DEA Expanding Surveillance of Prescription Drug Data

By Pat Anson, PNN Editor

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

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

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

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

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

‘Unlimited Access’ to Prescription Data

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

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

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

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

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

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

Bypassing PDMPs

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

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

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

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

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

‘Appalling for People’s Health’

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

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

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

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

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

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

By Pat Anson, PNN Editor

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

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

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

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

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

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

‘It’s All Data Driven’

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

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

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

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

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

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

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

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

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

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

High False Positive Rate

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

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

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

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

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

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

The Devil Effect on Patients with Pain

By Dr. Lynn Webster, PNN Columnist

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

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

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

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

The Pendulum Swings Toward Empathy

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

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

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

Casting Blame for the Opioid Crisis

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

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

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

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

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

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

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

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

Chasing a Pot of Gold

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

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

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

The Devil Effect Harms Us All

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

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

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

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

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

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

Fentanyl and Heroin Use Rise During Pandemic

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

Gabapentin Misuse

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

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

SOURCE: QUEST DIAGNOSTICS

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

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

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

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

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

Pre-Existing Conditions Deserve Affordable Treatment

By Dr. Lynn Webster, PNN Columnist

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

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

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

We’re All at Risk for Pain and Drug Abuse

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

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

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

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

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

Abolishing ACA Could Have Devastating Consequences

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

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

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

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

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

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

FDA Requires Stronger Warning Labels for Benzodiazepines

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

After Brief Decline, ‘Exponential Trajectory’ of U.S. Overdose Crisis Resumes

By Pat Anson, PNN Editor

A brief decline in fatal overdoses in 2018 was just a blip in the trajectory of a 40-year pattern of rising drug deaths in the United States, according to a new study published in the journal Addiction.

Researchers at the University of Pittsburgh Graduate School of Public Health analyzed over a million overdose deaths in the U.S. between 1979 and 2019 – and developed a startling chart that shows an exponential curve in overdoses that continues to rise virtually unchecked. The number of deaths has doubled every 10.7 years.   

"The U.S. has not bent the curve on the drug overdose epidemic," said lead author Hawre Jalal, MD, an assistant professor of health policy and management at Pitt Public Health. "We are concerned that policymakers may have interpreted the one-year downturn in 2018 as evidence for an especially effective national response or the start of a long-term trend. Unfortunately, that isn't supported by the data."

PITT PUBLIC HEALTH

Overdose deaths fell about 4% in 2018, which public health officials attributed to a decline in deaths involving prescription opioids and heroin. However, overdoses began rising again in 2019 and preliminary data for 2020 suggests the upward trajectory has resumed.    

Jalal and co-author Donald Burke, MD, say the 2018 decline in overdoses was largely caused by a reduced supply of carfentanil, an illicit drug and potent analogue of fentanyl that is 10,000 times more powerful than morphine.

China added carfentanil to its list of controlled substances in 2017 and began shutting down illicit drug factories that produced it. The U.S. supply of carfentanil soon began to dry up and law enforcement seizures of the drug fell dramatically in five states -- Ohio, Florida, Pennsylvania, Kentucky and Michigan. It was the “sudden rise and then fall of carfentanil availability” that led to the drop in overdoses, researchers found.

"We all celebrated when the overdose death rate dropped, but it was premature," said Burke, former dean of Pitt Public Health and a professor in the Department of Epidemiology. "When policymakers believe a problem is solved, history has shown that funding is reprioritized to other efforts. The drug overdose epidemic is not solved. It continues to track along an ever-rising curve, with deaths doubling nearly every decade. We must address the root causes of this epidemic."

Jalal calls the U.S. overdose crisis an “entangled epidemic” that’s been fueled by multiple drugs, including prescription opioids, but is now largely caused by illicit fentanyl.

“There is a force that keeps overdose deaths on an exponential trajectory. This is in spite of policies that have been trying to bend the curve,” Jalal told PNN. “The main problem is that we don’t know why it keeps tracking an exponential trajectory. I think we should do everything we can to bend the curve, but the policies that we’ve used so far have been more targeted toward drugs that can be modified easily. We can target prescription opioids and we can increase the use of naloxone and methadone, but I think we also have to invest in understanding what’s driving people to use drugs. That’s a major problem that we still don’t have an answer for.”

Jalal says lack of economic opportunity and social isolation — so-called “deaths of despair” — may be partly responsible for the overdose crisis, but more research is needed into the underlying causes. As for possible solutions, he’s as stumped as anyone.

