to waive limits and restrictions on prescriptions for opioid medication and other controlled substances during the COVID-19 pandemic.

In a briefing paper released this week, the AMA said it was alarmed by an increasing number of reports of opioid-related overdoses, particularly from illicit fentanyl. The AMA cited recent reports from the Pacific Northwest that thousands of people were unexpectedly dying from causes other than COVID-19, such as fentanyl-laced counterfeit pills and medical conditions aggravated by delays in getting routine healthcare.    

“The AMA is greatly concerned by an increasing number of reports from national, state and local media suggesting increases in opioid-and other drug-related mortality—particularly from illicitly manufactured fentanyl and fentanyl analogs,” the AMA said. “More than 40 states have reported increases in opioid-related mortality as well as ongoing concerns for those with a mental illness or substance use disorder.”

The AMA urged states to adopt new DEA guidance giving more flexibility to physicians treating patients with opioid use disorder (OUD). The DEA has already waived federal requirements for in-person visits before prescribing addiction treatment drugs such as buprenorphine (Suboxone), methadone and naltrexone.

For patients in pain, the AMA recommended that states take a number of steps to make it easier to obtain pain medication during the pandemic:

• Authorize physicians to prescribe opioid medication to existing patients without an in-person visit

• Waive limits on prescriptions for opioids and other controlled substances, including limits on dose, quantity and refills

• Waive requirements on electronic prescribing; authorize prescriptions to be sent to pharmacies via telephone

• Waive drug testing and in-person counseling requirements for opioid refills; allow for telephone counseling

• Enhance home-delivery medication options for patients with chronic pain

The AMA urged many of these same measures be adopted in the early stages of the pandemic.

In a recent letter to the DEA, the AMA strongly recommended that the agency keep its relaxed prescribing guidelines in place indefinitely.

“There is an urgent need to ensure that patients with pain and patients with OUD receive evidence-based care, and this need will not cease with the end of the COVID-19 pandemic,” wrote James Madara, MD, Executive Vice President and CEO of the AMA..

“The AMA strongly recommends, therefore, that all of the flexibilities that have been put in place by DEA during the COVID-19 PHE (public health emergency) be kept in place at a minimum until both the COVID-19 and the opioid public health emergencies come to an end.”

Understanding the Difference Between Prescription Fentanyl and Illicit Fentanyl

By Roger Chriss, PNN Columnist

The opioid overdose crisis is now being driven by fentanyl. But misunderstandings over what fentanyl is, where it comes from, how it is used and why have become so pervasive that they plague discourse and debate about the crisis. News reports about “fentanyl overdose deaths” appear almost daily.

October saw a particularly tragic death. As reported by the Daily Courier in Prescott, Arizona, a 14-year-old high school student died of an overdose after taking what investigators suspect was a counterfeit pill “laced with the potent narcotic painkiller fentanyl.”

The tragedy of this death cannot be overstated. Nor can thousands of other overdose fatalities caused by fentanyl. But the nature of the drug needs to be better understood if we are to prevent such deaths moving forward.

Fentanyl is not one drug. It is better thought of as a family of synthetic opioids that are structurally similar, and includes sufentanil and remifentanil. These are pharmaceutical fentanyls, used clinically as anesthetics and essential for medical procedures such as open heart surgery.

Collectively, these drugs are part of a super-family known as fentanyl analogues. There are dozens of such drugs. Some are compounds developed by pharmaceutical companies for legitimate medical use, and others are manufactured illegally for use as street drugs. These forms of fentanyl are commonly referred to as “illicitly manufactured fentanyl” by government agencies like the CDC. The DEA has classified “fentanyl-related substances” as Schedule I controlled substances, meaning they are illegal to manufacture, distribute or possess.

To make this even more complicated, the fentanyl drug carfentanil is used legally in the U.S. as a tranquilizer for elephants and other large animals. The DEA authorizes production of a minute quantity of carfentanil for veterinarians every year. But illicit carfentanil from overseas occasionally shows up on the street and causes fatal overdoses.

Further muddying matters is the new fentanyl-like street drug isotonitazene, which is known colloquially as “iso.” It is “fentanyl-like” in its risks and harms, but is not technically a fentanyl analogue. “Iso” is instead related to etonitazene. Neither of these drugs has any recognized medical use in humans.

