Naltrexone Shortage Disrupts Addiction Treatment

By Pat Anson, PNN Editor

An inexpensive drug used to manage chronic pain and treat substance use disorders has joined the growing list of medications that are in short supply in the United States.

The Food and Drug Administration and the American Society of Health-System Pharmacists (ASHP) both recently added naltrexone tablets to their drug shortage lists. It’s not clear what caused the shortage, but the ASHP says “there is insufficient supply for usual ordering.”  

Naltrexone is FDA-approved to treat both alcohol and opioid use disorder, and is also used off-label in low doses to treat some chronic pain conditions.

In 50mg doses, naltrexone blocks opioid receptors in the brain and reduces cravings for opiates or alcohol. But in smaller doses of 5mg or less, patients have found low-dose naltrexone (LDN) to be an effective pain reliever for interstitial cystitis, Ehlers-Danlos syndrome, fibromyalgia, and other painful conditions.

LDN advocates believe the drug modulates the immune system, reduces inflammation and stimulates the production of endorphins, the body's natural painkiller. Because it is an opioid antagonist, naltrexone should not be taken with opioid medication.

So far, the shortage only affects 50mg naltrexone tablets. Pain patients usually obtain LDN by prescription from compounding pharmacies, which make the low dose versions in-house.

Several drug makers are reporting short supplies of 50mg tablets, including Accord Healthcare, Major, Elite Laboratories, SpecGx, Sun Pharma, Tagi Pharma, and Avet Pharmaceuticals. The companies didn’t provide the ASHP with a reason for the shortage, but said the tablets are on back order and would be released when they become available.    

The naltrexone shortage comes at an inopportune time, as more people abused alcohol and other substances during the pandemic and sought treatment. The drug that helps them stay sober is now hard to get.

"People are coming in with more cravings," Dr. Aviva Zohar, an addiction medicine provider, told Philly Voice. "Even the feeling of, 'I don't know when my medicine is coming in,' is a huge struggle. It's horrific (and) causing a lot of stress.”

To make up for the shortage, some providers are giving patients Vivitrol, an injectable, extended-release formulation of naltrexone taken once a month. A single Vivitrol injection costs about $1,700, while a month’s supply of 50mg naltrexone tablets costs about $48.

The cheap price of naltrexone may be responsible for the shortage. Most drugs in short supply are low-cost generics with slim profit margins. Some manufacturers have reduced or stopped making generics because they’re not worth the cost of production or the risk of litigation.   

Three generic opioids commonly taken for pain — immediate-release oxycodone, oxycodone-acetaminophen, and hydrocodone-acetaminophen tablets — have been on the ASHP shortage list for nearly a year, with no end in sight.

Pain Patients Feel Abandoned by U.S. Healthcare System

By Pat Anson, PNN Editor

Many pain patients feel abandoned by the U.S. healthcare system and say it’s increasingly difficult to find a doctor or obtain opioid analgesics, according to a large new survey by Pain News Network. Some patients have turned to other substances – both legal and illegal -- for pain relief, and almost a third have contemplated suicide.

Nearly 3,000 pain patients or their caregivers participated in PNN’s online survey in the final weeks of 2023.

Over 90% of those with opioid prescriptions said they faced delays or problems last year getting their prescriptions filled at a pharmacy. Nearly a third were hoarding opioids because of fear they’ll not be able to get them in the future. And over 40% rated the quality of their pain care as “bad” or “very bad.”

“I’ve given up hope of getting help for chronic, severe pain in this country. I’m planning to move to where I can receive humane treatment,” one patient told us.

“The hoops in which I have had to jump through to get the minimal help that I have gotten throughout the years is ridiculous,” said another. “I have a very extensive and very well documented history of mental and physical trauma, but I am still treated as a drug seeker. I am currently unable to get any form of medication.”

“Every pain patient worries, from one month to the next, if their doctor will cut them off opioids or force taper them to such low levels that there is NO pain relief,” another patient wrote.

HOW WOULD YOU RATE THE CURRENT QUALITY OF YOUR PAIN CARE?

“I’ve spent the last 8 years explaining my inadequate pain control and lack of sleep that has fallen on deaf ears. I’ve tried so many different doctors and now feel like no one cares at all. Honestly feel as though they would rather see me die and be rid of me,” said another.

‘Impossible to Find Help’

About one in every four patients said they were tapered to a lower dose or taken off opioids — but only a small number were referred to addiction treatment. Less than one percent of those who stopped opioid treatment said it improved their pain and quality of life.

One in five patients couldn’t find a doctor to treat their pain. Many were abandoned by a physician or had a doctor who retired from clinical practice.   

  • 20% Unable to find doctor willing to treat pain

  • 14% Doctor retired or left their practice  

  • 12% Abandoned or discharged by a doctor

  • 27% Tapered to a lower dose or taken off opioids

  • 3%   Received a referral for addiction treatment

  • 0.6% Stopped opioids & pain and quality of life improved

“My primary retired. Then my rheumatologist moved to another state. Now most doctors don't prescribe and it's impossible to find help,” a patient wrote.

“Every pain management office in my area were nothing but nightmares waiting to happen. And every person I talked to… were solely concerned with either getting people off of pain medication or reducing the amount of medicine by over half,” said another.

“Doctors I talked to said they felt like they had a gun to their head and that they are being watched, so they won't prescribe or prescribe very little,” a patient wrote.

“My insurance just capped opioids to 7 days a month, so I have to choose whether to buy the other 3 weeks and cut back on my food budget, or take to my bed for 3 weeks a month,” said another.

“I am unable to find a new doctor to treat pain. A couple of years ago I was tapered from a previously working amount of pain med, so now I have daily severe pain and too many sleepless nights from pain. But the doc doesn't care. It seems my clinic system only sees me as an addict,” wrote another pain patient.

Risky Choices

With pain care increasingly difficult to find, nearly a third of patients said they considered suicide in the past year because their pain was so severe. Others adopted risky behaviors, such as hoarding opioid medication, obtaining opioids from another person, buying illicit substances off the black market, or using alcohol, cannabis and other substances for pain relief.    

  • 29% Considered suicide

  • 32% Hoarded opioid medication

  • 30% Used cannabis for pain relief

  • 14% Used alcohol for pain relief

  • 11% Used kratom for pain relief

  • 11% Obtained prescription opioids from friend, family or black market

  •  4%  Used heroin, illicit fentanyl or illegal substance for pain relief

“I was taken off my prescription opioid twice and attempted suicide twice because the other prescriptions were not effective,” one patient told us.

“I have a therapist that has been helpful, because I have considered taking my life. He is concerned that I'm not getting adequate pain relief,” said another.

“Since suicide is against my faith, I prayed for death,” one patient wrote. 

“I know so many people that have stopped going to doctors and started buying heroin off the street. They say it’s easier and cheaper,” another patient said.

“The obscenely high cost of medical marijuana made me suffer so much financially that I have been unable to make use of the compassion center’s offerings,” wrote another patient. “Why on earth do we let plants be illegal in the first place, then let them be sold for so much money that they are almost impossible to afford on a disability income?”

“We desperately need to get away from the denial of opioids as a way to deal with this crisis. So far, the results of these laws on opioids have been an abject failure. Deaths have not been reduced, but actually increased due to chronic pain patients having to resort to suicide,” said another.

“I hope that all the people who are in charge of this will one day feel what I do and have some grasp of the pain situation people are forced to live through. They take care of their dogs and cats better than human beings,” a patient said.

“I have considered suicide multiple times over the past few years. These laws, while meant to curb illicit abuse of these medications, are harming legitimate patients like myself,” another patient wrote. “The worst part is that, for the time being, it looks like things are going to get much, much worse for me and the millions of others like me.” 

PNN’s online survey was conducted from November 13 to December 31, 2023. A total of 2,961 U.S. pain patients or caregivers participated. We’ll be releasing more results in the coming days.  

America’s Biggest Fear: Fentanyl and Opioid Addiction

By Pat Anson, PNN Editor

The fentanyl crisis is the biggest public health problem in the US, according to two new surveys that highlight Americans’ growing fears about opioid addiction and the toxicity of street drugs.

The first survey, conducted by Axios-Ipsos, found that opioids and fentanyl have surpassed Covid-19, firearms, obesity and cancer as the nation’s #1 public health threat. Over one in four Americans (26%) ranked opioids and fentanyl first, replacing gun violence as the top threat to public health.  

Top U.S. Public Health Threats

Fentanyl is a synthetic opioid that is 100 times more potent than morphine. It has been used safely for decades as an analgesic during surgery and to treat severe pain, but in recent years illicit versions of fentanyl have come to dominate the black market, where they are used in counterfeit medication or mixed with substances like heroin. Most fatal overdoses in the U.S. involve illicit fentanyl, not prescription opioids.

The Axios-Ipsos survey found that about four in ten adults (44%) are aware that U.S. overdose deaths reached a record high last year. Americans who live in rural areas, which have some of the highest overdose rates, are even more familiar (51%) with the rising number of drug deaths. 

Over half the respondents (51%) said they cared a lot about overdoses and think the government should be doing more to reduce drug deaths (79%). Most also believe that government does not make the health and well-being of citizens a priority (62%).  