“I wish I knew. I truly wish,” Jalal said. “I think we have to pay attention to what’s driving this whole epidemic. Without understanding it, we are basically targeting our policies toward whatever we think might work or think we have control over. We’re not targeting why people use drugs or what’s causing people to die from drugs.”

A recent study by the CDC found that nearly 85% of overdose deaths in the first six months of 2019 involved illicit fentanyl, often taken in combination with other drugs. About 20% of overdoses were linked to prescription opioids.

The CDC study did not determine whether the opioid medication was obtained legally, or if it was diverted, stolen or bought on the street. Previous research in Massachusetts and British Columbia found that only about 2% of fatal overdoses involved a legitimate prescription for opioids.

A Pained Life: Don’t Throw Out the Bathwater

By Carol Levy, PNN Columnist

In 1976, my trigeminal neuralgia started. In those days, the environment regarding chronic pain was very different. My doctor had only one agenda: He wanted to stop or reduce my constant debilitating and disabling pain.

He couldn’t cure me, so he ordered opioid pain medication. When one opioid didn’t work, he tried another; Darvon, Percocet, Percodan, Demerol. So many I can’t recall them all. When none helped, he prescribed an 8-ounce bottle of opium.

The first pharmacist who saw the opium prescription shook his head. “Sorry. We don't carry it,” he said. The next pharmacy did. “Have a seat. It'll just be a few minutes,” the pharmacist said.

I wasn't looked at askance. No questions were asked about my doctor or diagnosis. I wasn’t warned: “This is a very strong drug. You need to be careful. You could become addicted.”

They trusted that my doctor knew what he was doing. They trusted me to be a responsible patient. I doubt it ever entered the pharmacist’s mind that I might be a drug seeker or abuser.

Now the tables have totally turned. Many of us get questioned by pharmacists. And some of our doctors have stopped writing opioid prescriptions. They should be cautious, right? Because opioids are addictive, you can become dependent or have other bad side effects. And they can be used illegally.

The same is true for steroids. Yet there seem to be no politicians, physicians or groups with an agenda that are working to scare the public about steroids or trying to get doctors to stop “overprescribing” them.  

When steroids first came out there were many, many horror stories about them. The 1956 film Bigger Than Life was about a school teacher (James Mason) taking corticosteroids. They helped his pain from an autoimmune disorder, but he soon became hyper-manic and ultimately psychotic, even trying to murder his son.

His doctor reduced the dosage, but because steroids helped his pain, the teacher continued to take more than prescribed. He even goes to another town, impersonates a doctor, and writes a fake prescription to obtain more of the pills.

Sound familiar?

The movie was a caricature of the potential risks of steroids, which include dependency and addiction. Opioids have the same risks, but most patients with chronic pain take them responsibly, as most on steroids do, and they do not become addicted, try to obtain them fraudulently or go off the deep end.

There will always be bad actors who will be irresponsible, but users of any medication should not be demonized because of a few bad apples. Steroids are easily obtained and the patients who use them are not seen as potential felons. And why would they? For most patients, steroids can be very helpful.

Those who can still get opioids for their pain are often seen as potential miscreants. Yet studies also show that for most patients, opioids do help.

You don’t throw out the baby with the bathwater. You don’t create guidelines scaring doctors into not writing steroid prescriptions because a small percentage of people will misuse or abuse them.

The medical community and the government need to stop throwing out the bathwater. When they refuse to write prescriptions for opioids that have helped patients, the side effect — intentional or not — is to throw us away, too.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

Only 2% of British Columbia Overdoses Linked to Prescription Opioids

By Pat Anson, PNN Editor

A new analysis of fatal opioid overdoses in British Columbia found that only about 2% of the deaths were caused by prescription opioids alone. The other overdoses mainly involved illicit fentanyl and other street drugs or a combination of illicit drugs and other medications, which were often not prescribed.

“Our data show a high prevalence of nonprescribed fentanyl and stimulants, and a low prevalence of prescribed opioids detected on toxicology in people who died from illicit drug overdose. These results suggest that strategies to address the current overdose crisis in Canada must do much more than target deprescribing of opioids,” researchers reported in the Canadian Medical Association Journal (CMAJ).

Vancouver, British Columbia was the first major North American city to be hit by a wave of overdoses involving illicit fentanyl, a potent synthetic opioid. A public health emergency was declared in BC in 2016 and strict guidelines were released to limit opioid prescribing. Although prescriptions dropped dramatically, fatal overdoses in BC continued to rise.

