Oklahoma Judge Orders J&J to Pay $572 Million in Damages

By Pat Anson, PNN Editor

In a precedent setting case, an Oklahoma judge has ruled that Johnson & Johnson is partly responsible for fueling Oklahoma’s opioid crisis and ordered the health care giant to pay $572 million in damages.

“The opioid crisis has ravaged the state of Oklahoma and must be abated immediately,” said Cleveland County District Judge Thad Balkman, reading his decision aloud from the bench.

Balkman said J&J concocted a ‘marketing scheme” for opioid pain medication that overstated the drugs’ effectiveness and underplayed their risks. The company’s subsidiary, Janssen Pharmaceutical, produced less than one percent of the opioids prescribed in Oklahoma, but supplied 60% of the ingredients in painkillers sold by other companies.  

“They developed and carried out a plan to directly influence and convince doctors to prescribe more and more opioids, despite the fact that defendants knew increasing the supply of opioids would lead to abuse, addiction, misuse, death and crime,” the judge said.

Oklahoma had asked for $17.5 billion from J&J to pay for addiction treatment, emergency care, law enforcement and other services needed to address the opioid crisis. J&J said it would appeal the judges “flawed” ruling.

"Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law support this outcome," Michael Ullmann, Executive Vice President and General Counsel for J&J, said in a statement. “This judgment is a misapplication of public nuisance law that has already been rejected by judges in other states.

"The unprecedented award for the State's 'abatement plan' has sweeping ramifications for many industries and bears no relation to the Company's medicines or conduct." 

Balkman’s ruling is not legally binding on any other court, but as the first opioid case to go to trial, it is expected to have a significant impact on negotiations to resolve nearly 2,000 lawsuits filed by states, cities and counties against opioid makers, distributors and pharmacies. Many of those cases have been consolidated before a federal judge in Ohio.

Oklahoma previously reached a $270 million out-of-court settlement with Oxycontin-maker Purdue Pharma and an $85 million deal with Teva Pharmaceutical. Endo International and Allergan recently agreed to pay $10 million and $5 million respectively to two Ohio counties to avoid going to trial.

Compared to the cost and bad publicity that J&J went through defending itself in Oklahoma, those settlements look prescient.

As PNN has reported, three law firms that acted as lead outside counsel for Oklahoma stand to collect 25% of the damages and penalties awarded to the state. Oklahoma’s star witness, anti-opioid activist Dr. Andrew Kolodny, testified that he was paid $500,000 for his services at a rate of $725 an hour.

Some Pharmacies Won’t Sell Suboxone, But Street Dealers Do

By Nina Feldman, WHYY

Louis Morano knew what he needed, and he knew where to get it.

He made his way to a mobile medical clinic parked on a corner of Philadelphia’s Kensington neighborhood, in the geographical heart of the city’s overdose crisis. People call it “the bupe bus.”

Buprenorphine is a drug that curbs cravings and treats the symptoms of withdrawal from opioid addiction. One of the common brand name drugs that contains it, Suboxone, blends buprenorphine with naloxone. Combined with cognitive behavioral therapy, it is one of the three FDA-approved medicines considered the gold standard for opioid-addiction treatment.

Morano had tried Suboxone before — he had purchased some from a street dealer and had used it to get through his workday, when he couldn’t use heroin. It kept the misery of withdrawal sickness at bay.

Morano, 29, has done seven stints in rehab for opioid addiction in the past 15 years. So he had a sense of how the drug would make him feel. He’d always sort of thought of it as a crutch. But after a slip following his latest stint in rehab, he said, he committed to recovery.

“I can’t do this anymore, and I need something,” Morano said.

The bupe bus — a project of Prevention Point Philadelphia, the city’s only syringe exchange program — is part of Philadelphia’s efforts to expand access to this particular form of medication-assisted treatment, known as MAT, for opioid addiction.

Morano was first in line at the mobile clinic. When the doors of the bus heaved open, Dr. Ben Cocchiaro waved Morano inside, where they squeezed into a tiny exam room.

