CDC: Still Not Enough Naloxone

By Pat Anson, PNN Editor

The Trump Administration is stepping up efforts to increase prescribing of naloxone, an overdose recovery drug credited with saving thousands of lives.

Although naloxone prescriptions have increased dramatically, a new CDC Vital Signs report estimates that nearly 9 million additional prescriptions could have been dispensed last year if every patient with a high-dose opioid prescription was offered naloxone.  Patients are considered “high risk” if they take an opioid dose of 50 morphine milligram equivalent (MME) or more per day.

Naloxone has been used for years by first responders and emergency medical providers to revive overdose victims. Current efforts are focused on expanding access to the drug by prescribing it directly to patients considered at risk of an overdose.

In 2018, CDC researchers say only one naloxone prescription was dispensed for every 70 high-dose opioid prescriptions nationwide. Naloxone “under-prescribing” was even more acute in rural counties, which are nearly three times more likely to be ranked low in naloxone dispensing than metropolitan counties.

“It is clear from the data that there is still much needed education around the important role naloxone plays in reducing overdose deaths. The time is now to ensure all individuals who are prescribed high-dose opioids also receive naloxone as a potential life-saving intervention,” CDC Director Robert Redfield, MD, said in a statement.

Ironically, federal policies contribute to the under-prescribing. In 2018, most (71%) Medicare prescriptions for naloxone required a copay, compared to 42% for commercial insurance.

In January, the Food and Drug Administration encouraged drug makers to make naloxone available over-the-counter without a prescription. The FDA even developed an OTC label for Narcan, a naloxone nasal spray that sells for about $135. Seven months later, the FDA could not confirm to PNN that any company had submitted an application for an OTC version of naloxone.

Last year the Department of Health and Human Services released guidance urging doctors to “strongly consider” prescribing naloxone to patients on any dose of opioids when they also have respiratory conditions or obstructive sleep apnea, are co-prescribed benzodiazepines, have a mental health or substance abuse disorder, or a history of illegal drug use or prescription opioid misuse.

Many states are also taking steps to increase naloxone prescribing. California now requires doctors to “offer” naloxone prescriptions to pain patients deemed at high risk of an overdose. State law does not make the prescriptions mandatory, yet some patients say they were “blackmailed” by pharmacists who refused to fill their opioid scripts unless naloxone was also purchased. Patients around the country report similar experiences.   

Unintended Consequences

The drumbeat for naloxone comes at a time when sales are already booming. There were 556,000 naloxone prescriptions in 2018, twice as many as in 2017.

There’s no doubt naloxone saves lives, but some researchers say the drug has had little effect on the overdose crisis and may in fact be making it worse. In a recent study published by SSRN, two economics professors warned of “unintended consequences” if naloxone becomes more widely available.

“We expect these unintended consequences to occur through two channels. First, the reduced risk of death makes opioid abuse more appealing, leading some to increase their opioid use — or use more potent forms of the drug — when they have naloxone as a safety net. Some of those abusers may become criminally active to fund their increased drug use,” wrote Jennifer Doleac, PhD, Texas A&M University, and co-author Anita Mukherjee, PhD, University of Wisconsin.

“Furthermore, expanding naloxone access might not in fact reduce mortality. Though the risk of death per opioid use falls, an increase in the number or potency of uses means the expected effect on mortality is ambiguous.”

The researchers said there were anecdotal reports of “naloxone parties” where attendees used heroin and prescription opioids to get high knowing they could be revived. News reports have also quoted first responders who are frustrated that the same opioid abusers “are saved again and again by naloxone without getting treatment.”

Would Decriminalization Solve the Overdose Crisis?

By Pat Anson, PNN Editor

Vancouver, British Columbia was the first major North American city to be hit by the overdose crisis. In 2016, after a wave of overdose deaths involving illicit fentanyl and even more deadly synthetic opioids like carfentanil, the western Canadian province declared a public health emergency.

Despite efforts to decrease the supply of prescription opioids in BC, over 3,600 more people have overdosed since the emergency was declared, with fentanyl detected in 87% of the deaths last year.

So when BC’s largest healthcare system recommends some radical solutions to the overdose crisis, it’s worth noting. Vancouver Coastal Health (VCH) released a report last month recommending that illegal drugs be decriminalized and that drug users be given access to prescription opioids as an alternative to the black market.

"Legalization and regulation of all psychoactive substances would reduce people's dependence on the toxic illegal supply, criminal drug trafficking and illegal activities that people with addictions must engage in to finance their drug use," said Dr. Patricia Daly, VCH’s chief medical health officer.  

Some Canadian drug policy experts think the idea makes sense.

"The illegal market is an absolute toxic mess right now," Donald MacPherson, executive director of the Canadian Drug Policy Coalition, told the CBC. "It's really in line with consumer protection strategy ... just like we do with every other substance that we ingest, whether it be food or drugs."

Also notable about the VCH report is that – unlike most regulators and politicians in Canada and the U.S. – prescription opioids are not singled out as the root cause of the overdose crisis. Instead, opioid medication is seen as part of the solution.

The report recommends pilot programs to see if prescription fentanyl and other opioid medications made available at supervised consumption sites could help high-risk illicit drug users “transition” to legal opioids.

“Piloting legal access to opioids is different from OAT (opioid agonist therapy) as treatment and would be low-barrier and flexible. Initial pilots would include observation of consumption, followed by pilots allowing distribution of opioids for people to take away for later consumption,” the report recommends.

The idea is controversial, but some doctors are warming up to it. A pilot program recently began at a Vancouver clinic, where hydromorphone tablets are given to about 50 patients who ingest them on site under staff supervision. In Ontario, over 400 healthcare providers and researchers recently signed an open letter asking that high dose injectable hydromorphone be made widely available to illicit drug users.