While most Americans trust the health information they get from federal agencies like the CDC (64%) and FDA (62%), there is more trust placed in health information from personal doctors (89%) and family members/close friends (75%). 

Other key findings about respondents’ drug use in the last three months:

  • 26% used a pain medication for which they had a prescription or knew someone who did

  • 3% used a pain medication for which they did not have a prescription or knew someone who did

  • 20% used cannabis or knew someone who did

  • 2% used hallucinogenic drugs or new someone who did

  • 2% used “other illegal drugs” or knew someone who did

“Pain medication” was not defined in the survey questions, so the responses may include some non-opioid analgesics.

The recently updated Axios-Ipsos American Health Index is based on a nationally representative sample of 1,162 adults, who were surveyed on a wide array of health topics from August 11-14.

Most Families Impacted by Addiction

The second survey, conducted by the non-profit KFF, asked a representative sample of 1,327 adults online and over the phone in July about a variety of drug and substance use issues.

Two-thirds of respondents said either they or a family member were addicted to alcohol or drugs, experienced homelessness due to addiction, or had a drug overdose resulting in hospitalization or death.  

Nearly three in ten (29%) said they or someone in their family were addicted to opioids, either prescription opioids or illicit ones like fentanyl and heroin. Opioid addiction was most common among rural residents (42%) and White adults (33%). Among those who experienced addiction firsthand, most said it had a negative impact on their family’s relationships and finances. 

Only 5% felt they themselves might be addicted to opioid painkillers, far less than those who believe they might be addicted to alcohol (13%). 

Fear about addiction is common. Over half (51%) of adults are worried that someone in their family will experience a substance use disorder and one-third (32%) are worried that someone in their family will overdose on opioids.  

About four in ten adults (39%) are worried that someone in their family will unintentionally consume illicit fentanyl, a fear that looms largest in rural areas (48%). 

SOURCE: KFF

Nearly three in ten respondents (29%) said they had been prescribed opioid pain medication in the past five years. Of those, most said their doctors had warned them about the risks of opioid addiction and dependence (57%), side effects from opioids (69%), other ways to manage pain (60%), and about keeping their medications in a safe place (58%).  

While fears about addiction to opioid pain medication are common, it doesn’t happen nearly as often as many people believe. A recent study in Australia found that 92% of patients prescribed opioids for the first time never progressed to long-term use. Less than 3% became persistent users or needed higher doses — and they were mostly seniors with chronic health problems.

Neither the KFF or Axios-Ipsos polls asked respondents about growing shortages of opioid pain medication or how the reduced supply was impacting legitimate pain patients.   

‘Unintended Victims’

The patient side of the story was shared this week in an opinion video by The New York Times. Video producers Vishakha Darbha, Lucy King and Adam Westbrook spoke with chronic pain patients who are the “unintended victims” of the national crackdown on opioid prescribing.

“America’s doctors have been put in a difficult position. But it doesn’t need to be this way. It is possible to stop overprescribing yet ensure that pain sufferers get the relief they deserve. The patients in our video have one message: Listen to us,” the producers said.

Expanded Insurance Coverage ‘Urgent Priority’ for Chronic Pain Patients

By Pat Anson, PNN Editor

A panel of experts convened by the University of Michigan is recommending expanded insurance coverage and better training of providers to address problems faced by millions of chronic pain patients on long-term opioid therapy. Although improving access to pain care is an “urgent priority,” it took nearly three years for the panel’s recommendations to be developed and released.

“Patients who take opioids for chronic pain face unique challenges in the present opioid policy landscape, including reduced access to care,” wrote lead author Adrianne Kehne, a former researcher at Michigan Medicine who is now a Research Project Manager at U.S. Department of Veterans Affairs.

“While there have been substantial efforts to improve access to care for OUD (opioid use disorder), the needs of this patient population have gone largely unrecognized and unaddressed.  Limited access to high-quality care has caused significant distress among both patients and providers, and increasing access is an urgent priority.”

In a paper recently published in the Journal of Pain Research, Kehne and her colleagues said recent efforts to improve access, such as a revised CDC guideline that takes a more flexible approach to opioid prescribing, may not be adequate.

“It remains to be seen how providers and policymakers respond to these new recommendations. The non-binding guideline may not be sufficient to reverse prescribing rules at the state and health system level or significantly change provider behaviors,” they wrote.

A Michigan-based panel of 24 experts, including providers, researchers, regulators, insurers and patients, first met online in September, 2020 to discuss ways to improve access to pain care. Their long-delayed recommendations -- which are only being made public now -- stop well short of reversing policies that discourage opioid prescribing.

Instead, they focus on changing insurance reimbursement policies, to allow providers to spend more time with patients and to offer multimodal, non-pharmacological treatments. Multimodal therapy includes acupuncture, chiropractic care, cognitive behavioral therapy, injected pain therapies and “collaborative care” techniques that are often not covered by insurance.

“In order to encourage more clinics to offer multimodal pain care and increase access for patients who currently don’t receive it, insurance companies and government health coverage programs such as Medicaid need to change how they pay for it,” said senior author Pooja Lagisetty, MD, an assistant professor of internal medicine at Michigan Medicine and the VA Ann Arbor Healthcare System.

“We are starting to see some change, most notably at the VA and in insurance coverage of physical therapy, but more is needed in order for patients and providers to have time to develop individualized approaches, overcome stigma around providing opioid-related care, and for clinics to begin offering non-medication services.”

Other key recommendations of the panel:

  • Make providers aware of how Michigan’s Prescription Drug Monitoring Program (PDMP) is “used in investigating and disciplining providers”

  • To reduce stigma, educate providers on the differences between addiction and dependency in patients on long-term opioid therapy

  • Improve provider education about chronic pain, as well as multimodal and non-pharmacological therapies

  • Train social workers in biopsychosocial factors involved in chronic pain treatment

  • Improve provider education and practices to address racial barriers and biases in pain care

  • Increase recruitment of providers from racial and ethnic minorities

The expert panel study was funded by the Michigan Health Endowment Fund, the National Institute on Drug Abuse and the National Institute on Aging.

Researchers say between 5 and 8 million U.S. patients currently take opioids long-term. That’s down from about 11 million a few years ago. Opioid prescribing in the U.S. has decline by 64% since its peak, and now stands at levels last seen in the year 2000. Despite that historic decline, fatal overdoses have climbed to record levels, fueled primarily by illicit fentanyl and other street drugs.

Should Suboxone Be Used to Treat Kratom Addiction?

By Pat Anson, PNN Editor

A man with a history of substance abuse – including addiction to kratom – has been successfully treated with buprenorphine/naloxone (Suboxone), according to a case study published in the journal Cureus.  Suboxone is a medication that is normally used to treat opioid use disorder.

Kratom is not derived from the opium poppy and is not an opioid. It’s an herbal supplement that comes from the leaves of a tree in southeast Asia, where it has been used for centuries as a stimulant and pain reliever. In recent years, millions of Americans have discovered kratom and use it to self-treat their pain, anxiety, depression and addiction.

The unidentified patient in the case study has a history of using cocaine, marijuana and alcohol, and suffers from anxiety and depression. He was introduced to kratom 12 years ago by his brother for stress relief and as a substitute for oxycodone. Over the years, the patient used more and more kratom, at one point spending up to $600 a week on kratom supplements.

After several failed attempts to wean himself off kratom, which resulted in severe withdrawal symptoms, the patient went to see his primary care physician, Dr. Paul Remick, one of the study’s co-authors. It was Remick who suggested that Suboxone might help him quit kratom.

“He’d been struggling with depression, anxiety, all these various issues. He was pretty reluctant to try therapy like Alcoholics Anonymous or trying to speak to a therapist,” explained lead author Martin Arhin, a medical student at the University of North Carolina at Chapel Hill. “Dr. Remick suggested Suboxone, since kratom has some like opioid-like properties. He felt like it could potentially work. And fortunately, it did.”

After 23 weeks of using Suboxone, the patient’s withdrawal symptoms subsided and he stopped using kratom. He’s also been successfully tapered off Suboxone, a drug that many people wind up taking for life.   

Suboxone is only approved for opioid use disorder and there is no clinical evidence that it can treat kratom addiction. Such a use, while legal, would be considered “off-label” by the FDA. But based on this one anecdotal case, Arhin and his co-authors say Suboxone could be a treatment for kratom dependence.

“Currently, there is no established evidence-based consensus for the treatment of kratom addiction and withdrawal, leaving individual providers to decide on the appropriate course of action,” they wrote. “We recognized the patient's dependency on kratom and subsequently implemented a treatment plan utilizing buprenorphine/naloxone, which effectively alleviated withdrawal symptoms and supported the patient's abstinence from kratom. We suggest that this drug combination may be a potential treatment for kratom addiction.”

‘Kratom Saved My Life’

Ironically, many people use kratom as an alternative to Suboxone. In a 2016 PNN survey of over 6,100 kratom users, nearly ten percent said they used kratom primarily as a treatment for opioid addiction. Most said it was very effective (91%) in easing their withdrawal symptoms and worked better than Suboxone, with fewer side effects.

“Kratom saved my life. I tried every other type of treatment for drug addiction over the past 10 years. Subutex, methadone, total abstinence and the 12 step program. Each time I failed. After 2 years of Suboxone, I stopped treatment and began using kratom,” one respondent told us.