Cocchiaro and Morano discussed how buprenorphine might help Morano’s recovery succeed this time, and whether he’d be open to seeing a therapist. Cocchiaro gave Morano instructions on how to take the medication, and then called a pharmacy to authorize a prescription.

Barriers to Treatment

To date, much of the research on barriers to buprenorphine access has focused on the fact that too few medical providers are certified to write the prescriptions. According to federal law, doctors must apply for a special waiver from the Substance Abuse and Mental Health Services Administration, or SAMHSA, to prescribe buprenorphine. To get the waiver, a doctor must undergo eight hours of training — and can prescribe the drug to a maximum of 30 patients at a time, to start. Given these constraints, many doctors don’t bother.

But pharmacists are also a part of the problem. Because they fill the prescriptions, pharmacists are the gatekeepers for the drug, and not all of them are willing to take on that role. Increasing pharmacists’ involvement in distributing buprenorphine might be just as important as persuading more doctors to prescribe it, according to Dan Ventricelli of the Philadelphia College of Pharmacy.

“We can write a bunch of prescriptions for people,” he said. “But if they don’t have a pharmacy and a pharmacist that’s willing to fill that medication for them, fill it consistently and have an open conversation with that patient throughout that treatment process, then we may end up with a bottleneck at the community pharmacy.”

Just a few blocks from the bupe bus in Kensington, Richard Ost owns an independent pharmacy. He said his store was one of the first in the neighborhood to stock buprenorphine. But after a while, Ost started noticing that people were not using the medication as directed — they were selling it instead.

Buprenorphine acts as a partial opioid agonist, which means it’s a low-grade opioid. When taken in pill or tablet form, it’s unlikely to cause the same feelings of euphoria as heroin would, but it might if it were dissolved and injected. Many people buy it on the street for the same reason Morano did: to keep from going into withdrawal between injecting heroin or fentanyl. Others buy it to try to quit using on their own.

“We started seeing people do it in our store in front of us,” said Ost. He said it’s unethical to dispense a prescription if a patient turns around and sells it illegally, rather than use it. “Once we saw that with a patient, we terminated them as a patient.”

Ost explained that the illegal market for Suboxone also meant customers trying to stay sober were being continually targeted and tempted.

“So if we were having a lot of people in recovery coming out of our stores, the people who were dealing illicit drugs knew that, and they would be there to talk to them and they would say, ‘Well, I’ll give you this’ or ‘I’ll give you that,’ or ‘I’ll buy your Suboxone’ or ‘I’ll trade you for this.’”

Ost said that eventually his staff didn’t feel safe, and that neither did the customers. He understands the value of bupe but said it just wasn’t worth it. He mostly has stopped carrying it.

Even those pharmacies that aim to stock buprenorphine can run into problems. Limits set by wholesalers require pharmacies to order the drug in small, frequent batches. Though pharmacies can apply for exemptions to order more at a time, or to have a higher percentage of their total stock consist of controlled substances, doing so invites a higher level of scrutiny from the wholesaler and, in turn, the Drug Enforcement Administration.

Another issue is that doctors and pharmacists receive different education about how long buprenorphine should be prescribed before tapering a patient off it. Many medical providers might prescribe the drug for long-term treatment, based on recent SAMHSA guidelines, while pharmacists may view longer courses of treatment as posing the risk of long-term dependency.

“It’s not even that they’re on different pages,” said Ventricelli of the College of Pharmacy. “It’s that they’re reading completely different books.”

If a patient going through withdrawal can’t get buprenorphine quickly, the stakes are high. Silvana Mazzella, associate executive director at Prevention Point, said that when it’s not available, patients are more likely to turn back to heroin or fentanyl.

“We’re in a situation where if you are in withdrawal, you’re sick, you need to get well, you want help today, and if you can’t get it through medication-assisted treatment, unfortunately you will find it a block away, very quickly, and very cheaply,” she said.

Doctors with Prevention Point have found a pharmacy near the bupe bus that will reliably dispense buprenorphine to their Philadelphia patients. It’s a neighborhood branch of a local chain, called the Pharmacy of America.