Substance Abuse and Socioeconomic Problems

The primary cause of the opioid crisis, according to the VCH report, is a “complex interaction” of socioeconomic problems, such as unemployment and homelessness, combined with substance abuse and an increasingly dangerous black market supply.

VCH analyzed the deaths of 424 overdose victims from 2017 and found that less than half (45%) even sought treatment for acute or chronic pain. They were far more likely to be unemployed (72%) and have a substance abuse problem (84%). About four out of ten overdose victims used opioids, alcohol or stimulants daily.

“Most of those who died used multiple substances including opioids, alcohol and stimulants such as cocaine and crystal meth. A significant percentage of those who died of opioid overdoses had primary alcohol use disorder and/or stimulant use disorder,” the report found.

Importantly, most of those who died were no strangers to the healthcare system. The vast majority (77%) had seen a healthcare provider in the year before they overdosed and one out of five (21%) had seen a provider a week before their death. Six out of ten (59%) had received Suboxone or methadone to treat opioid addiction, but the medications were either not effective or they dropped out of treatment.

In addition to decriminalization, the VCH report recommends improving access to addiction treatment, better substance abuse training of healthcare providers, and increased access to the overdose reversal drug naloxone.

Addiction and the 2020 Presidential Race

By Dr. Lynn Webster, PNN Columnist

I found the recent story about Hunter Biden's drug and alcohol problems disturbing, not because he has an addiction — there's no shame in that — but because of the way the media tiptoes around the problem.

There seems be some reluctance to discuss Hunter's problem because of the way it may affect his father – former Vice President Joe Biden – and Biden’s bid for the presidency in 2020. To me, this illustrates a serious barrier to addressing the terrible disease of addiction.

Drugs, Politicians and Their Families

Marijuana is not considered a hard drug today, but it was considered a serious drug of abuse 27 years ago, when President Bill Clinton admitted he had used it. The stigma attached to using marijuana at the time was such that he disingenuously claimed he didn't inhale.

Of course, Clinton wasn't the only president who used or abused chemicals. Nor was he the only president whose reputation took a hit when his drug use was exposed to the public:

President Richard Nixon was reported to have an alcohol problem that worsened as his presidency neared its end.

President George W. Bush reportedly used cocaine in his youth and admitted “drinking too much.” ABC News even polled voters to find out whether his cocaine use might affect their willingness to vote for him.

President Barack Obama admitted that he used marijuana and cocaine. He was also a cigarette smoker with a nicotine addiction, and dealt with media inquiries about his attempts to quit throughout his presidency.

Hunter Biden is not the only family member of a presidential candidate with addiction.

Jeb Bush's daughter, Noelle Bush, had a drug problem. New York City Mayor Bill de Blasio’s daughter, Chiara de Blasio, abused alcohol and drugs while dealing with depression. Sen. Amy Klobuchar's father has struggled with alcohol his whole life. And President Trump’s brother, Fred Trump, Jr., died of complications related to alcoholism, which contributes to an estimated 88,000 deaths per year.

What Do Candidates Know?

Clearly, the endemic nature of addiction in our culture means that we should be interested in how the candidates deal with the presence of drugs in their lives. Are they able to talk openly about drug use instead of letting it remain a dark and shameful secret? Are they compassionate and supportive of family members who struggle?

To what extent do they personally use drugs and alcohol in daily life? And by extension, how well do they cope with stress? These are relevant, appropriate questions for candidates auditioning for a job that impacts the entire world.

It would be inappropriate to vote for a candidate solely on the basis of whether or not their loved ones struggle with addiction. But one criteria we can use for voting is a candidate’s positions on the critical issue of addiction in America. Here is how I would evaluate a candidate:

1) How much awareness do they demonstrate on the basic issues, including:

• Do they know the difference in the prevalence of prescription opioid vs. illicit opioid abuse?

• Do they know that addiction is not determined by the drug, but by genetic and environmental factors?

• Do they know that the volume of pills prescribed to people in various parts of the country does not determine the number of overdose deaths?

• Do they know that the prevalence of overdose deaths correlates with the loss of jobs and lack of income opportunity?

2) Will they de-stigmatize the disease of addiction by:

• Decriminalizing the use of drugs?

• Acknowledging addiction is a disease?

• Understanding that babies cannot be born addicted?

• Educating people that physical dependence and withdrawal can occur without addiction?

3) Do they favor access to substance abuse treatment in a timely fashion for everyone who needs it, regardless of their ability to pay?

4) Will they advocate for people in pain to receive opioid therapy when appropriate at the dose determined by their provider, rather than by the government?

5) Will they acknowledge the unintended consequences of the CDC opioid prescribing guideline?

Shining a Light on Addiction

The ideal candidate should recognize the tragedies associated with all addictions, not just with prescription opioids. He or she must recognize that addiction is part of being human, and that some people are more vulnerable to addiction than others, just as some people are more vulnerable to developing cancer or heart disease.

Whoever becomes or remains our president must shine the light of information on addiction, rather than hide it in the darkness of misinformation, shame and denial. 

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.”

You can find him on Twitter: @LynnRWebsterMD.

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

‘Opioid of the Future’ Postponed

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is tapping the brakes on NKTR-181, an experimental opioid pain medication that has less abuse potential than traditional opioids like oxycodone or hydrocodone.

In an SEC filing, Nektar Therapeutics said it received a letter from the FDA on July 23 saying the agency was postponing all advisory committee meetings for opioid analgesics, including one scheduled for August 21 to discus Nektar’s new drug application for NKTR-181.