“Because of kratom, I no longer have to worry about heroin (or methadone or Suboxone) making me sick. I've been clean for 2 years. I can hold a job now, and I only use it when I need pain relief or need to relax,” another respondent wrote.

“I became hooked on oxycodone and had to take Suboxone to get off it. The problem is Suboxone withdrawals were nearly as bad, so I used kratom to cure that,” another patient said.

“Kratom truly saved my life. I've always suffered from extreme anxiety, but it has decreased drastically since taking it. Withdrawals from opiates and Suboxone are awful. I would not have been able to get clean without kratom. I'm confident in saying that if you make kratom illegal, the number of overdoses will rise,” wrote another kratom user.

The DEA and FDA have tried to make kratom illegal by having it declared a Schedule I controlled substance. So far, those efforts have failed due to a public backlash.

Kratom is sold legally in most U.S. states, but a handful of states and cities have banned it over concerns about addiction and overdoses.  About 100 deaths nationwide have been linked to kratom use, but in the vast majority of cases other drugs and illicit substances were involved.

About two million Americans use kratom, primarily to treat chronic pain. A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

Although many people use kratom to self-treat opioid addiction and ease withdrawal symptoms, the FDA won’t allow kratom vendors to advertise or promote kratom for addiction treatment or any other medical purpose. This month, the FDA sent a warning letter to the Sunshine Trading Company in Colorado, warning it to stop promoting its kratom products for “opiate withdrawal.”

“You market kratom products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal,” the FDA said.

In recent years, several other kratom vendors have received similar warning letters from the agency..

Studying Natural Opioids Could Lead to New Non-Addictive Analgesics

By Dr. John Streicher, University of Arizona

Opioid drugs such as morphine and fentanyl are like the two-faced Roman god Janus: The kindly face delivers pain relief to millions of sufferers, while the grim face drives an opioid abuse and overdose crisis that claimed nearly 70,000 lives in the U.S. in 2020 alone.

Scientists like me who study pain and opioids have been seeking a way to separate these two seemingly inseparable faces of opioids. Researchers are trying to design drugs that deliver effective pain relief without the risk of side effects, including addiction and overdose.

One possible path to achieving that goal lies in understanding the molecular pathways opioids use to carry out their effects in your body.

What Are Natural Opioids?

The opioid system in your body is a set of neurotransmitters your brain naturally produces that enable communication between neurons and activate protein receptors. These neurotransmitters include small protein-like molecules like enkephalins and endorphins. These molecules regulate a tremendous number of functions in your body, including pain, pleasure, memory, the movements of your digestive system, and more.

Opioid neurotransmitters activate receptors that are located in a lot of places in your body, including pain centers in your spinal cord and brain, reward and pleasure centers in your brain, and throughout the neurons in your gut. Normally, opioid neurotransmitters are released in only small quantities in these exact locations, so your body can use this system in a balanced way to regulate itself.

The problem comes when you take an opioid drug like morphine or fentanyl, especially at high doses, for a long time. These drugs travel through the bloodstream and can activate every opioid receptor in your body. You’ll get pain relief through the pain centers in your spinal cord and brain. But you’ll also get a euphoric high when those drugs hit your brain’s reward and pleasure centers, and that could lead to addiction with repeated use. When the drug hits your gut, you may develop constipation, along with other common opioid side effects.

Targeting Opioid Signals

How can scientists design opioid drugs that won’t cause side effects?

One approach my research team and I take is to understand how cells respond when they receive a message from an opioid neurotransmitter. Neuroscientists call this process opioid receptor signal transduction. Just as neurotransmitters are a communication network within your brain, each neuron also has a communication network that connects receptors to proteins within the neuron.

When these connections are made, they trigger specific effects like pain relief. So, after a natural opioid neurotransmitter or a synthetic opioid drug activates an opioid receptor, it activates proteins within the cell that carry out the effects of the neurotransmitter or the drug.

Opioid signal transduction is complex, and scientists are just starting to figure out how it works. However, one thing is clear: Not every protein involved in this process does the same thing. Some are more important for pain relief, while some are more important for side effects like respiratory depression or the decrease in breathing rate that makes overdoses fatal.

So what if we target the “good” signals like pain relief and avoid the “bad” signals that lead to addiction and death? Researchers are tackling this idea in different ways. In fact, in 2020, the U.S. Food and Drug Administration approved the first opioid drug based on this idea, oliceridine, as a painkiller with fewer respiratory side effects.

However, relying on just one drug has downsides. That drug might not work well for all people or for all types of pain. It could also have other side effects that show up only later on. Plenty of options are needed to treat all patients in need.

Inhibiting a Protein Relieves Pain

My research team is targeting a protein called Heat shock protein 90, or Hsp90, which has many functions inside each cell. Hsp90 has been a hot target in the cancer field for years, with researchers developing Hsp90 inhibitors as a treatment for many cancer types.

We’ve found that Hsp90 is also really important in regulating opioid signal transduction. Blocking Hsp90 in the brain blocked opioid pain relief. However, blocking Hsp90 in the spinal cord increased opioid pain relief. Our recently published work uncovered more details on exactly how inhibiting Hsp90 leads to increased pain relief in the spinal cord.

Our work shows that manipulating opioid signaling through Hsp90 offers a path forward to improve opioid drugs. Taking an Hsp90 inhibitor that targets the spinal cord along with an opioid drug could improve the pain relief the opioid provides while decreasing its side effects. With improved pain relief, you can take fewer opioids and reduce your risk of addiction. We are currently developing a new generation of Hsp90 inhibitors that could help realize this goal.

There may be many paths to developing an improved opioid drug without the burdensome side effects of current drugs like morphine and fentanyl. Separating the kindly and grim faces of the opioid Janus could help provide the pain relief we need without addiction and overdose. 

John Streicher, PhD, is an Associate Professor in the Department of Pharmacology at the University of Arizona. Dr. Streicher has published over 70 peer-reviewed articles and is engaged in numerous drug discovery campaigns to create new analgesics. He receives funding from the National Institutes of Health, the Arizona Biomedical Research Commission, the Flinn Foundation, and the University of Arizona.

This article originally appeared in The Conversation and is republished with permission.

DEA Lifts Limits on Buprenorphine Use

By Pat Anson, PNN Editor

After years of strict limits on the number of patients that a provider can treat with buprenorphine, it’s suddenly a lot easier to prescribe the drug for opioid use disorder (OUD). The Drug Enforcement Administration has eliminated the “X-Waiver” program for buprenorphine, a move required by Congress under the 2023 Appropriations Act.  

Elimination of the X-Waiver removes all patient caps and significantly increases the number of providers that can treat OUD with buprenorphine, a long-acting opioid similar to methadone. When combined with naloxone, an overdose prevention drug, buprenorphine reduces opioid cravings and eases withdrawal. Prescriptions for Suboxone and other buprenorphine/naloxone combinations now only require a provider to get a standard DEA registration for controlled substances.

“DEA fully supports this significant policy reform. ln this moment, when the United States is suffering tens of thousands of opioid-related drug poisoning deaths every year, the DEA 's top priority is doing everything in our power to save lives. Medication for opioid use disorder helps those who are fighting to overcome opioid use disorder by sustaining recovery and preventing overdoses,” DEA Administrator Anne Milgram wrote in a January 12 letter to providers.

The DEA is also developing a new mandatory eight-hour training program for providers to help them identify and treat OUD when they apply for or renew their registrations. The new training will be required on June 21.

“I think this is overdue. Buprenorphine can reduce the risks of overdose by 60% and is much safer than methadone,” says Lynn Webster, MD, an expert in pain management who is a Senior Fellow at the Center for U.S. Policy. “It would be controversial, but I believe low-dose buprenorphine should be OTC as a harm reduction measure. At least there should be a discussion about the potential benefit vs risk.”

Pressure to Prescribe

It remains to be seen how the elimination of the X-Waiver will affect pain patients. Over the years, we’ve heard complaints from patients who say they were coerced by their doctors into taking Suboxone, even though it’s not approved as a treatment for pain. With patient caps removed and more doctors able to prescribe buprenorphine, there could be added pressure on pain patients to take Suboxone – whether they show signs of OUD or not.

“I understand the pressure to use buprenorphine for pain rather than traditional opioids. It is a much safer opioid than most, so it should be considered as a first line therapy,” says Webster. “However, that is the rub. It is not effective or tolerated in many patients.  Patients have a legitimate concern that they may be coerced to transition to buprenorphine when their existing medications are working and there are no signs of abuse.     

“I don't think the change in regulations will mean more doctors will push their patients to use buprenorphine, because the mind-set is already there.” 

A little-known aspect of buprenorphine is that it blocks other opioids from working – meaning anyone who is taking it should be aware that if they have acute pain from an accident, trauma or surgery, they’ll have to rely on non-opioid pain relievers.  

While often touted as the most effective medication for OUD, most people who take buprenorphine relapse and starting taking opioids again. About two-thirds of the patients who receive Suboxone stop filling prescriptions for it after just three months. 

Although it’s difficult to get high on buprenorphine, it can still be misused. A 2021 study found the misuse rate for buprenorphine was over two times higher than misuse rates for hydrocodone, oxycodone and other opioid pain medications.