Researchers looked at 1,789 fatal overdoses in BC from 2015 to 2017 for which toxicology reports were available and found that 85% of them involved an opioid. Of those, only 2.4% of the deaths were linked to opioid medication alone. Another 7.8% of cases involved a combination of prescribed or non-prescribed opioids.

The findings are similar to a 2019 study of opioid overdoses in Massachusetts, which found that only 1.3% of the people who died had an active prescription for opioid medication.   

“Pain patients and their medications have never been responsible for overdose deaths – not then or now. Will the anti-opiate zealots, with all their data-dredged studies be taken to task for all the unnecessary suffering, disability, and premature deaths they have contributed to within the Canadian pain population?” asked Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, a patient advocacy group.

“The ‘prohibition’ approach that has wrongly been applied for years that focused on reducing access to pharmaceutical products directly contributed to exposure to higher risk illicit substances, which put people at risk of overdose.”

Most Overdoses Linked to Illicit Fentanyl

Researchers say efforts to reduce opioid prescribing in Canada were “insufficient to address the current overdose crisis” because street drugs are involved in the vast majority of deaths. They also warned against the forced tapering of patients on opioid pain medication.

“The risk of harms from these medications must be balanced with the potential harms of nonconsensual discontinuation of opioids for long-term users, including increased pain, risk of suicide and risk of transition to the toxic illicit drug supply,” wrote lead author Alexis Crabtree, MD, resident physician in Public Health at the University of British Columbia.  

Crabtree and her colleagues found that most overdoses involved a street drug, with fentanyl or fentanyl analogues linked to nearly 8 out of 10 overdose deaths. Many of the deaths involved multiple substances, including medications such as stimulants, anti-depressants, benzodiazepines, antipsychotics and gabapentinoids, which were often not prescribed to the victim.   

Over 7% of the overdoses involved methadone or buprenorphine (Suboxone), opioids that are used to treat addiction. About a third of the people who died had a diagnosis of substance use disorder in the year before their overdose.

In a commentary also published in CMAJ, a leading public health expert said it was time to decriminalize drugs and offer a “safe supply” to illicit drug users.

“Unless there is a radical change in our approach to the epidemic, overdose deaths will continue unabated. It is time to scale up safe supply and decriminalize drug use.”

— Dr. Mark Tyndall

“Unless there is a radical change in our approach to the epidemic, overdose deaths will continue unabated. It is time to scale up safe supply and decriminalize drug use,” wrote Mark Tyndall, MD, Executive Director of BC Centre for Disease Control and a professor at the School of Population and Public Health, University of British Columbia.

Tyndall says blaming the opioid crisis on excess prescribing by doctors and the unethical marketing of opioids by pharmaceutical companies fails to address the reasons people abuse drugs in the first place.

“While having a cheap and ready supply of opioid drugs does allow for misuse and addiction, this narrative fails to acknowledge that drug use is largely demand-driven by people seeking to self-medicate to deal with trauma, physical pain, emotional pain, isolation, mental illness and a range of other personal challenges and these are the people overdosing,” Tyndall wrote.

(Update: Canada’s Chief Public Health Officer, Dr. Theresa Tam, issued a statement August 26 saying the COVID-19 pandemic is contributing to an increase in drug overdoses and deaths across Canada.

“There are indications that the street drug supply is growing more unpredictable and toxic in some parts of the country, as previous supply chains have been disrupted by travel restrictions and border measures. Public health measures designed to reduce the impact of COVID-19 may increase isolation, stress and anxiety as well as put a strain on the supports for persons who use drugs,” Tam said.

“For the third consecutive month this year, the number of drug overdose deaths recorded in British Columbia has exceeded 170. These deaths represent a 136% increase over the number of deaths recorded in July 2019. There are news reports of an increase in overdoses in other communities across the country.” )

Study Finds Low Risk of Rx Opioid Abuse Among Young People

By Pat Anson, PNN Editor

The stories are heartbreaking. A young man gets a prescription for opioid pain medication and quickly becomes addicted.

“I lost everything. I had to leave school, and stop playing sports in college. I started to watch my life slip away. These drugs are addictive. One prescription can be all it takes to lose everything,” says Mike.

A mother loses her son to an overdose.

“My son… was 20 years old when he was prescribed opioids,” says Ann Marie. “It took him five days to get addicted.”