The FDA was due to make a final decision on NKTR-181 eight days later, but that too is apparently being postponed while the agency considers “a number of scientific and policy issues relating to this class of drugs.”

Nektar called NKTR-181 the “opioid of the future” because it is the first full mu-opioid agonist that can provide pain relief without the euphoria or “high” that can lead to abuse and addiction.

The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier, which slows its rate of entry into the brain.

In a Phase III clinical study, patients with chronic back pain reported that their pain scores dropped an average of 65% when taking NKTR-181 twice daily. Safety studies also found that recreational drug users had significantly less “drug liking” of NKTR-181 when compared to oxycodone.

NEKTAR IMAGE

The research was so promising the FDA gave NKTR-181 “fast track” designation to speed its development. Nektar executives told PNN two years ago they were hopeful the drug would be approved in late 2018, with a commercial launch early this year.

Obviously that didn’t happen. And the FDA’s fast track has turned into a slow walk.

Two FDA advisory committees met last month and decided “much better-quality data” was needed before approving any new opioids — even ones with low risk of abuse.  

The agency has been under growing public and political pressure to tighten its regulation of opioids. In February, a 60 Minutes report claimed the FDA “opened the floodgates” to the opioid epidemic by approving the use of OxyContin for chronic pain. The following month, the agency received a petition from Public Citizen calling for a moratorium on new opioid approvals because the agency “can no longer be trusted” due to its “poor record” of regulating opioids.

On July 25, Howard Robin, Nektar’s President and CEO, sold 100,000 shares of Nektar for $3.1 million. A spokesman said the sale was previously scheduled due to expiring options. The company’s chief financial officer and a director also sold shares this month. Nektar shares (NASDAQ: NKTR) lost about 10% of their value after the SEC filing was made public.

Teens Who Abuse Rx Opioids More Likely to Try Heroin

By Roger Chriss, PNN Columnist

A new study from the University of Southern California finds that teens who abuse prescription opioids are more likely to start using heroin by high school graduation.  

Published in JAMA Pediatrics, the study tracked nearly 3,300 students in ten public high schools in the Los Angeles area from 2013-2017. Nearly 600 of those students reported using prescription opioids to get high.

By the end of high school, a total of 70 students had started using heroin, including about 12% of those who abused opioid medication. Only 1.7% of students who did not misuse prescription opioids tried heroin.

The researchers looked closely at not only the nonmedical use of prescription opioids, but also the use of other substances. A family history of smoking, alcohol and drug problems, and interpersonal factors such as impulsiveness, anxiety, depression and delinquent behavior were also assessed.

Among all the different factors, the best predictor of heroin use was the abuse of prescription opioids. This tendency was significantly stronger than the use of alcohol, cannabis, cigarettes or other non-opioid drugs.

"Prescription opioids and heroin activate the brain's pleasure circuit in similar ways," said senior author Adam Leventhal, PhD, director of the USC Institute for Addiction Science. "Teens who enjoy the 'high' from prescription opioids could be more inclined to seek out other drugs that produce euphoria, including heroin.”

Researchers also found that students who initiated heroin use were more likely to be male, have less parental monitoring, more delinquent behavior, and impulsive personalities.

The USC study adds to previous research on the complex drug use trajectories that culminate with heroin. It has long been known that nonmedical prescription opioid use is associated with later heroin use, with some anti-opioid activists claiming that 80% of heroin addicts begin by abusing prescription opioids. That is a misleading statistic, as I discussed in a previous column.

There clearly is an association between the misuse of prescription opioids and heroin use, but as the USC researchers found, many other factors are also involved and more research is needed. Their study, for example, did not look at how teens who misused prescription opioids obtained them.  Most likely, they were obtained from friends or family members.

The USC study findings not only advance our understanding of heroin initiation, but also signal the importance of developing better policies to prevent nonmedical opioid use.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Opioid Addiction Rates Redux

By Roger Chriss, PNN Columnist

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Canadian Doctors Prescribe Opioids to Keep Patients Off Street Drugs

By Pat Anson, PNN Editor

So-called “safe injection sites” – supervised clinics where intravenous drug users can inject themselves -- remain controversial in the U.S. Efforts to establish such sites in San Francisco and Philadelphia are mired in political and legal opposition.

But supervised injection sites are already operating in several Canadian cities, where they are seen as an important resource in reducing the risk of overdose and getting drug users into treatment.

Some Canadian doctors, however, believe the injection sites leave out a key population – illicit drug users who don’t normally inject drugs. Rather than run the risk of those patients turning to risky street drugs, they are prescribing opioid medication to them.

“We have to be willing to step outside of our comfort zone and out of the medical establishment comfort zone and say that we need to keep people alive,” Dr. Andrea Sereda, a family physician at the London Intercommunity Health Centre in Ontario told Global News.

Sereda is prescribing hydromorphone tablets to about 100 patients, most of whom were homeless and using street drugs. So far there have been no fatal overdoses, half the patients have found housing, and they have regular contact with healthcare providers.

“It’s not just a prescription for pills, but it’s a relationship between myself and the patient and a commitment to make things better,” Sereda said. “That involves me taking a risk and giving them a prescription, but it also involves the patient committing to doing things that I recommend about their health and us working together.”

Sereda says her “safer supply” program is only intended for patients who have failed at addiction treatment programs where methadone or Suboxone are usually prescribed.

A similar pilot program recently began at a Vancouver clinic, where hydromorphone tablets are given to about 50 patients, who ingest them on site under staff supervision. At another clinic in Toronto, hydromorphone is prescribed to 10 patients who would normally rely on the black market, where drugs are often tainted with illicit fentanyl or its lethal chemical cousin, carfentanil.