There Is Another Drug Reform Bill the Senate Must Pass

By Michael C. Barnes, Guest Columnist

After last month’s midterm elections, the U.S. Senate passed the Medical Marijuana and Cannabidiol Expansion Research Act. The House had passed the bill in April, and President Biden signed it into law on December 2. The new law has been described as “modest” because it mostly facilitates research on marijuana and cannabidiol to support the development of medications for approval by the Food and Drug Administration (FDA).

The law also eliminates a longstanding regulatory roadblock that has prevented marijuana research; hindered the development of marijuana-derived, FDA-approved medications; and led to 37 state-regulated markets for marijuana products that do not meet federal consistency, purity, and potency standards. New research can be expected to yield marijuana-derived medications that the FDA can approve.

There is another regulatory burden that the Senate must eliminate before the end of this year. This change in federal law would also be modest, but it would facilitate access to treatment for opioid use disorder (OUD), which is essential amid the nationwide fentanyl poisoning crisis. S. 3257 would expand the time health care providers can hold long-acting, injectable buprenorphine (an FDA-approved medication for OUD) from 14 days to 60 days. It’s that simple. But like the new marijuana research law, the modest change will make a significant difference.

In the 12 months that ended June 30, 2022, 102,842 people died of a drug poisoning. Of those, 69,150 involved synthetic opioids, predominantly illegal fentanyl. Facilitating access to evidence-based treatment for OUD is more important now than ever. Changing the law cannot wait until the next Congress gets up and running.

S.3257 would amend the Controlled Substances Act, which currently requires that a health care provider administer injectable buprenorphine OUD medication to the patient named on the prescription within 14 days after the medication was delivered to the provider. The supposed purpose of the 14-day limit is to prevent the diversion of the medication to the illicit market.

But in 2020, the Government Accountability Office (GAO) reported that “all of the provider groups GAO spoke with said that diversion of injectable … buprenorphine is unlikely, and representatives from three of the six provider groups said that the design of these formulations reduce opportunities for diversion due to how they are administered.”

For patients and providers, the 14-day limit is too short considering the coordination required to facilitate injectable buprenorphine prescribing, insurance coverage and payment, delivery and receipt, and appointment scheduling and attendance. Sixty days are necessary to ensure that medication administration may take place at a time when the patient, provider, and medication are available.

Additionally, the 14-day limit wastes valuable health care resources and places patients’ recovery and lives at risk. For example, if an insured patient is not able to attend a medical appointment on or before the 14th day after the injectable buprenorphine was delivered to his or her provider, the medication must be disposed of.

It is unlikely that an insurer would pay for a replacement product, and it is common for patients not to be able to pay for medications out of pocket. As a result, a patient may be forced to go without a week or months’ worth of medication for OUD. This situation can put the patient at risk for a recurrence of OUD symptoms, active substance use, poisoning by illicit substance, and death.

In June, the House of Representatives passed H.R. 7666 with broad bipartisan support. Section 264 of H.R. 7666 contains a provision expanding the 14-day limit to 60 days.

In passing the marijuana research act, the Senate proved itself willing and capable of enacting modest yet meaningful drug reforms during its lame-duck session. To prevent drug poisonings and avoid wasting lifesaving medications, the Senate must do so again by expanding the 14-day limit to 60 days.

Michael C. Barnes is the managing attorney for Sequel Health Law. He serves as counsel to Aimed Alliance, a not-for-profit health policy organization.

The goal of Aimed Alliance is to create a society in which consumers can make informed and individually appropriate decisions about their health care, without those decisions being overridden by third parties.

Did Opioids Take Away Your Pain?

By Richard “Red” Lawhern, PhD

I write to and for pain patients in several medical journals and social media venues.  I’ve been doing this work for over 25 years. A few days ago, on one of those venues, I encountered the question asked in the headline: “Did opioids take away your pain?”

What follows is my answer.  

I come to this question from the perspective of a published healthcare writer and caregiver to a chronic neuropathic face pain patient. I weekly interact with thousands of patients in social media and via email distribution lists. Thus I “see” many types of pain and many lives impacted by pain.

Pain is the symptom that most often brings patients to a doctor's office. About 50 to 100 million U.S. citizens are affected by pain that significantly affects their quality of life and requires medical treatment.  In 2018, nearly one in five U.S. adults received a prescription for opioids. Prescription rates have dropped dramatically since then, potentially leaving millions of patients under-treated.

From deep study, I am convinced that opioid pain relievers are safe and effective for the great majority of people in whom they are medically managed by a trained and licensed clinician (doctor, physician assistant, nurse practitioner, etc.).

A small percentage of pain patients — estimated by some writers at 0.6% and others as high as 3% — are vulnerable to substance abuse and addiction. However, the numbers of medication abusers appear to be relatively constant, and are not affected by increased or decreased prescribing rates. This suggests that genetic factors might be involved in addiction, but medical literature isn’t conclusive on this issue. Other “causes” of addiction clearly contribute, such as social isolation, hopelessness, unemployment, and protracted untreated pain. 

Depression and anxiety almost certainly play significant roles in both addiction and suffering due to chronic pain. I see this demonstrated repeatedly in thousands of person-to-person contacts on social media.  I believe aggressive evaluation and treatment for depression is a necessary element for effective pain treatment.

Opioids are not needed by all pain patients. And some pain patients are either very slow or very fast metabolizers of opioids due to their genetics – causing a wide variation in the minimum effective dose between individuals.  Others may develop tolerance over time, requiring higher doses to obtain the same pain relief.

For patients managed over long periods on high doses, physical dependence (different from addiction), may develop and they may have withdrawal symptoms if they are tapered off treatment too rapidly. I see no consistent evidence for any effect that can be called “opioid induced hyperalgesia,” a theory that opioids can make pain worse.

Opioids create variable side effects — constipation, sleepiness, brain fog, nausea or low sexual libido.  These side effects can be managed in many people. And for patients who don’t find a balance, one opioid can be tapered down while a different opioid is titrated up. 

Unfortunately, many physicians seem to be unaware of the highly individual responses to these medications.  If a patient cannot tolerate one opioid and pain is severe enough to warrant using this class of medications, then other opioids can be tried.

There is no one-size-fits-all effective dose or safe dose in this class of medicines. I have talked with patients who get substantial pain reduction (rarely total pain relief) from minimal daily doses of 20 morphine milligram equivalent (MME). I’ve also talked with patients who benefited from a dose as high as 2,000 MME, while experiencing few side effects.  There is published literature in case reports pertaining to this widespread range of doses.

This background leads to a central observation:  the default procedure in long term treatment of pain is to first try non-opioids (primarily NSAIDS, sometimes anti-seizure meds for neuropathy); then to try relatively weak opioids like tramadol; and finally to try stronger opioids like hydrocodone or fentanyl patches. This procedure has been known for over 30 years as the World Health Organization’s “Pain Ladder.”

For all drug treatments, additional non-drug support therapy is appropriate.  By this, I mean patient and caregiver support groups, counseling, massage, physical therapy, acupuncture, cognitive behavioral therapy or interventional medicine. Given that such measures rarely improve pain more than marginally, they are not “preferable” to opioids. They can augment but not replace analgesic medication. 

For all opioid therapies, I believe the appropriate medical procedure is to taper up gradually from low doses, while observing and managing intended outcomes and unintended side effects, until a dose level is found that helps the patient manage their pain without creating dangerous side effects.  When this approach is used — even in patients who also deal with substance abuse issues — we see long-term improvements in patient quality of life. 

By contrast, it is now widely understood that forced tapering of patients to lower opioid doses or “cold turkey” withdrawal can be a direct cause of medical crises and sometimes patient suicide.  Patient desertion is never ethically or medically justifiable.

Used with appropriate oversight by a licensed physician, opioids are both safe and effective.  Addiction or substance abuse are rare in medically managed patients.  There is also no relationship between rates of prescribing versus hospital admissions or overdose related mortality. The continuing and widely shouted “association” between doctor-prescribed opioids and substance abuse is a false narrative that has enormously damaged patients and clinicians alike.

The original and draft revision of the 2016 CDC opioid guideline is fatally flawed by anti-opioid political agendas and outright fraudulent junk science. In my view, these guidelines must be publicly repudiated and withdrawn without replacement. All state guidelines referenced to the CDC must likewise be revised or withdrawn.

It is time to remove law enforcement from doctors’ offices, and return the practice of pain medicine to those with actual training and hands-on experience working with people in pain. 

Richard “Red” Lawhern, PhD, is a subject matter expert in public policy for regulation of prescription opioids and of clinicians who employ them on behalf of patients. Dr. Lawhern is a regular contributor to Pain News Network.

Opioid Prescriptions Down Sharply for Medicare Patients

By Pat Anson, PNN Editor

The number of Medicare beneficiaries receiving opioid prescriptions has declined significantly since 2016, according to a new government report that also found steep declines in the number of beneficiaries receiving high doses or who appear to be doctor shopping.

The report by the Department of Health and Human Service’s Office of Inspector General found that over 21 million people -- 23% of Medicare Part D beneficiaries -- received at least one opioid prescription in 2021, down from 33% of beneficiaries in 2016. Over 51 million people are currently enrolled in Part D.