These are some of the real-life stories being told in a CDC awareness campaign that warns against the use of prescription opioids. “It only takes a little to lose a lot,” is the theme in a series of CDC videos, billboards and online ads.

The stories are sad, but the widespread belief that adolescents and young adults can quickly become addicted to prescription opioids is not accurate for the vast majority of young people, according to a large new study published in JAMA Pediatrics.

Researchers at Indiana University looked at a database of over 77,000 young people in Sweden between the ages of 13 and 29 who were prescribed opioids for the first time. They were compared to a control group that was given non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief. Both groups had no previous signs of substance abuse.

Only 4.6% of those prescribed an opioid developed a substance use disorder or other substance-related issue, such as an overdose or criminal conviction within five years of being prescribed.  That compared to 2.4% of those in the control group.

"By using several rigorous research designs, we found that there was not a huge difference -- in fact, the difference was smaller than some previous research has found,” said Patrick Quinn, PhD, an assistant professor at the IU School of Public Health-Bloomington. “But the study still shows that even a first opioid prescription may lead to some risk."

Interestingly, young people given oxycodone were at no greater risk of developing a substance abuse problem than those given “weaker” opioids such as codeine or tramadol.

Quinn says further research is needed to determine how much substance abuse risk is caused by opioid medication alone and how much is related to other issues, such as mental health, genetics and environmental factors.

"We need to have a good understanding of what those risks might be in order for patients and doctors to make informed decisions," said Quinn. "Our findings highlight the importance of screening for substance use disorders and other mental health conditions among patients with pain, including those receiving opioid therapy."

A 2018 study of young people given opioids after their wisdom teeth were removed also found the risk of long-term use low. The study of over 70,000 teens and young adults found that only 1.3% were still being prescribed opioids months after their initial prescription by a dentist.  

Forced Opioid Tapering Is Risky and Unethical

By Roger Chriss, PNN Columnist

Prescription opioid use has come way down from its peak in 2012. Fewer people receive an initial opioid prescription, pill counts have been lowered, and more people are being taken off opioids.  The American Medical Association recently reported that there was a 37% decrease in opioid prescribing from 2014 to 2019.

The goal of this was to reduce the harms associated with opioid pain medication amid an ongoing drug overdose crisis. But there is no justification for forced opioid tapers. As PNN reported last year, outcomes for patients taken off opioids are not necessarily good. And despite an ongoing focus on reducing prescription opioid use, there is still no established deprescribing strategy or method.

A new study looked at a dozen randomized controlled trials for deprescribing opioids for chronic non-cancer pain. Researchers found that reducing or discontinuing treatment did not reduce opioid use in the intermediate term. It also didn’t increase the number of patients who stopped taking opioids.

After looking at the evidence, the authors of the systematic review concluded that the were unable to draw “firm conclusions to recommend any one opioid-analgesic-deprescribing strategy in patients with chronic pain."

Ethically Unjustified

But even if we knew how to taper patients on prescription opioids, it would still not be ethical to do so. Forced tapers offer relatively few benefits for the patient and may carry serious harms. Policies promoting opioid tapering have nonetheless proliferated in recent years, including one in Oregon that was tabled after a public outcry.

In a recent paper in The Journal of Law, Medicine & Ethics, physicians Stefan Kertesz, Ajay Manhapra, and Adam Gordon argued against the forced tapering policies being promoted by public agencies.

“Neither the 2016 Guideline issued by the Centers for Disease Control and Prevention nor clinical evidence can justify or promote such policies as safe or effective,” they said.

Specifically, Kertesz and his colleagues said “the provider is trained never to treat a patient as merely a means to an end.” In other words, involuntary tapers with the goal of satisfying prescribing metrics or state-mandated statistics are unethical.

A more detailed analysis of the ethics of deprescribing is taken up by Travis Rieder, PhD, author of the book, “In Pain: A Bioethicist’s Personal Struggle with Opioids.” In a new commentary in the AMA Journal of Ethics, Rieder concludes that nonconsensual tapering is “clinically and ethically wrong” because it exposes so-called legacy patients who are dependent on opioids to uncontrolled pain and withdrawal.

“Forcibly tapering otherwise stable patients off high-dose, chronic opioid therapy reveals that this practice might have an effect that is the opposite of what public health is calling for: it may be a harm expanding intervention, exposing those who have long received opioid medications variously to worsened pain, withdrawal, social instability amidst untreated dependence, or loss of medical care relationships,” Rieder said.