“I’ve had people who, literally, their urine is just all carfentanil,” Dr. Nanky Rai, a physician at Parkdale Queen West Community Health Centre told Global News. “That’s really what terrified me into action.”

Other physicians are warming up to the idea. Last week over 400 healthcare providers and researchers sent an open letter to Ontario Premier Doug Ford asking that high dose injectable hydromorphone be made widely available to illicit drug users.

“We could rapidly implement hydromorphone prescribing,” Jessica Hales, a Toronto nurse practitioner, said in a statement. “Clients want this. Prescribers are eager to deliver it. But it is not covered under the Ontario Public Drug Plan, which is how almost all of my clients access prescription drugs.”

What About Pain Patients?

But patient advocates say the safe supply movement should be expanded to include pain patients who have lost access to opioid medication or had their doses drastically reduced.

“The Chronic Pain Association of Canada fully endorses the safe supply initiative, but asks why we’re helping one group while hurting the other, pointlessly. Safe supply is equally critical for the million or so unfortunate Canadians, including children, who suffer high-impact chronic pain and can no longer obtain the drugs they need,” Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, said in a statement. 

“These patients have long been sustained by the pharmaceuticals and don’t abuse them. But now they’re routinely forced down or completely off their medications, blamed for overdoses they have no part in.”

Some pain patients are turning to street drugs. In PNN’s recent survey of nearly 6,000 chronic pain patients in the United States, eight out of ten said they are being prescribed a lower dose or that their opioid prescriptions were stopped. Many are turning to other substances for pain relief. About 15 percent have obtained opioid medication from family, friends or the black market, or used street drugs such as heroin and fentanyl.

“I know seven people personally that have gone to the streets to get pain relief. Four of them died because it was mixed with fentanyl. Two committed suicide,” one patient told us.

“I have been without a prescription for two years and have been getting medication on the street. I cannot afford this and I have no criminal history whatsoever. I have tried heroin for the first time in my life, out of desperation and thank God, did not like it,” wrote another patient.

Barry Ulmer says these patients need a safe supply too.

“Prescribing opiates safely to those with addiction makes sense. But simultaneously denying legitimate pain patients their medications doesn’t. It’s pointless — and cruel. Let’s give people with pain the same respect and care we give people with addiction,” he said.

Kratom Helps Me with Pain and Addiction

(Editor’s note: The author of this column is using the pseudonym “Marc Smith’ because he fears his employment and healthcare could be jeopardized if his true identity were known.)

By Marc Smith, Guest Columnist

I have had a long and treacherous battle with health problems and substance abuse. Starting at age 14, I was diagnosed with multiple reoccurring bone tumors on my right leg below the knee. This led to six major surgeries; three for tumor removal and three for MRSA bacterial infection treatment and debridement.

My knee is completely damaged from the tumor destroying the top of my tibia and the bacteria completely eating away at my meniscus and cartilage. I have severe chronic and acute pain in that leg. I am not a candidate for a knee replacement due to the bone being too damaged and it is not a stable site for an artificial joint.

I have also been in a severe car accident that lacerated my left arm, broke the fibula in my left leg and tore the meniscus in my left knee.

The treatment of these ailments came with a lot of prescribed narcotic pain medications on a regular basis from age 14 on. My tolerance to these medications grew astronomically over 15 years until they stopped working effectively.

I eventually was buying OxyContin on the street and abusing it heavily. This led to IV heroin and cocaine use, and the loss of anything of real value I had.

I struggled with this crippling addiction for 18 years. I tried methadone, Suboxone, Vivitrol and complete abstinence -- with no significant success with any of them. Finally, I tried a strong 12-step recovery program. It worked temporarily, but the physical pain would become too much and I would relapse on opiates.

A year ago, I found kratom and decided to try it for pain relief. It helps me with pain, helps me sleep, curbs craving, and allows me to function and participate in daily life without being in extreme pain. I do not have extreme tolerance building problems with kratom like I did with opioids. The side effects are extremely minor and do not impair my judgment or ability to function.

I am up at 4:30 AM every day and at the gym by 4:45 cycling for an hour. I have found the recumbent bike does not hurt my leg that badly. I lost weight due to exercise and diet changes that kratom helped me make. I am much more positive about taking care of myself and am able to be present for life.

My pain hasn’t completely vanished, but it is manageable due to kratom. My spiritual growth has been a big factor as well in my 12 months of sobriety. These two things working in harmony have literally saved my life. I am a completely different person and my family has their son back.

I do not want to die and the fact that this harmless plant is being targeted makes me scared for my life. Let’s focus on rehabilitation and recovery methods. Let’s focus on illicit fentanyl and other synthetic chemicals, not a natural botanical. Please, take a step back and look at kratom success stories like mine.

Do you have a story you want to share on PNN? Send it to: editor@painnewsnetwork.org.

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

Study Debunks Myths About Origins of Opioid Abuse

By Pat Anson, PNN Editor

It’s become a popular myth – and for some, a propaganda tool – to claim that opioid pain medication is a gateway drug to heroin and other street drugs.

An opioid education campaign called The Truth About Opioids – funded with taxpayer dollars from the White House Office of National Drug Control Policy — declares in big bold letters on its website that “80% of heroin users started with a prescription painkiller.”

The 80% figure stems from a 2013 study that found four out of five new heroin users had previously abused prescription opioids by using them non-medically.

Importantly, the heroin users were not asked if they had a valid prescription for opioids or even where they got them – but that doesn’t stop federal agencies from citing the study as proof that illegal drug use often starts with a legal opioid prescription.

The Drug Enforcement Administration last year used the 80% figure to justify steep cuts in the supply of prescription opioids, claiming in the Federal Register that addicts often get hooked “after first obtaining these drugs from their health care providers.”