The Centers for Medicare and Medicaid Services (CMS) adopted new safety rules in 2018 that discourage high dose prescribing and limit the initial supply of opioids to 7 days. The rules also allowed pharmacists and insurers to flag Medicare patients deemed to be at high risk, as well as their prescribers.

The rules appear to have had a major impact on prescribing. In 2016, over half a million Medicare beneficiaries received a daily opioid dose of at least 120 MED (morphine milligram equivalent). By 2021, that fell to less than 200,000 patients, a 60 percent decrease in high dose prescribing.   

MEDICARE PATIENTS RECEIVING HIGH DOSE OPIOIDS

HHS Office of Inspector General

Since 2016, the number of Medicare beneficiaries who appeared to be doctor shopping dropped from 22,300 to 1,800; while the number of doctors with “questionable” prescribing patterns fell from 401 to just 98.  Patients were flagged for doctor shopping if they were on high doses and received opioids from four or more prescribers or four or more pharmacists.

“The opioid epidemic continues to grip the nation. There is clearly still cause for concern and vigilance, even as some positive trends emerge,” the OIG report found. “The number of Medicare Part D beneficiaries who received opioids in 2021 decreased to approximately a quarter of a million beneficiaries, extending a downward trend from prior years. Further, fewer Part D beneficiaries were identified as receiving high amounts of opioids or at serious risk of misuse or overdose. The number of prescribers ordering opioids for large numbers of beneficiaries at serious risk was steady.”

But there is little evidence that less prescribing is reducing addiction and overdoses.  The Centers for Disease Control and Prevention estimates there were nearly 81,000 opioid-related deaths in 2021, nearly twice the number reported in 2016, when the CDC’s opioid guideline was released. The vast majority of deaths involved illicit fentanyl and other street drugs, not prescription opioids.

The OIG report found that 50,391 Part D beneficiaries experienced an opioid overdose (either fatal or non-fatal) in 2021, but did not break down how many were linked to illicit or prescription opioids.

Over one million Medicare beneficiaries were diagnosed with opioid use disorder (OUD) last year, but only one in five received a medication like Suboxone or methadone to treat their condition. Medicare patients were far more likely to receive naloxone, an overdose reversal drug. Over 445,000 beneficiaries received a prescription for naloxone, an 18% increase from 2020.

Why ‘Dopesick’ Should Get an Emmy for Fiction

By Dr. Lynn Webster and Hazel Shahgholi

Dopesick, the eight-part Hulu series on the opioid epidemic – sorry, the OxyContin epidemic -- has been nominated for 14 Emmy awards. Based on the best-selling book of the same name by Beth Macy, most of the nominations are well-earned, from the excellent acting of Michael Keaton (nominated for Outstanding Lead Actor) to the breakout performance of Kaitlyn Dever (nominated for Outstanding Supporting Actress) as an addicted patient.

As entertainment, Dopesick is an achievement, but the awards should only be given if the admission is made that the Hulu series is almost entirely fictional. So far, the series’ makers have failed to do so, with Executive Producer Danny Strong claiming that robust research was carried out to make the series as realistic as possible.

“I had done a ton of research, conceived and sold the show before I even knew the book Dopesick existed,” Strong told The Hollywood Reporter. "I read the book, and I loved it. I thought it was a beautiful book, incredibly well done.”

The problems with the Hulu series are many-fold, mostly arising from errors, conflations and under-examinations that are littered throughout Macy’s book, as well as the fact/fiction transition necessary in the baton pass from page to screen.

Strong took many elements of Macy’s dubiously factual text at face value, picking up on the well-established narrative that Purdue Pharma’s marketing of OxyContin was the root cause of the opioid epidemic.

As a result, the series was almost literally bound to fail as an adequate representation of the true origins and spread of opioid use disorder.

OxyContin Misinformation

We know that throughout the opioid epidemic, OxyContin made up, at most, only 4% of the total market for prescription opioids. This data was available at the time of Macy’s book release in 2018 and when the Hulu series came out in 2021. It’s not difficult to find, if one searches beyond the bombast of mainstream news about opioids to focus instead on medical literature and government data.

In the first episode, Strong creates a highly dramatic, but erroneous opening scene. While being questioned by a federal prosecutor, Dr. Samuel Finnix (Michael Keaton), a fictional general practitioner, is asked under oath, “What do you think caused so many deaths in such a short period of time?”

Flashbacks intervene before Finnix states, definitively: “OxyContin.” The prosecutor then hammers home the point by asking, “So just to be clear, you are blaming numerous deaths in your region on just one medication?” And with a heavy-heart, filled with prescriber regret and his own addiction stigmatization, Finnix states, “Yes.”

This total condemnation of Purdue, the Sackler family and OxyContin resides entirely in the realm of fiction. We know from a 2012 Bloomberg BusinessWeek exposé on Florida pill mill operators that it was actually oxycodone and hydrocodone-based generics that were fueling opioid use disorder. It is this type of dangerous, OxyContin-pincered misinformation that has propagated a national misunderstanding about opioids, and kept us from moving from blaming to healing.

Rather than the devoutly religious and close-knit Mallum family, who earn their daily bread through hard work in West Virginia’s mines, the Hulu series has the Sacklers sitting down to meet at opposite ends of a table, as opposed to holding hands in prayer. The Sackler family is separated into those who have “A Shares” and those with “B Shares” in Purdue -- a split that divides the heirs and sees them wrestle over profits. As depicted in the series, the Sacklers are not a family, but a business, through and through.

Fictionalizing the Truth

The time-leaps throughout this eight-part series are anchored on the discoveries of law enforcement as it digs deep into Purdue Pharma. But this organizing principle proves thoroughly dizzying, obfuscating the “human interest” element that makes up much of Macy’s book.

Because the series is also determined to paint physicians and patients in an antagonistic relationship, we end up with just two fictional representations of “doctors” and “patients” -- Keaton’s Dr. Finnix and Dever’s Betsy Mallum, whose characters were explained by Strong in a 2021 interview with NPR, in which he praised the merits of not being “stuck to the truth.”

“If I made these characters composite characters, I get way more of these anecdotes into these arcs with fewer characters and get more truthful stories into the show," Strong said. "By fictionalizing, [emphasis added] I wouldn't be stuck to the truth of one person's life. I could use as many anecdotes as I wanted. I could achieve a more universal truth; a higher truth."

Dr. Finnix is the epitome of a “composite character” into whom most material and several arcs are heavy-handedly stuffed. He is emblematic of a problematic prescriber. We only meet three of his patients in detail — Mallum, his ex-miner patient Jonas, and a young woman named Elizabeth-Anne — all of whom become addicts. Finnix himself becomes addicted, getting high on his patients’ diverted supply. This distillation of Finnix cannot be taken as a “more universal truth,” even in a meager sense, as we shall explore.

The mechanism by which Finnix becomes addicted to OxyContin happens in a flash that straddles two episodes. One moment he is the ever-attentive country physician, happily working 16-hour days, making night calls to elderly patients with dementia to ensure all their daily meds have been duly taken, attending to the injuries of his coal-mining patients, and often delivering their children.

Finnix is a man of simple pleasures; he enjoys fishing with members of the Finch Creek community of which he forms the responsible backbone, until the devil invades the town in the form of OxyContin. Upon receiving a call about an explosion in a mine that has left several workers in critical condition, he speeds back to Finch Creek from a visit to Washington D.C. to see his late-wife’s sister, who has encouraged him to start dating again.

In his haste, Finnix doesn’t buckle-up and is T-boned by another vehicle. He suffers several broken ribs in the accident and is prescribed 20mg of OxyContin, much to his surprise, as he usually starts his patients on 10mg tablets.

Cut to Episode 4, entitled “Pseudo-Addiction.” Without any explanation of why the hitherto cautious prescriber has not had follow-up treatment with an independent physician -- we see Finnix cast in utter damnation, diverting OxyContin prescriptions for his own personal use. Presumably, adding another physician to the story would have taken up too much screen time, and undone the drama of Keaton’s lone composite character.

Dependency and Addiction

Let’s pause for a moment to unpack Strong’s haste. It is again based on a conflation made by Macy, who fails in her book to differentiate between the medical terms “dependency” and “addiction.” This is a false narrative. Addiction and dependence are related, but cannot be equated, and should not be conflated. Many drugs, including antidepressants and anticonvulsants, can cause such physiologic adaptation that abrupt withdrawal can cause serious, even life-threatening events. This is the case with opioids, too.

But being dependent is not the same as being addicted. And by not using the term “dependency” extensively in her book, Macy paints a false picture that hyperbolizes all opioid use, prescription or illicit, as inherently a kind of addiction -- when there are millions of people with chronic pain dependent on opioids, but not addicted.

Interestingly, Strong’s series does use the word “dependency” once, in Episode 4, via a nameless, testifying physician character, and in a scientifically false and unhelpful way. With cuts to Finnix locking the last of his patients’ diverted pills in a glass kitchen cabinet, before smashing said cabinet to smithereens, the unnamed physician states, “Opioids are uniquely challenging as they can change a person’s brain chemistry. But in a desperate effort to end the cycle of dependency, some people try to quit cold turkey, but the results can often be disastrous.”

It is important to note that this moment in the series can be enlarged by turning to statements made by Strong in an interview on MSNBC’s Morning Joe, in which he claimed that “you can be addicted in three days” to OxyContin.