“Taking such risks into account, continuing to prescribe high-dose opioid therapy for a legacy patient does not clearly constitute ethical or legal misprescribing.”

‘Large-Scale Social and Medical Experiment’

There is little doubt that prescription opioids involve serious risks and lead to harm for some patients. In some urgent cases, a forced taper may be justifiable in light of specific risks to an individual. But in general, forced tapers not only introduce new risks and create new harms, but they also damage the doctor-patient relationship and deny the patient’s status as an individual.

Stanford pain psychologist Beth Darnall, PhD, calls forced tapering a “large-scale social and medical experiment” being conducted without sufficient evidence on how to do it the right way.

“You may have a patient that has been on a stable dose of opioids for 10 years, and then you start de-prescribing. We are now exposing them to new risks for opioid overdose, for suicidality, for actual suicide, for withdrawal symptoms, for increased pain,” Darnall told The Guardian.

It's worth noting that both Darnall and Rieder were recently named to a new CDC panel that will advise the agency as it prepares to update its 2016 opioid prescribing guideline.

Physicians already have a wide variety of tools to reduce risk and improve outcomes without resorting to the ethically unjustifiable approach of forced tapers. It’s time to emphasize those tools and underscore the ethical importance of patient outcomes.

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. 

Misleading Data and Bias in Canadian Opioid Reporting

By Marvin Ross, Guest Columnist

It is sometimes said that there are lies, damned lies and statistics. That prophetic statement, often mistakenly attributed to British Prime Minister Benjamin Disraeli, explains the complete confusion in the minds of the public about the use of opioid medication.

By conflating data on prescribed opioids with illicit opioids – an apples to oranges comparison -- the average person has no real understanding of the value of opioid pain relievers. How often do we hear people say they refuse to take pain medication for fear of becoming addicted?

One Canadian agency that confuses, conflates and even admits that its data is misleading is the Canadian Centre on Substance Use and Addiction (CCSA). The reports they publish suggest that prescribed opioids are a major problem to be avoided. They are out of step with some of the provincial coroners and federal agencies such at the Public Health Agency of Canada and Health Canada.

Let's first look at what these other agencies report.

Last month, British Columbia reported its highest number of illicit drug deaths ever, nearly 6 deaths per day, with the vast majority involving fentanyl and its analogues. In neighboring Alberta, 127 of the 142 deaths in the first quarter of 2020 involved fentanyl. Neither province talks about deaths from prescribed opioids, as the main issue is illicit drugs.

While fentanyl is a prescribed drug and has many legitimate uses, only 5% of all opioids prescribed in Canada is fentanyl. Given its frequency in overdoses, it must come from illegal sources.

The Public Health Agency divides their overdose statistics into those involving patients with prescribed opioids and those with substance abuse problems.  Prescribed opioids accounted for 0.02% of total hospitalizations, while for the substance abuse population it was 0.04% of hospitalizations.

There are distinct differences in age between the two groups. People in the prescribed group were usually men and women aged 60 and older. For those with substance abuse problems, the most prevalent age group is 20 to 39 years of age. It is well known that illicit drug use is more prevalent in younger people, as this data demonstrates.

Health Canada tracks reported adverse drug reactions for prescriptions and finds that analgesics are the least likely drugs to result in an adverse event. Only 1.8% of all adverse reactions involve pain medications.

Confusing Illicit Opioids with Legitimate Opioids

These statistics all demonstrate that the problem is illicit drug use and not valid prescribed opioids given to patients in pain. In contrast, the CCSA conflates legitimate and illicit opioids, and provides a totally biased picture of what is happening.

Their July 20 report is entitled “Prescription Opiods” with no mention of illicit opioids. But then they provide data that really pertains to the illicit kind.

In 2017, 11.8% of Canadians were prescribed opioids, down from 13% in 2015. Little changed was the proportion of patients who used their prescriptions for non medical uses, which is 3 percent. So, 97% of patients prescribed opioids used them properly.

Despite that, Canada, like the United States, introduced draconian prescribing guidelines to control the 3% and, of course, that negatively impacted the 97%.

There were nearly 16,000 overdose deaths in Canada between 2016 and 2019, according to the CCSA report, with emergency room visits for opioid poisoning doubling for the 25-44 age group. Given this is a report about prescription opioids, the impression the naive reader would get is that deaths and hospital visits all pertain to legally prescribed opioids.