“The 80% statistic is misleading and encourages faulty assumptions about the overdose crisis and medical care,” Roger Chriss explained in a PNN column last year.

A new study by researchers at Penn State University debunks the myth that the opioid crisis was driven primarily by doctors’ prescriptions. The researchers conducted a series of surveys and in-depth interviews with opioid abusers in southwestern Pennsylvania -- a region hard hit by opioid addiction -- asking detailed questions about their drug use.

The study was small – 125 people were surveyed and 30 of them were interviewed – but the findings provide a an important new insight into the origins of opioid abuse and the role played by painkillers.

"What emerged from our study -- and really emerged because we decided to do these qualitative interviews in addition to a survey component -- was a pretty different narrative than the national one,” said lead author Ashton Verdery, PhD, an assistant professor of sociology, demography and social data analytics at Penn State. "There's a lot about that narrative that I think is an overly simplistic way of thinking about this."

‘Opioids Were Never the First Drug’

Verdery and his colleagues found that over two-thirds of those interviewed (66.7%) first abused a prescription opioid that was given, bought or stolen from a friend or family member. Another 7% purchased the drugs from a stranger or dealer. Only one in four (26%) started by abusing opioid medication that was prescribed to them by a doctor.

“We found that most people initiated through a pattern of recreational use because of people around them. They got them from either siblings, friends or romantic partners," said Verdery. “Participants repeatedly reported having a peer or caregiver in their childhood who had a substance use problem. Stories from childhood of witnessing one of these people selling, preparing, or using drugs were very common. Being exposed to others’ substance use at an early age was often cited as a turning point for OMI (opioid misuse) and of drug use in general.”

And prescription opioids were not the gateway drugs they are often portrayed to be. Polysubstance abuse was common and usually began with drugs such as alcohol, marijuana, cocaine, methamphetamine, prescription sedatives and prescription stimulants.

“It is important to note that interviewees universally reported initiating OMI only after previously starting their substance use career with another drug (e.g., alcohol, marijuana, cocaine). Opioids were never the first drug used, suggesting that OMI is likely associated with being further along in one’s drug using career,” Verdery reported in the Journal of Addictive Studies.

Verdery says additional studies are needed on the origins of drug abuse and that researchers should focus on the role that other substances play in opioid addiction. Only then can proper steps be taken to prevent abuse and addiction before they start.

"We think that understanding this mechanism as a potential pathway is worth further consideration," said Verdery. "It's not just that people were prescribed painkillers from a doctor for a legitimate reason and, if we just crack down on the doctors who are prescribing in these borderline cases we can reduce the epidemic.”

What ‘Rocketman’ Tells Us About Pain and Addiction

By Lynn Webster, MD, PNN Columnist

“Rocketman” is a new biopic about the legendary singer Elton John. The emotionally-driven musical fantasy takes some liberties with certain details of John's life, but it illuminates an essential truth: childhood trauma can lead to pain, addiction and other severe health problems.

The movie is generating some Oscar buzz, but it offers more to viewers who want to see how painful childhood experiences can adversely affect people when they become adults.

The film begins with the flamboyantly wealthy and gifted Elton John strutting down a hallway -- in full costume complete with a colorful headpiece from a recent stage show -- to his first Alcoholics Anonymous meeting.

He becomes the center of attention at the AA meeting when he begins to describe -- through flashbacks told, in part, through song and dance -- his childhood, which was devoid of love and acceptance.

“rocketman” Paramount pictures

Elton John is a musical prodigy, but his talent couldn't save him from the harm caused by a father who rejected him and a mother who didn't protect him. As John told The Guardian, "My dad was strict and remote and had a terrible temper; my mum was argumentative and prone to dark moods. When they were together, all I can remember are icy silences or screaming rows."

As John remembers it, "The rows were usually about me, how I was being brought up."

How Childhood Trauma Affects Health

In her TED Talk, Dr. Nadine Burke Harris describes how childhood trauma can affect health over a lifetime — laying the foundation for seven out of 10 leading causes of death in the United States, including addiction and even suicide.

As Dr. Harris points out, our healthcare system treats childhood trauma as a social or mental health problem rather than as a medical issue. Doctors are trained to refer traumatized children to specialists rather than providing intervention and treatment themselves. But childhood trauma may lead to serious medical problems and can even reduce life expectancy by 20 years, according to a study published in the American Journal of Preventive Medicine.

The CDC’s Adverse Childhood Experiences Study (also known as the ACE Study) defined and examined this problem. The study acknowledged 10 types of childhood trauma, including verbal, physical, and sexual abuse; parental rejection and neglect; mental illness or incarceration of a family member; divorce; and substance dependence.

Of the 17,000 adults who participated in the study, two-thirds had experienced at least one of these childhood traumas. Eighty-seven percent had lived through more than one. The consequences of this can be staggering. People who experienced four childhood traumas were 2.5 times more likely to have pulmonary disease and hepatitis. And they were four times more prone to depression and had 12 times the risk for suicidality.

“Adverse childhood experiences are the single greatest unaddressed public health threat facing our nation today,” says Dr. Robert Block, President of the Academy of Pediatrics.

Trauma Rewires the Brain

Adverse childhood experiences rewire the brain. The heightened response to stress that some children develop can affect the reward center of the brain and the executive functioning of the prefrontal cortex. It can also result in maladaptive behaviors associated with pain and addiction.

About a decade ago, Dr. Norman Doidge provided an understanding of how our brains have the capacity to change in his book, “The Brain that Changes Itself: Stories of Personal Triumph from the Frontiers of Brain Science.”  His highly acclaimed research offers scientific hope that there is treatment for the adverse effects of childhood trauma and chronic pain.