That is blatantly false. Neural adaptation can occur as soon as ingesting the first pill. But this is not necessarily problematic, it is simple science and occurs with many drugs, not just opioids. The claim that you can become addicted to opioids in three days is simply not true, and there is no scientific evidence to support this statement. Physical dependency, which they clearly conflate with addiction, is not even a medical problem at day three, day seven, or day fourteen. It may never even become a problem.

But this question cannot even be properly attended to until the differentiation between addiction and dependency is substantiated in these depictions. Respectfully, how can Strong purport to “redefine our understanding” of something that he himself does not understand? 

Strong’s need to distill information is so extreme that Dr. Finnix is funneled into an OxyContin-self-prescribing-and-diverting-monster between the rolling of one set of credits and the opening of a new episode.

Strong’s MSNBC interview is hyperbolically backdropped by a hysterical graphic claiming over 760,000 overdose deaths — a conflated statistic that doesn’t distinguish what drugs caused the deaths. Was it OxyContin? Oxycodone? Hydrocodone? Heroin? Cocaine? Methamphetamine? Poly drug use?

Whether the deaths were due to illicit misuse, diverted pills or legitimate prescriptions is also ignored. We are only told by the reporter conducting the interview that, “OxyContin is the brand most people know.” Indeed. The opioid epidemic has become a cash-cow for misrepresentation.

MSNBC

It is important to note that pseudo-addiction is also mischaracterized in the Hulu series. It is used as a mechanism to accuse Purdue Pharma of encouraging irresponsible over-prescribing, when in fact it attends to patients in a state of severe “uncontrolled” pain. Uncontrolled pain is as devastating as it sounds, especially when we have means to treat it.

Once again, it is a concept that should be considered scientifically and medically, not simply as a harmful concept “invented” by Purdue for profit gains. Uncontrolled pain was not invented by Purdue at all, and has been studied from as early as 1989, before being expanded into the use of opioids for responsible pain management and becoming common amongst pain specialists for over three decades.

‘Selling Poison’

Dr. Finnix follows a similar path as the composite “addict” character, Betsy Mallum: from OxyContin use to chronic opioid abuse. He never moves to heroin, but he does buy OxyContin illicitly, while being schooled by a local drug dealer on how to get a faster high by crushing and snorting the pills through a straw.

It's not long before Finnix’s collapse is total. He has begun to behave uncharacteristically, beating his Purdue sales rep before manhandling him out of his office for “selling poison.”

The axe finally drops in a grizzly scene when Finnix is high during a surgical procedure. Then, while accompanying his now butchered patient to the ER, he complains to the attending doctor of rib-ache and requests OxyContin unabashedly. The doctor offers him a 10mg tablet, but Finnix ups the request to a 20mg pill in a manner that paints him as perhaps the most suspicious doctor-shopping-doctor imaginable.

The onus of representation for the addict group falls mostly on Betsy Mallum (Dever), who, when quizzed in an interview with Entertainment Weekly over the fact/fiction nature of her character replies:Yes. She's a fictional character that represents a lot of people.”

Betsy is the first patient that Dr. Finnix turns into an addict. She receives the “First-Bottle” of OxyContin, to borrow Episode 1’s title, and uses the pain medicine to continue to work at the mines despite an excruciating work-related injury.

There are two points of note here: Finnix prescribes OxyContin to her with strict instructions for when to take the pills -- one in the morning and one at night -- which Betsy does. He also provides the appropriate advice of a rest period from her grueling work in the mines. He offers to go down and talk to management himself in order for the young woman be able to take a break to aid her physical healing. Betsy does not take his advice.

This is because of the important part the socioeconomic environment plays in Betsy’s crucial and unexamined predisposition toward addiction and substance abuse disorder. She knows how the mining industry works and that, in her father’s own account, she is the smallest "but strongest” one down there.

Betsy therefore has the obligation of needing both to retain her work: she’s a small-statured female and knows she is at high-risk for disposability in a shrinking industry, but she must also fulfill a need for validation from her domineering and deeply religious father. A father who would cast her out if she were to reveal her true self: her sexuality as a lesbian involved in a behind-closed-doors relationship with fellow mine worker, Grace.

This moves us on to a pivotal point. Even though Betsy is the recipient of the “first bottle,” she dumps her prescription by Episode 3, “The Fifth Vital Sign,” without tapering of any kind and without informing Dr. Finnix. Subsequently, she descends into a world of illicit diverted pills and eventually heroin. It is the latter drug that takes her life, the night before she is to enter a Suboxone treatment program and after a conversation with Grace, when she finds out that her first love can only be a friend moving forward.

Due to her addiction, Betsy never manages to make “enough money underground” to move to Grace’s Eureka Springs, Arkansas; a real place that Grace describes to Betsy as “Oz for country queers.” Devoid of hope after losing her first love, Betsy informs her flop house drug dealer that she is entering a Suboxone treatment center the following day. “So give me one hell of a sendoff,” she states as her final, fatal words.

The Fifth Vital Sign

To move beyond the episode’s sign-posting, the show depicts the medical community’s adoption of pain as the “Fifth Vital Sign” as a ploy to fuel over-prescribing. At the time the phrase was introduced, pain was vastly under-treated, there was a pressing need to bring attention to the unmet needs of chronic pain sufferers across the nation, and to facilitate dialogue between physicians and their patients to assess their pain levels and explore treatments — with opioids being just one — to increase their quality of life.

Introducing pain as a “vital sign” was an entirely reasonable pathway to take by the medical community. Although it is reasonable to argue that pain is not a vital sign in the way that breathing and heart beats are, it is nevertheless vital to assess pain.  But once again, it was not a Purdue “invention” as the show would usher you to believe, it was first discussed by Dr. James Campbell in an address to the American Pain Society in 1995. The term has faced some controversy, but it was well-intentioned.

What Macy failed to do in her mishaps over medical research in her book, which led to Strong’s OxyContin demonization, does not befit an analysis of the overdose death of Betsy Mallum. Per scientific examination, the pivotal 1998 CDC-Kaiser Permanente Adverse Childhood Experiences (ACE) study used ten different measures of adverse childhood experiences, drawing the conclusion that that “for each traumatic event that happened to a child, they were two to four times more likely to grow up to be an addicted adult.”

The one we can outline as specific to Betsy is “parental rejection.” This is what she fears the most. When Betsy attempts to come out to her mother by stating that she “likes girls… always have… and not just as friends,” her words fall on deaf ears, with her mother quite literally pretending she didn’t hear the utterance: “Did you say something dear?”

It’s a statement Betsy’s mother later regrets, realizing its impact, but by then it is far too late. Finnix’s pre-OxyContin-addiction fishing trip during which he tries to irk Betsy’s rigid father into the enlightened mindset that being gay is not a sin but just a state of being, also misfires and leads to a demonizing, make-no-mistake style dinner scene.

Unable to live as her true self through fear of rejection and in the throes of withdrawal, Betsy burns the false-self: the one that is content sitting at home and knitting quilts with her in-denial mother.

When the news of her death is revealed, we see the camera focus on a picture of Betsy as a young child. This is also emblematic of denial; but this time not of the fictional Mallum family alone, but also of the filmmakers and Macy, who push for the narrative of the destruction of innocence via the opioid scourge.

Addiction’s Root Causes

The Mallum parents, through the zealot foisting of religion on a girl who “never believed in any of that stuff anyway,” did their daughter a deathly disservice. And they are more culpable for her death than Purdue Pharma or Dr. Finnix.

Betsy had a predisposition for substance abuse disorder, but Finnix did not. Although in Episode 4 we see him in a hallucinated waltz with his deceased wife, he seems content as a widower — although the dance scene does belie his underlying existential pain.

The filmmakers didn’t even throw in any trite backstory or anecdote of Finnix having an alcoholic father or brother — a detail that would barely be substantiating for predisposition per today’s medical rigor over addiction’s root causes. But it would have at least stimulated the viewer into questioning why this character had morphed so horrifically and so expressly.

The young Betsy, on the other hand, has a story of her own and one that would undeniably predispose her to substance abuse. Despite Strong’s claims, one must stick to individual stories to understand addiction, its roots, and the specific drugs that may come to fuel it.

By choosing to fictionalize via character composites, and by picking a “patient” so heavily predisposed to substance abuse disorder due to ACE and environmental factors, Dopesick doesn’t adequately represent the patient side of the doctor-patient relationship at all. The human element that is strong-armed into Finnix and Betsy is loaded for downfall, because that makes for good viewing.  One arc is devastating — Betsy’s — and Finnix’s is convoluted, although redemptive in the end.

Covering all bases in this fashion is hyper-unrealistic, difficult to digest, and self-serving on the part of the filmmakers in their need to enthrall their audience.

‘We Have Another Pharma Case’

There is another clandestine narrative at work in Dopesick. A prosecutor fights prostate cancer as he tries to bring Purdue to justice. After waking from a surgical procedure to remove the cancer, even while semi-conscious and in extreme post-surgical pain, he is aghast at the insistency of a nurse who tries to “force” OxyContin upon him. Heroically, he refuses and relays the tale back to his boss, who declares he made the “right choice” to fight the pain with the over-the-counter, non-narcotic Motrin.