Next, the CCSA points out that, while the number of opioid prescriptions in Canada has fallen, 5.5% of those taking them can still become addicted. That estimate for addiction is low, but there is other research suggesting that it is even lower. In keeping with their anti-opioid bias, they state that prescription “opioids can also produce a feeling of well-being, relaxation or euphoria (“high”).”

What people who take opioids for pain experience is a decrease in pain or no pain at all, if they are lucky. That's it – there’s usually no high and no euphoria. Addicts take these drugs for its high.

They then move on to talk about the healthcare costs associated with the use of opioids, but again do not differentiate between prescribed and illicit. This leaves the reader with the impression that anyone who takes opioids for any reason is costing the health system extra for adverse events, hospitalizations, overdoses and deaths.

In fact, they are mostly talking about illicit uses as the data they provide is not dissimilar to the data provided by the Public Health Agency or Health Canada. To hammer home the CCSA’s deception, the very next section deals with driving under the influence of prescription drugs.

In 2018, two prominent health experts completed a review of all the independent health agencies funded by Health Canada and recommended that three of them had outlived their usefulness. One of those was the Canadian Centre on Substance Use and Addiction, which they recommended be abolished. For some reason, it still exists.

I asked CCSA to explain their misleading statistics and it took them almost three weeks to respond. Research and policy analyst Samantha King, PhD, admitted the data is misleading unless readers take a deep dive into the footnotes.

“We are aware that for some of the data captured in the summary, including hospitalizations due to opioid poisonings and opioid-related deaths, there is no ability to differentiate between legal or illegal sources of opioids that are causing these harms. For this reason, these sections only refer to opioids in general and contain footnotes where appropriate, highlighting the limitations of the data,” King wrote to me in an email.

So, why call the report “Prescription Opioids” when, unlike coroners and other federal agencies in Canada, you cannot differentiate between illicit opioids and legitimate ones? All I can say is that it is fortunate that Canada's handling of the Covid-19 Pandemic is being handled by the Public Health Agency and not CCSA.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He is a regular contributor to the Huffington Post.

The CDC, Opioids and Cancer Pain

By Roger Chriss, PNN Columnist

In 2016, the Centers for Disease Control and Prevention issued its controversial opioid prescribing guideline. Insurers, states and other federal agencies soon followed with mandatory policies and regulations to reduce the use of opioid pain medication. All this was supposed to exclude cancer-related pain care, but in practice that’s not what happened.

Dr. Judith Paice, director of the Cancer Pain Program at Northwestern University’s Feinberg School of Medicine, told the National Cancer Institute in 2018 that the opioid crisis “has enhanced fear — fear of addiction in particular” among both patients and doctors.

“Many primary care doctors no longer prescribe opioids. Oncologists are still prescribing these medications, but in many cases they’re somewhat anxious about doing so. That has led some patients to have trouble even obtaining a prescription for pain medication,” Paice said.

In 2019, the Cancer Action Network said there has been “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.” One out of four said a pharmacy had refused to fill their opioid prescription and nearly a third reported their insurance refused to pay for their opioid medication.

That same year, CDC issued a long-awaited clarification noting the “misapplication” of the guideline to patients it was never intended for, including “patients with pain associated with cancer.”  

Long Term Use of Opioids Uncommon

Cancer pain management in the U.S. has been severely impacted by the CDC guideline, even though rates of long-term or “persistent” opioid use are relatively low and stable:

• A major review of over 100,000 military veterans who survived cancer found that only 8.3% were persistent opioid users. Less than 3% showed signs of opioid abuse or dependence.

• A study of older women with breast cancer who were prescribed opioids found that only 2.8% were persistent opioid users.  

• A study of 276 patients with head or neck cancer found that only 20 used opioids long-term – a rate of 7.2 percent.

• And a study of nearly 23,500 women with early-stage breast cancer who had a mastectomy or mastectomy found that 18% of them were using opioids 90 to 180 days after surgery, while 9% were still filling opioid prescriptions 181 to 365 days later.

While any sign of opioid abuse or addiction is concerning, these studies show that long-term use of opioid medication is relatively uncommon among cancer survivors. The American Cancer Society says opioids are “often a necessary part of a pain relief plan for cancer patients” and “can be safely prescribed and used” for cancer pain.