Risks Are Very Different

In other words, there is a vast gulf between pharmaceutical fentanyl and illicitly manufactured fentanyl. The former is a tightly controlled Schedule II prescription medication, approved for use in hospitals and to treat breakthrough cancer pain. The latter is an illegal substance cooked up in illicit labs that is often added to heroin or used to make counterfeit pills, which are then sold on the street or online.

This distinction is critical for understanding the opioid overdose crisis. The risks of a prescription opioid like fentanyl when given for medical use to a legitimate patient are very different from the risks of an illicit opioid being used non-medically by a random street buyer. Importantly, the risks for medical use can be addressed and managed. The risks of illicit use are much harder to deal with and often prove fatal.

The distinction also leads to confusion. The abundance of fentanyl on the street is rarely a result of diversion, and is unrelated to the supply of pharmaceutical fentanyl. These are different drugs, much as the cocaine nasal spray recently approved by the FDA as a local anesthetic is completely separate from the cocaine bought on the street. Pain experts are now pushing for a new classification for illicit fentanyl analogues, in the hope of clarifying this difference.

But fentanyl has so saturated the street drug market that more than a name change will be needed. As Ben Westhoff explains in the book “Fentanyl, Inc.”, preventing future opioid deaths will require “sweeping new public-health initiatives, including treatment programs and campaigns to educate everyone, from users and medical providers to teachers and police, about the drugs’ dangers.”

Understanding the difference between pharmaceutical fentanyl and illicitly manufactured fentanyl is an essential step in the effort to reduce overdose deaths.

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. 

DEA Expanding Surveillance of Prescription Drug Data

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration is making plans for a major expansion of its monitoring of prescriptions for opioids and other controlled substances, with the goal of identifying virtually every prescriber, pharmacy and patient in the country that shows signs of drug diversion or abusing their medication.

In a request for proposal (RFP) made in early September, the DEA asked software contractors to submit bids for the creation of a nationwide data system that would track “a minimum of 85 percent of all prescriptions” for Schedule II through V controlled substances. The RFP was first reported by the website Filter.

Critics say the surveillance program will have a chilling effect on many healthcare providers, who are already fearful of being flagged by law enforcement for prescribing and dispensing opioids and other medications to patients suffering from pain and other illnesses.  

“This RFP illustrates that the DEA, and U.S. Department of Justice more broadly, remains fixated on monitoring and scrutinizing the medical decisions of licensed health professionals while illegal fentanyl and heroin contribute to two-thirds of opioid-involved drug poisonings in the U.S.,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers.

“DEA agents have no business second guessing health care providers’ decisions on medical need and patient care. That’s a job for state licensing boards – and only when there is a valid complaint to investigate.”

‘Unlimited Access’ to Prescription Data

Hundreds of medications would be covered under the DEA’s surveillance program, including drugs used to treat pain, opioid use disorder, anxiety, and attention deficit hyperactivity disorder (ADHD).  Under the program, DEA investigators would have “unlimited access” to prescription data compiled over the last five years, including the names of prescribers and pharmacists, types of medication, quantity, dose, refills and forms of payment.

The names of patients would be encrypted, but if investigators suspect a medication was being abused or diverted, they could get a subpoena to quickly identify the patients involved.

“The subpoena process would be that we would generate a DEA Administrative Subpoena and send it to you for the unmasking of specified patients. The data provider would then need to respond to us providing the unmasked patient information that was requested within three business days,” the DEA said in response to a contractor who inquired how the subpoena process would work.      

Asked how many DEA investigators would have access to the prescription data, the agency said there could be over a thousand.

“We would start with 1,100 users and would renegotiate if more were needed. It is unlikely that 1,100 users will all access the system concurrently but is hypothetically possible in the future,” the agency replied.

Why the DEA is seeking to expand its monitoring of opioid prescriptions is unclear. In recent years, the number of prescriptions has fallen by about a third and the DEA itself estimates that less than one percent of legally prescribed opioids are diverted.

Bypassing PDMPs

State-run prescription drug monitoring programs (PDMPs) already track much of the information DEA is seeking, but law enforcement access to the data usually requires an active investigation or warrant – no data mining or fishing expeditions allowed. To maintain patient privacy, some states prohibit sharing prescription data with federal or out-of-state law enforcement agencies. Last year, the DEA had to sue Colorado to get access to the state’s PDMP data.

The DEA’s plan would bypass these privacy safeguards and effectively create a national PDMP for law enforcement. The agency would even be allowed to share some prescription data with unnamed “outside agencies and/or organizations without prior review by the Contractor.”      