What makes the parallel between the prosecutor and Finnix so powerful is that both characters moved from bigger towns to small West Virginian areas and both describe this life choice as the “best decision I ever made.”

The difference between the two characters is that good old Dr. Finnix, the responsible and attentive physician, falls prey to addiction almost immediately, while the representative of law enforcement holds strong.

Per the narrative of the “Iron Law of Prohibition” that this show peddles, representatives of the law must be invulnerable. The show pushes this weak theory clearly. After all, who could be more of a “drop out” than a physician, who is the biggest threat? It’s not the Sacklers, if we follow the human element, but prescribers.

This good/bad dichotomy is cemented in the last statement made by the chief prosecutor of his future plans: “We have another pharma case we’re looking into…” Tellingly, the drug company is not named, perhaps because it couldn’t be.

The fight for pharmaceutical anti-opioid justice is a good story and resonates with the public. But as a society, perhaps we should focus on addiction and its role in the human condition. Treating addiction, as opposed to distilling and misleading the public about its causes, might be a better way to slow the continuing rise of drug overdoses in America.

(Update: Dopesick won two Emmys, for outstanding lead actor and outstanding cinematography.)

Lynn R. Webster, MD, is Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript. He also consults with the pharmaceutical industry. Lynn is the author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die.

Hazel Shahgholi is a senior editor and journalist based in New York City. Her most recent roles include Deputy Editor of amNY Metro, Editor in Chief of The Bronx Times, and Production Editor for MedPage Today.


Raising Lazarus: Another Take on the Opioid Crisis

By Pat Anson, PNN Editor

Beth Macy’s bestselling book Dopesick” – and the Hulu series based on it -- helped shape the popular narrative on the origins of the opioid crisis: that Purdue Pharma and the Sackler family duped physicians into prescribing highly addictive OxyContin to millions of pain patients, setting off a public health and overdose crisis that continues to this day.

Macy’s new book “Raising Lazarus” focuses on many of the same themes, but with an important new addition. She recognizes that opioid hysteria and fear of addiction went too far, depriving many people in pain of the medications they need to lead functional and productive lives.

“In recent years, law enforcement agencies, the CDC, and other medical authorities had overreacted to the first wave of the opioid crisis by clamping down too hard on opioid-prescribing,” Macy wrote. “Some doctors responded to the revised 2016 CDC opioid-prescribing guideline – and their fear of DEA prosecution – by declaring draconian caps and essentially abandoning their patients.

“People who needed opioids were refused access. Others with decades-long chronic conditions like extreme rheumatoid arthritis were abandoned by doctors and were now left bedbound. Some who were denied the opioids they’d been taking for decades attempted suicide or resorted to illegal drugs.”  

Those are welcome words from a noted critic of opioid “overprescribing.” But that passage – which is buried halfway through a 373-page book – doesn’t represent what Raising Lazarus is all about. Macy’s new book primarily deals with Purdue’s corporate greed and the ongoing struggles of working-class people in Appalachia to overcome addiction and a healthcare system that simply doesn’t work for them.

Macy is a bit defensive and resorts to gaslighting when she acknowledges past criticism from pain patients for Dopesick “drawing too much attention to overprescribed opioid pills.” Many of their complaints are valid, she admits, “if sometimes over-the-top and oblivious to the root causes of the crisis.”

Interestingly, Macy never actually quotes one of those “over-the-top” pain patients in Raising Lazarus, but she did interview Stanford pain psychologist Dr. Beth Darnall about the reluctance of doctors to prescribe opioids.

“Doctors are so concerned about being flagged, concerned about their license and their livelihood, they don’t want to take (chronic pain patients) on, and so you end up with patient abandonment, and iatrogenic harms that can create a medically dangerous situation,” Darnall told Macy.    

‘The Cruel World of Purdue Pharma’

Greed, no doubt, is one of the primary causes of the opioid crisis and Macy describes in detail how the Sacklers manipulated the political and legal system, paying their chief counsel the handsome rate of $1,790 an hour to gum things up as best he could to preserve the family fortune and prevent them from going to prison.

But she gives a free pass to others who have profited from the opioid crisis, often at the expense of pain patients, most notably the private plaintiff law firms suing drug makers on behalf of cities, counties and states.

Macy credits the late attorney Paul Hanly as being “the first to crack open the cruel world of Purdue Pharma” without pointing out that his law firm, Simmons Hanly Conroy, boasts that it “effectively invented large-scale, multi-defendant opioid litigation” and stands to make billions of dollars in contingency fees from settlement money.  

Also unmentioned is the $400,000 in campaign donations given by Simmons Hanly Conroy to former Sen. Claire McCaskill (D-MO) in 2018, who conveniently produced a well-publicized report that year critical of drug makers and medical pain societies that the law firm was suing. Overwhelmed with legal fees defending themselves, two of those pain societies filed for bankruptcy, a loss that pain management specialists, researchers and patients could ill afford.

Macy does quote anti-opioid activists like Dr. Andrew Kolodny and Dr. Anna Lembke, but doesn’t mention that they testified as paid expert witnesses for Hanly and other plaintiff law firms, making well into six figures for their testimony, which they often failed to disclose in conflict of interest statements.  

“The opioid-litigation money is a once-in-a-generation opportunity,” Macy writes, with unintended irony.

Macy is hopeful the settlement money – once estimated at $50 billion -- will go towards addiction treatment and better healthcare for communities ravaged by the opioid crisis. Unfortunately, much of it has already been spent on legal fees, media and public relations campaigns, and political donations. That’s not counting shady industries that have grown and prospered due to the opioid crisis; from drug testing and stem cell providers to cannabis promoters and drug cartels.  

Even though fentanyl and other street drugs are responsible for the vast majority of overdoses, Macy still clings to the tired notion that opioid pain medication started it all.

“A quarter century into the crisis, many people with OUD (opioid use disorder) have long since transitioned from painkillers to heroin, methamphetamine, and fentanyl, the ultra-potent synthetic opioid. And we now have a generation of drug users that started with heroin and fentanyl,” she writes. “Death by drugs is now a national problem, but the crisis began as an epidemic of overprescribed painkillers in the distressed communities that were least likely to muster the resources to fight back.”

I look forward to Macy’s next book and hope that she hears more from the distressed community of pain patients. They need a champion to fight for them too, not more gaslighting.

Another Look at the Opioid Risk Tool

By Dr. Lynn Webster

I'm a proud grandfather to two young granddaughters. They are my world. Watching the U.S. Supreme Court rescind women's right to decide what to do with their own bodies made me feel angry that my granddaughters will be subjected to dehumanizing discrimination.

This tyranny against women extends beyond the Supreme Court’s decision over Roe vs. Wade.

I have read multiple accounts of women who are being denied access to opioid medication because they acknowledge a history of toxic adverse experiences as children or adolescents. Many such instances have occurred after women completed the Opioid Risk Tool, a questionnaire that asks a person if they have a history of preadolescent sexual abuse.

The refusal to prescribe opioids to women with a history of preadolescent sexual abuse is a defensive measure by providers to avoid being accused of causing an Opioid Use Disorder (OUD).

Why I Developed the Opioid Risk Tool

The Opioid Risk Tool (ORT) that I developed more than 20 years ago was designed to assess the risk of someone who was prescribed opioids for chronic pain treatment showing aberrant drug-related behavior.

The ORT was a simple questionnaire that could be administered and scored in less than a minute. It was developed at a time when we had no way to assess the risk of developing opioid abuse in patients who were prescribed an opioid for non-cancer pain. We needed a tool to help evaluate whether the risk of potential harm from opioids outweighed the potential good for each individual.

I never intended for doctors to use the ORT to determine who should or shouldn’t be prescribed an opioid. My goal was to help doctors identify patients who might require more careful observation during treatment, not to deny the person access to opioids.

Since abuse and addiction are diagnosed by observing atypical behaviors, knowing which patients are at greatest risk for displaying those behaviors is useful in establishing appropriate levels of monitoring for abuse. This was intended to protect the patient from potential harm. It was never supposed to be used as an excuse to mistreat patients.

The original version of the ORT contained 10 questions, including whether a patient had a history of preadolescent sexual abuse. Women who answered "yes" scored 3 points; while men who responded affirmatively scored 0 points. The higher you scored, the more closely your doctor would need to monitor your opioid use during your treatment.

The ORT questionnaire was based on the best evidence at the time. Multiple studies have since confirmed the validity of the questions used in the questionnaire. However, many people have criticized the question that asks about a history of preadolescent sexual abuse because of a perceived gender inequity. In addition, some doctors have generalized the ORT's question about preadolescent trauma so that it applies to a history of female sexual abuse at all ages.

I have written that the ORT has been weaponized by doctors who are looking for a reason to deny patients -- particularly, women -- adequate pain medication.

There are doctors who use their power to determine whether to treat a woman's chronic pain with an opioid or allow her to suffer needlessly based on the ORT's answers. This is no less malevolent than a forced taper resulting in suicides or the use of the CDC opioid prescribing guideline to criminally charge providers for not following the CDC's recommendation. In all of these situations, an injustice is being committed against innocent people.

It is also not much different from the Supreme Court’s decision to ignore a woman’s right to access full reproductive rights. Both are attacks on women.