Cancer patients and their doctors have been successfully managing opioid risks long before the CDC guideline or associated state laws and regulations. Perhaps it is time for lawmakers, regulators, insurers and pharmacies to learn from the cancer community rather than getting in the way of clinical best practices.

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. 

Study: Using Cannabis for Pain Relief Reduces Risk of Opioid Overdose

By Pat Anson, PNN Editor

Illicit drug users who use cannabis for pain relief are less likely to experience an opioid overdose or use heroin, according to a Canadian study recently published in the online journal PLOS ONE.

Researchers at the University of British Columbia (UBC) the BC Centre on Substance Use (BCCSU) interviewed nearly 900 illicit drug users in Vancouver who reported using cannabis between 2016 and 2018. Participants were asked whether they used cannabis to relieve pain, improve sleep, address nausea or for recreation. Most said they used cannabis for a medically therapeutic reason.

"We're seeing more and more in our research that people are using cannabis for therapeutic reasons," says lead author Stephanie Lake, a doctoral candidate at UBC's School of Population and Public Health. "We're also seeing that, for some individuals in our study, this therapeutic use corresponds with either less use of illicit opioids or a reduced risk of overdose."

Participants who used cannabis for pain relief had lower odds of a non-fatal opioid overdose and for injecting heroin daily. Previous research from the BCCSU found that many people at risk of overdose, particularly those living with pain, may be using cannabis to reduce their reliance on illicit opioids.

Another key finding of the study was that therapeutic cannabis users relied on illicit sources for their cannabis supply – even though medical marijuana was fully legalized in Canada in 2013. About half of study participants said that illegal dispensaries were their most important source of cannabis.

"The mounting evidence related to the motivations behind people's cannabis use strongly suggests that improving access to cannabis for therapeutic purposes could help reduce overdose risk associated with illicit opioid use," says M.J. Milloy, PhD, a research scientist at BCCSU who was senior author of the study.

"Authorities should pause their efforts to close unregulated sources of cannabis and eliminate the illicit market until barriers to legal cannabis are addressed, especially during the overdose crisis."

Vancouver was the first major North American city to be hit by a wave of overdoses involving illicit fentanyl, heroin and other street drugs. A public health emergency was declared in British Columbia in 2016. Since then, Vancouver has become a laboratory of sorts for novel ways at addressing addiction, such as providing a “safe supply” of prescription opioids and prescription heroin to illicit drug users.

“Our community and many others across Canada and the United States are experiencing an opioid overdose crisis rooted, in part, in inadequately or inappropriately-managed chronic pain and sparked by widespread exposure to an unregulated illicit opioid supply contaminated with potent opioid analogues,” researchers concluded. “Our finding may also reflect an opioid-sparing effect of cannabis, whereby opioids are not replaced, but the dosage or frequency of opioid required for analgesia is reduced with the use of cannabis.”

Other studies have debunked the idea that medical cannabis reduces opioid use. Two large studies published last year found no evidence that legalizing cannabis reduces prescription opioid use, overdose or mortality.

“We tested this relationship and found no evidence that the passage of medical marijuana laws — even in states with dispensaries — was associated with a decrease in individual opioid use of prescription opioids for nonmedical purposes," researchers found.

A 2018 study suggested that cannabis legalization could actually make the opioid crisis worse, concluding that “cannabis use appears to increase rather than decrease the risk of developing nonmedical prescription opioid use and opioid use disorder.”

The Other Side of Cannabis

By Madora Pennington, PNN Columnist

I knew from my friend Nick’s Facebook feed that he was a cannabis enthusiast. His posts preached how it cures pretty much everything and will lead us to world peace.

Nick never tired of encouraging me to try it for my pain from Ehlers-Danlos Syndrome, even as I explained repeatedly that since my mother was psychotic, I avoid all drugs which may cause psychosis. Theoretically, I am at higher risk for that adverse reaction.

Psychosis is a disconnection from reality. A person may have delusions, hallucinations, talk incoherently and experience agitation. Since the 1970s, researchers have been investigating whether cannabis can trigger a psychotic break or full-blown schizophrenia. Daily users of highly potent cannabis are five times more likely to develop psychosis. The risk comes not only from genetic factors, but also from early-life neglect or abuse and even being born in the winter.

Having a rare and complicated medical condition, I get a lot of advice. I took Nick’s insistence I go on cannabis as kindness, as I take all unsolicited health tips. Our social media friendship grew. When my husband and I took a trip to his part of the world, he invited us to stay with him.