The DEA did not respond to multiple requests for comment. In the RFP, the agency said it was required by law to maintain “comprehensive, detailed, accessible, and timely prescription, pharmacy, and prescriber information.”

Much of the data mining the agency is planning appears to go beyond the prescription data that is currently covered by PDMPs.  For example, the DEA wants to know the distance patients travel to see their doctors and pharmacies; whether patients living at the same address are getting the same drugs; whether a patient pays in cash for their medications; and whether a patient is getting a combination of opioids and benzodiazepines to treat their pain and anxiety.

“This DEA program will increase the fear associated with prescribing and dispensing controlled medications, making it even more difficult for people with pain, opioid use disorder, anxiety, insomnia, and ADHD to access individualized treatment. More such patients will be left in despair. It’s as though the federal government is unaware or does not care that the U.S. is in the midst of a suicide epidemic,” Barnes told PNN. 

‘Appalling for People’s Health’

The software contractor is also expected to provide DEA with a list of top prescribers and pharmacies that are writing and filling prescriptions for fentanyl, oxycodone, hydrocodone, buprenorphine and other opioids. The inclusion of buprenorphine is troubling to substance abuse treatment experts, because it is a primary ingredient of Suboxone. 

“The impact of including buprenorphine will be appalling for people’s health,” said Dr. Hannah Cooper, the chair of substance use disorder research at Emory University. Cooper fears the DEA surveillance program would make doctors and pharmacies reluctant to supply Suboxone to patients who need addiction treatment. 

“The idea that patient-level data is available to the DEA is quite frightening. We don’t want to make people worry that their decisions will be monitored by this highly punitive federal agency,” Cooper told Filter. “If you’ve been inhabiting a space where you’ve been persecuted by the federal government for some time, and they now have access to your private medical information, there will be tremendous consequences for population health and health equity.”

“This program will undoubtedly decrease the prescribing of controlled medications, including buprenorphine for opioid use disorder,” said Barnes. “Why in the world would the federal government, in the midst of a worsening drug-poisoning epidemic, discourage the prescribing of a medication to treat opioid use disorder and prevent opioid poisonings?”

The DEA deadline for receiving proposals from software contractors was October 20. No contract awards have been announced. The surveillance program could begin as early as December 1, 2020 and continue for a minimum of one year, with an option for up to four years. The potential cost of the program has not been disclosed.

New Screening Tool Identifies 80% of Patients at High Risk of Rx Opioid Abuse

By Pat Anson, PNN Editor

A new opioid screening tool is being introduced that claims to predict – with 80% accuracy – which patients receiving an opioid prescription are likely to have an overdose or get an opioid abuse diagnosis within the next six months.

Geneia, a healthcare data firm based in Pennsylvania, is integrating the opioid screening tool into its analytics platform, which is used by hospitals, insurers, employers and physician groups providing healthcare to over 7 million patients.

Contrary to popular belief, abuse is relatively rare in patients prescribed opioids, so it’s a bit like finding a needle in a haystack. Less than one percent (0.7%) of patients on opioids suffer an overdose or abuse their medication, according to Geneia.

But the consequences of opioid abuse are so serious medically, legally and financially to both patients and providers that healthcare organizations are eager to identify patients who are most at risk.

"An ounce of prevention is worth a pound of cure," said Fred Rahmanian, Geneia’s chief analytics and technology officer. "Knowing in advance who is at high-risk for an opioid abuse diagnosis or overdose enables physicians to choose alternative pain management strategies."

For example, a hospital using Geneia’s screening tool might give a surgery patient deemed to be “high-risk” a non-opioid pain reliever like acetaminophen for post-operative pain.

‘It’s All Data Driven’

Opioid screening tools have been used for years to help providers identify high-risk patients. Usually they involve questionnaires in which a patient’s medical history is assessed, along with their personal and family history of alcohol and drug use. The risk assessment might also include genetic testing or asking if a patient suffered sexual abuse as a minor.   

Geneia’s screening tool is different. It only looks at the diagnostic codes used in a patient’s medical and pharmacy claims – known as ICD-10 codes – without getting any direct input from providers about patient history. The company’s algorithms search the diagnostic codes for 22 different variables that may indicate a patient may be prone to opioid abuse.

“It’s all data driven,” says Geneia CEO Heather Lavoie, who downplays the importance of questionnaires about patient history.