The head pharmacist, Anthony Shirley, said he’s comfortable filling the scripts because he trusts that the doctors at Prevention Point will write prescriptions only for patients who need the medication. He has heard firsthand from patients who say buprenorphine saved their lives.

“That’s something you can’t really put a price tag on,” Shirley said. For him, the calculation is simple: His store is in an area where many people need buprenorphine. That means it’s his job to get it to them.

This story is part of a partnership that includes WHYY, NPR and Kaiser Health News. KHN is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

Panel Recommends All Adults Be Screened for Illicit Drug Use

By Pat Anson, PNN Editor

The next time you visit a doctor, he or she may want to know more than what medications you take or if you consume alcohol.

An influential national panel of health experts is recommending for the first time that U.S. doctors screen all adult patients for illicit drug use, including the nonmedical use of opioids and other prescription drugs. “Nonmedical” means the use of a friend’s or relative’s prescription or buying medications off the street. It can also mean using a legal medication more frequently or in higher doses than prescribed.

The U.S. Preventive Services Task Force concluded with “moderate certainty” that screening for illicit drug use would be beneficial because it would lead to a more accurate diagnosis and treatment for substance abuse.

Screening typically involves questions about drug use and frequency. This can include questions on routine intake forms or asking patients directly when they visit with a healthcare provider. Screening does not include drug testing, although nothing would stop a doctor from ordering such tests.

“Illicit drug use can have a devastating impact on individuals and families,” said task force co-vice chair Karina Davidson, PhD, a professor of behavioral medicine at the Zucker School of Medicine at Hofstra University. “Clinicians can help by screening their adult patients and connecting people who use illicit drugs to the care they need to get better.”

About 11.5% of Americans age 18 years or older reported using cannabis or illicit drugs in a national survey. Illicit drug use is more common in young adults ages 18 to 25 years (24.2%) than in older adults (9.5%).  About one in five illicit drug users reported the nonmedical use of psychotherapeutic drugs, including opioids, pain relievers, or other medications. Less than 8% reported using cocaine, hallucinogens, or inhalants.

Although illicit drug use is relatively common among adolescents (7.9%) aged 12 to 17, the task force said there was not enough evidence to support screening for Americans under the age of 18.

“We want to help prevent illicit drug use in teens, so we’re calling for more research on the benefits of screening,” said task force member Carol Mangione, MD, chief of general internal medicine at the David Geffen School of Medicine at UCLA. “Clinicians should continue to use their professional judgement to determine what’s best for their teen patients.”

The task force’s draft report is available for public comment through September 9. After the task force reviews the comments, it will issue a final report. The panel’s recommendations are not mandatory for healthcare providers, but like many federal guidelines – such as the 2016 CDC opioid guideline -- they could be adopted as a “standard of care” by medical associations and healthcare systems.  Some already recommend that providers routinely screen their patients about illicit drug use.

AG’s Call for Weakening of HIPAA Laws

Federal laws that have long protected the privacy of patients undergoing addiction treatment may also be changing. The National Association of Attorneys General wants Congress to end regulations that prevent doctors from sharing information about their patients’ addiction treatment histories.

In a letter recently sent to congressional leaders, 39 state attorneys general called on Congress to “replace the cumbersome, out-of-date, privacy rules” contained in the Health Insurance Portability and Accountability Act (HIPAA). One section of the law – known as 42 CFR Part 2 – sets strict rules about disclosing patient records for substance abuse treatment.

“These privacy rules were created more than 40 years ago in a time of intense stigma surrounding substance use disorder treatment. They were created to assure patients that they would not face adverse legal or civil consequences when seeking treatment by protecting confidentiality of substance use disorder patient records,” the AG’s said.

“Unfortunately, they now serve to perpetuate that stigma, as the principle underlying these rules is that substance use disorder treatment is shameful and records of it should be withheld from other treatment providers in ways that we do not withhold records of treatment of other chronic diseases. While maintaining confidentiality is imperative to encouraging individuals to seek and obtain treatment, the inability to share records among providers can burden coordination of care, potentially resulting in harm to the patient.”