Dr. Doidge describes neuroplasticity as the process through which an injured brain can heal itself. An example of this healing process was reported by National Public Radio's Patti Neighmond. It is called emotional awareness and expression therapy (EAET).

Developed in 2011 by psychologist Mark Lumley and Dr. Howard Schubiner, EAET combines talk therapy with cognitive behavioral therapy to change brains that have been structurally altered by trauma. The NIH’s Pain Management Best Practices Inter-Agency Task Force has recognized EAET as potentially beneficial to some people in chronic pain.

Preventing the Need for Drugs

“Rocketman” reflects more than the consequences of a single individual's traumatic childhood. It illuminates a broader social problem that sows the seeds for substance use disorders in adults. 

The approach we take to solving substance use disorders today is focused on treatment and law enforcement. Neither approach seems to be curbing the problem, which suggests the need for a better strategy. Long-term solutions to substance use disorders must include prevention. This means we need to understand what creates the demand for drugs.

Elton John’s story poignantly illustrates two of the causes of addictive behavior:

1. Memories of pleasurable experiences are the reason drugs are repeatedly abused

2. Memories of painful life experiences are commonly the genesis of drug initiation

There is compelling evidence that the trajectory of our mental and physical health begins with how we are treated as children. It may seem Pollyannish to say this, but our first line of defense is to love and accept our children, regardless of their gender identity, abilities or individual traits.

As “Rocketman” testifies, anything else can set children on the path to developing a substance use disorder and, in some cases, chronic pain. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. Lynn is a former president of the American Academy of Pain Medicine, 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.

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

Prescription Opioids Play Minor Role in Massachusetts Overdoses

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

Opioid Prescriptions Down 39% since 2015

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

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

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

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

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

Emmy Winning Video Perpetuates Myths About Addiction

By Dr. Lynn Webster, PNN Columnist

"Rebekkah's Story" recently won an Emmy for Short Format Daytime Program at the 46th Annual Daytime Emmy Awards. The six-and-a-half minute video was produced by Truth Initiative, a non-profit created to campaign against tobacco use that recently launched an opioid misuse and education campaign called The Truth About Opioids.

Rebekkah is a young woman addicted to opioid medication and heroin who spent five days in a “treatment box” publicly detoxing on a New York City street.  The documentary has also been broadcast on television and can be seen online:  

Though billed as educational, the producers of “Rebekkah’s Story” failed to accurately convey the facts. This is not the first time we've seen movies about drug use and addiction that misinform.  

I wrote a blog not long ago about the problems with two mainstream movies -- "Ben Is Black" and "Beautiful Boy"— both of which reinforced unhelpful narratives about addiction. In both films, good people from good families found themselves caught in the web of addiction, seemingly with no personal responsibility for it. 

"Rebekkah's Story" continues in the same tradition. It exploits Rebekkah and her experience while perpetuating three myths about addiction that do us no favors as our nation struggles with this terrible illness.

At the same time, millions of Americans with chronic pain are being forced off opioid medication — left to suffer in part because of these three myths:

Myth #1: Heroin Use Starts With Prescription Drugs

The movie begins with a misleading statistic: “Eighty percent of heroin users started with a prescription painkiller.” That implies taking painkillers as prescribed for medical use leads to using heroin 80% of the time, and that is not accurate. 

The 80% statistic comes from a 2013 study of heroin users who reported nonmedical use of opioid pain relievers before initiating heroin. Most of them had not been prescribed those opioids for pain; they obtained the drugs from family or friends for nonmedical use.  

In fact, the vast majority of people who use heroin have abused other substances prior to abusing prescription opioids. Usually, their long history of substance abuse begins in adolescence with tobacco, alcohol and other substances besides opioids. Moreover, by 2015, one in three heroin users initiated their opioid use with heroin.

Rebekkah's situation -- progressing from oxycodone to heroin -- was unusual. The video presents her story as a cautionary tale of what can happen if you use prescription opioids, but her story is atypical. Almost always, there are other factors that contribute to the transition from appropriate use to abuse and addiction. This is a truth not addressed in the film. 

The film begs the question: Why did Rebekkah start to use heroin? What did heroin provide that she could not resist? 

Myth #2: Withdrawal Is Synonymous to Addiction

"She had been an accomplished dancer and athlete, and that was lost when her addiction took over her life and self-image," explains the video's website. "Now Rebekkah is regaining control of both — courageously making her detox public in order to help other people while she works towards a new start."

The producers of “Rebekkah’s Story” present a poignant story, but they propose that withdrawal is synonymous with addiction. That is incorrect.

Withdrawal may be associated with addiction, but it does not necessarily follow from addiction. Not everyone who goes through withdrawal has the disease of addiction, and not everyone with addiction must go through the agonizing withdrawal that Rebekkah did.

A major problem that most people with addiction face is the stigma associated with their disease and their inability or unwillingness to obtain help. Fear of facing a legal penalty (such as incarceration) or a social consequence (estrangement from family members, job loss, etc.) often prevent those who use heroin from seeking treatment.  

People experience opioid withdrawal largely because the healthcare and criminal justice systems make access to appropriate and safe treatment illegal, unavailable or unaffordable.  

Myth #3: Detoxification Ends Addiction 

The ending of "Rebekkah's Story" differs from reality, too. Addiction is usually a life-long disease and patients who recover frequently relapse. The video's tidy and triumphant resolution does not accurately reflect what occurs in real life.  

It's troubling how the producers went about creating the video in ways that subtly strengthen and exploit the three myths about addiction.