“Oftentimes you don’t get accurate information. Even about family history of substance use and abuse,” she told PNN. “People are not good historians. There’s often a lot of misinformation, so you’re not always getting an accurate response to questionnaires. Obviously, sometimes you do, but not universally. And so, the benefit is that we can, with very little information, be highly predictive.”

“Glad to see there are efforts to help identify people at increased risks of abuse.  We need accurate and easy to use predictive criteria for those at increased risk of abuse and overdose,” says PNN columnist Dr. Lynn Webster, a pain management expert who developed the first “opioid risk tool” about 15 years ago.  

“Much of the accuracy of tools depends on definitions.  Unfortunately, there are multiple definitions of abuse, misuse and addiction. This makes it difficult to understand what is actually being assessed and predicted with any tool, including this one.” 

Webster is puzzled why Geneia’s screening tool omits a patient’s personal history and genetic testing, and says it may rely too heavily on diagnostic codes.    

“Unfortunately, few physicians know how to diagnose abuse from misuse and addiction. For example, many providers still believe that if someone experiences withdrawal they are addicted, which is not necessarily true,” said Webster. “The bottom line is that if the tool is based on ICD-10 diagnoses it relies on the clinician’s ability to make accurate diagnoses, most of whom have never been trained to make such diagnoses.  

“I am surprised that genetic evaluation is not considered in their tool since the vulnerability of opioid addiction is mostly genetic. The balance of the vulnerability to addiction comes from environmental factors like social-economic despair and mental health disorders.”  

Another thing that makes Geneia’s screening tool unique is that it can be used with children and adolescents. Opioid risk tools are typically only used for patients 18 years of age or older.

High False Positive Rate

Geneia tested its screening tool against a database of several million insurance claims, and says it accurately identified 80 to 88 percent of patients who are likely to have an opioid abuse diagnosis or an overdose.

But analytics are not foolproof. Geneia’s screening tool has a false positive rate of nine percent – meaning about one in every ten patients will be flagged inappropriately as high-risk.

“The false positive rate, depending on the data-set, is pretty high because it’s a very rare event rate. It’s really hard to pick the needle out of the haystack,” explained Jasmine McCammon, a data scientist who designed Geneia’s screening tool.  

On the flip side of opioid abuse, the screening tool also identifies patients who are at not high risk, giving reassurance to doctors who are uncertain about whether a patient should be given opioids.

Regardless of what the screening tool finds, CEO Lavoie says the company’s analytics should never be used as a diagnostic device.

“Predictive models shouldn’t be used in place of strong medical practice. They really are to help advise and to provide contextual information, so they (doctors) can work with the patient more directly. It’s in no way a surrogate for good care, but it does help provide additional caution,” Lavoie said.

The Devil Effect on Patients with Pain

By Dr. Lynn Webster, PNN Columnist

Society's response to pain management has shifted over the years. While pain treatment today often generates controversy, in the past it was viewed differently.

During the U.S. Civil War, a wounded soldier who was in agony was often given enough chloroform “to render him insensible to pain." Afterwards, soldiers may not have recalled the pain they felt, even if they remembered having surgery. We were concerned enough for our soldiers to ease their suffering with the most effective medication that was available.

At other periods in our history, society worried more about the risks of treating pain than the debilitating and sometimes lethal effects of the pain itself. At times, we even questioned whether pain was real and whether people were just inventing symptoms to receive attention or drugs.

People with pain have often been stigmatized. They have been expected to just tough it out, and those who couldn't were accused of being weak.

The Pendulum Swings Toward Empathy

In the 1990s, most people dying of cancer experienced excruciating pain, despite the fact that doctors had the means to help them. Opioids could ease their suffering. And a consensus began to grow in the medical profession that prescribing opioids for cancer-related pain was the right thing to do. Soon after, doctors began prescribing opioids for non-cancer pain, such as arthritis. The number of prescriptions increased.

Treating pain with opioids became acceptable -- even expected -- when the alternative was to let people suffer. It seemed reasonable at the time. There was little evidence then that opioids would cause serious harm if people used the pain medication as directed.

We always acknowledged that a subset of the patient population was at risk for abuse or addiction. Pain doctors like me did the best we could for patients with the research that was available to us at the time. Perhaps, in some cases, we would do things differently now.