Two bills under consideration in Congress, the Overdose Prevention and Patient Safety Act and the Protecting Jessica Grubb’s Legacy Act would amend 42 CFR Part 2 to allow for addiction treatment records to be shared. The bills have been endorsed by over 40 national healthcare organizations, including the American Hospital Association, the American Psychiatric Association, and the American Society of Addiction Medicine.

Study: Prescription Drug Databases Overestimate Opioid Misuse

By Pat Anson, PNN Editor

Prescription drug monitoring has long been seen as the gold standard for tracking the opioid crisis. Patients who fill an opioid prescription for more than three months are considered long-term users with a higher risk of misuse, addiction and overdose. Many pharmacy chains assign a “risk score” to these patients and their doctors could even get a warning letter from the government.

But in a small study of emergency room patients, Canadian researchers found the risk of opioid misuse by long-term users is small and one out of five patients who fill opioid prescriptions don’t even use them. Their findings suggest that prescription databases alone are a poor way to measure opioid misuse.

“The rate of long‐term opioid use reported by filled prescription database studies should not be used as a surrogate for opioid misuse,” said lead author Raoul Daoust, MD, a professor and researcher in the Department of Family Medicine and Emergency Medicine at the University of Montreal.

Daoust and his colleagues surveyed 524 patients who were discharged from a hospital emergency department (ED) with an opioid prescription for acute pain. Instead of just relying on a database to track their prescriptions, the researchers asked the patients about their opioid use.

Three months after discharge, only 47 patients – about 9 percent – said they were still using opioids. Of those, 72% said they used opioids to treat their initial pain and 19% were using the drugs to treat a new pain condition.

The remaining four patients said they used opioids for another reason, suggesting possible misuse. That’s less than one percent (0.8%) of the original 524 patients.

“Within the limit of our study, our results suggest that the risk of long‐term opioid use for reasons other than pain is low for ED discharged patients with an opioid prescription treating an acute pain condition,” Daoust reported in the journal Academic Emergency Medicine.

Daoust’s findings are controversial because they throw into question the widely accepted theory that all opioid prescribing is risky, whether it’s for chronic or acute pain. The methodology used in his study was questioned by one critic.

"Emergency physicians should not be reassured by the authors' findings. The lack of a denominator, poor response rate (56%), and applied definition of misuse are significant limitations,” said Gail D'Onofrio, MD, a professor of emergency medicine and chair in the department of emergency medicine at Yale University.

D'Onofrio cites a 2017 CDC study, which found that the probability of long-term opioid use increases sharply after the first few days of treatment.

“Transitions from acute to long-term therapy can begin to occur quickly: the chances of chronic use begin to increase after the third day supplied and rise rapidly thereafter,” CDC researchers warned.

But that analysis is based solely on the number of opioid prescriptions – not actual opioid use. And Daoust found that studies like that are a poor way to measure risk.

“These studies used filled prescriptions databases that could overestimate opioid use since not all patients filling an opioid prescription consumed them. As a case in point, in this study, 21% of patients who filled their opioid prescription after the initial ED visit did not consume them,” Daoust reported.

What is the risk of long-term opioid use after an emergency room visit? In a large 2017 study by the Mayo Clinic, only about 1 percent of ER patients given an opioid prescription progressed to long term use – similar to what Daoust found.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, scientific director of the Mayo Clinic Division of Emergency Medicine Research. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

A 2018 study also questioned the value of prescription drug monitoring programs (PDMPs) which have long been promoted as critical tools in the fight against opioid abuse. The study found little evidence that PDMPs are reducing overdoses and that they may lead to unintended consequences such as patients turning to street drugs for pain relief.

Are Rx Opioids Scapegoats for the Opioid Crisis?

By Dr. Lynn Webster, PNN Columnist

The Washington Post recently published a series of stories about the volume of opioid medication distributed over the past several years in the United States. Over 76 billion pills were distributed from 2002 through 2012.

That sounds like a huge amount, but it is difficult to know what the number means. What is clear is that the stories are meant to suggest the number of pills is excessive and responsible for the rise in opioid overdose deaths. 