Their set was a makeshift hospital room projected in a cubicle visible to pedestrians walking near Times Square. The setting was essentially a stage for performance art at Rebekkah's expense.

Rebekkah takes on the role of a gladiator engaging in combat against a metaphorical beast: the agony of opioid addiction.

She is the heroine with whom we should empathize. We are supposed to share her anger toward the wicked doctors who prescribed her pain medication. 

People watch as Rebekkah suffers from withdrawal without receiving the medical treatment that should be available to anyone in withdrawal. It was surprising that, in the documentary, an addiction physician was complicit in exploiting a person undergoing withdrawal.   

No one should be forced to experience what Rebekkah went through. She should have been given appropriate medical care as she recovered from heroin abuse. 

"Rebekkah's Story" claims to tell the truth about opioids. It does not. All it shows is Rebekkah’s decision to voluntarily and publicly experience a horrible withdrawal that was both unnecessary and avoidable.

Unfortunately, compliant and non-addicted pain patients who are currently being forced off opioid medication don’t have the same stage to tell their stories. Their voices often go unheard, and their agonies are invisible.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and is 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.

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

Liability Trial of Opioid Drug Maker Could Set Precedents

By Jackie Fortier, Kaiser Health News

All eyes will be on Oklahoma this week when the first case in a flood of litigation against opioid drug manufacturers begins. Oklahoma Attorney General Mike Hunter’s suit alleges Johnson & Johnson, the nation’s largest drugmaker, helped ignite a public health crisis that has killed thousands of state residents.

With just two days to go before the trial, one of the remaining defendants, Teva Pharmaceutical, announced an $85 million settlement with the state on Sunday. The money will be used for litigation costs and an undisclosed amount will be allocated “to abate the opioid crisis in Oklahoma,” according to a press release from Hunter’s office.

In its own statement, Teva said the settlement does not establish any wrongdoing on the part of the company, adding Teva “has not contributed to the abuse of opioids in Oklahoma in any way.”

That leaves Johnson & Johnson as the sole defendant.

Court filings accuse the company of overstating the benefits of opioids and understating their risks in marketing campaigns that duped doctors into prescribing the drugs for ailments not approved by regulators.

The bench trial — with a judge and no jury — is poised to be the first of its kind to play out in court.

Nora Freeman Engstrom, a professor at Stanford Law school, said lawyers in the other cases and the general public are eager to see what proof Hunter’s office offers the court.

“We’ll all be seeing what evidence is available, what evidence isn’t available and just how convincing that evidence is,” she said.

Most states and more than 1,600 local and tribal governments are suing drugmakers and distributors. They are trying to recoup billions of dollars spent on addressing the fallout tied to opioid addiction.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million. Soon after, Hunter dropped all but one of the civil claims, including fraud, against the remaining defendants. Teva settled for $85 million in May, leaving Johnson & Johnson as the only opioid manufacturer willing to go to trial with the state.

But he still thinks the case is strong.

“We have looked at literally millions of documents, taken hundreds of depositions, and we are even more convinced that these companies are the proximate cause for the epidemic in our state and in our country,” Hunter said.

The companies involved have a broad concern about what their liability might be, said University of Kentucky law professor Richard Ausness.

“This case will set a precedent,” he said. “If Oklahoma loses, of course they’ll appeal if they lose, but the defendants may have to reconsider their strategy.”

With hundreds of similar cases pending — especially a mammoth case pending in Ohio — Oklahoma’s strategy will be closely watched.

“And of course lurking in the background is the multi-state litigation in Cleveland, where there will ultimately be a settlement in all likelihood, but the size of the settlement and the terms of the settlement may be influenced by Oklahoma,” Ausness said.

Rx Opioids ‘Useful Products’

The legal case is complicated. Unlike tobacco, where states won a landmark settlement, Ausness pointed out that opioids serve a medical purpose.

“There’s nothing wrong with producing opioids. It’s regulated and approved by the Food and Drug Administration, the sale is overseen by the Drug Enforcement Administration, so there’s a great deal of regulation in the production and distribution and sale of opioid products,” Ausness said. “They are useful products, so this is not a situation where the product is defective in some way.”

It’s an argument that has found some traction in court. Recently, a North Dakota judge dismissed all of that state’s claims against Purdue, a big court win for the company. In a written ruling that the state says it will appeal, Judge James Hill questioned the idea of blaming a company that makes a legal product for opioid-related deaths.

“Purdue cannot control how doctors prescribe its products and it certainly cannot control how individual patients use and respond to its products,” the judge wrote, “regardless of any warning or instruction Purdue may give.”

Now the Oklahoma case rests entirely on a claim of public nuisance, which refers to actions that harm members of the public, including injury to public health.

“It’s sexy you know, ‘public nuisance’ makes it sound like the defendants are really bad,” Ausness said.

If the state’s claim prevails, Big Pharma could be forced to spend billions of dollars in Oklahoma helping ease the epidemic. “It doesn’t diminish the amount of damages we believe we’ll be able to justify to the judge,” Hunter said, estimating a final payout could run into the “billions of dollars.”

Hunter’s decision to go it alone and not join with a larger consolidated case could mean a quicker resolution for the state, Ausness said.

“Particularly when we’re talking about [attorneys general], who are politicians, who want to be able to tell the people, ‘Gee this is what I’ve done for you.’ They are not interested in waiting two or three years [for a settlement], they want it now,” he said. “Of course, the risk of that is you may lose.”

Oklahoma has the second-highest uninsured rate in the nation and little money for public health. Of the $270 million Purdue settlement, $200 million is earmarked for an addiction research and treatment center in Tulsa, though no details have been released. An undisclosed amount of the $85 million Teva settlement will also go to abating the crisis.