Casting Blame for the Opioid Crisis

Ultimately, “overprescribing” was recognized as one of the contributors to America’s drug crisis. Looking back, it is easy to cast blame. We now have better information about the risks of using opioids. But there were few effective tools at the time to control pain, so prescribing opioids seemed like a valid alternative to letting patients suffer unnecessarily.

As more opioids were prescribed, there was a corresponding increase in all drug overdoses. That set off alarms, even though the causes of overdoses are myriad and complicated, and there is no simple correlation between rising opioid prescriptions and increased overdose deaths.

Societal attitudes began to shift again in the first decade of the 21st century. Families who lost loved ones to overdoses were looking for someone to blame. There were public and private demands to hold someone accountable for their deaths. The initial target was the pharmaceutical industry.

This wasn't anything new. The American public has more hostility toward Big Pharma than any other industry. A 2019 Gallop poll found that the public felt more distrust of Big Pharma than they did of the federal government!

The news media covered the tragedies of teenagers and young adults who were dying from overdoses. Often, those deaths involved opioids. The media also covered stories of families torn apart by addiction. Then the media's narrative shifted to allegations of deceit, greed and cover-ups by the pharmaceutical industry.

At first, they focused on Purdue Pharma. The company was making billions of dollars from OxyContin, and they were accused of irresponsibly promoting its use. The federal government filed a lawsuit against Purdue Pharma and this week announced a $8.3 billion settlement with the company.  

I recall the initial complaints about OxyContin were unrelated to the increased number of opioid related overdoses. Instead, Workers Compensation groups were complaining about the skyrocketing cost of the drug. In the late 1990’s, I recall hearing the medical director of Utah’s workers’ compensation program speak to the local pain society. He angrily insisted that the cost of OxyContin was exploding and must be stopped.

A new "Opium War" had begun. But this time, it was not between the Chinese and British. Instead, it involved health insurers and opioid manufacturers.

Chasing a Pot of Gold

The need to blame someone for the overdoses and make them pay for the harm opioids caused accelerated. Opioid manufacturers and physicians were in the cross-hairs of policymakers and law enforcement agencies.

Opioid distributors and patient advocacy groups were also accused of contributing to the drug crisis. It was alleged that distributors knowingly and irresponsibly supplied communities with large amounts of pills that far exceeded the amount needed for medical purposes. Advocacy groups were accused of being front organizations for opioid manufacturers. Whether or not distributors were irresponsible depends on one’s perspective, but the accusation about patient organizations was often baseless and malicious.

Of course, the bandwagon of accusers grew as the potential pot of gold increased. Lawsuits filed by states, cities and counties could result in a golden egg if they could convince a sympathetic jury or judge that they had been wronged. The sympathies of the public turned more and more against the drugs used in pain treatment.

The Devil Effect Harms Us All

Greed and the harm it causes is a well-known story. However, what is not as well appreciated is how it leads to a cognitive bias called the "devil effect" -- in which one bad quality creates the impression that there must be only negative qualities associated with a person or entity.

The belief that Big Pharma is inherently bad makes it difficult to appreciate the good things (such as vaccines and cures) that come from the industry, and to separate it from the bad things. Today, when doctors consult with or accept any funding from the industry, particularly the companies that make opioids, it is often referred to as “being in bed with the devil.”

Society’s belief that Big Pharma is inherently evil helps explain why people in pain are struggling. The truth is, Big Pharma is not intrinsically bad -- although there are some bad actors in the industry -- and drugs used to manage pain are essential partners in healing when used appropriately.

Our tendency toward black or white blanket perceptions -- and our choice to not learn about the complexities that would allow for a more balanced approach in our reasoning -- has consequences for every aspect of society. When it comes to pain management, the devil effect has yielded the terrible unintended cost of suffering by innocent people.

The pendulum eventually may swing back toward empathy for people who are suffering, but not until more people recognize the influence the devil effect has on society's attitudes towards Big Pharma, opioids and people in pain.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find Lynn on Twitter: @LynnRWebsterMD. 

Fentanyl and Heroin Use Rise During Pandemic

By Pat Anson, PNN Editor

The use of illicit fentanyl and heroin rose dramatically during the first two months of the COVID-19 pandemic, according to a large new study by Quest Diagnostics. Misuse of hydrocodone, morphine and some other opioid medications also increased.

The study adds to growing signs that Americans are turning to potent illicit drugs to cope with the stress and economic disruption caused by the pandemic.