This presumed correlation is one reason for the recent lawsuits that have been filed against opioid manufacturers and distributors. It has also spawned policies that appear to have worsened, not prevented, overdoses.

Though the situation has been framed largely as a prescribing problem, the reasons for the drug crisis are many. While overprescribing has certainly been a factor, it is probably less important than other factors, such as joblessness, homelessness and despair, which are more challenging to address.

Let’s look at the data about the relationship between opioid prescriptions and overdose death rates. The number of opioid prescriptions in the United States peaked in 2012 and began a steady decline. By 2017, they reached a 15-year low.

Despite the decline in the number of opioids prescribed, overdoses from all opioids – both legal and illegal -- continued to increase. Overdoses involving prescription opioids represent only about 25% of the total number of drug overdoses.  

Obviously, something more than the supply of prescription opioids is driving overdoses higher.

No Correlation Between Opioid Prescriptions and Overdoses

After winning a year-long court battle with the Justice Department, the Post and HD Media, publisher of the Charleston Gazette-Mail in West Virginia, were able to access data from the DEA’s Automation of Reports and Consolidated Orders System (ARCOS).

The information in the database shows that, between 2006 and 2012, West Virginia received the largest per capita amount of prescription opioids. The state also experienced the highest opioid-related death rate during that period. Is there a correlation?

Kentucky also had a high number of pills and a high death rate, but as Jacob Sullum recently reported in Reason, Kentucky’s death rate in 2017 was actually lower than Maryland’s and Utah’s, where prescription rates are substantially lower. He also pointed out that although Oregon’s prescription rate was among the highest in the country, the rate of deaths involving pain pills in Oregon was just 3.5 per 100,000, lower than the rates in most states. 

Sullum further showed that Kentucky, Nevada, Oklahoma, Oregon, South Carolina and Tennessee were among the 10 states with the highest per capita prescribed pills during the 2006-2012 period. But they were not the states with the highest overdose rates. 

In a separate analysis, the CDC and Agency for Healthcare Research Quality found no correlation -- not even a weak one -- between opioid prescribing rates and overdoses when comparing data from each state. 

In addition, the rate of opioid prescribing is highest nationally for people 55 years and older, but that age group has the lowest rate.  

This lack of correlation between opioid overdoses and the volume of prescribed opioids is consistent internationally. In 2016, England prescribed the most opioids and saw the most overdose deaths in its history. However, the drug responsible for many of those deaths was heroin, not prescription opioids. 

There is a raging opioid crisis in West Africa where, despite a low prescription rate, the number of overdoses has surged. 

In 2018, Scotland's drug overdose rate exceeded that of the United States -- largely because of heroin. There is no evidence of an overall increase in opioid prescribing in Scotland. 

No Simple Answers to the Opioid Crisis

It is clear that the data does not support a simple answer to the opioid crisis. Focusing all of our efforts on decreasing the supply of prescriptions will not solve the problem and is already creating unintended consequences.

In fact, cocaine and methamphetamine were involved in more overdose deaths in the U.S. in 2018 than prescription opioids. As the supply of prescription opioids has decreased due to the policies of the last few years, people have moved from prescription opioids to other illicit drugs.

The solution to the opioid crisis must be multi-pronged. Overprescribing played a role in causing the crisis, but sociological factors appear to have driven the demand. We must consider what prompts people to turn to drugs in despair. A recent study published in SSM-Population shows job loss bears a significant correlation to opioid-caused deaths.

In addition, in the Proceedings of the National Academy of Sciences, Princeton University economists Anne Case and Angus Deaton (recipient of the 2015 Nobel prize in economics) showed mortality from substance use was linked to declining economic opportunity and financial insecurity.

Solving the drug crisis will not be easy. However, the disenfranchised members of our most impoverished communities deserve viable solutions to their problems. It is crucial to understand the degree to which job loss and hopelessness contribute to the drug problem.

Reputable data proves that the volume of opioids prescribed is not solely, or even primarily, responsible for the opioid crisis. Let’s focus on what is responsible.

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.”

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.

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.