This story is part of a partnership that includes StateImpact Oklahoma, NPR and Kaiser Health News. KHN is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Heroin and Fentanyl Fueling Veteran Overdoses, Not Rx Opioids

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

Forced Opioid Tapering: ‘The Next Great Experiment’

By Pat Anson, PNN Editor

Last month the Food and Drug Administration warned doctors not to abruptly discontinue or rapidly taper patients on opioid pain medication. The agency said it had received reports of “serious harm” to patients who’ve been suddenly cutoff, including withdrawal symptoms, uncontrolled pain, psychological distress and suicide.  

A new study published in the Journal of Substance Abuse Treatment shows just how common the practice is. And how millions of pain patients are being subjected to a public health experiment with hardly anyone keeping track of what happens to them.

“The United States went through a great ‘experiment’ of expanding treatment of pain with opioids which has proved to be disastrous for public health. We have entered the next great ‘experiment’ of discontinuing opioid medications among the millions of Americans who are currently taking them,” said lead author Tami Mark, PhD, senior director of behavioral health at RTI International, a non-profit research institute.

“Little is known about how many individuals are tapering off opioid medications, whether observed tapering follows any… guidelines, and the extent to which rapid tapering is associated with negative consequences.”

Mark and her colleagues looked at medical and pharmacy claims for nearly 500 Medicaid patients in Vermont who had high doses of opioid medication discontinued from 2013 to 2017.

All of the patients were prescribed a daily dose of at least 120 MME (morphine milligram equivalent) and over half had been on that high dose for over a year. 

Although most clinical guidelines recommend a “go slow” approach to opioid tapering – especially for patients on high doses – only 5 percent of the Vermont patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in 21 days or less, including about half who were cut off from opioids without any tapering.

The Centers for Disease Control and Prevention recommends that patients on opioids be tapered only 10% a week, with even slower tapers of 10% a month for long-term users. Had those guidelines been applied in Vermont, most tapers would have taken up to a year to complete.

Half of Tapered Patients Hospitalized

What happened to the patients who were cut off? Nearly half were hospitalized or had an emergency room visit for an “opioid-related adverse event” -- a medical code that can mean anything from severe withdrawal symptoms to acute respiratory failure. For tapered patients, the risk of being hospitalized was reduced by 7% for each additional week of tapering.

Researchers don’t know how many of the discontinued patients committed suicide or how many were referred to addiction treatment. Notably, less than one percent received medication assistance treatment (MAT) such as Suboxone.

The study did not look at why patients were taken off opioids or who initiated the discontinuation. But researchers believe some of the rapid discontinuations “may be due to a breakdown in the clinical relationship between physicians and patients” – suggesting the patients were forcibly tapered or abandoned by their doctors.

In its warning to doctors, the FDA strongly recommends that patients not be forcibly tapered and that patients and doctors should jointly agree to a tapering plan.

“Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients,” the FDA said.

Forced Tapering Widespread

How many patients have been forcibly tapered or discontinued is unclear, but it probably runs in the millions. A recent report from IQVIA found that there were 75 million fewer opioid prescriptions filled last year compared to 2014, with the biggest decline in high dose prescriptions. 

In PNN’s recent survey of nearly 6,000 pain patients, over 80 percent said they had been taken off opioids or had their dose reduced since the CDC released its controversial opioid guideline in 2016. Many were turning to other substances – both legal and illegal – for pain relief. And nearly half said they had considered suicide because their pain is poorly treated.

“I have been forced to taper to 90 MME. I had been stable and functional for 10 years at 135 MME. Now I can no longer work, and can barely take care of my children. I am considering suicide because my pain is unbearable,” one patient told us.

“I have been forcibly tapered by more than half and my pain is not being relieved at this dose. I am now unable to work or care for my children,” another patient wrote. “I live in constant anxiety (which worsens my pain) that I will be abandoned, refused any pain management, or reduced to a dose so low that taking my own life is the only way to escape the pain.”

“My forced taper was a little over a year ago. Before that I lived a small but functional life on high dose opioids. I took the same dose, from the same doctor for over a decade. Then I was forced off of 75% of my dose,” said another patient. “Once we got down to my current dose the medication was no longer enough to control my pain. I now live a tiny, nonfunctional life. I spend all my time in bed watching TV. I never leave the house. Showers are my worst enemy. And I am lucky. I wasn’t abandoned by my doctor.”

A noted critic of opioid prescribing calls reports like these exaggerations. Andrew Kolodny, MD, the Executive Director and founder of Physicians for Responsible Opioid Prescribing (PROP), told Stateline that the number of doctors who are inappropriately tapering patients is likely very small and should not be blamed on the CDC.

"We have a very real problem in this country. But the CDC guidelines didn't cause it," Kolodny said. "The problem is that millions of Americans have been put on round-the-clock opioids at very high doses and for reasons that doctors now realize were not appropriate.

"What the FDA needs to tell doctors is that because it is so excruciating to come off of opioids, they need to be very selective about who they put on them.”

In a series of Tweets two years ago, Kolodny said patients on high doses should be forcibly tapered “even if patient refuses” and challenged assertions that forced tapering was risky and widespread.

Now Kolodny says he sympathizes with patients but claims they are being manipulated.

“Their emotions are real. But they’re being effectively manipulated to controversialize the CDC guidelines,” he told Stateline.

Many of Kolodny’s colleagues disagree. Over 300 healthcare professionals warned in a joint letter last year that forced opioid tapering has led to “an alarming increase in reports of patient suffering and suicides” and called for an urgent review of tapering policies at every level of healthcare.

“This is a large-scale humanitarian issue,” the letter warns. “New and grave risks now exist because of forced opioid tapering.”