“It’s the social isolation, the depression, the anxiety, stress, job loss, the loss of health insurance and the election. All these things that add stress to our lives are driving people to increase use of alcohol at home and, in the case of this study, drug misuse,” said co-author Harvey Kaufman, MD, Senior Medical Director for Quest Diagnostics. 

Kaufman and his colleagues analyzed data from over 872,000 urine drug tests, comparing samples taken before the pandemic to those taken from March 15 to May 14, 2020. The urine samples came largely from people undergoing substance abuse treatment or were prescribed opioids and other controlled substances, and are not representative of the population at large.

Interestingly, while the rate of drug misuse remained largely the same before and during the pandemic – about 49 percent – there were notable shifts in the type of drugs being misused.

Drug positivity rates increased by 44% for heroin and 35% for non-prescribed fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine. Positivity rates for non-prescribed opiate medication (hydrocodone, hydromorphone, codeine and morphine) rose by 10 percent. There were no significant changes in the misuse of oxycodone and tramadol. 

Fentanyl was frequently found in urine samples that tested positive for amphetamines (89%), benzodiazepines (48%), cocaine (34%), and opiates (39%). The abuse of multiple substances in combination with fentanyl has been a growing problem for years, but Quest researchers were surprised by how much it has accelerated.

“It’s shocking that something could move that quickly. It’s been well underway for half a dozen years, but the pandemic supercharged it,” Kaufman told PNN.

Gabapentin Misuse

One surprising detail in the Quest study is that the nerve drug gabapentin (Neurontin) is being misused more often than any other prescription drug. Non-prescribed gabapentin was found in nearly 11% of urine samples — second only to marijuana — in the first two months of the pandemic. While that’s down from pre-pandemic levels, it adds to a growing body of evidence that gabapentin is being overprescribed and abused.

POSITIVITY RATES FOR NON-PRESCRIBED DRUGS (MARCH-MAY 2020)

SOURCE: QUEST DIAGNOSTICS

Gabapentin was originally developed as an anti-convulsant, but it has been repurposed to treat chronic pain and is often prescribed off-label as an alternative to opioids. When taken as prescribed, there is little potential for gabapentin to be misused. However, when taken with muscle relaxants, opioids or anxiety medications, gabapentin can produce a feeling of euphoria or high.

A likely factor in the decline in gabapentin misuse during the pandemic is a drop in physician visits. Fewer visits mean fewer prescriptions, and gabapentin may have become less available for diversion.

Just as stay-at-home orders forced many patients to cancel or postpone healthcare appointments, it also led a significant decline in drug testing. Orders for lab tests by Quest dropped by as much as 70% in the first few weeks of the pandemic. They have since rebounded, but are still well below pre-pandemic levels.

“COVID-19 interrupted non-essential patient care, but it hasn’t stopped drug misuse,” co-author Jeffrey Gudin, MD, Senior Medical Advisor to Quest, said in a statement. “Given the psychological, social, and financial impacts of the COVID-19 crisis, more efforts are needed to ensure that patients are taking medications as prescribed. While the nation focuses on the pandemic, we must not lose sight of the ongoing drug misuse epidemic, which continues to kill upwards of 70,000 Americans each year.” 

After briefly declining in 2018, drug overdoses began rising again in 2019. According to one preliminary study, drug overdoses are up about 17 percent so far this year.

Pre-Existing Conditions Deserve Affordable Treatment

By Dr. Lynn Webster, PNN Columnist

The National Institutes of Health reports that about 10 percent of Americans experience a substance use disorder (SUD) at some point in their lives. Most of those who suffer from an SUD receive no treatment.

About twice as many Americans – 20 percent -- have chronic pain. Many of them also cannot find adequate treatment or even a provider willing to treat them. 

Making treatment accessible for both of these conditions -- which are defined as pre-existing for insurance purposes -- is always a topic of concern. These days, it is of paramount concern that access to treatment is available. And it requires us to take action.

We’re All at Risk for Pain and Drug Abuse

Poverty and hopelessness are risk factors for drug abuse, even though not everyone who is economically challenged develops an SUD. Unfortunately, prevention and treatment programs for SUDs are less available to those who cannot pay for them and who most need them.

Anyone can suffer from chronic pain, but even those with resources may not have access to adequate pain management.