Fortunately, Martin Cheatle, PhD, and his team published a revised Opioid Risk Tool in the July 2019 edition of the Journal of Pain. In his research, Dr. Cheatle found that a revised ORT using 9 questions instead of 10 was as accurate as, if not better than, the original ORT in weighing the risk of patients for OUD. The revised ORT eliminates the use of a woman's sexual abuse history as a risk factor.

At a time when females have had their human rights taken away by a Supreme Court vote, it is especially appropriate to reconsider how we assess risks for potential opioid abuse for women.

It distresses me to know that, while the original ORT served to help assess the risk opioids posed for individuals, it has also caused harm. Since the question about a woman's sexual abuse history does not provide any additional benefit, there is no reason to retain it. The revised ORT should be used instead of the original ORT.

Lynn R. Webster, MD, is Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript. He also consults with the pharamaceutical industry.

Lynn is the author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. You can find him on Twitter: @LynnRWebsterMD.

 

Drug Addiction Is the Problem, Not Prescription Opioids

By Christine Kucera, Guest Columnist

The Centers for Disease Control and Prevention (CDC) is the leading national public health institute of the United States. The agency is responsible for protecting the public from health and safety threats. 

In my opinion, the CDC has no business writing clinical guidelines! Medical guidelines for healthcare/disease management, medication management, and clinical decision making should be developed, reviewed and approved by a diverse team of clinical subject area specialists and key stakeholders, including medical specialists, medical groups, advisory teams, advocates and patients. Not regulatory agencies!

The 2016 CDC opioid guideline, as currently written, has harmed and damaged millions of lives, and caused unspeakable suffering. In effect, the CDC sanctioned torture by failing to promptly address and correct the negative impact of its guideline on individual patient care, addiction and pain management treatment and resources.

The CDC has clearly overstepped its authority by creating a guideline meant to regulate the use of prescription opioids. Any regulatory measures which prevent patients from accessing prescription opioids as indicated for their health and well-being are unethical and should be reconsidered, if not totally withdrawn.

The CDC continues to propagate the false narrative that any patients requiring prescription opioids for any type of pain are or will become addicts. And it continues to claim — without any evidence — that if opioid prescriptions are limited in quantity, type, duration and dose, there will be a reduction in addiction, overdose and death. The facts indicate otherwise. Overdoses are at record high levels.

The True Causes of Addiction

Substance addiction exists because our government has failed to address its true causes, which include poor access to addiction treatment, unethical pain treatment, lack of quality care standards across medical institutions, and lack of legislative laws that protect patients from suffering needlessly. 

Addiction is caused by preventable and manageable health disparities, untreated and undertreated mental and physical suffering, genetic metabolic variability, lack of resources, lack of all-inclusive healthcare insurance, lack of provider managed pain care, lack of treatment centers, lack of access to appropriately prescribed medications, lack of drug monitoring systems, lack of access to mental health and pain care providers, lack of timely access to a comprehensive network of providers, and lack of individualized care. 

Maybe if the CDC actually focused on the above health and safety issues, we would have guidance on solving the real problems. The CDC has failed miserably to recognize that individual pain care is as unique as the patient who is suffering in pain. Every single person that has pain seeks relief.

Relief comes in many different forms, both healthy and unhealthy. These forms of relief may be self-directed and/or medically managed by clinical staff and providers, and includes exercise, yoga, rest, mobilization, heat/ice therapy, massage, mindfulness, acupuncture, Chinese herbal medicine, bio-feedback, diet, weight loss, surgeries, water therapy, bicycling, strength/weight training, martial arts, immunotherapy, TENS, anti-inflammatories, anti-seizure medication, muscle relaxants, antidepressants, biologicals, medical/recreational cannabis, CBD, kratom, prescription opioids, illicit/illegal drugs and alcohol — to name a few. 

Every Patient is Different

The journey each patient in pain takes is individual. The pain you've experienced and lived with is different from mine and everyone else’s.  

The terms “acute pain” and “chronic pain” are also misleading and are part of the false narrative. Pain is a symptom. Its management depends on its physical and/or mental cause, not how long it lasts. Pain is the body's way of sending up a red flag that something is not right.

Duration means nothing in the world of pain, as every minute of the day is different in type, in location and in intensity. Pain goes through cycles, and no person experiences pain the same way.  

Until the individuals who wrote this God awful, evil guideline experience pain that is unrelenting, agonizing, non-stop, 24/7 for their entire life, they should back off the false narrative, go back into their non-medical cave, and leave the medical decision making up to the actual physicians who are trained to manage pain with all the tools available and at any quantity required by a patient.  

What the CDC should be addressing are the sources of suffering, identifying at-risk individuals and providing a framework for implementing resources and systems of care that are fluid and adaptive to the unique circumstances of each individual.  

There are too many outstanding questions and issues which also continue to impact patients and providers. What are the FDA and DEA’s roles and responsibilities? How do their policies meet the objectives of the CDC guideline to reduce addiction, overdose and death? What impact do they have on medical providers treating patients in pain? 

Addiction is the public health issue requiring CDC input, not the utilization of prescription opioids for pain treatment. 

Christine Kucera is an intractable pain patient survivor of over 30 years. She lives with reactive psoriatic arthritis, spondylitis, polyarthritis, sacroiliitis, degenerative disc disease, dermatomyositis, mixed connective tissue disease, psoriasis, lupus, spinal radiculopathy, thoracic outlet syndrome, endometriosis stage IV, and other painful conditions.

Prior to becoming disabled, Christine was a healthcare research systems developer and analyst for federally funded CMS, AHRQ, and NIH grants and programs. 

Little Evidence Opioid Use by Children Leads to Addiction

By Pat Anson, PNN Editor

Healthcare providers have become more cautious in recent years about giving opioid pain medication to children, fearing that even short-term use could lead to a lifetime of addiction or even a fatal overdose.

But in a review at the University of Alberta, pediatric researchers found little evidence to support a link between short-term opioid use in childhood and opioid use disorder (OUD) later in life.

“We actually didn’t find a lot of evidence to directly answer our question,” said senior author Michele Dyson, PhD, assistant professor of pediatrics in the Faculty of Medicine & Dentistry and associate director of the Alberta Research Centre for Health Evidence.

“If opioids are used as indicated, they can be a safe and effective strategy for pain management,” she said. “In some cases, they really are part of the best treatment plan to manage a child’s pain.”

Dyson and her colleagues reviewed 21 observational studies involving nearly 50 million patients under the age of 18 who were exposed to opioids for less than 14 days. Most of the studies were considered low quality and did not look at the duration of opioid use.

One study did show a potential link between short-term exposure and later abuse. But researchers concluded the findings overall were not definitive because they did not specify duration of exposure or lacked a control group. Their findings are reported in the journal Pediatrics.

“There is limited evidence to determine if short-term therapeutic exposure to opioids in childhood is
definitively associated with future nonmedical opioid use or development of an OUD; however, this review suggests a link between lifetime therapeutic opioid use (unknown duration) and nonmedical opioid use. The existing evidence on risk factors for nonmedical opioid use or OUD after short-term therapeutic exposure is unclear,” researchers concluded.

Conflicting Advice

Whether opioid medication is appropriate for children is a controversial issue. Earlier this year, the World Health Organization (WHO) released new guidelines recommending that opioids only be used for children who are dying or seriously ill and not expected to recover.

Like the Alberta study, a WHO advisory panel found little good quality research on how to treat childhood pain, but recommended that children with chronic pain be treated with physical therapy and psychological interventions such as cognitive behavioral therapy.  

An international study in The Lancet came to a very different conclusion, warning that opioid prescribing guidelines intended for adults are being “inappropriately applied to young people.” Because of the stigma associated with opioids, researchers said childhood pain was often untreated or poorly treated, leading to chronic pain, disability and other negative consequences in adulthood.

“Health-care professionals, young people, and parents continue to hold misconceptions and believe myths about opioid use in pediatric patients, whereby the media depicts opioids as the villain and the underlying reason for substance misuse,” researchers said. “Opioids have their place in pediatric pain medicine.”

That finding is at odds with a 2018 warning from the U.S. Food and Drug Administration, which said that cough and cold medications containing opioids pose “serious risks” to children and should no longer be prescribed to patients younger than 18.

A recent study found that opioid misuse is relatively rare in U.S. adolescents and young adults. Less than 1% of those who filled an opioid prescription for the first time overdosed or developed opioid use disorder within the next 12 months.

The conflicting advice can be confusing to both parents and providers.

“Parents see stories about overdoses in the news and are afraid for their children, while physicians and prescribers are also worried because they don’t know what the evidence is,” says Dyson. “Health-care providers don’t want to cause harm, and at the same time, they still want to be able to treat pain appropriately.”

Dyson and her team at the University of Alberta have developed a series of infographics to help physicians, parents and young people recognize that opioid pain relievers are sometimes needed.

One such graphic plainly states: “Opioids don’t have to be scary!”

UNIVERSITY OF ALBERTA INFOGRAPHIC

“While we can’t say for sure that a short-term prescription for pain is linked with misuse, there is some evidence that that could happen,” she explained. “There is likely some risk, but it needs to be balanced with the harms of stigmatizing opioid use and under-treating pain, which comes with its own significant short- and long-term consequences.”