Nick picked us up at the train station in the English countryside looking like a dashing movie star. Slim and trim in a crisp Oxford shirt and Ray Bans, spryly maneuvering our luggage, he was still attractive in his 70s. Speaking English like Prince Charles, he confessed, “I am actually a cannabis farmer. I expect no trouble from the local police, but would you prefer to get a hotel room in town?”

My husband and I once risked our lives in the back alleys of Hong Kong to get me a fake Hermes bag. We did not need to consult with each other. We opt for adventure. I would not miss my chance to live a Jane Austen fantasy.

We ate off Nick’s three centuries-old family silver, the forks worn down from hundreds of years of scooting food across the plate. We sat beneath the Regency era portraits of his ancestors. Nick had a room devoted to his cannabis crop, growing fast underneath sun simulating lamps. The odor from the plants permeated his entire country home.

In real life, just as on Facebook, Nick’s favorite subject was the virtues of cannabis. He had been using it since he was a young man. Decades ago, he had spent a couple of years in prison for distribution. Recently his wife had left him over his devotion to marijuana. It was clear from Nick’s stories and life choices that cannabis had created tremendous tension with his family.

We talked of him coming to stay with us in Los Angeles, how we could all go to San Francisco to visit the Haight, as Nick was a genuine 1960s hippie. But leaving home to travel was a problem for him. When he does, he has to ask a friend to tend to his plants, which also means asking the friend to break the law.

Our days with Nick at his charming cottage were governed by his need to partake. Our visits to local sites were cut short, so he could be done driving and functioning for the day, and get home to get high. He did not seem to enjoy the excursions and seemed overwhelmed by being out and about, his anxiety growing, urging us to wrap up and get back home.

Cannabis Side Effects

Like Nick, many people are certain that marijuana helps them get by. On it, life is tolerable and pleasant. Anxiety is calmed. They are out of pain and able to sleep. But are they really benefiting?

At first, marijuana has a calming effect, but over time it negatively changes the way the brain works, causing anxiety, depression and impaired social functioning. With regular use, memory, learning, attention, decision-making, coordination, emotions, and reaction time are impaired. Heavy cannabis use lowers IQ. 

This damage can persist, even after use stops. Teenage users are more likely to experience anxiety, depression and suicidality in young adulthood. According to the CDC, about 1 in 10 marijuana users will become addicted. For people who begin using younger than age 18, 1 in 6 become addicted.

As is the case with other mood-altering substances, cannabis withdrawal symptoms — which include irritability, nervousness, anxiety, depression, insomnia, loss of appetite, abdominal pain, shakiness, sweating, fever, chills and headache — provokes the desire to use.

If someone is using cannabis to escape emotional distress, they never get the chance to deal with underlying problems. Psychiatrist Dr. David Puder recommends to his patients on cannabis that they stop in order to benefit from therapy.

“When they are off of marijuana, they have the ability to be present and really process what they will need to process in therapy in order to get over anxiety and depression,” Puder says, noting that users will often experience a flood of emotions and memories once they stop.

Medical marijuana has been approved for chronic pain and over 50 other health conditions by various states. Whether it actually helps with pain is uncertain. The U.S. Surgeon General warns the potency of marijuana has changed over time and what is available today is much stronger than previous versions. Higher doses of THC (the psychoactive chemical in cannabis) are more likely to produce anxiety, agitation, paranoia and psychosis. Consumers are not adequately warned about these potential harms.

House Guests

Our friend Nick was sure his marijuana use was his choice and that he was not addicted. He insisted my husband and I get high with him.

What is a polite house guest to do? Go along, of course, although we prefer whiskey and a steak. Nick promised we would love it, and that we were free to go upstairs and have sex and open up about anything. We giggled awkwardly. I ingested the smallest possible dose.

Nick then got higher than we had seen him during our entire visit, wolfing down his dinner in minutes. Then, after promising we’d have a tremendous evening of emotional openness and transcendent sharing, he burst into tears recounting how he was the victim of violence in his youth.

I felt for him, it was a horrifying event. Was this unresolved trauma the cause of a lifetime of drug use, denial and self-isolation? We had to wonder. It was truly awkward and uncomfortable, but Nick didn’t seem to remember his outburst. When we returned home, he continued to hound me to take up cannabis.

Madora Pennington writes about Ehlers-Danlos Syndrome and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

The opinions expressed in this column are those of the author alone and do not inherently reflect the views, opinions and/or positions of Pain News Network.