My concern is more than theoretical. It is personal. I have friends, former patients and family members who suffer from SUDs. If the Affordable Care Act (ACA) — widely known as Obamacare — ends and we lose coverage of pre-existing conditions, I fear they will be abandoned in exactly the same way as people in pain have been abandoned ever since the CDC issued its 2016 opioid prescribing guideline.

In recent years, I have received hundreds of emails and calls from people in pain. Their medications have been tapered and they don't know where to turn for help. Untreated chronic pain, as well as untreated SUDs, can result in ruinous consequences: disability, destitution, isolation, poverty and suicide.

We need to help healthcare providers find more effective ways to treat their patients. The Centers of Excellence in Pain Education (CoEPEs) program was created to teach healthcare professionals about pain and its treatment. Since this is something most doctors do not study adequately during medical school, it's important to have continuing medical education opportunities to learn about the stigma associated with pain treatment and substance abuse disorders.

Abolishing ACA Could Have Devastating Consequences

The current administration has appealed to the Supreme Court to abolish the ACA. President Trump has said that Obamacare "must fall." Given the fact that we're in the middle of a pandemic and millions of people are unemployed and may have lost access to employer-sponsored healthcare, the timing seems terrible.  

But even without a pandemic, reversing the ACA would be devastating for millions of Americans who have an SUD or chronic pain. President Trump signed an executive order on September 24 that claims to protect people with pre-existing conditions. However, experts dispute whether his executive order can actually do what it promises.

Regardless, eliminating the ACA will likely allow insurance companies to charge higher rates for people with pre-existing conditions. This would essentially render treatment for chronic pain and SUD unaffordable for many people, leading to an increase of the terrible consequences mentioned above. And, of course, SUDs and chronic pain are only two of the pre-existing conditions that would no longer be protected. 

It is time for everyone to understand the consequences that losing the ACA may have for their community, family, friends and themselves. There is still time to be heard, but you have to act quickly. Click here to find your federal, state, and local elected officials and express your views.  

Let us also send healing thoughts and prayers to President Trump, the First Lady and everyone else infected with COVID-19.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find Lynn on Twitter: @LynnRWebsterMD. 

FDA Requires Stronger Warning Labels for Benzodiazepines

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is ordering drug manufacturers to update warning labels for benzodiazepines to strongly caution patients and providers about the risk of abuse, addiction, dependence and withdrawal. The agency said current warning labels are inadequate about the risks associated with anti-anxiety medications such as Xanax and Valium, even when they are taken as prescribed.

Benzodiazepines are generally used to treat anxiety, insomnia, seizures and social phobia, and they were once commonly prescribed to chronic pain patients to reduce anxiety and help them sleep. In recent years, many pain patients were taken off the drugs because they are considered risky when taken with opioid medication.

“While benzodiazepines are important therapies for many Americans, they are also commonly abused and misused, often together with opioid pain relievers and other medicines, alcohol and illicit drugs,” said FDA Commissioner Stephen Hahn, MD. “We are taking measures and requiring new labeling information to help health care professionals and patients better understand that while benzodiazepines have many treatment benefits, they also carry with them an increased risk of abuse, misuse, addiction and dependence.”

In 2019, an estimated 92 million benzodiazepine prescriptions were dispensed by U.S. pharmacies, with alprazolam (Xanax) being the most common, followed by clonazepam (Klonopin) and lorazepam (Ativan).

The FDA said it reviewed post-marketing databases and its Adverse Events Reporting System, and found that benzodiazepines were often prescribed for long periods. In 2018, about half of patients prescribed the drugs received them for two months or more, even though most benzodiazepines are only recommended for short-term use. Physical dependence can occur after taking benzodiazepines for several days or weeks, according to the FDA.

“They are also widely abused and misused, often together with alcohol, prescription opioids, and illicit drugs, which worsen the risks of serious problems. We also found that some patients have had serious withdrawal reactions after benzodiazepines were stopped suddenly or the dose was reduced too quickly. Some patients experienced withdrawal symptoms lasting many months,” the agency said.

The FDA previously warned about the risks of combining benzodiazepines with opioids in 2016. Opioids and benzodiazepines are both central nervous system depressants that can cause sleepiness, respiratory depression, coma and death. In 2016, the number of emergency department visits due to non-medical use of benzodiazepines was higher than the number of ER visits for non-medical use of prescription opioids.

Fatal overdoses involving benzodiazepines increased from 1,298 deaths in 2010 to 11,537 deaths in 2017. The vast majority of those overdoses also involved other substances.